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Pharmaceuticals and Life Sciences




Pharma 2020: Marketing the future
Which path will you take?
Table of contents




Previous publications in this series include:



   Pharmaceuticals                                                              Pharmaceuticals and Life Sciences




   Pharma 2020: The vision                                                      Pharma 2020: Virtual R&D
   Which path will you take?*                                                   Which path will you take?




   *connectedthinking                  
   Pharma 2020: The vision                               #                      Pharma 2020: Virtual R&D                              1




Published in June 2007 this paper highlights a number of                     This report published in June 2008 explores opportunities
issues that will have a major bearing on the industry over                   to improve the R&D process. It proposed that new
the next 11 years. The publication outlines the changes we                   technologies will enable the adoption of virtual R&D; and
believe will best help pharmaceutical companies realise the                  by operating in a more connected world the industry, in
potential the future holds to enhance the value they provide                 collaboration with researchers, governments, healthcare
to shareholders and society alike.                                           payers and providers, can address the changing needs of
                                                                             society more effectively.




“Pharma 2020: Marketing the future” is the third in this series of papers on the future of the pharmaceutical industry published by
PricewaterhouseCoopers. It discusses the key forces reshaping the pharmaceutical marketplace, including the growing power of healthcare payers,
providers and patients, and the changes required to create a marketing and sales model that is fit for the 21st century. These changes will enable
the industry to market and sell its products more cost-effectively, to create new opportunities and to generate greater customer loyalty across the
healthcare spectrum.
Table of contents




Introduction	                                          2	
		
What will the healthcare landscape look like in 2020?	 4

Recognising the interdependence of the pharmaceutical and
healthcare value chains	                                                            8

Investing in the development of medicines the market wants to buy	                  10

Forming a web of alliances to offer supporting services	                            12

Developing a plan for marketing and selling specialist therapies	                   13

Creating a culture that is suitable for marketing specialist healthcare packages	   15

Managing multi-country launches and live licensing 	                                18

Adopting a much more flexible approach to pricing	                                  18

Creating a marketing and sales function that is fit for the future	                 19

Conclusion	                                                                         22
	




Pharma 2020: Marketing the future
Introduction                                         trends reshaping the pharmaceutical                  that, between 1996 and 2005, total
                                                     marketplace).1 All these challenges                  real spending on pharmaceutical
The social, demographic and economic                 have major ramifications for the way in              promotions rose from US$11.4 billion
                                                     which Pharma markets and sells the                   to US$29.9 billion in the US (the only
context in which the pharmaceutical
                                                     medicines it develops – the subject on               country for which expenditure on all
industry (Pharma) operates is changing
                                                     which we shall focus here.                           major marketing and sales activities
dramatically, as we noted in “Pharma                                                                      is available).2 Another study suggests
2020: The vision”, the White Paper                   The industry has traditionally relied on             that the true figure (including meetings
PricewaterhouseCoopers* published in                 aggressive marketing to promote its                  and e-promotions) is closer to US$57.5
June 2007 (see sidebar, Seven major                  products. One recent study estimates                 billion in real terms.3


Seven major trends reshaping the pharmaceutical marketplace
The pharmaceutical marketplace is changing dramatically, with huge implications for the industry as a whole. We have identified
seven major socio-economic trends.

The burden of chronic disease is                     performance of different medicines.                  where demand for medicines is likely
soaring. The prevalence of chronic                   Widespread adoption of electronic                    to grow most rapidly over the next 13
diseases like diabetes is growing                    medical records will give them the                   years, are highly varied. Developing
everywhere. As greater longevity forces              outcomes data they need to determine                 countries have very different clinical and
many countries to lift the retirement age,           best medical practice, discontinue                   economic characteristics, healthcare
more people will still be working at the             products that are more expensive or less             systems and attitudes towards the
point at which these diseases start. The             effective than comparable therapies and              protection of intellectual property. Any
social and economic value of treatments              pay for treatments based on the outcomes             company that wants to serve these
for chronic diseases will rise accordingly,          they deliver. So Pharma will have to prove           markets successfully will therefore have
but Pharma will have to reduce its                   that its medicines really work, provide              to devise strategies that are tailored to
prices and rely on volume sales of such              value for money and are better than                  their individual needs.
products because many countries will                 alternative forms of intervention.
                                                                                                          Many governments are beginning
otherwise be unable to afford them.
                                                     The boundaries between different                     to focus on prevention rather than
Healthcare policy-makers and                         forms of healthcare are blurring. The                treatment, although they are not yet
payers are increasingly mandating                    primary-care sector is expanding as                  investing very much in pre-emptive
or influencing what doctors can                      clinical advances render previously fatal            measures. This change of emphasis
prescribe. As treatment protocols                    diseases chronic. The self-medication                will enable Pharma to enter the realm
replace individual prescribing decisions,            sector is also increasing as more                    of health management. But if it is to do
Pharma’s target audience is also                     prescription products are switched to                so, it will have to rebuild its image, since
becoming more consolidated and more                  over-the-counter status. The needs                   healthcare professionals and patients
powerful, with profound implications                 of patients are changing accordingly.                will not trust the industry to provide
for its sales and marketing model.                   Where treatment is migrating from the                such services unless they are sure it has
The industry will have to work much                  doctor to ancillary care or self-care,               their best interests at heart.
harder for its dollars, collaborate with             patients will require more comprehensive
                                                                                                          The regulators are becoming more
healthcare payers and providers, and                 information. Where treatment is
                                                                                                          risk-averse. The leading national and
improve patient compliance.                          migrating from the hospital to the
                                                                                                          multinational agencies have become
                                                     primary-care sector, patients will require
Pay-for-performance is on the rise.                                                                       much more cautious about approving
                                                     new services such as home delivery.
A growing number of healthcare payers                                                                     truly innovative medicines, in the wake
are measuring the pharmacoeconomic                   The markets of the developing world,                 of problems with medicines like Vioxx.

*‘PricewaterhouseCoopers’ refers to the network of member firms of PricewaterhouseCoopers International Limited, each of which is a separate and
independent legal entity.


2	                                                                                                                                PricewaterhouseCoopers
Much of this increase in spending has
                                              Too many cooks spoil the broth
gone on the expansion of the sales
force. However, many of the industry’s        Between 1996 and 2005, the number of US sales representatives nearly doubled
biggest markets are now saturated with        to 100,000, although the number of practising physicians rose by just 26%. The
sales representatives, and its selling        market is getting very crowded in other countries, too. In a recent poll of British
techniques are becoming increasingly          general practitioners, respondents reported receiving an average of four visits
ineffective (see sidebar, Too many            a month and five promotional mailings a week. Similarly, one Malaysian doctor
cooks spoil the broth).4                      participating in a study of promotional practices in emerging countries was
                                              approached by 16 multinationals and nine local generics companies within a five-
Hence the fact that returns on detailing
                                              week time span.
(sales visits to doctors) have begun
to decline in the developed world.            The battle for market share has triggered considerable alarm. Some 20% of US
Between 2004 and 2005, there was a            and British doctors now refuse to see any sales representatives. The regulations
23% drop in dollar growth per detail in       governing the behaviour of sales representatives are also getting tougher. Various
the US, although detailing still accounts     US states have passed laws requiring pharmaceutical companies to report all
for more than half the market share           gifts or payments to healthcare professionals exceeding $25, while Australia has
new brands win during their first year of     banned pharmaceutical companies from providing doctors with personal gifts,
life. The picture is rather more varied in    entertainment or lavish hospitality.
Western Europe, but detailing plays a         Several industry trade groups have likewise introduced new codes of practice
much smaller role in stimulating sales in     – and they are actively enforcing the rules. The Prescription Medicines Code of
these countries.5                             Practice Authority (PMCPA), which administers the code of practice laid down by
Conversely, detailing is still very           the Association of the British Pharmaceutical Industry, is one such instance. The
important in many developing                  PMCPA “names and shames” the most serious offenders, by reprimanding them
nations. In China, for example, nearly        publicly and publicising the violations they have committed in advertisements in
three-quarters of the information             the medical and pharmaceutical press.
doctors receive about new medicines
comes from meetings with sales               promotional” information.9 And                to US advertising and French-speaking
representatives and conferences.6 But        Pharma’s spending on DTC advertising          Canadians, who primarily watch French-
here, too, resistance to “irresponsible”     only accounts for about US$5 billion,         language media – over a five-year
marketing practices is growing,7 and, in     which is just 14% of its total marketing      period. They found that DTC advertising
May 2007, the member governments of          budget.10 However, the jury is still out on   had no effect on sales of two of the
the World Health Organisation passed a       just what this expenditure provides.          three products and that, although sales
resolution to enact or enforce legislation                                                 of the third spiked by more than 40%
banning the “inaccurate, misleading or       In the early days, the returns appeared
                                                                                           when the campaign began, the spike
unethical promotion of medicines”.8          to be substantial. Between 1999 and
                                                                                           was quite brief.12
                                             2000, sales of the 50 products that
Direct-to-consumer (DTC) advertising
                                             were most heavily advertised in the           Much of the industry’s expenditure
– the other big weapon in Pharma’s
                                             US soared by 32%, compared with               on DTC advertising may have been
marketing artillery – has also failed to
deliver all that the industry expected.      an average increase of 13.6%.11 But           pointless, but the damage to its
Only two countries – the US and New          more recent research suggests that            reputation is arguably a more serious
Zealand – currently allow companies          DTC advertising has little, if any, long-     problem. In January 2008, the US House
to market their medicines directly to        term impact on demand. In one study           of Representatives Committee on Energy
consumers, although the European             published in the British Medical Journal,     and Commerce initiated an investigation
Commission is considering a proposal         the researchers compared the uptake           into the misleading and deceptive
to lift the ban on direct communications     of three medicines in two populations –       advertising of medicines, after several
that provide “objective...non-               English-speaking Canadians exposed            particularly flagrant abuses of the rules.13




Pharma 2020: Marketing the future	                                                                                                    3
Table of contents




Table 1: Big Pharma has been slashing         In short, aggressive marketing –            •	 The buying and selling of medicines
its workforce                                 whether it be to doctors or patients – is      is based solely on technical data like
                                 Announced    becoming increasingly ineffective as a         safety and efficacy, as distinct from
 Company                           Job Cuts   means of stimulating demand for new            subjective criteria like quality of life.
                                              therapies and overcoming reluctance to
 Pfizer                              10,000                                               We shall discuss the changes that have
                                              pay premium prices for products that
                                                                                          invalidated these assumptions in more
 AstraZeneca                          7,600   are deemed to offer only minor clinical
                                                                                          detail in the next chapter.
 Merck & Co.                          7,200   improvements. Industry critics are also
                                              becoming increasingly vociferous in
 Bayer                                6,000
                                              their complaints that it is wasteful or
 Schering-Plough                      5,500   even unethical.
                                                                                          What will the healthcare
 Johnson & Johnson                    5,000
                                              Big Pharma has responded with various
                                                                                          landscape look like in
 GlaxoSmithKline                      5,000   cost-cutting measures. Pfizer set the       2020?
 Amgen                                2,600   pace in late 2006, when it said that it
 Novartis                             2,500   would cut 20% of its US sales force.14      For many years, pharmaceutical
                                              Other companies rapidly followed suit       companies decided what their products
 Wyeth                                1,200
                                              and, by October 2008, the industry          were worth, and priced them accordingly.
 sanofi-aventis                        700    leaders had announced plans to shed         But healthcare policy-makers, payers
 Total                               53,300   another 53,300 jobs, many of them in        and patient groups are now playing
                                              marketing and sales (see Table 1).15        an increasingly important role in the
Source: PricewaterhouseCoopers
                                              They are now turning their attention        valuation process – and this trend will
                                              to developing countries like India,         accelerate, as healthcare expenditure
                                              where 10 multinationals are reported        everywhere continues to soar.
                                              to be trimming the number of sales
                                                                                          The aging of the population, together
                                              representatives they employ.16
                                                                                          with dietary changes and more
                                              However, both industry executives and       sedentary lifestyles, is driving up the
                                              commentators recognise that the failings    disease burden in both developed
                                              of the current marketing and sales          and developing countries.17 People’s
                                              model cannot be addressed simply by         expectations are also rising as new
                                              reducing the size of the sales force;       therapies for treating serious illnesses
                                              the problems go very much deeper.           like cancer reach the market. The
                                              We believe that they stem from three        global healthcare bill has risen
                                              incorrect assumptions, namely that:         commensurately; between 2000 and
                                                                                          2006, expenditure on healthcare as
                                              •	 Pharma alone determines the value
                                                                                          a percentage of gross domestic product
                                                 of its products
                                                                                          (GDP) climbed in every country in
                                              •	 Products alone create value; and         the OECD.18




4	                                                                                                             PricewaterhouseCoopers
Many policy-makers and payers have           doctor was electronically notified that
                                                                                          The push for e-prescribing
therefore started trying to measure          the product concerned was off plan.21
exactly what they are getting for their                                                   More than 70% of all doctors in
                                             E-prescribing has enormous commercial
money. A number of countries, including                                                   Denmark, the Netherlands and
                                             implications for Pharma. Most of the
Australia, Canada, Finland, New                                                           Sweden write prescriptions
                                             activities it performs to market its
Zealand and the UK, have established                                                      electronically, and the European Union
                                             medicines to doctors take place before
agencies specifically to conduct formal                                                   is promoting the practice in other
                                             the prescribing decision is made –
clinical and economic evaluations                                                         member states. Doctors in Darwin,
                                             and e-prescribing could mitigate that
of medicines. The US Senate is also                                                       Australia, are also testing a new
                                             influence, unless the industry can           system that, if successful, could be
considering a bill to create a Health
                                             collaborate with healthcare payers to        rolled out nationwide, and the US has
Care Comparative Effectiveness
Research Institute, which would perform      shape the information doctors receive.       just passed a new law to increase
a similar function.19                        However, healthcare payers will want         e-prescribing among doctors
                                             hard proof that a product really is safer,   participating in the Medicare
Similarly, some governments are              more effective or more economical than       programme. Eligible physicians will
actively encouraging the use of              its rivals, and they will have many more     receive a 2% bonus for writing
e-prescribing (see sidebar, The push         resources to investigate such claims         electronic scripts in 2009 and 2010,
for e-prescribing).20 The main aim of        than any individual doctor or practice.      dropping to 1% in 2011 and 2012, and
these efforts is to reduce prescribing                                                    0.5% in 2013. But penalties will be
errors. But e-prescribing will also enable   With greater use of pharmaco-
                                             economics, strict formularies and            imposed on those who do not use
healthcare payers to influence the                                                        e-prescribing by 2012.
prescribing decision much more easily,       e-prescribing, healthcare policy-makers
by providing doctors with clinical and       and payers are increasingly assessing        Interest in e-prescribing is not confined
financial information at the very point at   the relative value of different medicines.   to the developed world. India’s largest
which they are choosing which products       Patients are playing a bigger part in        retail pharmacy chain, Apollo
to prescribe.                                the process, too. Indeed, they are           Pharmacies, has recently started
                                             even helping to decide which products        offering doctors and patients an
This will have a major impact on the         should reach, or remain on, the market.      e-prescription service. Similarly, the
decisions doctors make. In one recent                                                     Turkish government has launched
                                             Patient power was a critical factor in the
survey, for example, two-thirds of                                                        several e-prescribing pilot programmes
                                             decision to approve Herceptin for use
the physicians participating in a US                                                      as part of a bigger initiative to establish
                                             on the British National Health Service
e-prescribing initiative reported that                                                    a national health network, and the
                                             (NHS) in the treatment of early-stage
they were more likely to prescribe a                                                      Russian Ministry of Health and Social
                                             breast cancer, for example.22
generic or plan-preferred medicine                                                        Development introduced new
when using an e-prescribing system.          Patients will become even more               prescribing rules, including computer-
Analysis of some 3.3m e-prescriptions        influential, as access to reliable           readable prescription forms for the
bore out their claims; 39% of those          healthcare information increases, the        beneficiaries of federal and regional
that failed to comply with the formulary     use of co-payments proliferates and          insurance schemes, in 2007.
requirements were changed when the           the trend towards self-medication




Pharma 2020: Marketing the future	                                                                                                  5
Table of contents




grows (see sidebar, Health 2.0 hits
                                                Health 2.0 hits the headlines
the headlines).23 Public expenditure
still accounts for the bulk of healthcare       The number of people using the Internet to find healthcare information has
spending in every G7 country except             increased dramatically over the last decade. Some 66% of US adults go online to
the US, but patients in the E7 countries        research their conditions, as do more than half of all Europeans. Numerous blogs
typically foot more than half the bill          and online forums have also sprung up to cater for increasingly information-hungry
themselves (see Figure 1).                      patients. They include sites such as patientslikeme.com, which enables patients to
                                                compare symptoms and side effects; medhelp.org, where doctors and patients
The split between public and private
                                                work together to create “wikis”; and various disease-specific forums for patients
healthcare spending is also changing
                                                with conditions like cancer and epilepsy.
in some G7 countries, as they try
to reduce the burden on the public              The next stage in the so-called Health 2.0 revolution is the proliferation of
exchequer. In Britain, for example, the         electronic personal health records. Microsoft and Google have both launched
government recently gave permission             services to help people create and store their own personal health records on the
for cancer patients to buy “top-up”             World Wide Web. But there are many other, smaller companies offering similar
drugs privately, without losing their right     services, including myPHR.com, medicalrecords247.org and ihealthrecord.org.
to free care under the NHS.24
Conversely, in the US, President Barack
Obama plans to put a bigger share
of healthcare costs on the public tab,
by expanding coverage to uninsured
Americans. He has also promised to
lower the cost of medicines by allowing       Figure 1: Private expenditure on health as a percentage of total healthcare
the importation of safe products              spending in the G7 and E7 countries
from other developed countries,
increasing the use of generics in public      90%                G7 Countries                                           E7 Countries
programmes, taking on pharmaceutical
companies that block cheaper generics
                                              80%
from the market and eliminating the ban       70%
on the federal government negotiating
                                              60%
drug prices.25 But, whether it is patients,
governments or health insurers who            50%
are picking up the costs, one thing is
                                              40%
clear: the days when pharmaceutical
companies could dictate how much              30%
their medicines should fetch, without
                                              20%
regard for the other stakeholders in the
healthcare arena, are over.                   10%
The opportunities for generating value         0%
from pure product offerings are also
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months, at least three companies
                                                           G




have started offering personal genome         Source: World Health Organisation, “World Health Statistics 2008”




6	                                                                                                                       PricewaterhouseCoopers
services for the masses. 23andMe               which medicines are particularly safe,
                                                                                                On the right track
(which is backed by Google) charges            efficacious and cost-effective in different
just US$399 to analyse people’s DNA            patient populations, and include such            Numerous new sources of clinical data
and tell them how likely they are to suffer    information in their treatment protocols         are emerging. The US National
from more than 90 health conditions and        (see sidebar, On the right track).27 They        Comprehensive Cancer Network has,
inherited traits. deCodEme (a branch           will also be able to revise the prices they      for example, established an oncology
of the Icelandic genetics company              pay upwards or downwards, depending              database to collect socio-
deCODE Genetics) and Navigenics                on how specific medicines perform over           demographic, clinical and non-clinical
offer more comprehensive versions of           time (see Figure 2).                             information on patients suffering from
this service for US$985 and US$2,500,                                                           various forms of cancer. The American
                                               The industry has already been forced
respectively.26 Cheap gene sequencing                                                           Medical Group Association has set up
                                               to take the first steps down the path            a system to let doctors share
and disease disposition analysis will fuel
                                               to pay-for-performance. In the UK, for           comparative outcomes data, so that
popular demand for targeted medicines
                                               example, reimbursement of Velcade,               they can treat their patients more
and personalised healthcare.
                                               Johnson & Johnson’s new cancer                   effectively. And the International
By 2020, electronic medical records,           treatment, is contingent on proof of a           Serious Adverse Events Consortium
e-prescribing and remote monitoring            measurable reduction in the size of a            aims to develop genetic markers for
will also give healthcare payers and           patient’s tumour.28 Similarly, payment for       identifying which individuals are at risk
providers in many countries access             Lucentis, Novartis’s therapy for age-            of experiencing serious drug-related
to extensive outcomes data, as we              related macular degeneration, is subject         adverse events.
indicated in “Pharma 2020: The vision”.        to a dose-capping scheme under which
They will then be able to determine            the company bears the costs of treating

Figure 2: By 2020, pay-for-performance will be the norm in many countries


                             Today
                                     Patient        Prescription                               Payment




                             2020
                                     Patient        Prescription           Outcome




                                                                                     Medicine works/does not work



                                                                                        Medicine is safe/unsafe


                                                                                     Specified populations in which
                                                                                      medicine works and is safe



                                                                                     Payment based on performance
Source: PricewaterhouseCoopers



Pharma 2020: Marketing the future	                                                                                                      7
Table of contents




any patient who requires more than 14          definition of what constitutes a “good”      Recognising the
injections.29 The British government now       medicine will expand. In addition
plans to extend this approach, with a          to clinical considerations like safety       interdependence of the
flexible pricing system under which the        and efficacy, it will include qualitative    pharmaceutical and
prices of new medicines can be raised,         criteria – such as the extent to which
if they prove more effective than initially    a treatment makes patients feel better,
                                                                                            healthcare value chains
expected.30                                    enables them to keep working or
                                                                                            The relationship between pharmaceutical
US health insurer UnitedHealthcare             reduces the cost of caring for them.
                                                                                            companies, healthcare payers and
is also piloting a performance-based                                                        providers is at best wary – and
                                               By 2020, we believe that
pricing experiment with Genomic                                                             sometimes downright antagonistic. Yet
                                               pharmaceutical companies will therefore
Health, which makes a genetic test                                                          analysis of their value chains suggests
                                               have to collaborate much more closely
to identify which women with early-                                                         that they have far more in common than
stage breast cancer would benefit from         with everyone in the healthcare arena
                                               to provide a range of products and           might first seem the case.
chemotherapy.31 And, by 2020, we think
that all new medicines will be paid for on     services from which patients can pick        In its simplest form, a value chain is
the basis of the outcomes they deliver.        and choose all but the core prescription,    the series of activities an entity (either
                                               both to differentiate their offerings more   singular or collective) performs to create
However, most treatments perform                                                            value for its customers and thus for the
                                               effectively and to preserve the value
much better in clinical trials than they                                                    entity itself. The pharmaceutical value
                                               of the medicines they make. More
do in everyday life, partly because the                                                     chain starts with the raising of capital
                                               specifically, they will have to:
level of compliance is much higher.
                                                                                            to fund R&D and concludes with the
Numerous clinical studies show, for            •	 Recognise the interdependence of          marketing and sale of the resulting
instance, that most patients who                  the pharmaceutical and healthcare         products. In essence, it is about making
are taking statins can reduce their               value chains                              innovative medicines that can command
cholesterol to normal levels. But in one
                                               •	 Ensure that they invest in developing     a premium price (see Figure 3).
study of long-term compliance patterns,
only 33% of patients were still using             medicines the market really wants         The payer value chain starts with the
a statin at the end of 12 months, and                                                       raising of revenues through premiums,
                                               •	 Form a web of alliances to offer
only 13% were still doing so at the                                                         taxes or out-of-pocket payments.
                                                  supporting services
end of five years.32 Thus, if Pharma is                                                     The payer then creates value for its
to command premium prices for its              •	 Develop comprehensive plans for           customers (patients, policyholders and
products in future, it will need to help          marketing and selling specialist          payers) by managing the administrative
patients manage their health. Otherwise,          therapies                                 process and giving them access to
it risks having to reduce its charges or                                                    medical care. The payer’s goal is thus
                                               •	 Create organisational cultures that       to make a financial or political profit by
even incurring financial penalties for
failing to deliver all that it has promised.      are suitable for marketing specialist     maximising its revenues or reputation
                                                  healthcare packages                       (with its customers or voters, depending
To put it another way, good medicines
                                               •	 Manage multi-country launches and         on whether it is a commercial enterprise
will still be the cornerstone of any
                                                  live licensing                            or government) and the quality of the
pharmaceutical company’s marketing
                                                                                            service it secures, while minimising its
and sales strategy, but they will not          •	 Adopt a more flexible approach to         costs (see Figure 4).
be sufficient in isolation. By, 2020,             pricing; and
prescription therapies will be only one                                                     The provider’s goal is to deliver a high
of the components in a collection of           •	 Build marketing and sales functions       quality of care efficiently. This usually
products and services from which                  that are fit for the future.              means treating patients as economically
patients can select. Furthermore, as the                                                    as possible, for as long as required. The
balance of power shifts from Pharma                                                         provider value chain therefore begins
to healthcare payers and patients, the                                                      with an analysis of the factors affecting




8	                                                                                                              PricewaterhouseCoopers
Figure 3: The pharmaceutical value chain

   Raising of Finance                   Research                    Development                         Manufacturing                  Marketing & Sales
                                                                                                        & Distribution
    (Via the capital                 (Target identification,             (Clinical trials,             (Process development,               (Development of
       markets)                    synthesis & screening of            submission of new                scale-up, commercial            promotional materials,
                                    molecule, in vitro and             drug application to             production, shipping to           detailing, account &
                                     in vivo testing, initial             regulators)                                                   brand management)
                                                                                                            warehouse)
                                       testing in man)
                                             Prevention
Source: PricewaterhouseCoopers



Figure 4: The healthcare payer value chain


       Raising of Finance                      Provision of Cover                 Medical Services Management                            Bill Payment

   (Through premiums, taxes or                (Analysis of population                (Practice guidelines, clinical                 (Referral management,
     out-of-pocket payments)                   at risk, administrative              guidance, pharmacoeconomic                     monitoring & payment of
                                                   services etc.)                   evaluations, formularies etc.)                healthcare providers’ bills)



Source: PricewaterhouseCoopers
Note: Our diagram represents the key activities in the payer value chain, not the entity that performs a specific activity, since this clearly varies from one
healthcare system to another.

Figure 5: The healthcare provider value chain


     Analysis of                        Prevention                       Primary Care                    Secondary &                   Long-Term Care
   Population at Risk                                                                                    Tertiary Care
     (Epidemiological             (Vaccinations, healthcare          (Diagnosis, treatment,          (Diagnosis & treatment of          (Disease management,
         studies)                       advice etc.)                    minor surgery)                   serious illnesses,            nursing care at home, in
                                                                                                     major surgery, emergency        nursing homes & hospices)
                                                                                                      services, hospital care)

Source: PricewaterhouseCoopers
Note: Our diagram represents the key activities in the provider value chain. Again, different entities perform different activities in different healthcare systems.




the health of a given population and                     policies and practices of the providers                  and, while they continue to clash, they
the preventative measures that can be                    used. The value providers generate                       are struggling to attain their respective
taken to forestall illness. Thereafter, it               depends on the revenues payers raise                     goals. The quality of the care they
progresses through the various stages                    and the medicines Pharma makes. And                      collectively deliver is lower, and the
of treatment from primary care to long-                  the value Pharma generates depends                       cost higher, than it would otherwise
term care (see Figure 5).                                on getting access to the patients whom                   be – and society can no longer afford
                                                         providers serve and income from the                      such inefficiencies. So, if mankind is
However, although these three value
                                                         payers who fund those providers.                         to ensure that it gets the healthcare it
chains are different, they are also heavily
interdependent. The value healthcare                     In short, none of the three parties can                  needs, the three parties must be much
payers generate depends on the                           do its job properly without the others                   more closely aligned.




Pharma 2020: Marketing the future	                                                                                                                                     9
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We believe that creating feedback loops             Investing in the                                play a key role in deciding whether a
to capture outcomes data will help to                                                               medicine is innovative, using different
close the gap. It will enable Pharma                development of                                  definitions of innovation at different
both to establish a more dynamic                    medicines the market                            points in the product lifecycle (see
relationship with payers and providers,                                                             sidebar, What is innovation?).33
and to play a bigger role in giving
                                                    wants to buy
                                                                                                    The process starts with the researcher,
patients the support they require. This
                                                    One of the many areas in which Pharma           who identifies the scientific potential of
will ultimately result in the convergence
                                                    needs to work much more closely with            a particular molecule. It continues with
of the separate, linear value chains that
                                                    healthcare payers and providers is in           the investor, who backs that belief with
exist today into a single, circular value
                                                    determining the sort of medicines the           capital; the regulator, who approves the
chain (see Figure 6).
                                                    market actually wants to buy. We have           labelling claim; and the pharmaceutical
                                                    identified seven stakeholders who each          company, which commits resources to


Figure 6: By 2020, the pharmaceutical, payer and provider value chains will be much more closely intertwined



                                                                                                    Changes in epidemiology will
                                                            Med                                     influence the need for healthcare
                                                                 ica                                funding & Pharma’s research
                                 er                                  lS
                           C   ov            Primary care              er
                                                                          vic
                                                                                                    priorities. Payers, providers &
                                                             Se
                        of           tio
                                        n
                                                            Te  co
                                                                   n         e                      Pharma will collaborate on
                                   en                         rtia da                               epidemiological studies.
               on




                              ev
                                                                                 s




                                                                  ry r y
                            Pr
                                                                                   M
                  i




                                                                    ca
               vis




                                                                                      an




                                                                                                    Payers will shift to outcomes-based
                                                                        &
           Pro




                                                                                         ag
                                                                     re




                                                                                                    pricing. Pharma will collaborate with
                                                                                           em
                                                                                Lo




                                                                                                    payers and providers to determine
             popul is of




                                                                                  ng-

                                                                                              ent
               at ris n




                                                                                                    which of the medicines in its pipeline
                    atio




                                                                                     term
                     k
                     s




                                                                                                    really add value and can thus
              Analy




                                                                                                    command the premium prices it
                                                                                          care




                                                                                                    needs to maximise its return on
                                              Patient                                               investment.
              Mark les




                                                                                                    Payers, in consultation with the
                                                                                       ce
                                                                               of f ising
               & Sa




                                                                                                    medical profession, will issue clinical
                                                                                   inan
                  etin




                                                                                 Ra




                                                                                                    guidelines. They will also give
                       g




                                                                                                    providers incentives to prevent &
                                                                                                    manage disease, as distinct from
            Ra



                           M




                               n                                                                    treating it. Pharma’s focus will shift to
                            Di ufac
                            a
              isi


                         &




                                                                       ch
                                                                                      t




                              st                                                                    the development of cures and
                                                                                   en




                                 rib turin                           ar
                 ng




                                                                   se
                                                                               ym




                      fF            uti g                                                           healthcare packages for helping
                                                                Re          a
                    o




                                       on
                         inan                                             lP
                                                                           l                        patients comply with their medical
         Payer                ce             Development                Bi                          regimens and manage the diseases
         Provider
         Pharma                                                                                     from which they suffer more
                                                                                                    effectively.




Source: PricewaterhouseCoopers



10	                                                                                                                       PricewaterhouseCoopers
the production and promotion of the
                                                 What is innovation?
treatment. Once a medicine has reached
the market, it is the healthcare payer,          Innovative products are typically defined as those which cure a disease or
provider and patient, respectively, who          condition; prevent a disease or condition; reduce mortality or morbidity; reduce the
adjudicate on its innovativeness: the            cost of care; improve the quality of life; are safer or easier to use; or improve
healthcare payer by paying a premium             patient compliance and persistence. Most industry experts also distinguish
price for it; the provider by choosing it        between “radical” and “incremental” innovation, although the distinction is not
over other therapies; and the patient by         always very helpful. Pharmaceutical companies often engage in a race to develop
taking it as instructed or even pressing         new products which all have the same mode of action, and the third or fourth
for a prescription (see Figure 7).               market entrant may be superior to the first or second.
However, not all of these “referees”
are equally important. If the
sponsoring company is to recover its
development costs and earn a return          Figure 7: Seven stakeholders are involved in deciding whether a new product
on its investment, any new products it       is innovative
launches must command a premium
price while they are still under patent
protection. The healthcare payer – be it
                                                                                                                  Patient
a government, health insurer, employer
or patient – is therefore the ultimate                                                              Provider                  Regulator
arbiter of whether or not a product is
considered innovative, and the shift in                                                           Payer
the balance of power from prescribers              Researcher          Investor       Regulator           Pharmaceutical company
to payers will only increase that control.   $
Yet, for many years, most
pharmaceutical firms invested relatively
little effort in understanding the payer’s
perspective during the R&D process,
and those that did so generally waited                              R&D 12 Years                          Marketing & Sales 8 Years
until the end. This is why many of the
medicines they have recently launched
have failed to qualify as innovative. In     Source: PricewaterhouseCoopers

2006, only five Big Pharma companies
earned more than 10% of their revenues
                                             Table 2: Only eight truly innovative medicines were launched in 2007
from major products launched within
the previous five years.34 Moreover,                                                                                        Country of
there are no signs of any immediate           Company                     Brand name         Primary indication             first launch
improvement. In 2007, only eight              Novartis                    Tekturna           Hypertension                   US
of the 27 new therapies launched              GlaxoSmithKline             Tykerb             Breast cancer                  US
worldwide were the first of their kind
(see Table 2). More than half were            PharmaMar                   Yondelis           Soft tissue sarcoma            UK, Germany
“me-too” treatments with at least three       Alexion                     Soliris            Paroxysmal nocturnal           US
predecessors.35                                                                              haemoglobinuria
A number of companies now look                Pfizer                      Selzentri           HIV                           US
at whether the medicines they are             GlaxoSmithKline             Altabax             Bacterial skin infections US
developing are as effective as, or more       LEO Pharma                  ATryn               Thrombosis                    UK
effective than, other existing therapies
(and certain countries now require            Bristol-Myers Squibb Ixempra                    Breast cancer                 US
that they do so). Some firms also            Sources: IMS Intelligence.360 (2008) and PricewaterhouseCoopers analysis

Pharma 2020: Marketing the future	                                                                                                         11
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conduct extensive safety profiling in                  the commercial sphere. Indeed, they        known examples being Genentech’s
Phase II to reduce the risk of finding                 should review every compound in their      partnership with DAKO to devise a test
safety problems in Phase III, which                    pipelines, since no molecule that enters   for identifying which patients with breast
accounts for more than 25% of all R&D                  clinical development today will be         cancer can benefit from Herceptin.39
costs.36 However, very few focus on                    launched before 2015, when the market
                                                                                                  However, Pharma will also have to enter
demonstrating the superior economic                    for medicines will be even tougher
                                                                                                  the health management space, with
value of their candidate molecules – and               than it is now. Performing a rigorous
                                                                                                  compliance programmes, nutritional
even fewer consider pricing before the                 assessment of what payers, providers
                                                                                                  advice, exercise facilities, health
end of Phase III.                                      and patients regard as innovation in
                                                                                                  screening and other such services. One
                                                       Phase II will enable the industry to
Two recent exceptions to this pattern                                                             firm that has already gone some way
                                                       terminate any candidates that look
point to a more constructive way                                                                  down this road is Baxter Healthcare,
                                                       unlikely to generate much demand
forward. In late 2007, Novartis struck                                                            which offers a range of services for
                                                       and concentrate its resources on more
a groundbreaking deal with the                                                                    patients suffering from renal failure.
                                                       commercially promising products (see
English National Institute for Health                                                             These services vary from country to
                                                       Figure 8).
and Clinical Excellence (NICE) under                                                              country, but they include a global
which it agreed to pay the agency a                                                               educational website with customisable
consultancy fee for advising it on the                                                            tools and information tailored to the
design of a Phase III trial to measure
                                                       Forming a web of                           needs of paediatric patients; a network
the efficacy and cost-effectiveness of                 alliances to offer                         of nurses who provide dialysis training
an experimental new drug.37 And, in                                                               at home or in hospital; a home delivery
June 2008, GlaxoSmithKline took the
                                                       supporting services                        service; and a travel service to support
equally unprecedented step of giving                                                              peritoneal dialysis patients travelling
                                                       The development of medicines the           locally or globally.40
government healthcare officials in the
                                                       market actually wants to buy will
UK, France, Italy and Spain a say in                                                              Novo Nordisk has gone even further in
                                                       not be enough, though. By 2020,
deciding which compounds to progress                                                              its quest to “defeat diabetes”.41 In 2001,
                                                       pharmaceutical companies will need
through its pipeline.38                                                                           the company launched a global initiative
                                                       to offer a suite of supporting services
We believe that all pharmaceutical                     for the treatments they launch. A few      called DAWN, in conjunction with the
companies should adopt a similar                       companies have already paired up           International Diabetes Federation, to
approach and extend the concept                        to develop complementary therapies         provide “psychosocial support” for
of “de-risking” from the clinical to                   and diagnostics, one of the best           patients with diabetes.42 It also operates
                                                                                                  a “National Changing Diabetes”
                                                                                                  programme in 66 countries, via which it
Figure 8: Pharma needs to adopt a price de-risking strategy in early development                  provides training for medical staff, free
                                                                                                  blood sugar screening services, support
      Percentage of spending in each phase of R&D. 11.3% of spending uncategorized                for diabetes patient organisations and
                                                                                                  equipment for diabetes clinics, as
      Preclinical     Phase I         Phase II          Phase III      Regulatory    Phase IV
                                                                                                  well as working with governments to
         25.7           5.8            11.7              25.5             6.9          13.3       improve the diagnosis and treatment of
                                                                                                  the disease.43
                                   Point at which           Point at which
                                   pharmaceutical           pharmaceutical                        Meanwhile, Medtronic recently launched
                                     companies                companies                           a wireless monitoring service for
                                      should be               typically start
                                   thinking about            thinking about
                                                                                                  patients with cardiac disease, which
                                  pricing to de-risk             pricing                          enables them to send data from their
                                   their portfolios                                               implanted devices directly to their
Source: PricewaterhouseCoopers




12	                                                                                                                   PricewaterhouseCoopers
doctors. The latest devices can even        Developing a plan for                        Generics for free
be programmed to update and send
patient data automatically.44 And other     marketing and selling                        San Diego based MedVantx has
precedents for moving into health           specialist therapies                         developed an automated system for
management exist outside Pharma                                                          dispensing generics free at the point
itself. In the UK, for example, insurance   The industry’s changing product mix          of care. When a doctor wants to
giant Prudential has joined forces          will act as yet another incentive to move    give a patient a sample, the machine
with Virgin Active Health Club to offer     into health management. In the 1990s,        dispenses a 30-day supply and logs the
a critical illness policy that provides     most of the medicines Pharma made            transaction. The health insurer then pays
subsidised gym membership and               were primary-care therapies for diseases     for the product.
rewards people who exercise regularly       afflicting large patient populations,        The idea is to give doctors an
by reducing their premiums.45
                                            such as hypertension, diabetes,              alternative to the free samples issued
By 2020, this model will apply to the       high cholesterol and depression.             by pharmaceutical companies. Such
industry as a whole. Some companies         But genomics, proteomics and                 samples are popular with patients
may choose to provide such services         metabolomics are providing new tools         because they provide an opportunity
themselves, but most will function          with which to develop larger molecules       to try a medication before paying for it.
as nodes for a network of providers,        that more closely mimic naturally            One pilot programme conducted by Blue
including device manufacturers,             occurring molecules in the human body.       Cross & Blue Shield of Rhode Island is
dieticians, health and fitness clubs,                                                    estimated to have reduced the insurer’s
                                            Biotech companies like Amgen,
mobile telecoms operators and                                                            expenditure on medicines by nearly $2m.
                                            Biogen and Genentech were among
compliance call centres. They will
                                            the first firms to capitalise on these
be responsible for managing the
                                            scientific advances. However, many          Generics for free).48 The opportunities
mechanics of contracting and delivering
                                            pharmaceutical companies have now           for developing primary-care treatments
these services, and thus collectively       redirected much of their investment
providing healthcare packages that                                                      with the potential to command premium
                                            from chemical entities to proteins          prices are thus shrinking rapidly.
individual patients can tailor to their     for specific cancers, immunological
own needs.                                  conditions and blood factor deficiencies    Conversely, demand for specialist
Moving into health management will not      too. At least 400 of the 2,000-odd          medicines is soaring. In 2007, 55 of the
be easy, not least because the provision    treatments currently in development         106 blockbusters on the market were
                                            are biologicals or protein-based            specialist treatments, up from just 12
of services is very different from the
                                            compounds.46                                in 2001.49 And IMS Health predicted
provision of products. Nevertheless, this
                                                                                        that sales of all specialist therapies
route has several significant advantages.   Increasing generic competition has          could reach US$295-300 billion by the
It will enable pharmaceutical companies     reinforced this shift in the industry’s     end of 2008, accounting for 44% of
to generate new sources of revenue,         research focus; as many of the products     worldwide spending on prescription
build stronger brands and forge closer      developed in the 1990s come off patent,     pharmaceuticals.50
relationships with the patients who         generics manufacturers are filling an
use their products and services. It will    ever larger part of the primary-care        Yet, although specialist medicines hold
also help them to protect the value of      space. Generics already account for         huge clinical and commercial promise,
the medicines they launch, both by          65% of all prescriptions dispensed          they come with one major drawback:
increasing compliance and by reducing       in the US and for as many as 70% of         their charging profile. Tufts Center
the threat of getting locked out through    all prescriptions dispensed in Central      for the Study of Drug Development
e-prescribing, since it is very much        and Eastern Europe,47 a trend that will     estimates that the cost of developing a
easier to substitute a standalone product   accelerate, as automated dispensing         new biological is about US$1.2 billion,
than it is a product which comes with       systems neutralise the effect of            nearly US$400m more than the average
personalised satellite services.            distributing free samples (see sidebar,     for a small molecule.51 But specialist




Pharma 2020: Marketing the future	                                                                                              13
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Figure 9: Many specialist therapies cost thousands, or even hundreds of thousands, benefits and risks associated with using
of dollars a year                                                                  them and to communicate with an
                                                                                               audience that is very well informed.
                                    Cancer
                                                                                               Second, since specialist therapies
                                                                                               cost such a lot, they attract far more
Alpha-1 Proteinase Inhibitor Deficiency
                                                                                               scrutiny before being approved for
                                                                                               reimbursement – and reimbursement
       Pulmonary Arterial Hypertension                                                         is crucial, because few patients can
                                                                                               afford to pay for them out of their own
                              Haemophilia                                                      pockets. This trend will increase with
                                                                                               the proliferation of more sophisticated
                          Fabry’s Disease                                                      pharmacoeconomic models, reducing
                                                                                               the opportunities for “hype”. It also
                       Gaucher’s Disease                                                       means that anyone who promotes
                                                                                               such medicines will need to have a
                “Bubble Boy” Syndrome                                                          clear grasp of the health economics
                                                                                               underlying them.
                                               0     100,000 200,000 300,000 400,000           Third, many specialist therapies are
                                               Average Price in US dollars                     used to treat patients with specific
                                                                                               disease subtypes, so they must be
Source: D. Stevens, “Specialty Pharmacy to Therapy Management: The Next Generation”,           accompanied by a diagnostic. And
presented at PCMA Specialty Pharmacy Annual Meeting, October 2005                              since they are more difficult to get to
                                                                                               the target site, they must generally
therapies are currently used to treat              value in the eyes of payers, providers      be delivered by injection or infusion.
conditions that affect only 3% of the              and patients, not just those of the         Many such therapies must thus be
general population.52 A company that               executives that have backed them. It        administered by a doctor or nurse but,
develops a specialist medicine must                is also increasing the importance of        even when patients can administer
therefore amortise its investment                  the marketing and selling process. But      their own medicines, they usually
(including the money it spends on                  though most pharmaceutical firms have       require intensive patient education
marketing and sales) over a much                   recognised the potential of specialist      and monitoring, especially in the early
smaller number of patients.                        medicines, they continue to use a           stages of treatment.
                                                   marketing and sales model that was
So it is not surprising that specialist                                                        This not only adds to the overall cost
                                                   designed to promote primary-care
therapies often sell for many thousands                                                        of using specialist therapies, it also
                                                   products for mass-market consumption.
of dollars (see Figure 9). Nor is it                                                           means that different payment centres
surprising that healthcare payers                  In fact, specialist therapies have          (and reimbursement procedures)
everywhere are taking steps to slow                a number of unique features that            may be involved. In the US, for
down their utilisation. If demand for              differentiate them from conventional        example, specialist treatments are
such products were to grow at current              medicines and mean that they must           often reimbursed under a healthcare
rates, the global market for specialist            be marketed quite differently. First,       payer’s medical benefit rather than
                                                   they typically have a broader range         its pharmaceutical budget. Similarly,
therapies alone would be worth about
                                                   of activity and greater potential to        in the UK, the cost of monitoring and
US$1.4 trillion by 2020, double the                       1
                                                   generate an immune response. They           maintaining patients on specialist
US$712 billion the entire prescription
                                                   are also prescribed by specialists rather   medicines frequently falls on the primary
products market was worth in 2007.53
                                                   than general practitioners. So anyone       care trusts covering the areas in which
The shift towards specialist therapies             who is marketing such medicines             those patients live, rather than the
is thus accentuating the need to                   must possess considerable scientific        hospitals that treated them in the
develop healthcare packages that have              knowledge – both to understand the          first place.



14	                                                                                                               PricewaterhouseCoopers
Lastly, many specialist treatments must       will therefore have to develop a                at risk of experiencing health problems.
be ordered as necessary, rather than          comprehensive marketing and sales               It can also, as we have already noted,
kept in stock – partly because they           strategy that is tailored to the distinctive    generate additional revenues from the
are so expensive and partly because           characteristics of such products                support services it provides.
they have relatively short shelf lives.       (see Table 3). It will have, among
They must also be transported and             other things, to offer complementary
stored with much greater care than            diagnostics and support services; to            Creating a culture that
small molecules, because they are             appoint a smaller, smarter sales force
much more fragile. Both these factors         capable of engaging with powerful               is suitable for marketing
have considerable implications for            healthcare payers and medical                   specialist healthcare
the supply chain. The ability to “make        specialists; to build a responsive direct
to order” requires the integration of         distribution network; and to invest much        packages
a company’s demand management                 more effort in educating patients.
with its manufacturing, packaging and                                                         Selling specialist therapies and support
                                              But if it succeeds in doing these things,       services as distinct from standalone
distribution processes – changes that
                                              it can expect to enjoy a longer period          small molecules has numerous other
will necessitate a substantial capital
                                              of exclusivity and greater customer             implications, and any pharmaceutical
investment in new skills and supply
                                              loyalty, since biologicals are very             company that wants to make the
chain systems.
                                              difficult to manufacture and most               transition will need to undergo even
Any pharmaceutical company that               patients are reluctant to switch from           more sweeping changes. It will, for
wants to sell specialist therapies            one to another because they are more

Table 3: Specialist therapies require different marketing and sales models from those used for mass-market medicines

 Mass-market medicines               Specialist therapies                                    Marketing implications
 Treat common illnesses              Treat rare diseases and specific disease                A much smaller target market
                                     subtypes
                                                                                             Must generally be used with a
                                                                                             diagnostic, which adds to the overall
                                                                                             cost but improves compliance
 Relatively simple products          Very complex products                                   Require more scientifically educated
                                                                                             sales representatives
 Typically prescribed by general     Prescribed by specialists                               Require a much smaller sales force
 practitioners
 Low price per dose                  Very high price per treatment                           Require much more extensive proof of
                                                                                             clinical efficacy
                                                                                             Outcomes-based pricing
 Usually oral formulations           Usually delivered by infusion or injection              Require intensive patient education &
                                                                                             monitoring
                                                                                             Costs may be spread across different
                                                                                             payment centres & budgets with
                                                                                             different reimbursement procedures
 Relatively easy to manufacture      Difficult to manufacture                                Less vulnerable to generic competition
 Easy to transport                   Require special distribution & storage facilities       More expensive to ship & store
 Generally kept in stock             Often delivered to order                                Must be supported by a much more
                                                                                             flexible supply chain

Source: PricewaterhouseCoopers

Pharma 2020: Marketing the future	                                                                                                    15
Table of contents




                                             Many companies will likewise have to        a more integrated environment. Various
Playing by the rules
                                             recruit and train people with new skills,   elements may have to be altered,
The majority of pharmaceutical               including:                                  ranging from new cycle time targets
companies have established                                                               for different steps in the R&D process
                                             •	 Researchers who are as capable of
compliance programmes that are                                                           to new measures of effectiveness in
                                                considering commercial imperatives
based on the guidelines the Office                                                       marketing and sales.
                                                like pricing and sales as they are
of Inspector General of the US
                                                of considering scientific issues like
Department of Health and Human                                                           Most companies will also have to
                                                safety and efficacy
Services issued in April 2003. But they                                                  alter their corporate compliance
have typically taken quite a reactive        •	 Manufacturing experts who can            programmes. At present,
approach. They have concentrated                manage the complex processes             pharmaceutical compliance functions
on mitigating legal risks, such as              required to produce large molecules      typically spend the bulk of their time
violations of the US Anti-Kickback              and drug-device combinations             and resources monitoring the way in
Statute, US False Claims Act, US                that amalgamate different scientific     which marketing and sales staff interact
Foreign Corrupt Practices Act and               disciplines
                                                                                         with healthcare professionals, and
various US state-level marketing
                                             •	 Supply chain managers who can            ensuring that everyone complies with
disclosure reporting laws. They
have also added yet another layer               handle chilled-chain distribution        the existing legislation (see sidebar,
of controls to those they use in their          through multiple channels and            Playing by the rules).54 But, as the
existing business operations, rather            supervise a large network of service     industry shifts to specialist medicines,
than creating integrated, value-adding          providers                                payers and patients play a bigger part in
compliance functions.                        •	 Health economists who can advise         the purchasing process and a growing
                                                on the pricing and reimbursement         number of companies offer healthcare
example, have to decide whether to              of new medicines, and provide input      packages that include products and
continue developing primary-care                into the design of clinical trials for   services supplied by other firms, so the
medications or focus exclusively on             candidate molecules                      compliance function’s responsibilities
specialist therapies (as Genentech           •	 Key account managers who                 will increase. It will have to monitor
does). Similarly, it will have to decide        can negotiate with increasingly          communications with payers and
what sort of business model it should           powerful healthcare payers and           patients; collect, analyse and report
use – be it diversified, federated or one       pharmacoeconomic assessment              on information from third parties; and
of various other permutations.                  agencies; and                            assume responsibility for managing
Clearly, “hard” financial, operational       •	 Disease management specialists           a broader range of risks across the
and legal criteria will play a big role in      with a profound understanding of         extended enterprise – all activities that
shaping these choices but, whatever             how to help patients through the         will necessitate the acquisition of much
path they take, most companies will             disease lifecycle.                       better operational and information
also have to make major cultural                                                         management skills.
adaptations. They will have to build         Finding people with the requisite skills
much closer links between their R&D          will not be easy, given the breadth of      In short, focusing on the development of
and marketing and sales functions to         knowledge the industry requires and         specialist medicines and services rather
foster cross-disciplinary collaboration      the battle for brains now being waged       than primary-care blockbusters entails
and ensure that the views of healthcare      in almost every part of the world. Many     making significant organisational and
payers are fed into the development          companies will therefore have to adopt      cultural changes – some of which may
process. One way of doing this is to         new talent management strategies, as        not be immediately obvious (see Table 4).
create dual reporting relationships,         well as ensuring that the performance
                                                                                         And implementing these changes will
with employees in R&D reporting to           measures and incentive systems they
                                                                                         take enormous effort.
management in marketing and sales,           use are aligned with the behaviour that
and vice versa.                              will be needed to operate effectively in



16	                                                                                                         PricewaterhouseCoopers
Table 4: Specialist medicines require totally new organisational and cultural characteristics


                            Blockbuster model                            Specialist model
 Strategy                   Development of mass-market                   Development of specialist medicines for treating specific
                            blockbusters                                 disease subtypes
                            Generation of new prescriptions              Cooperation with healthcare payers & providers to
                                                                         optimise the healthcare resource mix
                                                                         Responsibility for compliance & persistence
 Organisation               Vertically integrated                        Networked
 Culture                    Fragmented, with separation of disciplines Integrated, with collaboration across disciplines & brands
                            & brands
 R&D                        Restricted research agenda                   Comprehensive research agenda
                            R&D silos                                    Internal & external connectivity, partnering & adaptive trials
                            Cumbersome decision-making processes         Nimble decision-making processes

                            Reward systems based on number rather        Reward systems based on collaboration & commercial
                            than quality of candidate molecules          awareness
 Manufacturing              Narrow product range                         Wide product range (including diagnostics, biomarkers &
                                                                         novel delivery technologies)
                            Batch-based, “made to forecast”              Flexible, “assembled to order” manufacturing
                            manufacturing
                            Six Sigma processes                          Unique manufacturing processes
 Distribution               Traditional channels, primarily wholesalers Multiple channels, including direct distribution to patients
                                                                        or their healthcare providers
                            Conventional distribution                    Chilled-chain distribution and storage
 Pricing                    What the market will bear, rebates &         Pay-for-performance
                            discounting
 Marketing & Sales          Intensive detailing                          Individual negotiations with large healthcare payers;
                                                                         specialist advice for secondary & tertiary healthcare
                                                                         providers; & educational programmes for patients
                            Based on differentiation of competing        Based on treatment of specific disease states and
                            medicines                                    measurement of outcomes

Source: PricewaterhouseCoopers




Pharma 2020: Marketing the future	                                                                                                    17
Pharma 2020: Marketing the future guide to reshaping pharmaceutical sales and promotion
Pharma 2020: Marketing the future guide to reshaping pharmaceutical sales and promotion
Pharma 2020: Marketing the future guide to reshaping pharmaceutical sales and promotion
Pharma 2020: Marketing the future guide to reshaping pharmaceutical sales and promotion
Pharma 2020: Marketing the future guide to reshaping pharmaceutical sales and promotion
Pharma 2020: Marketing the future guide to reshaping pharmaceutical sales and promotion
Pharma 2020: Marketing the future guide to reshaping pharmaceutical sales and promotion
Pharma 2020: Marketing the future guide to reshaping pharmaceutical sales and promotion
Pharma 2020: Marketing the future guide to reshaping pharmaceutical sales and promotion
Pharma 2020: Marketing the future guide to reshaping pharmaceutical sales and promotion
Pharma 2020: Marketing the future guide to reshaping pharmaceutical sales and promotion
Pharma 2020: Marketing the future guide to reshaping pharmaceutical sales and promotion
Pharma 2020: Marketing the future guide to reshaping pharmaceutical sales and promotion

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Pharma 2020: Marketing the future guide to reshaping pharmaceutical sales and promotion

  • 1. Pharmaceuticals and Life Sciences Pharma 2020: Marketing the future Which path will you take?
  • 2. Table of contents Previous publications in this series include: Pharmaceuticals Pharmaceuticals and Life Sciences Pharma 2020: The vision Pharma 2020: Virtual R&D Which path will you take?* Which path will you take? *connectedthinking  Pharma 2020: The vision # Pharma 2020: Virtual R&D 1 Published in June 2007 this paper highlights a number of This report published in June 2008 explores opportunities issues that will have a major bearing on the industry over to improve the R&D process. It proposed that new the next 11 years. The publication outlines the changes we technologies will enable the adoption of virtual R&D; and believe will best help pharmaceutical companies realise the by operating in a more connected world the industry, in potential the future holds to enhance the value they provide collaboration with researchers, governments, healthcare to shareholders and society alike. payers and providers, can address the changing needs of society more effectively. “Pharma 2020: Marketing the future” is the third in this series of papers on the future of the pharmaceutical industry published by PricewaterhouseCoopers. It discusses the key forces reshaping the pharmaceutical marketplace, including the growing power of healthcare payers, providers and patients, and the changes required to create a marketing and sales model that is fit for the 21st century. These changes will enable the industry to market and sell its products more cost-effectively, to create new opportunities and to generate greater customer loyalty across the healthcare spectrum.
  • 3. Table of contents Introduction 2 What will the healthcare landscape look like in 2020? 4 Recognising the interdependence of the pharmaceutical and healthcare value chains 8 Investing in the development of medicines the market wants to buy 10 Forming a web of alliances to offer supporting services 12 Developing a plan for marketing and selling specialist therapies 13 Creating a culture that is suitable for marketing specialist healthcare packages 15 Managing multi-country launches and live licensing 18 Adopting a much more flexible approach to pricing 18 Creating a marketing and sales function that is fit for the future 19 Conclusion 22 Pharma 2020: Marketing the future
  • 4. Introduction trends reshaping the pharmaceutical that, between 1996 and 2005, total marketplace).1 All these challenges real spending on pharmaceutical The social, demographic and economic have major ramifications for the way in promotions rose from US$11.4 billion which Pharma markets and sells the to US$29.9 billion in the US (the only context in which the pharmaceutical medicines it develops – the subject on country for which expenditure on all industry (Pharma) operates is changing which we shall focus here. major marketing and sales activities dramatically, as we noted in “Pharma is available).2 Another study suggests 2020: The vision”, the White Paper The industry has traditionally relied on that the true figure (including meetings PricewaterhouseCoopers* published in aggressive marketing to promote its and e-promotions) is closer to US$57.5 June 2007 (see sidebar, Seven major products. One recent study estimates billion in real terms.3 Seven major trends reshaping the pharmaceutical marketplace The pharmaceutical marketplace is changing dramatically, with huge implications for the industry as a whole. We have identified seven major socio-economic trends. The burden of chronic disease is performance of different medicines. where demand for medicines is likely soaring. The prevalence of chronic Widespread adoption of electronic to grow most rapidly over the next 13 diseases like diabetes is growing medical records will give them the years, are highly varied. Developing everywhere. As greater longevity forces outcomes data they need to determine countries have very different clinical and many countries to lift the retirement age, best medical practice, discontinue economic characteristics, healthcare more people will still be working at the products that are more expensive or less systems and attitudes towards the point at which these diseases start. The effective than comparable therapies and protection of intellectual property. Any social and economic value of treatments pay for treatments based on the outcomes company that wants to serve these for chronic diseases will rise accordingly, they deliver. So Pharma will have to prove markets successfully will therefore have but Pharma will have to reduce its that its medicines really work, provide to devise strategies that are tailored to prices and rely on volume sales of such value for money and are better than their individual needs. products because many countries will alternative forms of intervention. Many governments are beginning otherwise be unable to afford them. The boundaries between different to focus on prevention rather than Healthcare policy-makers and forms of healthcare are blurring. The treatment, although they are not yet payers are increasingly mandating primary-care sector is expanding as investing very much in pre-emptive or influencing what doctors can clinical advances render previously fatal measures. This change of emphasis prescribe. As treatment protocols diseases chronic. The self-medication will enable Pharma to enter the realm replace individual prescribing decisions, sector is also increasing as more of health management. But if it is to do Pharma’s target audience is also prescription products are switched to so, it will have to rebuild its image, since becoming more consolidated and more over-the-counter status. The needs healthcare professionals and patients powerful, with profound implications of patients are changing accordingly. will not trust the industry to provide for its sales and marketing model. Where treatment is migrating from the such services unless they are sure it has The industry will have to work much doctor to ancillary care or self-care, their best interests at heart. harder for its dollars, collaborate with patients will require more comprehensive The regulators are becoming more healthcare payers and providers, and information. Where treatment is risk-averse. The leading national and improve patient compliance. migrating from the hospital to the multinational agencies have become primary-care sector, patients will require Pay-for-performance is on the rise. much more cautious about approving new services such as home delivery. A growing number of healthcare payers truly innovative medicines, in the wake are measuring the pharmacoeconomic The markets of the developing world, of problems with medicines like Vioxx. *‘PricewaterhouseCoopers’ refers to the network of member firms of PricewaterhouseCoopers International Limited, each of which is a separate and independent legal entity. 2 PricewaterhouseCoopers
  • 5. Much of this increase in spending has Too many cooks spoil the broth gone on the expansion of the sales force. However, many of the industry’s Between 1996 and 2005, the number of US sales representatives nearly doubled biggest markets are now saturated with to 100,000, although the number of practising physicians rose by just 26%. The sales representatives, and its selling market is getting very crowded in other countries, too. In a recent poll of British techniques are becoming increasingly general practitioners, respondents reported receiving an average of four visits ineffective (see sidebar, Too many a month and five promotional mailings a week. Similarly, one Malaysian doctor cooks spoil the broth).4 participating in a study of promotional practices in emerging countries was approached by 16 multinationals and nine local generics companies within a five- Hence the fact that returns on detailing week time span. (sales visits to doctors) have begun to decline in the developed world. The battle for market share has triggered considerable alarm. Some 20% of US Between 2004 and 2005, there was a and British doctors now refuse to see any sales representatives. The regulations 23% drop in dollar growth per detail in governing the behaviour of sales representatives are also getting tougher. Various the US, although detailing still accounts US states have passed laws requiring pharmaceutical companies to report all for more than half the market share gifts or payments to healthcare professionals exceeding $25, while Australia has new brands win during their first year of banned pharmaceutical companies from providing doctors with personal gifts, life. The picture is rather more varied in entertainment or lavish hospitality. Western Europe, but detailing plays a Several industry trade groups have likewise introduced new codes of practice much smaller role in stimulating sales in – and they are actively enforcing the rules. The Prescription Medicines Code of these countries.5 Practice Authority (PMCPA), which administers the code of practice laid down by Conversely, detailing is still very the Association of the British Pharmaceutical Industry, is one such instance. The important in many developing PMCPA “names and shames” the most serious offenders, by reprimanding them nations. In China, for example, nearly publicly and publicising the violations they have committed in advertisements in three-quarters of the information the medical and pharmaceutical press. doctors receive about new medicines comes from meetings with sales promotional” information.9 And to US advertising and French-speaking representatives and conferences.6 But Pharma’s spending on DTC advertising Canadians, who primarily watch French- here, too, resistance to “irresponsible” only accounts for about US$5 billion, language media – over a five-year marketing practices is growing,7 and, in which is just 14% of its total marketing period. They found that DTC advertising May 2007, the member governments of budget.10 However, the jury is still out on had no effect on sales of two of the the World Health Organisation passed a just what this expenditure provides. three products and that, although sales resolution to enact or enforce legislation of the third spiked by more than 40% banning the “inaccurate, misleading or In the early days, the returns appeared when the campaign began, the spike unethical promotion of medicines”.8 to be substantial. Between 1999 and was quite brief.12 2000, sales of the 50 products that Direct-to-consumer (DTC) advertising were most heavily advertised in the Much of the industry’s expenditure – the other big weapon in Pharma’s US soared by 32%, compared with on DTC advertising may have been marketing artillery – has also failed to deliver all that the industry expected. an average increase of 13.6%.11 But pointless, but the damage to its Only two countries – the US and New more recent research suggests that reputation is arguably a more serious Zealand – currently allow companies DTC advertising has little, if any, long- problem. In January 2008, the US House to market their medicines directly to term impact on demand. In one study of Representatives Committee on Energy consumers, although the European published in the British Medical Journal, and Commerce initiated an investigation Commission is considering a proposal the researchers compared the uptake into the misleading and deceptive to lift the ban on direct communications of three medicines in two populations – advertising of medicines, after several that provide “objective...non- English-speaking Canadians exposed particularly flagrant abuses of the rules.13 Pharma 2020: Marketing the future 3
  • 6. Table of contents Table 1: Big Pharma has been slashing In short, aggressive marketing – • The buying and selling of medicines its workforce whether it be to doctors or patients – is is based solely on technical data like Announced becoming increasingly ineffective as a safety and efficacy, as distinct from Company Job Cuts means of stimulating demand for new subjective criteria like quality of life. therapies and overcoming reluctance to Pfizer 10,000 We shall discuss the changes that have pay premium prices for products that invalidated these assumptions in more AstraZeneca 7,600 are deemed to offer only minor clinical detail in the next chapter. Merck & Co. 7,200 improvements. Industry critics are also becoming increasingly vociferous in Bayer 6,000 their complaints that it is wasteful or Schering-Plough 5,500 even unethical. What will the healthcare Johnson & Johnson 5,000 Big Pharma has responded with various landscape look like in GlaxoSmithKline 5,000 cost-cutting measures. Pfizer set the 2020? Amgen 2,600 pace in late 2006, when it said that it Novartis 2,500 would cut 20% of its US sales force.14 For many years, pharmaceutical Other companies rapidly followed suit companies decided what their products Wyeth 1,200 and, by October 2008, the industry were worth, and priced them accordingly. sanofi-aventis 700 leaders had announced plans to shed But healthcare policy-makers, payers Total 53,300 another 53,300 jobs, many of them in and patient groups are now playing marketing and sales (see Table 1).15 an increasingly important role in the Source: PricewaterhouseCoopers They are now turning their attention valuation process – and this trend will to developing countries like India, accelerate, as healthcare expenditure where 10 multinationals are reported everywhere continues to soar. to be trimming the number of sales The aging of the population, together representatives they employ.16 with dietary changes and more However, both industry executives and sedentary lifestyles, is driving up the commentators recognise that the failings disease burden in both developed of the current marketing and sales and developing countries.17 People’s model cannot be addressed simply by expectations are also rising as new reducing the size of the sales force; therapies for treating serious illnesses the problems go very much deeper. like cancer reach the market. The We believe that they stem from three global healthcare bill has risen incorrect assumptions, namely that: commensurately; between 2000 and 2006, expenditure on healthcare as • Pharma alone determines the value a percentage of gross domestic product of its products (GDP) climbed in every country in • Products alone create value; and the OECD.18 4 PricewaterhouseCoopers
  • 7. Many policy-makers and payers have doctor was electronically notified that The push for e-prescribing therefore started trying to measure the product concerned was off plan.21 exactly what they are getting for their More than 70% of all doctors in E-prescribing has enormous commercial money. A number of countries, including Denmark, the Netherlands and implications for Pharma. Most of the Australia, Canada, Finland, New Sweden write prescriptions activities it performs to market its Zealand and the UK, have established electronically, and the European Union medicines to doctors take place before agencies specifically to conduct formal is promoting the practice in other the prescribing decision is made – clinical and economic evaluations member states. Doctors in Darwin, and e-prescribing could mitigate that of medicines. The US Senate is also Australia, are also testing a new influence, unless the industry can system that, if successful, could be considering a bill to create a Health collaborate with healthcare payers to rolled out nationwide, and the US has Care Comparative Effectiveness Research Institute, which would perform shape the information doctors receive. just passed a new law to increase a similar function.19 However, healthcare payers will want e-prescribing among doctors hard proof that a product really is safer, participating in the Medicare Similarly, some governments are more effective or more economical than programme. Eligible physicians will actively encouraging the use of its rivals, and they will have many more receive a 2% bonus for writing e-prescribing (see sidebar, The push resources to investigate such claims electronic scripts in 2009 and 2010, for e-prescribing).20 The main aim of than any individual doctor or practice. dropping to 1% in 2011 and 2012, and these efforts is to reduce prescribing 0.5% in 2013. But penalties will be errors. But e-prescribing will also enable With greater use of pharmaco- economics, strict formularies and imposed on those who do not use healthcare payers to influence the e-prescribing by 2012. prescribing decision much more easily, e-prescribing, healthcare policy-makers by providing doctors with clinical and and payers are increasingly assessing Interest in e-prescribing is not confined financial information at the very point at the relative value of different medicines. to the developed world. India’s largest which they are choosing which products Patients are playing a bigger part in retail pharmacy chain, Apollo to prescribe. the process, too. Indeed, they are Pharmacies, has recently started even helping to decide which products offering doctors and patients an This will have a major impact on the should reach, or remain on, the market. e-prescription service. Similarly, the decisions doctors make. In one recent Turkish government has launched Patient power was a critical factor in the survey, for example, two-thirds of several e-prescribing pilot programmes decision to approve Herceptin for use the physicians participating in a US as part of a bigger initiative to establish on the British National Health Service e-prescribing initiative reported that a national health network, and the (NHS) in the treatment of early-stage they were more likely to prescribe a Russian Ministry of Health and Social breast cancer, for example.22 generic or plan-preferred medicine Development introduced new when using an e-prescribing system. Patients will become even more prescribing rules, including computer- Analysis of some 3.3m e-prescriptions influential, as access to reliable readable prescription forms for the bore out their claims; 39% of those healthcare information increases, the beneficiaries of federal and regional that failed to comply with the formulary use of co-payments proliferates and insurance schemes, in 2007. requirements were changed when the the trend towards self-medication Pharma 2020: Marketing the future 5
  • 8. Table of contents grows (see sidebar, Health 2.0 hits Health 2.0 hits the headlines the headlines).23 Public expenditure still accounts for the bulk of healthcare The number of people using the Internet to find healthcare information has spending in every G7 country except increased dramatically over the last decade. Some 66% of US adults go online to the US, but patients in the E7 countries research their conditions, as do more than half of all Europeans. Numerous blogs typically foot more than half the bill and online forums have also sprung up to cater for increasingly information-hungry themselves (see Figure 1). patients. They include sites such as patientslikeme.com, which enables patients to compare symptoms and side effects; medhelp.org, where doctors and patients The split between public and private work together to create “wikis”; and various disease-specific forums for patients healthcare spending is also changing with conditions like cancer and epilepsy. in some G7 countries, as they try to reduce the burden on the public The next stage in the so-called Health 2.0 revolution is the proliferation of exchequer. In Britain, for example, the electronic personal health records. Microsoft and Google have both launched government recently gave permission services to help people create and store their own personal health records on the for cancer patients to buy “top-up” World Wide Web. But there are many other, smaller companies offering similar drugs privately, without losing their right services, including myPHR.com, medicalrecords247.org and ihealthrecord.org. to free care under the NHS.24 Conversely, in the US, President Barack Obama plans to put a bigger share of healthcare costs on the public tab, by expanding coverage to uninsured Americans. He has also promised to lower the cost of medicines by allowing Figure 1: Private expenditure on health as a percentage of total healthcare the importation of safe products spending in the G7 and E7 countries from other developed countries, increasing the use of generics in public 90% G7 Countries E7 Countries programmes, taking on pharmaceutical companies that block cheaper generics 80% from the market and eliminating the ban 70% on the federal government negotiating 60% drug prices.25 But, whether it is patients, governments or health insurers who 50% are picking up the costs, one thing is 40% clear: the days when pharmaceutical companies could dictate how much 30% their medicines should fetch, without 20% regard for the other stakeholders in the healthcare arena, are over. 10% The opportunities for generating value 0% from pure product offerings are also da ce ly n k S il na In ndia M ia o ia ey y az U pa ic U Ita s ss an rk an hi a ne rapidly diminishing. In the past 15 ex Br an Ja Ru m C Tu I Fr do er C months, at least three companies G have started offering personal genome Source: World Health Organisation, “World Health Statistics 2008” 6 PricewaterhouseCoopers
  • 9. services for the masses. 23andMe which medicines are particularly safe, On the right track (which is backed by Google) charges efficacious and cost-effective in different just US$399 to analyse people’s DNA patient populations, and include such Numerous new sources of clinical data and tell them how likely they are to suffer information in their treatment protocols are emerging. The US National from more than 90 health conditions and (see sidebar, On the right track).27 They Comprehensive Cancer Network has, inherited traits. deCodEme (a branch will also be able to revise the prices they for example, established an oncology of the Icelandic genetics company pay upwards or downwards, depending database to collect socio- deCODE Genetics) and Navigenics on how specific medicines perform over demographic, clinical and non-clinical offer more comprehensive versions of time (see Figure 2). information on patients suffering from this service for US$985 and US$2,500, various forms of cancer. The American The industry has already been forced respectively.26 Cheap gene sequencing Medical Group Association has set up to take the first steps down the path a system to let doctors share and disease disposition analysis will fuel to pay-for-performance. In the UK, for comparative outcomes data, so that popular demand for targeted medicines example, reimbursement of Velcade, they can treat their patients more and personalised healthcare. Johnson & Johnson’s new cancer effectively. And the International By 2020, electronic medical records, treatment, is contingent on proof of a Serious Adverse Events Consortium e-prescribing and remote monitoring measurable reduction in the size of a aims to develop genetic markers for will also give healthcare payers and patient’s tumour.28 Similarly, payment for identifying which individuals are at risk providers in many countries access Lucentis, Novartis’s therapy for age- of experiencing serious drug-related to extensive outcomes data, as we related macular degeneration, is subject adverse events. indicated in “Pharma 2020: The vision”. to a dose-capping scheme under which They will then be able to determine the company bears the costs of treating Figure 2: By 2020, pay-for-performance will be the norm in many countries Today Patient Prescription Payment 2020 Patient Prescription Outcome Medicine works/does not work Medicine is safe/unsafe Specified populations in which medicine works and is safe Payment based on performance Source: PricewaterhouseCoopers Pharma 2020: Marketing the future 7
  • 10. Table of contents any patient who requires more than 14 definition of what constitutes a “good” Recognising the injections.29 The British government now medicine will expand. In addition plans to extend this approach, with a to clinical considerations like safety interdependence of the flexible pricing system under which the and efficacy, it will include qualitative pharmaceutical and prices of new medicines can be raised, criteria – such as the extent to which if they prove more effective than initially a treatment makes patients feel better, healthcare value chains expected.30 enables them to keep working or The relationship between pharmaceutical US health insurer UnitedHealthcare reduces the cost of caring for them. companies, healthcare payers and is also piloting a performance-based providers is at best wary – and By 2020, we believe that pricing experiment with Genomic sometimes downright antagonistic. Yet pharmaceutical companies will therefore Health, which makes a genetic test analysis of their value chains suggests have to collaborate much more closely to identify which women with early- that they have far more in common than stage breast cancer would benefit from with everyone in the healthcare arena to provide a range of products and might first seem the case. chemotherapy.31 And, by 2020, we think that all new medicines will be paid for on services from which patients can pick In its simplest form, a value chain is the basis of the outcomes they deliver. and choose all but the core prescription, the series of activities an entity (either both to differentiate their offerings more singular or collective) performs to create However, most treatments perform value for its customers and thus for the effectively and to preserve the value much better in clinical trials than they entity itself. The pharmaceutical value of the medicines they make. More do in everyday life, partly because the chain starts with the raising of capital specifically, they will have to: level of compliance is much higher. to fund R&D and concludes with the Numerous clinical studies show, for • Recognise the interdependence of marketing and sale of the resulting instance, that most patients who the pharmaceutical and healthcare products. In essence, it is about making are taking statins can reduce their value chains innovative medicines that can command cholesterol to normal levels. But in one • Ensure that they invest in developing a premium price (see Figure 3). study of long-term compliance patterns, only 33% of patients were still using medicines the market really wants The payer value chain starts with the a statin at the end of 12 months, and raising of revenues through premiums, • Form a web of alliances to offer only 13% were still doing so at the taxes or out-of-pocket payments. supporting services end of five years.32 Thus, if Pharma is The payer then creates value for its to command premium prices for its • Develop comprehensive plans for customers (patients, policyholders and products in future, it will need to help marketing and selling specialist payers) by managing the administrative patients manage their health. Otherwise, therapies process and giving them access to it risks having to reduce its charges or medical care. The payer’s goal is thus • Create organisational cultures that to make a financial or political profit by even incurring financial penalties for failing to deliver all that it has promised. are suitable for marketing specialist maximising its revenues or reputation healthcare packages (with its customers or voters, depending To put it another way, good medicines • Manage multi-country launches and on whether it is a commercial enterprise will still be the cornerstone of any live licensing or government) and the quality of the pharmaceutical company’s marketing service it secures, while minimising its and sales strategy, but they will not • Adopt a more flexible approach to costs (see Figure 4). be sufficient in isolation. By, 2020, pricing; and prescription therapies will be only one The provider’s goal is to deliver a high of the components in a collection of • Build marketing and sales functions quality of care efficiently. This usually products and services from which that are fit for the future. means treating patients as economically patients can select. Furthermore, as the as possible, for as long as required. The balance of power shifts from Pharma provider value chain therefore begins to healthcare payers and patients, the with an analysis of the factors affecting 8 PricewaterhouseCoopers
  • 11. Figure 3: The pharmaceutical value chain Raising of Finance Research Development Manufacturing Marketing & Sales & Distribution (Via the capital (Target identification, (Clinical trials, (Process development, (Development of markets) synthesis & screening of submission of new scale-up, commercial promotional materials, molecule, in vitro and drug application to production, shipping to detailing, account & in vivo testing, initial regulators) brand management) warehouse) testing in man) Prevention Source: PricewaterhouseCoopers Figure 4: The healthcare payer value chain Raising of Finance Provision of Cover Medical Services Management Bill Payment (Through premiums, taxes or (Analysis of population (Practice guidelines, clinical (Referral management, out-of-pocket payments) at risk, administrative guidance, pharmacoeconomic monitoring & payment of services etc.) evaluations, formularies etc.) healthcare providers’ bills) Source: PricewaterhouseCoopers Note: Our diagram represents the key activities in the payer value chain, not the entity that performs a specific activity, since this clearly varies from one healthcare system to another. Figure 5: The healthcare provider value chain Analysis of Prevention Primary Care Secondary & Long-Term Care Population at Risk Tertiary Care (Epidemiological (Vaccinations, healthcare (Diagnosis, treatment, (Diagnosis & treatment of (Disease management, studies) advice etc.) minor surgery) serious illnesses, nursing care at home, in major surgery, emergency nursing homes & hospices) services, hospital care) Source: PricewaterhouseCoopers Note: Our diagram represents the key activities in the provider value chain. Again, different entities perform different activities in different healthcare systems. the health of a given population and policies and practices of the providers and, while they continue to clash, they the preventative measures that can be used. The value providers generate are struggling to attain their respective taken to forestall illness. Thereafter, it depends on the revenues payers raise goals. The quality of the care they progresses through the various stages and the medicines Pharma makes. And collectively deliver is lower, and the of treatment from primary care to long- the value Pharma generates depends cost higher, than it would otherwise term care (see Figure 5). on getting access to the patients whom be – and society can no longer afford providers serve and income from the such inefficiencies. So, if mankind is However, although these three value payers who fund those providers. to ensure that it gets the healthcare it chains are different, they are also heavily interdependent. The value healthcare In short, none of the three parties can needs, the three parties must be much payers generate depends on the do its job properly without the others more closely aligned. Pharma 2020: Marketing the future 9
  • 12. Table of contents We believe that creating feedback loops Investing in the play a key role in deciding whether a to capture outcomes data will help to medicine is innovative, using different close the gap. It will enable Pharma development of definitions of innovation at different both to establish a more dynamic medicines the market points in the product lifecycle (see relationship with payers and providers, sidebar, What is innovation?).33 and to play a bigger role in giving wants to buy The process starts with the researcher, patients the support they require. This One of the many areas in which Pharma who identifies the scientific potential of will ultimately result in the convergence needs to work much more closely with a particular molecule. It continues with of the separate, linear value chains that healthcare payers and providers is in the investor, who backs that belief with exist today into a single, circular value determining the sort of medicines the capital; the regulator, who approves the chain (see Figure 6). market actually wants to buy. We have labelling claim; and the pharmaceutical identified seven stakeholders who each company, which commits resources to Figure 6: By 2020, the pharmaceutical, payer and provider value chains will be much more closely intertwined Changes in epidemiology will Med influence the need for healthcare ica funding & Pharma’s research er lS C ov Primary care er vic priorities. Payers, providers & Se of tio n Te co n e Pharma will collaborate on en rtia da epidemiological studies. on ev s ry r y Pr M i ca vis an Payers will shift to outcomes-based & Pro ag re pricing. Pharma will collaborate with em Lo payers and providers to determine popul is of ng- ent at ris n which of the medicines in its pipeline atio term k s really add value and can thus Analy command the premium prices it care needs to maximise its return on Patient investment. Mark les Payers, in consultation with the ce of f ising & Sa medical profession, will issue clinical inan etin Ra guidelines. They will also give g providers incentives to prevent & manage disease, as distinct from Ra M n treating it. Pharma’s focus will shift to Di ufac a isi & ch t st the development of cures and en rib turin ar ng se ym fF uti g healthcare packages for helping Re a o on inan lP l patients comply with their medical Payer ce Development Bi regimens and manage the diseases Provider Pharma from which they suffer more effectively. Source: PricewaterhouseCoopers 10 PricewaterhouseCoopers
  • 13. the production and promotion of the What is innovation? treatment. Once a medicine has reached the market, it is the healthcare payer, Innovative products are typically defined as those which cure a disease or provider and patient, respectively, who condition; prevent a disease or condition; reduce mortality or morbidity; reduce the adjudicate on its innovativeness: the cost of care; improve the quality of life; are safer or easier to use; or improve healthcare payer by paying a premium patient compliance and persistence. Most industry experts also distinguish price for it; the provider by choosing it between “radical” and “incremental” innovation, although the distinction is not over other therapies; and the patient by always very helpful. Pharmaceutical companies often engage in a race to develop taking it as instructed or even pressing new products which all have the same mode of action, and the third or fourth for a prescription (see Figure 7). market entrant may be superior to the first or second. However, not all of these “referees” are equally important. If the sponsoring company is to recover its development costs and earn a return Figure 7: Seven stakeholders are involved in deciding whether a new product on its investment, any new products it is innovative launches must command a premium price while they are still under patent protection. The healthcare payer – be it Patient a government, health insurer, employer or patient – is therefore the ultimate Provider Regulator arbiter of whether or not a product is considered innovative, and the shift in Payer the balance of power from prescribers Researcher Investor Regulator Pharmaceutical company to payers will only increase that control. $ Yet, for many years, most pharmaceutical firms invested relatively little effort in understanding the payer’s perspective during the R&D process, and those that did so generally waited R&D 12 Years Marketing & Sales 8 Years until the end. This is why many of the medicines they have recently launched have failed to qualify as innovative. In Source: PricewaterhouseCoopers 2006, only five Big Pharma companies earned more than 10% of their revenues Table 2: Only eight truly innovative medicines were launched in 2007 from major products launched within the previous five years.34 Moreover, Country of there are no signs of any immediate Company Brand name Primary indication first launch improvement. In 2007, only eight Novartis Tekturna Hypertension US of the 27 new therapies launched GlaxoSmithKline Tykerb Breast cancer US worldwide were the first of their kind (see Table 2). More than half were PharmaMar Yondelis Soft tissue sarcoma UK, Germany “me-too” treatments with at least three Alexion Soliris Paroxysmal nocturnal US predecessors.35 haemoglobinuria A number of companies now look Pfizer Selzentri HIV US at whether the medicines they are GlaxoSmithKline Altabax Bacterial skin infections US developing are as effective as, or more LEO Pharma ATryn Thrombosis UK effective than, other existing therapies (and certain countries now require Bristol-Myers Squibb Ixempra Breast cancer US that they do so). Some firms also Sources: IMS Intelligence.360 (2008) and PricewaterhouseCoopers analysis Pharma 2020: Marketing the future 11
  • 14. Table of contents conduct extensive safety profiling in the commercial sphere. Indeed, they known examples being Genentech’s Phase II to reduce the risk of finding should review every compound in their partnership with DAKO to devise a test safety problems in Phase III, which pipelines, since no molecule that enters for identifying which patients with breast accounts for more than 25% of all R&D clinical development today will be cancer can benefit from Herceptin.39 costs.36 However, very few focus on launched before 2015, when the market However, Pharma will also have to enter demonstrating the superior economic for medicines will be even tougher the health management space, with value of their candidate molecules – and than it is now. Performing a rigorous compliance programmes, nutritional even fewer consider pricing before the assessment of what payers, providers advice, exercise facilities, health end of Phase III. and patients regard as innovation in screening and other such services. One Phase II will enable the industry to Two recent exceptions to this pattern firm that has already gone some way terminate any candidates that look point to a more constructive way down this road is Baxter Healthcare, unlikely to generate much demand forward. In late 2007, Novartis struck which offers a range of services for and concentrate its resources on more a groundbreaking deal with the patients suffering from renal failure. commercially promising products (see English National Institute for Health These services vary from country to Figure 8). and Clinical Excellence (NICE) under country, but they include a global which it agreed to pay the agency a educational website with customisable consultancy fee for advising it on the tools and information tailored to the design of a Phase III trial to measure Forming a web of needs of paediatric patients; a network the efficacy and cost-effectiveness of alliances to offer of nurses who provide dialysis training an experimental new drug.37 And, in at home or in hospital; a home delivery June 2008, GlaxoSmithKline took the supporting services service; and a travel service to support equally unprecedented step of giving peritoneal dialysis patients travelling The development of medicines the locally or globally.40 government healthcare officials in the market actually wants to buy will UK, France, Italy and Spain a say in Novo Nordisk has gone even further in not be enough, though. By 2020, deciding which compounds to progress its quest to “defeat diabetes”.41 In 2001, pharmaceutical companies will need through its pipeline.38 the company launched a global initiative to offer a suite of supporting services We believe that all pharmaceutical for the treatments they launch. A few called DAWN, in conjunction with the companies should adopt a similar companies have already paired up International Diabetes Federation, to approach and extend the concept to develop complementary therapies provide “psychosocial support” for of “de-risking” from the clinical to and diagnostics, one of the best patients with diabetes.42 It also operates a “National Changing Diabetes” programme in 66 countries, via which it Figure 8: Pharma needs to adopt a price de-risking strategy in early development provides training for medical staff, free blood sugar screening services, support Percentage of spending in each phase of R&D. 11.3% of spending uncategorized for diabetes patient organisations and equipment for diabetes clinics, as Preclinical Phase I Phase II Phase III Regulatory Phase IV well as working with governments to 25.7 5.8 11.7 25.5 6.9 13.3 improve the diagnosis and treatment of the disease.43 Point at which Point at which pharmaceutical pharmaceutical Meanwhile, Medtronic recently launched companies companies a wireless monitoring service for should be typically start thinking about thinking about patients with cardiac disease, which pricing to de-risk pricing enables them to send data from their their portfolios implanted devices directly to their Source: PricewaterhouseCoopers 12 PricewaterhouseCoopers
  • 15. doctors. The latest devices can even Developing a plan for Generics for free be programmed to update and send patient data automatically.44 And other marketing and selling San Diego based MedVantx has precedents for moving into health specialist therapies developed an automated system for management exist outside Pharma dispensing generics free at the point itself. In the UK, for example, insurance The industry’s changing product mix of care. When a doctor wants to giant Prudential has joined forces will act as yet another incentive to move give a patient a sample, the machine with Virgin Active Health Club to offer into health management. In the 1990s, dispenses a 30-day supply and logs the a critical illness policy that provides most of the medicines Pharma made transaction. The health insurer then pays subsidised gym membership and were primary-care therapies for diseases for the product. rewards people who exercise regularly afflicting large patient populations, The idea is to give doctors an by reducing their premiums.45 such as hypertension, diabetes, alternative to the free samples issued By 2020, this model will apply to the high cholesterol and depression. by pharmaceutical companies. Such industry as a whole. Some companies But genomics, proteomics and samples are popular with patients may choose to provide such services metabolomics are providing new tools because they provide an opportunity themselves, but most will function with which to develop larger molecules to try a medication before paying for it. as nodes for a network of providers, that more closely mimic naturally One pilot programme conducted by Blue including device manufacturers, occurring molecules in the human body. Cross & Blue Shield of Rhode Island is dieticians, health and fitness clubs, estimated to have reduced the insurer’s Biotech companies like Amgen, mobile telecoms operators and expenditure on medicines by nearly $2m. Biogen and Genentech were among compliance call centres. They will the first firms to capitalise on these be responsible for managing the scientific advances. However, many Generics for free).48 The opportunities mechanics of contracting and delivering pharmaceutical companies have now for developing primary-care treatments these services, and thus collectively redirected much of their investment providing healthcare packages that with the potential to command premium from chemical entities to proteins prices are thus shrinking rapidly. individual patients can tailor to their for specific cancers, immunological own needs. conditions and blood factor deficiencies Conversely, demand for specialist Moving into health management will not too. At least 400 of the 2,000-odd medicines is soaring. In 2007, 55 of the be easy, not least because the provision treatments currently in development 106 blockbusters on the market were are biologicals or protein-based specialist treatments, up from just 12 of services is very different from the compounds.46 in 2001.49 And IMS Health predicted provision of products. Nevertheless, this that sales of all specialist therapies route has several significant advantages. Increasing generic competition has could reach US$295-300 billion by the It will enable pharmaceutical companies reinforced this shift in the industry’s end of 2008, accounting for 44% of to generate new sources of revenue, research focus; as many of the products worldwide spending on prescription build stronger brands and forge closer developed in the 1990s come off patent, pharmaceuticals.50 relationships with the patients who generics manufacturers are filling an use their products and services. It will ever larger part of the primary-care Yet, although specialist medicines hold also help them to protect the value of space. Generics already account for huge clinical and commercial promise, the medicines they launch, both by 65% of all prescriptions dispensed they come with one major drawback: increasing compliance and by reducing in the US and for as many as 70% of their charging profile. Tufts Center the threat of getting locked out through all prescriptions dispensed in Central for the Study of Drug Development e-prescribing, since it is very much and Eastern Europe,47 a trend that will estimates that the cost of developing a easier to substitute a standalone product accelerate, as automated dispensing new biological is about US$1.2 billion, than it is a product which comes with systems neutralise the effect of nearly US$400m more than the average personalised satellite services. distributing free samples (see sidebar, for a small molecule.51 But specialist Pharma 2020: Marketing the future 13
  • 16. Table of contents Figure 9: Many specialist therapies cost thousands, or even hundreds of thousands, benefits and risks associated with using of dollars a year them and to communicate with an audience that is very well informed. Cancer Second, since specialist therapies cost such a lot, they attract far more Alpha-1 Proteinase Inhibitor Deficiency scrutiny before being approved for reimbursement – and reimbursement Pulmonary Arterial Hypertension is crucial, because few patients can afford to pay for them out of their own Haemophilia pockets. This trend will increase with the proliferation of more sophisticated Fabry’s Disease pharmacoeconomic models, reducing the opportunities for “hype”. It also Gaucher’s Disease means that anyone who promotes such medicines will need to have a “Bubble Boy” Syndrome clear grasp of the health economics underlying them. 0 100,000 200,000 300,000 400,000 Third, many specialist therapies are Average Price in US dollars used to treat patients with specific disease subtypes, so they must be Source: D. Stevens, “Specialty Pharmacy to Therapy Management: The Next Generation”, accompanied by a diagnostic. And presented at PCMA Specialty Pharmacy Annual Meeting, October 2005 since they are more difficult to get to the target site, they must generally therapies are currently used to treat value in the eyes of payers, providers be delivered by injection or infusion. conditions that affect only 3% of the and patients, not just those of the Many such therapies must thus be general population.52 A company that executives that have backed them. It administered by a doctor or nurse but, develops a specialist medicine must is also increasing the importance of even when patients can administer therefore amortise its investment the marketing and selling process. But their own medicines, they usually (including the money it spends on though most pharmaceutical firms have require intensive patient education marketing and sales) over a much recognised the potential of specialist and monitoring, especially in the early smaller number of patients. medicines, they continue to use a stages of treatment. marketing and sales model that was So it is not surprising that specialist This not only adds to the overall cost designed to promote primary-care therapies often sell for many thousands of using specialist therapies, it also products for mass-market consumption. of dollars (see Figure 9). Nor is it means that different payment centres surprising that healthcare payers In fact, specialist therapies have (and reimbursement procedures) everywhere are taking steps to slow a number of unique features that may be involved. In the US, for down their utilisation. If demand for differentiate them from conventional example, specialist treatments are such products were to grow at current medicines and mean that they must often reimbursed under a healthcare rates, the global market for specialist be marketed quite differently. First, payer’s medical benefit rather than they typically have a broader range its pharmaceutical budget. Similarly, therapies alone would be worth about of activity and greater potential to in the UK, the cost of monitoring and US$1.4 trillion by 2020, double the 1 generate an immune response. They maintaining patients on specialist US$712 billion the entire prescription are also prescribed by specialists rather medicines frequently falls on the primary products market was worth in 2007.53 than general practitioners. So anyone care trusts covering the areas in which The shift towards specialist therapies who is marketing such medicines those patients live, rather than the is thus accentuating the need to must possess considerable scientific hospitals that treated them in the develop healthcare packages that have knowledge – both to understand the first place. 14 PricewaterhouseCoopers
  • 17. Lastly, many specialist treatments must will therefore have to develop a at risk of experiencing health problems. be ordered as necessary, rather than comprehensive marketing and sales It can also, as we have already noted, kept in stock – partly because they strategy that is tailored to the distinctive generate additional revenues from the are so expensive and partly because characteristics of such products support services it provides. they have relatively short shelf lives. (see Table 3). It will have, among They must also be transported and other things, to offer complementary stored with much greater care than diagnostics and support services; to Creating a culture that small molecules, because they are appoint a smaller, smarter sales force much more fragile. Both these factors capable of engaging with powerful is suitable for marketing have considerable implications for healthcare payers and medical specialist healthcare the supply chain. The ability to “make specialists; to build a responsive direct to order” requires the integration of distribution network; and to invest much packages a company’s demand management more effort in educating patients. with its manufacturing, packaging and Selling specialist therapies and support But if it succeeds in doing these things, services as distinct from standalone distribution processes – changes that it can expect to enjoy a longer period small molecules has numerous other will necessitate a substantial capital of exclusivity and greater customer implications, and any pharmaceutical investment in new skills and supply loyalty, since biologicals are very company that wants to make the chain systems. difficult to manufacture and most transition will need to undergo even Any pharmaceutical company that patients are reluctant to switch from more sweeping changes. It will, for wants to sell specialist therapies one to another because they are more Table 3: Specialist therapies require different marketing and sales models from those used for mass-market medicines Mass-market medicines Specialist therapies Marketing implications Treat common illnesses Treat rare diseases and specific disease A much smaller target market subtypes Must generally be used with a diagnostic, which adds to the overall cost but improves compliance Relatively simple products Very complex products Require more scientifically educated sales representatives Typically prescribed by general Prescribed by specialists Require a much smaller sales force practitioners Low price per dose Very high price per treatment Require much more extensive proof of clinical efficacy Outcomes-based pricing Usually oral formulations Usually delivered by infusion or injection Require intensive patient education & monitoring Costs may be spread across different payment centres & budgets with different reimbursement procedures Relatively easy to manufacture Difficult to manufacture Less vulnerable to generic competition Easy to transport Require special distribution & storage facilities More expensive to ship & store Generally kept in stock Often delivered to order Must be supported by a much more flexible supply chain Source: PricewaterhouseCoopers Pharma 2020: Marketing the future 15
  • 18. Table of contents Many companies will likewise have to a more integrated environment. Various Playing by the rules recruit and train people with new skills, elements may have to be altered, The majority of pharmaceutical including: ranging from new cycle time targets companies have established for different steps in the R&D process • Researchers who are as capable of compliance programmes that are to new measures of effectiveness in considering commercial imperatives based on the guidelines the Office marketing and sales. like pricing and sales as they are of Inspector General of the US of considering scientific issues like Department of Health and Human Most companies will also have to safety and efficacy Services issued in April 2003. But they alter their corporate compliance have typically taken quite a reactive • Manufacturing experts who can programmes. At present, approach. They have concentrated manage the complex processes pharmaceutical compliance functions on mitigating legal risks, such as required to produce large molecules typically spend the bulk of their time violations of the US Anti-Kickback and drug-device combinations and resources monitoring the way in Statute, US False Claims Act, US that amalgamate different scientific which marketing and sales staff interact Foreign Corrupt Practices Act and disciplines with healthcare professionals, and various US state-level marketing • Supply chain managers who can ensuring that everyone complies with disclosure reporting laws. They have also added yet another layer handle chilled-chain distribution the existing legislation (see sidebar, of controls to those they use in their through multiple channels and Playing by the rules).54 But, as the existing business operations, rather supervise a large network of service industry shifts to specialist medicines, than creating integrated, value-adding providers payers and patients play a bigger part in compliance functions. • Health economists who can advise the purchasing process and a growing on the pricing and reimbursement number of companies offer healthcare example, have to decide whether to of new medicines, and provide input packages that include products and continue developing primary-care into the design of clinical trials for services supplied by other firms, so the medications or focus exclusively on candidate molecules compliance function’s responsibilities specialist therapies (as Genentech • Key account managers who will increase. It will have to monitor does). Similarly, it will have to decide can negotiate with increasingly communications with payers and what sort of business model it should powerful healthcare payers and patients; collect, analyse and report use – be it diversified, federated or one pharmacoeconomic assessment on information from third parties; and of various other permutations. agencies; and assume responsibility for managing Clearly, “hard” financial, operational • Disease management specialists a broader range of risks across the and legal criteria will play a big role in with a profound understanding of extended enterprise – all activities that shaping these choices but, whatever how to help patients through the will necessitate the acquisition of much path they take, most companies will disease lifecycle. better operational and information also have to make major cultural management skills. adaptations. They will have to build Finding people with the requisite skills much closer links between their R&D will not be easy, given the breadth of In short, focusing on the development of and marketing and sales functions to knowledge the industry requires and specialist medicines and services rather foster cross-disciplinary collaboration the battle for brains now being waged than primary-care blockbusters entails and ensure that the views of healthcare in almost every part of the world. Many making significant organisational and payers are fed into the development companies will therefore have to adopt cultural changes – some of which may process. One way of doing this is to new talent management strategies, as not be immediately obvious (see Table 4). create dual reporting relationships, well as ensuring that the performance And implementing these changes will with employees in R&D reporting to measures and incentive systems they take enormous effort. management in marketing and sales, use are aligned with the behaviour that and vice versa. will be needed to operate effectively in 16 PricewaterhouseCoopers
  • 19. Table 4: Specialist medicines require totally new organisational and cultural characteristics Blockbuster model Specialist model Strategy Development of mass-market Development of specialist medicines for treating specific blockbusters disease subtypes Generation of new prescriptions Cooperation with healthcare payers & providers to optimise the healthcare resource mix Responsibility for compliance & persistence Organisation Vertically integrated Networked Culture Fragmented, with separation of disciplines Integrated, with collaboration across disciplines & brands & brands R&D Restricted research agenda Comprehensive research agenda R&D silos Internal & external connectivity, partnering & adaptive trials Cumbersome decision-making processes Nimble decision-making processes Reward systems based on number rather Reward systems based on collaboration & commercial than quality of candidate molecules awareness Manufacturing Narrow product range Wide product range (including diagnostics, biomarkers & novel delivery technologies) Batch-based, “made to forecast” Flexible, “assembled to order” manufacturing manufacturing Six Sigma processes Unique manufacturing processes Distribution Traditional channels, primarily wholesalers Multiple channels, including direct distribution to patients or their healthcare providers Conventional distribution Chilled-chain distribution and storage Pricing What the market will bear, rebates & Pay-for-performance discounting Marketing & Sales Intensive detailing Individual negotiations with large healthcare payers; specialist advice for secondary & tertiary healthcare providers; & educational programmes for patients Based on differentiation of competing Based on treatment of specific disease states and medicines measurement of outcomes Source: PricewaterhouseCoopers Pharma 2020: Marketing the future 17