2. UpperQuadrant.com/PharmaLaunchSuite 1
Market Access Roadmap
How Barriers to Access can Cost Millions.
Bringing a Drug to Market
With today’s advances in research and
medical technology, biologics are
refreshing the pipeline of many
biotech/pharma organizations, large and
small. Further, this evolution to targeted
therapeutics reinforces the notion that the
industry is advancing towards personalized
medicine. This adaptation provides
assurance that plenty of money is, and will
continue to be, spent on drug research and
development to satisfy market needs.
Recently, the costs
associated with bringing a
drug to market have been
cited with great variability.
According to a 2013 Forbes
study, bringing a single drug
to market costs about $350
million, all before the first
prescription is written.
Importantly, though,
“because so many drugs fail, large
pharmaceutical companies that are
working on dozens of drug projects at once
spend $5 billion per new medicine.” The
Tufts Center for the Study of Drug
Development cited the cost as $2.5 billion.
While the actual cost is elusive and
difficult to quantify, one thing is certain –
it’s very expensive.
Before brand marketers, field reps, or
payer marketers formulate their respective
launch strategies, hundreds of millions of
dollars have already been sunk into the
product. Therefore it is vital that the
launch achieves deep market penetration
and favorable access, as quickly and
efficiently as possible.
The Financial Risk of a New Drug
A 2010 study published in Health
Economics found that the revenue of only 2
out of 10 new drugs ever meet or exceed
their R&D cost.
Drug development is not for the weak. It is
quite expensive and challenging, with
multiple points of failure that can kill a
drug long before it is launched and has a
chance to recoup its investment. Roughly
speaking, the process can be broken down
into five segments:
Discovery; Pre-Clinical
Safety Testing;
Clinical; Regulatory
Review & Approval
and; ultimately, the
Launch. Pitfalls that
can occur at any of
these points are
briefly described,
below:
 Discovery phase – a suitable
candidate may not be identified, or
if it is, it may not have a desirable
risk/benefit profile worthy of
progressing into pre-clinical safety
assessment.
 Pre-Clinical Safety Testing –
Candidates demonstrating potential
activity are run through a rigorous
battery of assessments designed to
predict potential toxicity prior to
entry into humans. During this
phase, many compounds will be
derailed due to damage to certain
organs or even potential
carcinogenity.
Before brand marketers, field
reps, or payer marketers
formulate their respective
launch strategies, hundreds of
millions of dollars have already
been sunk into the product.

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 Clinical Trial phase – During this
stage, unexpected safety issues may
present themselves, or it could be
determined that its medical
benefits are simply inadequate.
The basis of this phase is often a
cost-benefit analysis that leads to
the discontinuation of many once-
promising compounds.
 Regulatory Review & Approval
phase - FDA and other international
regulatory bodies may not approve
the use of a drug, limit its
applications, or otherwise restrict
its use. In other cases, regulators
may send the drug back for
additional analyses, pre-clinical
testing or clinical trials.
 Launch phase – Even after
regulatory approval, the drug may
not get favorable payer coverage,
or find itself buried under
requirements for prior-
authorization.
If a new drug makes it through the
gauntlet, and achieves FDA approval, it has
the chance to turn a profit for the
company. But even with favorable
coverage, high number
of lives with access, and
great market
penetration, things can
still go awry. Distribution
problems, high co-pays,
changes in patient’s
benefit design, and prior
authorization challenges
can all conspire to erode
potential revenue.
When considering the sunk costs associated
with R&D and approval, there is much
more money at stake during launch than
that dependent on market-access.
Statistics suggest that drugs that perform
poorly in the first year continue to
flounder going forward. As a result, there
is a powerful sense of urgency to get things
accomplished correctly the first time.
Organizational teams responsible for
market access, payer coverage, brand
marketing, and managed markets have a
fiduciary duty to facilitate a successful and
error-free launch.
The launch phase is the culmination of
years of expensive work, and by virtue of
its role, it is a critical make or break
checkpoint: every access-related error has
the potential to cost tens or even hundreds
of millions of dollars over time.
Bolstering Existing Drugs by
Tracking Access Post-Launch
Even when a drug has been on the market
for some time, it doesn’t mean that there
aren’t important steps that should be
taken to ensure prolonged late-lifecycle
success. Many pitfalls remain that can still
stifle revenue long after a successful drug
launch.
Reimbursement or contract issues can arise
at any time during the lifespan of a drug,
so it’s essential to identify, track and
mitigate problems as
soon as possible. For
example, if a physician
isn’t getting reimbursed
for a specialty drug that
they are prescribing,
they won’t likely
continue to prescribe
that drug. In many cases,
these unhappy doctors
may share their
frustration with their colleagues, further
limiting patient access.
Insurance contract changes also have the
potential to negatively impact coverage
and access numbers.
Pharma companies equipped to
identify, track, and monitor any
anomalies or potentially harmful
trends are the ones that will be
ensured continued brand success
throughout the lifecycle.

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Field reps are the key to identifying such
issues. If field reps are privy to these
types of problems and are empowered to
accurately articulate them to the main
office, the company is provided an
opportunity to quickly respond to the
problem, reducing risk to future revenue.
Identifying, tracking and monitoring any
anomalies or potentially harmful trends are
critical. Pharma companies equipped to
capture these valuable insights to access
barriers are the ones that will be ensured
continued brand success throughout the
lifecycle.
Preserving Market Share despite
New Competition
The pharmaceutical market place is quickly
evolving: yesterday’s blockbuster drugs do
not provide the guaranteed market share
that pharmaceutical companies have grown
to expect. Most all mainstream companies
are facing a serious threat from patent
expirations resulting in new competition
from generic drugs. These new generics
give insurance companies more options
when deciding which drug to cover.
In addition, competitors are hard at work
developing “me too” drugs, claiming
superiority due to enhanced convenience,
increased efficacy, decreased side effects,
or faster onset of action.
Both activities seriously dilute blockbuster
market share.
In short, post-launch isn’t a time to be on
auto-pilot; there are many factors that can
derail the success of a drug throughout its
lifecycle. Keeping a pulse on the market
and customers will allow companies to
maintain maximum market access and
favorable coverage.
Protecting Your Brand
Investment
Considerable resources are invested in
building and maintaining the field teams
that monitor payers and physicians.
Organizations that put forth a solid
investment here, will be rewarded with a
treasure trove of invaluable field
information.
Successful launch teams need to quickly
and efficiently collect and analyze field-
derived data. Poorly equipped
organizations may face a collection of
logistical problems. The simplest
approaches, such as sharing spreadsheets,
may either completely deter or make it
difficult for those in the field to efficiently
report critical information. As a result
companies employing such primitive
approaches face a huge disadvantage when
creating, adapting and executing a brand
strategy.
Upper Quadrant’s UQube Pharma gives
companies the tools necessary to glean
insights from the most important
information during launch: field data.
Pharma companies can utilize UQube’s
Pharma Launch Suite to track and report
on everything from payer interactions and
coverage details during launch, to contract
changes and access issues after launch.
A simple economic analysis suggests that
implementation of software designed to
easily give real-time insights, is required to
protect the millions of dollars already
invested prior to launch.
The UQube Pharma Launch Suite is
comprised of four main components that
are designed to make collecting field data
86% of the prescriptions filled in 2012
were generic drugs, compared to only
49% in 2000. – IMS Health’s ‘2014
National Prescription Audit’

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accurate, fast and easy during each phase
of a launch:
 Payer Coverage Tracker
 Access Issue Tracker
 Payer Contract Tracker
 Marketing Campaign Tracker
Three of the four Launch Suite components
help launch teams in creating and
maintaining favorable access:
The Payer Coverage Tracker aggregates
all payer-related data into a single, secure
location. This allows payer marketers to
see a holistic view of the number of lives
affected, gaps in coverage areas, and
coverage details by payer.
The Access Issue Tracker helps launch
teams to standardize how issues with
access and reimbursement are collected,
analyzed and reported, giving launch
teams insights to mitigate any potential
revenue loss.
The Payer Contract Tracker is a
convenient tool that launch teams can use
to organize all payer-specific contract
details, negotiation schedules, and
contract changes. This tool can easily
become the historical reference for
program updates and contract details.
This template can then be employed by
launch teams to identify trends or spikes in
contract changes.
To see more details or do request a demo on the Pharma Launch Suite visit
http://www.upperquadrant.com/PharmaLaunchSuite.