This document provides an overview of prescription drug research and development. It discusses the long and costly process of developing new medicines, with high failure rates even in late-stage clinical trials. The pharmaceutical industry invested $48.5 billion in R&D in 2012, the majority of private biopharmaceutical R&D spending globally. New drug development aims to create entirely new classes of treatments or improve existing ones to help more patients.
5. INTRODUCTION
This chart pack provides facts and figures about prescription
medicines and their role in the health care system. Topics
include medicines’ impact on health and quality of life, the
drug discovery and development process, biopharmaceutical
spending and costs, the challenge of treatment gaps and
improving use of prescribed therapies, the marketing and
promotion of medicines, and the role of the biopharmaceutical
sector in the U.S. economy.
Data and information found in this publication were drawn
from a wide range of sources, including government agency
reports, peer-reviewed journals, and the Pharmaceutical
Research and Manufacturers of America’s (PhRMA’s) own
research and analysis. PhRMA hopes this publication provides
useful context for discussions about the role of medicines in
the U.S. health care system.
1
7. 1 ADVANCES IN
TREATMENT
Medicines’ Impact on Health and Quality of Life
Prescription medicines play a large role in saving and
improving lives. Over the last 25 years, prescription
medicines have significantly reduced deaths from major
diseases such as heart disease, several cancers, and
HIV/AIDS. They have also improved the quality of life for
people suffering from conditions such as arthritis and
Alzheimer’s disease. Recent advances have included, for
example, entirely new classes of treatments for diabetes,
hypertension, and HIV/AIDS; a new generation of
personalized medicines; and the very first treatments
for a number of rare diseases, such as Pompe disease
and Hunter syndrome. As our population ages and faces
increased rates of disease, medical advances will be key
to alleviating suffering.
1 • Advances in Treatment 3
8. U.S. Life Expectancy 1950–2011*
“While nutrition, sanitation, other public health measures, and expanded access to care have been major sources
of increasing human health, innovative medicines have also played a profound role in this progress.”
— The President’s Committee of Advisors on Science and Technology1
85
81.1
78.8 79.3
80
77.4
76.3
At Birth (in Years)
74.7 74.1
75 73.1
71.8
71.1
70
70
66.6 67.1
65.6
65
Women
Men
60
1950 1960 1970 1980 1990 2000 2011
*Life expectancies prior to 1997 were calculated using a slightly different methodology
than for those post-1997. Source: U.S. Centers for Disease Control and Prevention (CDC)2
1 • Advances in Treatment 4
9. Cardiovascular Disease:
Declining Rates of Death and Heart Failure
“Factors contributing to the decline in heart disease and stroke mortality include better control of risk factors,
improved access to early detection, and better treatment and care, including new drugs and expanded uses for
existing drugs.”
— U.S. Centers for Disease Control and Prevention3
U.S. Death Rates Due to Diseases of the Heart*
450
401.6 397.0
388.9
375.0
Age-adjusted Death Rates per 100,000
400
355.9
332.0
350 313.8 309.9
296.3
300 280.4
266.5
247.8
232.3
250 211.1
190.9 180.1
200 173.7
150
100
50
0
1979 1981 1983 1985 1987 1989 1991 1993 1995 1997 1999 2001 2003 2005 2007 2009 2011
*Age-adjusted death rates based on Year 2000 U.S. Standard Population. 1980–1998 causes of death are classified by
the Ninth Revision International Classification of Diseases (ICD-9). Beginning in 1999, causes of death are classified by
the Tenth Revision International Classification of Diseases (ICD-10). Source: CDC4
1 • Advances in Treatment 5
10. HIV/AIDS: Decline in Death Rates
The number of U.S. AIDS deaths decreased dramatically following the introduction of highly active antiretroviral
treatment (HAART) and has continued to decline.
Annual Number of AIDS Deaths in the United States
18
16
16.2
Deaths Per 100,000 Population
14
12 1996: HAART becomes widely available
10
8
6
6.0
5.3 5.0
4 4.7
4.2
3.7
2 3.1
2.5
0
1995 1997 1999 2001 2003 2005 2007 2009 2011
Source: CDC5
1 • Advances in Treatment 6
11. Cancers: Decline in Death Rates
According to the American Cancer Society, improvements in treatment contributed to the increase in cancer
survival.6
Percent Change by Decade in U.S. Death Rates from Cancer
4% 4.7%
3.9%
-1%
-6%
-7.6%
-11%
-15.5%
-16%
1970–1980 1980–1990 1990–2000 2000–2011
Source: CDC7
1 • Advances in Treatment 7
12. Rare Diseases: Drug Approvals for Rare Diseases
Have Increased
Rare diseases are those that affect 200,000 or fewer people in the United States. There are between 6,000 and
7,000 rare diseases affecting 25 million Americans.
Number of Drug Approvals for Rare Diseases*
450
400
350
300
250
200
1983: Orphan Drug Act passed
150
100
50
0
Cumulative Prior Orphan Drug Approvals New Orphan Drug Approvals
*Approvals for rare diseases include initial approvals of new medicines and subsequent
approvals of existing medicines for rare disease areas. Source: U.S. Food and Drug Administration (FDA)8
1 • Advances in Treatment 8
13. Future Impact: Need for New Treatments
for Alzheimer’s Disease
The development of a new treatment that delays the onset of Alzheimer’s could reduce Medicare and Medicaid
spending on patients with Alzheimer’s by more than $100 billion annually by 2030.*
Projected Annual Medicare & Medicaid Spending, With and Without New Treatment Advances (Billions)**
$1,000
Projected Medicare and Medicaid Spending
$900 Current Trajectory
Projection with Delayed Onset Treatment Advance
$800
$805
$700
$600
(in Billions)
$500 $529
$400 $443
$300
$297 $276
$200
$174 $157
$100 $140
$122 $122
$0
2010 2020 2030 2040 2050
*Assumes research breakthroughs that delay the average age of onset of Alzheimer’s disease by five years beginning in 2010.
**Projected savings to Medicare and Medicaid assume research breakthroughs that slow the progression of Alzheimer’s disease.
This would dramatically reduce spending for co-morbid conditions and expensive nursing home care. Source: Alzheimer’s Association9
1 • Advances in Treatment 9
14. Notes and Sources
1. Executive Office of the President (EOP), President's Committee of Advisors on Science and Technology. “Report to the President
on Propelling Innovation in Drug Discovery, Development, and Evaluation.” Washington, DC: EOP, September 2012.
2. U.S. Department of Health and Human Services (HHS), CDC, National Center for Health Statistics (NCHS). “Health, United States,
2008 With Chartbook.” Hyattsville, MD: HHS, 2009; 1950–2006 data from M. Heron, et al. “Deaths: Final Data for 2006.”
National Vital Statistics Reports 2009; 57(14): 5. Hyattsville, MD: NCHS. www.cdc.gov/nchs/data/nvsr/nvsr57/nvsr57_14.pdf
(accessed June 2010); 2007 data from J. Xu, et al. “Deaths: Final Data for 2007.” National Vital Statistics Reports 2010; 58(19):
13. Hyattsville, MD: NCHS. www.cdc.gov/nchs/data/nvsr/nvsr58/nvsr58_19.pdf (accessed June 2010); 2008–2009 data from K.
Kochanek, et al. “Deaths: Preliminary Data for 2009.” National Vital Statistics Reports 2011; 59(4): 28. Hyattsville, MD: NCHS.
www.cdc.gov/nchs/data/nvsr/nvsr59/nvsr59_04.pdf (accessed August 2011); 2010–2011 data from D.L. Hoyert and J. Xu.
“Deaths: Preliminary Data for 2011.” National Vital Statistics Reports 2012; 61(6): 5. Hyattsville, MD: NCHS.
www.cdc.gov/nchs/data/nvsr/nvsr61/nvsr61_06.pdf (accessed December 2012).
3. HHS, CDC, NCHS. “Health, United States, 2006 With Chartbook on Trends in the Health of Americans.” Hyattsville, MD: HHS,
2006. www.cdc.gov/nchs/data/hus/hus06.pdf (accessed December 2012).
4. CDC, NCHS, National Vital Statistics System. "Unpublished table NEWSTAN 79–98S created on 00/03/02: Age-Adjusted Death
Rates for 72 Selected Causes by Race and Sex Using Year 2000 Standard Population: United States, 1979–98." Mortality.
Atlanta, GA: CDC, 2002. www.cdc.gov/nchs/data/mortab/aadr7998s.pdf (accessed February 2013); D.L. Hoyert, et al. “Deaths:
Final Data for 1999.” National Vital Statistics Reports 2001; 49(8): 1–3. Hyattsville, MD: NCHS.
www.cdc.gov/nchs/data/nvsr/nvsr49/nvsr49_08.pdf (accessed February 2013); K.D. Kochanek, et al. “Deaths: Final Data for
2009.” National Vital Statistics Reports 2011; 60(3): 32. Hyattsville, MD: NCHS.
www.cdc.gov/nchs/data/nvsr/nvsr60/nvsr60_03.pdf (accessed December 2012); D.L. Hoyert and J. Xu. “Deaths: Preliminary
Data for 2011.” National Vital Statistics Reports 2012; 61(6): 28. Hyattsville, MD: NCHS.
www.cdc.gov/nchs/data/nvsr/nvsr61/nvsr61_06.pdf (accessed December 2012).
1 • Advances in Treatment 10
15. Notes and Sources
5. HHS, CDC, NCHS. “Health, United States, 2003 With Chartbook on Trends in the Health of Americans.” Hyattsville, MD: HHS,
2003; HHS, CDC, NCHS. “Health, United States, 2009 With Chartbook on Medical Technology.” Hyattsville, MD: HHS, 2010; 2007
data from J. Xu, K.D. Kochanek, and B. Tejada-Vera. “Deaths: Preliminary Data for 2007.” National Vital Statistics Reports 2009;
58(1): 5. Hyattsville, MD: NCHS. www.cdc.gov/nchs/data/nvsr/nvsr58/nvsr58_01.pdf (accessed December 2009); 2009 data
from K.D. Kochanek, et al. “Deaths: Final Data for 2009.” National Vital Statistics Reports 2011; 60(3): 41. Hyattsville, MD: NCHS.
www.cdc.gov/nchs/data/nvsr/nvsr60/nvsr60_03.pdf (accessed December 2012); 2011 data from D.L. Hoyert and J. Xu. “Deaths:
Preliminary Data for 2011.” National Vital Statistics Reports 2012; 61(6): 38. Hyattsville, MD: NCHS.
www.cdc.gov/nchs/data/nvsr/nvsr61/nvsr61_06.pdf (accessed December 2012).
6. American Cancer Society. “Cancer Facts & Figures, 2011.” Atlanta, GA: American Cancer Society, 2011.
www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-029771.pdf (accessed
December 2012).
7. HHS, CDC, NCHS. “Health, United States, 2011 With Special Features on Socioeconomic Status and Health.” Hyattsville, MD:
HHS, 2012; K.D. Kochanek, et al. “Deaths: Final Data for 2009.” National Vital Statistics Reports 2011; 60(3): 32. Hyattsville, MD:
NCHS. www.cdc.gov/nchs/data/nvsr/nvsr60/nvsr60_03.pdf (accessed December 2012); D.L. Hoyert and J. Xu. “Deaths:
Preliminary Data for 2011.” National Vital Statistics Reports 2012; 61(6): 28. Hyattsville, MD: NCHS.
www.cdc.gov/nchs/data/nvsr/nvsr61/nvsr61_06.pdf (accessed December 2012).
8. U.S. Food and Drug Administration (FDA), Office of Orphan Product Development. “Orphan Drug Designations and Approvals
Database.” Available at www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm (accessed December 2012).
9. Alzheimer's Association. “Changing the Trajectory of Alzheimer's Disease: A National Imperative.” Washington, DC: Alzheimer's
Association, May 2010.
1 • Advances in Treatment 11
16.
17. 2 RESEARCH AND
DEVELOPMENT
The Process of Drug Discovery and Development
More than 5,000 medicines are in development globally.
PhRMA member companies invested $48.5 billion in
biopharmaceutical research and development (R&D) in 2012,
accounting for the majority of private biopharmaceutical
R&D spending. Development of new medicines is a long
and high-risk process, and it has become more costly and
complex over the last decade. Even among the new drug
candidates reaching Phase III trials, about one-third fail.
Companies “race” to bring the first medicine in a class to
market, and just two in ten approved drugs are ultimately
commercial successes. Recent biopharmaceutical advances
— driven by scientific research and creative genius — would
have been impossible without a system of laws that provide
the structure, stability, and opportunity for the needed
investment.
2 • Research and Development 13
18. Medicines in Development by Regulatory Phase Globally
In 2011, 5,408 medicines* were in clinical development worldwide.
Phase I Phase II
2,164 2,329
Phase III
Regulatory 833
Review in
the United
States, 82
*Defined as single products which are counted exactly once regardless of the number of indications pursued. Source: Analysis Group1
2 • Research and Development 14
19. More than 900 Biologic Medicines in Development in 2013
Biologic medicines — large, complex molecules derived from living cells — frequently represent novel strategies
that have the potential to transform the clinical treatment of disease.
Number of Medicines in Development in 2013, by Therapeutic Category*
Autoimmune Disorders 71
Blood Disorders 43
A vast array of biologic
Cancers/Related Conditions 338 medicines are in
development, for
Cardiovascular Disease 58 example:
Diabetes/Related Conditions 28 • A monoclonal
Digestive Disorders 26 antibody to treat
juvenile rheumatoid
Eye Conditions 25 arthritis
Genetic Disorders 30 • Several cancer
vaccines for
Infectious Diseases 176 malignant
Musculoskeletal Disorders 34 melanoma
Neurologic Disorders 39
• A gene therapy to
treat bladder cancer
Respiratory Disorders 38
Skin Diseases 30
Transplantation 13
Other 58
0 50 100 150 200 250 300 350 400
*Some medicines are being explored in more than one therapeutic category. Source: PhRMA2
Source: Biotechnology Research Continues to Bolster Arsenal Against Disease with 633 Medicines in Development. PhRMA, 2008.
2 • Research and Development 15
20. Potential First-in-Class Medicines in the Pipeline
70% of drugs across the pipeline are potential first-in-class medicines.
Percentage of Projects in Development that are Potentially First-in-Class Medicines
in Selected Therapeutic Areas, 2011
Neurology 84%
Cardiovascular 81%
Cancer 80%
Psychiatry 79%
Immunology 72%
Diabetes 71%
HIV/AIDS 69%
Infections 57%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Source: Analysis Group3
2 • Research and Development 16
21. The Research and Development Process
Developing a new medicine takes an average of 10–15 years.
Source: PhRMA4
2 • Research and Development 17
22. Government and Industry Roles in Research & Development
Government and biopharmaceutical industry research complement one another.
PhRMA Member Companies: $48.5 Billion
Clinical Research
Clinical
Research
Translational
Research Translational Research
Basic
Basic Research Research
National Institutes of Health: $30.9 Billion*
*NIH spending is for FY 2012. PhRMA member companies’ spending is estimated for CY 2012.
PhRMA member companies account for the majority of private biopharmaceutical R&D spending.
Non-member company data are not included. Sources: PhRMA5; NIH Office of Budget6; adapted from E. Zerhouni7
2 • Research and Development 18
23. PhRMA Member Company R&D Spending
“The pharmaceutical industry is one of the most research-intensive industries in the United States.
Pharmaceutical firms invest as much as five times more in research and development, relative to their sales,
than the average U.S. manufacturing firm.”
— Congressional Budget Office (CBO)8
PhRMA Member Company R&D Expenditures: 1995–2012
$60
$50.7
$47.9 $47.4 $48.6 $48.5*
$50 $46.4
$43.4
Expenditures (Billions of Dollars)
$39.9
$40 $37.0
$34.5
$29.8 $31.0
$30 $26.0
$22.7
$21.0
$19.0
$20 $16.9
$15.2
$10
$0
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
*Estimated for CY 2012. Source: PhRMA9
2 • Research and Development 19
24. Drug Development Costs Have Increased
According to a 2007 study, it costs an average of $1.2 billion to develop one new drug.10 More recent studies
estimate the costs to be even higher.11
The Average Cost to Develop One New Approved Drug — Including the Cost of Failures
$1.4
$1.2
$1.2B
Billions (Constant Dollars, Year 2000)
$1.0
$0.8
$800M
$0.6
$0.4
$320M
$0.2
$140M
$0.0
mid-1970s mid-1980s late-1990s early-2000s
Sources: J.A. DiMasi and H.G. Grabowski10; J. Mestre-Ferrandiz, et al. and S.M. Paul, et al.11; J.A. DiMasi, et al.12
2 • Research and Development 20
25. Complexity of Clinical Trials Has Increased
During the last decade, clinical trial designs and procedures have become much more complex, demanding more
staff time and effort, and discouraging patient enrollment and retention.
Trends in Clinical Trial Protocol Complexity
Percentage
2000–2003 2008–2011
Change
Total Procedures per Trial Protocol (median)
105.9 166.6 57%
(e.g., bloodwork, routine exams, x-rays, etc.)
Total Investigative Site Work Burden
28.9 47.5 64%
(median units)
Total Eligibility Criteria 31 46 58%
Clinical Trial Treatment Period
140 175 25%
(median days)*
Number of Case Report Form Pages per
55 171 227%
Protocol (median)
*These numbers reflect only the “treatment duration” of the protocol. Source: K.A. Getz, et al. and Tufts Center for the Study of Drug Development13
2 • Research and Development 21
26. Illustrative Pharmaceutical Lifecycle
New pharmaceutical medicines face competition after a relatively short period on the market.
FDA Generics
Approval Enter Market
Most brand drugs
face competition
from other brands
Drug Development Brand Drug Lifespan Generics
Average time to develop a Average time on market
new medicine before generic entry
= 10–15 yrs = 11.8* yrs
*Refers to new drugs (i.e., excludes new forms of administration) with annual sales in 2008 of more than $100 million,
which accounted for 95% of the sales of new medicines exposed to generic competition. Sources: PhRMA14; H.G. Grabowski, et al.15
2 • Research and Development 22
27. Earlier and More Frequent Patent Challenges
by Generic Companies
On average, new brand drugs face generic competition after 11.8* years, but generic companies can
challenge patents as soon as 4 years after a brand enters the market.
Share of Brand Products that Ever Experienced a “Paragraph IV” Patent Challenge**
from a Generic Manufacturer, Among Those Facing Generic Entry in Year Listed
100%
Hundreds
80%
75%
60%
40%
20%
17%
0%
1995 2008
Year of First Generic Entry
*Refers to new drugs (i.e., excludes new forms of administration) with annual sales in 2008 of more than
$100 million, which accounted for 95% of the sales of new medicines exposed to generic competition.
**A generic company may file with FDA a Paragraph IV certification to “challenge” patents associated with
brand-name medicines, potentially allowing generic market entry before the patent expiration date. Source: H.G. Grabowski, et al.16
2 • Research and Development 23
28. Competing Medicines Race for Approval
By 1995, nearly all first-in-class medicines being approved already had potential competitors in
Phase II clinical testing.
Percentage of First-in-Class Medicines with a Competitor
Already in Phase II Clinical Testing at Time of Approval
100%
90%
90%
80%
70% 77%
71%
60%
50%
50%
40%
30%
20%
23%
10%
0%
1970s 1980–1984 1985–1989 1990–1994 1995–1999
Source: J.A. DiMasi and L.B. Faden17
2 • Research and Development 24
29. Increasing Competition Within Therapeutic Categories
The time a medicine is the only drug available in its therapeutic class has declined dramatically — from a median
of more than 10 years in the 1970s to less than two years by 1998.
Time Between Approval of First and Second Drugs in a Therapeutic Class
12
10
10.2
Median Number of Years
8
6
4
4.1
2
1.2
0
1970s 1980s 1990–2003
Year of Approval of First-in-Class Medicine
Source: Tufts Center for the Study of Drug Development18
2 • Research and Development 25
30. Few Approved Medicines are Commercially Successful
Ongoing investment in R&D depends on the commercial success of a few products that must make up for all the
rest, including those that never reach the market.
Just 2 in 10 Approved Medicines Produce Revenues that Exceed Average R&D Costs
$2,000
$1,880
After-Tax Present Value of Sales
$1,500
(Millions of 2000 Dollars)
$1,000
After-Tax Average R&D
$701
$500
$434
$299
$87
$162 $39 $21
$6 -$1
$0
1 2 3 4 5 6 7 8 9 10
New Medicine Introduced Between 1990 and 1994, grouped by Tenths, by Lifetime Sales
Source: J.A. Vernon, et al.19
2 • Research and Development 26
31. Accounting Treatment of R&D
Overstates Biopharmaceutical Profits
“Correctly accounting for R&D as a long-lived investment tends to reduce substantially, if not to eliminate
altogether, the inference that pharmaceutical companies are on average achieving supranormal profit returns.”20
— F.M. Scherer, AEI-Brookings Joint Center for Regulatory Studies
“...the standard accounting measure of profits overstates true returns to R&D-intensive industries, such as
pharmaceuticals, and makes it difficult to meaningfully compare profit levels among industries. Accounting
measures treat most R&D spending (except for capital equipment) as a deductible business expense rather than
as a capitalized investment. But the intangible assets that research and development generate — such as
accumulated knowledge, new research capabilities, and patents — increase the value of a company’s asset base.
Not accounting for that value overstates a firm’s true return on its assets.”21
— Congressional Budget Office
“Usual profit figures greatly overstate the industry’s economic profit rate.”22
— J.P. Newhouse, Harvard University
Sources: F.M. Scherer20; CBO21; J.P. Newhouse22
2 • Research and Development 27
32. Notes and Sources
1. Analysis Group. "Innovation in the Biopharmaceutical Pipeline: A Multidimensional View." Boston, MA: Analysis Group, January
2013. www.analysisgroup.com/uploadedFiles/Publishing/Articles/2012_Innovation_in_the_Biopharmaceutical_Pipeline.pdf
(accessed January 2013).
2. Pharmaceutical Research and Manufacturers of America. "Medicines in Development: Biologic Medicines." Washington, DC:
PhRMA, 2013.
3. Analysis Group, Op. cit.
4. Pharmaceutical Research and Manufacturers of America. "Drug Discovery and Development: Understanding the R&D Process."
Washington, DC: PhRMA, 2007. www.innovation.org/drug_discovery/objects/pdf/RD_Brochure.pdf (accessed February 2013).
5. Pharmaceutical Research and Manufacturers of America. “PhRMA Annual Membership Survey.” 2013.
6. National Institutes of Health (NIH), Office of Budget. “History of Congressional Appropriations, Fiscal Years 2000–2012.”
Bethesda, MD: NIH, 2012. http://officeofbudget.od.nih.gov/pdfs/FY12/Approp.%20History%20by%20IC)2012.pdf (accessed
February 2013).
7. Adapted from E. Zerhouni. “Transforming Health: NIH and the Promise of Research.” Transforming Health: Fulfilling the Promise
of Research. Washington, DC. November 2007. Keynote address. www.researchamerica.org/transforming_health_transcript
(accessed January 2013).
8. CBO. “Research and Development in the Pharmaceutical Industry.” Washington, DC: CBO, October 2006.
9. Pharmaceutical Research and Manufacturers of America. "PhRMA Annual Membership Survey." 1996–2012.
10. J.A. DiMasi and H.G. Grabowski. "The Cost of Biopharmaceutical R&D: Is Biotech Different?" Managerial and Decision
Economics 2007; 28: 469–479.
11. More recent estimates range from $1.5 billion to more than $1.8 billion. See e.g. J. Mestre-Ferrandiz, J. Sussex, and A. Towse.
“The R&D Cost of a New Medicine.” London, UK: Office of Health Economics, 2012; S.M. Paul, et al. “How to Improve R&D
Productivity: The Pharmaceutical Industry’s Grand Challenge.” Nature Reviews Drug Discovery 2010; 9: 203–214.
2 • Research and Development 28
33. Notes and Sources
12. J.A. DiMasi, et al. “The Price of Innovation: New Estimates of Drug Development Costs.” Journal of Health Economics 2003; 22:
151–185. Study findings originally reported in 2005 dollars. Based on correspondence with the study author, these figures were
adjusted to 2000 dollars.
13. K.A. Getz, R.A. Campo, and K.I. Kaitin. “Variability in Protocol Design Complexity by Phase and Therapeutic Area.” Drug
Information Journal 2011; 45(4): 413–420; updated data provided through correspondence with Tufts Center for the Study of
Drug Development.
14. Pharmaceutical Research and Manufacturers of America. "Drug Discovery and Development: Understanding the R&D Process."
Washington, DC: PhRMA, 2007. www.innovation.org/drug_discovery/objects/pdf/RD_Brochure.pdf (accessed February 2013).
15. H.G. Grabowski, et al. “Evolving Brand-name and Generic Drug Competition may Warrant a Revision of the Hatch-Waxman Act.”
Health Affairs 2011; 30(11): 2157–2166.
16. Estimate is based on sample of 200 New Molecular Entities (NMEs) experiencing first generic entry between 1995 and 2008.
The 11.8 refers to the market exclusivity period, which is defined as the time between launch of the brand-name version of the
drug and its first generic competitor. See H.G. Grabowski, et al. "Evolving Brand-name and Generic Drug Competition may
Warrant a Revision of the Hatch-Waxman Act." Health Affairs 2011; 30(11): 2157–2166.
17. J.A. DiMasi and L.B. Faden. "Follow-On Drug R&D: New Data on Trends in Entry Rates and the Timing of Development." Tufts
Center for the Study of Drug Development Working Paper. Boston, MA: Tufts Center for the Study of Drug Development,
September 2009.
18. Tufts Center for the Study of Drug Development. Unpublished data. March 2010. Median data for shorter time periods
published in: Tufts Center for the Study of Drug Development. “Marketing Exclusivity for First-in-Class Drugs Has Shortened to
2.5 Years.” Impact Report 2009; 11(5).
2 • Research and Development 29
34. Notes and Sources
19. J.A. Vernon, et al. “Drug Development Costs When Financial Risk Is Measured Using the Fama-French Three-Factor Model.”
Health Economics 2009; 19(8): 1002–1005; Drug development costs represent after-tax out-of-pocket costs in 2000 dollars for
drugs introduced from 1990–1994. The same analysis found that the total cost of developing a new drug was $1.3 billion in
2006. Average R&D costs include the cost of the approved medicines as well as those that fail to reach approval.
20. F.M. Scherer. “Pharmaceutical Innovation.” AEI-Brookings Joint Center for Regulatory Studies Working Paper 07–13. July 2007.
21. CBO. “Research and Development in the Pharmaceutical Industry.” Washington, DC: CBO, October 2006.
22. J.P. Newhouse. “How Much Should Medicare Pay for Drugs?” Health Affairs 2004; 23(1): 89–102.
2 • Research and Development 30
35.
36. 3 SPENDING AND COSTS
Biopharmaceutical Spending and Health Care Costs
Prescription medicines represent a small share of national
health spending. Since 2000, growth in prescription drug
spending has slowed markedly, while prices for prescription
medicines have risen in line with overall medical inflation.
Innovator pharmaceutical companies produce medical
advances through pioneering scientific work and large-scale
investments. The innovators’ work and investment lead both
to new medicines and, over time, to generic copies that
consumers use at low cost for many years.
Health plans use many tools — such as tiered formularies
and cost sharing — to steer use toward generics and lower-
cost medicines. Payers also typically require patients to pay
a higher share of the costs of medicines out-of-pocket
compared with other health services.
3 • Spending and Costs 32
37. Sharply Declining Prescription Medicine Spending
Growth: 1999–2011*
Spending growth for prescription medicines has slowed dramatically over the past decade, with historically low
rates of growth observed in recent years.
20%
18%
18.4%
16%
15.4%
14% 14.7%
14.0%
12%
10% 11.3%
9.2% 9.5%
8%
6% 6.5%
4% 5.2% 5.0%
2% 2.8% 2.9%
0.4%
0%
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
*Total retail sales including brand medicines and generics. Source: Centers for Medicare & Medicaid Services (CMS)1
3 • Spending and Costs 33
38. Medicines Account for a Small and Declining Share of
Health Spending Growth
Growth in Health Care Expenditures Attributable to Prescription Drugs, 1997–2011
100%
7%
17% 13%
90%
80%
70%
60%
50%
93%
83% 87%
40%
30%
Prescription Drugs
20%
All Other Health Care
10%
0%
1997–2001 2002–2006 2007–2011
Source: CMS2
3 • Spending and Costs 34
39. Retail Spending on Prescription Medicines is a Small Share
of Total U.S. Health Care Spending
Health Care Dollar, 2011
Prescription
Drugs
$0.10
Other*
$0.25
Government Hospital Care
Admin. & Net Cost
$0.34
of Private Health
Insurance
$0.06
Physician and
Home Health and Clinical Services
Nursing Home Care $0.22
$0.03
*Other includes dental, home health, and other professional services as well as durable medical equipment costs. Source: PhRMA analysis based on CMS3
3 • Spending and Costs 35
40. Growth in Prescription Medicine Prices Has Been in Line
with Other Health Care Prices
Consumer Price Index (Dec 1999 = 100)
235
Hospital & Related Services
215
195
175
All Medical Costs
155 Prescription Medicines
135 Consumer Price Index
115
95
Source: PhRMA analysis based on Bureau of Labor Statistics4
3 • Spending and Costs 36
41. More Than Four Out of Five U.S. Prescriptions
Are Filled with Generics
Generic Share* of Prescriptions Filled 1984–2012
90%
80% 84%
70%
71%
60%
50%
52%
40% 43%
30% 33%
20%
19%
10%
0%
1984 1990 1996 2002 2008 2012
*Generic share includes generics and branded generics. Sources: IMS5,6,7,8,9
3 • Spending and Costs 37
42. The U.S. Prescription Drug Lifecycle Promotes
Innovation and Affordability
Innovator pharmaceutical companies produce medical advances through pioneering scientific work and large-
scale investments. The innovators’ work and investment lead both to new medicines and, over time, to generic
copies that consumers use at low cost for many years.
Daily Cost of Top 10 Therapeutic Classes* Most Commonly Used by Medicare Part D Enrollees
$1.50
$1.50
Actual
Estimated
$1.20
$1.00
Cost per Day ($)
$0.90
$0.65
$0.60
$0.30
$0.00
*Ten therapeutic classes most commonly used by Part D enrollees in 2006 were: lipid regulators, ACE inhibitors, calcium
channel blockers, beta blockers, proton pump inhibitors, thyroid hormone, angiotensin II, codeine and combination products, Source: M.L. Aitken and E.R. Berndt10
antidepressants, and seizure disorder medications.
3 • Spending and Costs 38
43. Insurance Covers a Lower Share of Prescription
Drug Costs Than of Other Medical Services
On average, privately-insured consumers pay out-of-pocket more than 20% of their total prescription drug
spending, compared with 4% of spending for inpatient hospital care and 7% on hospital outpatient care.
Percentage of Spending for Each Type of Service Paid Out-of-Pocket:
Privately-insured People Under Age 65
40%
30%
20% 22%
17%
10%
9%
7%
4%
0%
Hospital Inpatient Hospital Outpatient Emergency Room Physicians Prescription Drugs*
*Includes brand & generic Sources: P.J. Cunningham11; PhRMA analysis based on Medical Expenditure Panel Survey (MEPS)12
3 • Spending and Costs 39
44. Powerful Purchasers Negotiate on Behalf of Patients
A small number of large purchasers dominate the U.S. prescription drug market.
Prescription Volume by Pharmacy Benefit Management (PBM) Companies, 2012
Company Number of Prescriptions Market Share (%)*
1. Express Scripts/Medco Health
1,411 million 29.5%
Solutions**
2. CVS/Caremark 775 million 16.2%
3. Argus Health Systems 504 million 10.5%
4. OptumRx, Inc. 319 million 6.7%
5. ACS, Inc. 250 million 5.2%
Top 5 PBMs Total 3,259 million 68.2%
Top 10 PBMs Total 4,107 million 85.9%
Top 15 PBMs Total 4,584 million 95.9%
All PBMs in U.S. 4,780 million 100%
*Figures may not sum to totals due to rounding.
**Medco was acquired by Express Scripts in April 2012. Figure for Express Scripts/Medco is the sum
of the individual script totals for each entity for the most recently reported 12 month period in 2012. Source: Atlantic Information Services, Inc.13
3 • Spending and Costs 40
45. In the U.S. System, Health Plans Have Powerful Tools to
Reduce Spending on Medicines
Tiered Copays Formularies Prior Authorization
Higher cost to patients for List of covered drugs Physicians required to justify
brands than for generics and medicine’s use before it’s
preferred brands covered
Payers drive nearly all use of
medicines to generics and
“preferred” brands.
Concentrated Purchasing Power Financial Incentives
Individual Pharmacy Benefit Managers Payments to physicians and/or
buy medicines for more people than
Step Therapy pharmacies for generic prescribing or
in entire European countries Patients must try and fail on switching patients to preferred drugs
alternatives before certain
medicines are covered
Source: IMS Health, Inc.14
3 • Spending and Costs 41
46. Newly Introduced Generics are Adopted Rapidly
When a generic version of a medicine becomes available for the first time, it can capture as much as 90% of the
market within 3 months.
Generic Share of Filled Prescriptions Following the Launch of a New Generic Osteoporosis Treatment
100%
Mail
Retail
80%
60%
Generic Use Rate
40%
20%
0%
0 7 14 30 60 90 120 150 180
Number of Days After Launch
Source: Express Scripts, Inc.15
3 • Spending and Costs 42
47. Medicines Account for a Small Share of Health Spending
Differences Between the United States and Other Countries
Per Capita Health Care Spending 2010, United States vs. Canada and Germany
$9,000
$8,233
$8,000
All Other Health Care Spending
$7,000
Prescription Drugs
$6,000
$5,000
$4,445 $4,338
$4,000
$3,000
94% of the 91% of the
$2,000 difference
$1,000
6% of the difference 9% of the difference
$0
Canada United States Germany
Source: PhRMA analysis based on Organisation for Economic Co-operation and Development16
3 • Spending and Costs 43
48. Notes and Sources
1. CMS. "National Health Expenditures by Type of Service and Source of Funds, CY 1960–2011." Baltimore, MD: CMS, 2012.
www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-
Reports/NationalHealthExpendData/NationalHealthAccountsHistorical.html (accessed January 2013).
2. Ibid.
3. PhRMA analysis based on CMS, “National Health Expenditures Projections 2011–2021." Baltimore, MD: CMS, 2012.
www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-
Reports/NationalHealthExpendData/NationalHealthAccountsProjected.html (accessed January 2013).
4. PhRMA analysis based on U.S. Bureau of Labor Statistics (BLS). “Consumer Price Index—All Urban Consumers, History Table.”
Washington, DC: BLS, 2012. www.bls.gov/cpi/#tables (accessed December 2012).
5. PhRMA analysis based on IMS Health, Inc. “IMS National Prescription AuditTM.” Danbury, CT: IMS Health, 2012.
6. IMS Health, Inc. “IMS Institute Reports U.S. Spending on Medicines Grew 2.3 Percent in 2010, to $307.4 Billion.” Danbury, CT:
IMS Health, 2010. www.imshealth.com/portal/site/imshealth/ (accessed August 2011).
7. PhRMA analysis based on IMS Health, Inc. “IMS National Prescription AuditTM.” Danbury, CT: IMS Health, 2011.
8. IMS Institute for Healthcare Informatics. “The Use of Medicines in the United States: Review of 2011.” Parsippany, NJ: IMS
Health, April 2012.
9. IMS Health, Inc. “IMS National Prescription Audit™: December 2012.” Danbury, CT: IMS Health, 2012.
10. M.L. Aitken and E.R. Berndt. “Medicare Part D at Age Five: What Has Happened to Seniors' Prescription Drug Prices?” Parsippany,
NJ: IMS Institute for Healthcare Informatics, July 2011.
www.imshealth.com/ims/Global/Content/Home%20Page%20Content/IMS%20News/IHII_Medicare_Part_D2.pdf (accessed
October 2012).
11. P.J. Cunningham. “Despite the Recession's Effects on Incomes and Jobs, the Share of People with High Medical Costs was Mostly
Unchanged.” Health Affairs 2012; 31(11): 2563–2570.
3 • Spending and Costs 44
49. Notes and Sources
12. PhRMA analysis based on Agency for Healthcare Research and Quality (AHRQ). “Medical Expenditure Panel Survey.” Rockville,
MD: AHRQ, 2009. www.meps.ahrq.gov/mepsweb/ (accessed December 2012). Prescription drug spending includes brand and
generic ingredients, pharmacy, and distribution costs. Estimates are not restricted to individuals with private coverage that
includes prescription coverage, which can be expected to account for less than 2%.
13. Atlantic Information Services, Inc. (AIS). “Pharmacy Benefit Survey Results: 4th Quarter 2012.” 2012. www.AISHealth.com
(accessed February 2013).
14. IMS Health, Inc. “IMS National Prescription Audit™: December 2012.” Danbury, CT: IMS Health, 2004–2012.
15. Express Scripts, Inc. “2009 Drug Trend Report.” St. Louis, MO: Express Scripts, April 2010. www.express-
scripts.com/research/research/dtr/archive/2009/dtrfinal.pdf (accessed February 2013).
16. PhRMA analysis based on Organisation for Economic Co-operation and Development (OECD). “OECD Health Data 2012—
Frequently Requested Data.” Paris, France: OECD Publishing, June 2012.
www.oecd.org/els/healthpoliciesanddata/oecdhealthdata2012-frequentlyrequesteddata.htm (accessed December 2012).
3 • Spending and Costs 45
50.
51. 4 OUTCOMES AND
SAVINGS
Overcoming Gaps in Treatment, Improving Outcomes, and
Reducing Costs through Better Use of Medicines
Undertreatment of chronic disease and less than optimal
use of prescribed medicines are significant public health
problems, costing the U.S. economy hundreds of billions of
dollars each year. Improved use of prescribed medicines,
however, can result in better health outcomes, lower costs
for other health care services, and increased worker
productivity.
4 • Outcomes and Savings 47
52. Most Americans Use Few or No Medicines — a Small Share
of People Fill the Majority of Prescriptions
The top 20% of people who used medicines accounted for almost two-thirds of all prescriptions filled in 2010.
100%
20% 64%
90%
80%
80%
70%
(39% of the
population
60% uses no
medicines)
50%
40%
30% 36%
20%
10%
0%
% of Population % of Prescription Fills
Source: MEPS1
4 • Outcomes and Savings 48
53. Medicines’ Changing Role in Recommended Care
Revisions to clinical guidelines based on the latest research have resulted in appropriate increases in the use of
medicines in recent years.
Changes in the size of the treatable population as target levels change, such as lower
targets for blood pressure, blood glucose, lipids
Changes in the number and type of recommended medicines — such as a shift from single
to combination therapy — to better control conditions
Changes in therapeutic regimen and duration to better control conditions, such as longer
continuation of treatment for depression
Source: R.W. Dubois and B.B. Dean2
4 • Outcomes and Savings 49
54. Failure to Prescribe the Indicated Treatment is the
Most Common Prescribing Quality Problem
RAND researchers report that failure to prescribe an indicated treatment is a far more common quality problem
than is inappropriate medicine use.
Quality Problems Among Vulnerable Older Patients
Failure to prescribe when called
50%
for by guidelines
Inadequate monitoring 36%
Inadequate education/
19%
continuity/ documentation
Inappropriate medication 3%
0% 10% 20% 30% 40% 50% 60%
Percentage of Quality Indicators Failed*
*Quality indicators were developed and implemented based on systematic literature reviews and multiple layers of expert judgment. Source: RAND Health3
4 • Outcomes and Savings 50
55. Diabetes:
An Example of Underdiagnosis and Undertreatment
Uncontrolled diabetes can lead to kidney failure, amputation, blindness, and stroke.
26 million Americans with DIABETES
19 million are DIAGNOSED 7 million are UNDIAGNOSED
16 million are TREATED 3 million are
• Blood sugar control (diet and exercise, medicines) • diagnosed but
• Testing to prevent complications • NOT TREATED
8 million receive some treatment
8 million are treated and have their
but their disease is
disease CONTROLLED
NOT SUCCESSFULLY CONTROLLED
8 million have
18 million have UNCONTROLLED diabetes
CONTROLLED diabetes
Sources: CDC4; National Health and Nutrition Examination Survey (NHANES)5
4 • Outcomes and Savings 51
56. Better Use of Medicines Improves Patient Health
Diabetes patients who take their medicines as prescribed experience fewer complications.
18%
15.9% 15.7%
16%
14% 13.0%
11.8%
12%
Likelihood of Event
10.8%
10.1%
10%
8.0% 7.8%
8%
5.8%
6%
4.0% 4.0%
4%
1.8%
2%
0%
Acute Myocardial Amputation/ Ulcer Cerebrovascular Neuropathy Renal Events Retinopathy
Infarction Disease
Non-Adherent Patients Adherent Patients
Source: T.B. Gibson, et al.6
4 • Outcomes and Savings 52
57. Recommended Medicines Can Save Lives and Dramatically
Improve Health
“...achieving effective blood pressure control would be approximately equivalent to eliminating all deaths from
accidents, or from influenza and pneumonia combined.”
— David Cutler, Ph.D., Harvard University
Annual Hospitalizations and Deaths Avoided through Use of Recommended Antihypertensive Medications
Annual Hospitalizations Avoided Annual Premature Deaths Avoided
Prevention Achieved:
833,000 86,000
Based on Current Treatment Rates
Potential Additional Prevention:
If Untreated Patients Received 420,000 89,000
Recommended Medicines
Source: D.M. Cutler, et al.7
4 • Outcomes and Savings 53
58. Prescription Medicines Are Part of the Solution to
Controlling Medical Spending
Better use of medicines reduces use of avoidable medical care, resulting in reductions in medical spending.
Adherence to Medicines Lowers Total Health Spending for Chronically Ill Patients
Drug Spending Medical Spending
$2,000
$1,058
$656 $429 $601
Difference in Annual Spending Between
Adherent and Nonadherent Patients
$0
-$1,860
-$2,000
-$4,337
-$4,413
-$4,000
-$6,000
-$8,000 -$8,881
-$10,000 Congestive Heart Failure Diabetes Hypertension Dyslipidemia
Source: M.C. Roebuck, et al.8
4 • Outcomes and Savings 54
59. Gaining Drug Coverage Reduced Other Medical Spending
The Medicare drug benefit increased access to medicines for those previously without drug coverage, resulting
in reduced non-drug medical spending9 and overall savings of $13.4 billion in 2007, the first full year of the
program.10
Average Reduction in Medical Spending in 2006 and 2007,
for Beneficiaries Gaining Drug Coverage through Part D
Average
Total
Spending
Reduction
per
-$816 Beneficiary
-$268
-$1,224
-$140
*Home health, durable medical equipment, hospice, and outpatient institutional services Sources: J.M. McWilliams, et al.9; C.C. Afendulis and M.E. Chernew10
4 • Outcomes and Savings 55
60. Better Use of Medicines Yields Significant Health Gains and
Savings on Other Services
In 2012, the CBO announced that its budget estimates would recognize reductions in other medical expenditures
associated with Medicare policy initiatives that increased the use of prescription medicines.11
Numerous studies demonstrate the value of better access to and use of medicines in improving health
outcomes and reducing use of other medical services:
• Better adherence to antihypertensive medications could save approximately
200,000 lives over 5 years.12
• Improved medication adherence among diabetes patients could prevent
more than 1 million emergency department visits and hospitalizations
annually, for potential savings of $8.3 billion each year.13
• Non-adherence has also been linked to excess hospitalizations for conditions
such as chronic obstructive pulmonary disease,14,15 osteoporosis,16 congestive
heart failure, hypertension, diabetes, and dyslipidemia,17 with costs of roughly
$170 billion per year.18
Sources: CBO11; J.E. Bailey, et al.12; A.K. Jha, et al.13; B.C. Stuart, et al.14; L. Simoni-Wastila, et al.15 R. Halpern, et al.16; M.C. Roebuck, et al.17; and W.H. Schrank et al.18
4 • Outcomes and Savings 56
61. High Cost-Sharing Reduces Adherence
RAND researchers found that doubling co-pays reduced patients’ adherence to prescribed medicines by 25% to
45% and increased emergency-room visits and hospitalizations.
Percent Change in Adherence from Doubling Medicine Co-pays
0%
Percent Change in Days Supplied of Medicine
-5%
-10%
-15%
-20%
-26% -26% -25%
-25%
-30% -33% -32%
-34%
-35%
-40%
-45% -44%
-45%
-50%
Source: D.P. Goldman, et al.19
4 • Outcomes and Savings 57
62. New Classes of Medicines Can Improve
Adherence and Persistence
Studies have found better adherence to newer medicines.20 Similar results have been found even when insurance
requires higher patient cost-sharing for the newer medicines compared to older medicines.21
Persistence Patterns Among Antihypertensive Patients, by Drug Class
60%
Prescribed Therapy After 48 Months
Percentage of Patients Adhering to
50%
51%
47%
40%
41%
35%
30%
20%
16%
10%
0%
Thiazide Diuretics (1957) Beta Blockers (1967) Calcium-Channel Blockers ACE Inhibitors (1981) ARBs (1995)
(1981)
Drug Class (Year of First Launch22)
Sources: P.R. Conlin, et al.20; D.A. Taira, et al.21; FDA22
4 • Outcomes and Savings 58
63. Notes and Sources
1. IHS Global Insight Analysis based on 2010 Medical Expenditure Panel Survey (MEPS). http://meps.ahrq.gov/mepsweb/ (accessed
December 2012).
2. R.W. Dubois and B.B. Dean. “Evolution of Clinical Practice Guidelines: Evidence Supporting Expanded Use of Medicines.” Disease
Management 2006; 9(4): 210–223.
3. RAND Health. "U.S. Healthcare Facts About Cost, Access, and Quality." Santa Monica, CA: RAND Corporation, 2005 citing T.
Higashi, et al. "The Quality of Pharmacologic Care for Vulnerable Older Patients." Annals of Internal Medicine 2004; 140(9): 714–
720.
4. CDC. "National Diabetes Fact Sheet: National Estimates and General Information on Diabetes and Prediabetes in the United
States, 2011." Atlanta, GA: HHS, CDC, 2011. www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf (accessed December 2012).
5. IHS Global Insight Analysis based on 2010 National Health and Nutrition Examination Survey (NHANES), Op. cit.
6. T.B. Gibson, et al. “Cost Sharing, Adherence, and Health Outcomes in Patients with Diabetes.” American Journal of Managed Care
2010; 16(8): 589–600.
7. D.M. Cutler, et al. “The Value of Antihypertensive Drugs: A Perspective on Medical Innovation.” Health Affairs 2007; 26(1): 97–
110.
8. M.C. Roebuck, et al. “Medication Adherence Leads to Lower Health Care Use and Costs Despite Increased Drug Spending.”
Health Affairs 2011; 30(1): 91–99.
9. J.M. McWilliams, A.M. Zaslavsky, and H.A. Huskamp. “Implementation of Medicare Part D and Nondrug Medical Spending for
Elderly Adults with Limited Prior Drug Coverage.” JAMA 2011; 306(4): 402–409.
10. C.C. Afendulis and M.E. Chernew. “State-Level Impacts of Medicare Part D.” American Journal of Managed Care 2011; 17 Suppl
12:S.
11. CBO. “Offsetting Effects of Prescription Drug Use on Medicare’s Spending for Medical Service.” Washington, DC: CBO, November
2012.
12. J.E. Bailey, et al. “Antihypertensive Medication Adherence, Ambulatory Visits, and Risk of Stroke and Death." Journal of General
Internal Medicine 2010; 25(6): 495–503.
4 • Outcomes and Savings 59
64. Notes and Sources
13. A.K. Jha, et al. “Greater Adherence to Diabetes Drugs is Linked to Less Hospital Use and Could Save Nearly $5 Billion Annually.”
Health Affairs 2012; 31(8): 1836–1846.
14. B.C. Stuart, et al. “Impact of Maintenance Therapy on Hospitalization and Expenditures for Medicare Beneficiaries with Chronic
Obstructive Pulmonary Disease.” American Journal of Geriatric Pharmacotherapy 2010; 8(5): 441–453.
15. L. Simoni-Wastila, et al. “Association of Chronic Obstructive Pulmonary Disease Maintenance Medication Adherence With All-
Cause Hospitalization and Spending in a Medicare Population.” American Journal of Geriatric Pharmacotherapy 2012; 10(3):
201–210.
16. R. Halpern, et al. “The Association of Adherence to Osteoporosis Therapies with Fracture, All-Cause Medical Costs, and All-
Cause Hospitalizations: A Retrospective Claims Analysis of Female Health Plan Enrollees with Osteoporosis.” Journal of
Managed Care Pharmacy 2011; 17(1): 25–39.
17. M.C. Roebuck, et al. “Medication Adherence Leads To Lower Health Care Use And Costs Despite Increased Drug Spending.”
Health Affairs 2011; 30(1): 91–99.
18. W.H. Schrank, et al., "A Blueprint for Pharmacy Benefit Managers to Increase Value." American Journal of Managed Care 2009;
15(2): 87–93.
19. D.P. Goldman, et al. “Pharmacy Benefits and the Use of Drugs by the Chronically Ill.” JAMA 2004; 291(19): 2344–2350.
20. P.R. Conlin, et al. “Four-year Persistence Patterns Among Patients Initiating Therapy with the Angiotensin II Receptor Antagonist
Losartan Versus Other Antihypertensive Drug Classes.” Clinical Therapeutics 2001; 23(12): 1999–2010.
21. D.A. Taira, et al. “Copayment Level and Compliance with Antihypertensive Medication: Analysis and Policy Implications for
Managed Care.” American Journal of Managed Care 2006; 12(11): 678–683.
22. U.S. Food and Drug Administration. “Drugs@FDA: FDA Approved Drug Products.”
www.accessdata.fda.gov/scripts/cder/drugsatfda/ (accessed July 2010).
4 • Outcomes and Savings 60
65.
66. 5 MARKETING AND
PROMOTION
Informing Consumers and Providers about Medicines
Biopharmaceutical marketing and promotion are important
and extensively regulated ways of informing consumers and
health care professionals about medicines.
Biopharmaceutical company representatives help speed the
dissemination of improvements in medical care, and many
physicians value this information.
Direct-to-consumer advertising (DTCA) by biopharmaceutical
companies can lead patients to seek additional information
and consult their doctors about previously untreated
conditions; it also informs patients about medicines’ risks
and benefits.
While marketing and promotion increase awareness of
medical treatment options, other factors, including
formulary design and utilization-management strategies,
often have a greater impact on prescribing decisions.
5 • Marketing and Promotion 62
67. Many Factors Affect Prescribing Decisions
Factors Influencing Prescribing Decisions in the United States in 2011
Clinical knowledge and experience 84% 13%
Patient's particular situation, including drug interactions,
side effects, and contraindications
80% 16%
Clinical practice guidelines 53% 39%
Articles in peer-reviewed medical journals 47% 42%
Information from colleagues and peers 40% 49%
Patient's insurance coverage and formulary 40% 41%
Information from pharmaceutical company representatives 18% 51%
Pharmaceutical company-sponsored educational programs
featuring physician speakers, not CME
17% 47%
Information from insurance and prescription benefits manager
representatives
15% 40%
A great deal Some
Source: KRC Research (survey of physicians)1
5 • Marketing and Promotion 63
68. Physicians Find Biopharmaceutical Representatives’
Information Up-to-date, Useful, and Reliable
Physicians’ Assessment of Biopharmaceutical Representatives’ Information
Up-to-date and timely 38% 56% 94%
Useful 32% 60% 92%
Reliable 27% 57% 84%
Strongly agree Somewhat agree
Source: KRC Research (survey of physicians)2
5 • Marketing and Promotion 64
69. Advertising Often Prompts Patients to Seek
Additional Information
Consumer Responses to Viewing Advertisements for Prescription Medicines
50%
45% 47%
40%
35%
30%
25% 27%
20%
15%
14%
10%
5% 8%
0%
Sought Information Initiated Conversation Newly Aware of Requested Specific
with Doctor Medical Condition Medication
Source: Princeton Survey Research Associates International3
5 • Marketing and Promotion 65