throbber
PRESCRIPTION DRUG TRENDS
`
` October 2004
`
`
`
`Overview
`National attention is focused on prescription drugs because of
`rapidly rising prescription costs and issues relating to
`implementation of the new Medicare drug benefit. Growing
`concerns about the affordability of needed drugs, coupled
`with the significant profitability of drug manufacturers, are
`causing policymakers and others to consider new approaches
`to addressing drug costs.
`
`Rising Expenditures for Prescription Drugs
`Spending in the U.S. for prescription drugs was $162.4 billion
`in 2002, 4 times larger than the amount spent in 1990.
`Although prescription drug spending is a relatively small
`proportion (11%) of national health care spending, it is one
`of the fastest growing components, increasing at double-digit
`rates in each of the past 8 years. National prescription
`spending increased 15% from 2001 to 2002, compared to an
`8% increase for physician and clinical services and a 10%
`increase for hospital care (Figure 1).
`
`25%
`
`20%
`
`15%
`
`10%
`
`5%
`
`0%
`
`Figure 1
`Change in Selected National Health Expenditures, 1970-2002
`
`Average Annual Percent
`Change, Prior 10 Years
`
`14%
`13%
`
`13%
`
`13%
`
`10%
`
`8%
`
`Annual Percent Change
`20%
`
`11%
`
`6%
`
`6%
`
`6%
`
`4%
`
`3%
`
`6%
`
`4%
`
`15%
`
`10%
`
`8%
`
`1980
`
`1990
`
`1993
`
`1996
`
`1999
`
`2002
`
`Hospital Care
`
`Physician and Clinical Services
`
`Prescription Drugs
`
`
`Source: Data from Centers for Medicare and Medicaid Services at
`www.cms.hhs.gov/statistics/nhe/default.asp (National Health Accounts).
`
`Factors Driving Increases in Prescription Spending
`Three main factors are driving the increases in prescription
`drug spending (Figure 2):
`• the increasing number o prescriptions (utilization) wasf
`
`responsible for 42% of the overall increase in prescription
`spending from 1997-2002;
`
`• changes in the types of dugs used (with newer, higher-r
`
`priced drugs replacing older, less-expensive drugs)
`accounted for 34% of the increase; and
`
`• manufacturer price increases for existingdrugs
`accounted for 25% of the increase.
`
`Figure 2
`
`The Relative Contributions of Price, Utilization, and Types of
`Prescription Drugs Used to Rising Prescription Drug Expenditures,
`1997-2002
`
`Number of
`Prescriptions
`Dispensed
`
`42%
`
`34%
`
`Types of
`Prescriptions
`
`25%
`
`Manufacturer
`Price Increases
`
`
`Source: KFF analysis of price and utilization data from IMS Health and expenditure
`
`data from Centers for Medicare and Medicaid Services at
`www.cms.hhs.gov/statistics/nhe/default.asp (National Health Accounts).
`
`Among the key trends are:
`• Utilization. From 1993 to 2003, the number of
`prescriptions purchased increased 70% (from 2.0 billion
`to 3.4 billion), compared to a U.S. population growth of
`13%; the average number of prescriptions per capita
`increased from 7.8 to 11.8.1
`
`•
`
`•
`
`Price. Retail prescription prices (which reflect both
`manufacturer price changes for existing drugs and
`changes in use to newer, higher-priced drugs) have
`increased an average of 7.4% a year from 1993-2003,2
`more than double the average inflation rate of 2.5%.3
`
`Changes in Types of Drugs Used. TMost of the top-
`selling prescriptions are newer, higher-priced brand name
`drugs, whose availability is affected by the research and
`development (R&D) activities of pharmaceutical
`manufacturers and government-supported research.
`Manufacturer R&D spending increased from $12.7 billion
`in 1993 to an estimated $33.2 billion for 2003, with R&D
`4
`estimated to be 17.7% of sales in 2003. New drug use
`is also affected by the number of new drugs (new
`molecular entities) approved by the U.S. Food and Drug
`Administration, typically about 30 a year over the past 10
`5
`years, but only 21 in 2003.
`
`The Henry J. Kaiser Family Foundation is a non-profit, private operating foundation dedicated to providing information and analysis on health care issues to
`policymakers, the media, the health care community, and the general public. The Foundation is not associated with Kaiser Permanente or Kaiser Industries.
`2400 Sand Hill Road, Menlo Park, CA 94025 Phone: (650) 854-9400 Facsimile: (650) 854-4800 www.kff.org
`Washington, DC Office: 1330 G Street, NW, Washington, DC 20005 Phone: (202) 347-5270 Facsimile: (202) 347-5274
`
`Medac Exhibit 2081
`Koios Pharmaceuticals v. Medac
`IPR2016-01370
`Page 00001
`
`

`

`
`seeking supplemental rebates (26 states), and making more
`drugs subject to prior authorization (21 states).13
`
`Outlook for the Future
`U.S. spending for prescription drugs is projected to increase
`by 10.7 percent annually between 2004 and 2013.14 This is a
`slower growth rate than we have seen in recent years, with
`the slowdown due in part to fewer new drugs being
`introduced into the market, a reduction in direct-to-consumer
`advertising, the impending loss of patent protection for some
`leading drugs, new cost-sharing provisions in private
`insurance contracts, and a lower rate of price growth.15 On
`the other hand, implementation of the new drug benefit in
`Medicare is likely to increase aggregate drug spending by
`improving the financial access of elderly and disabled
`edicare beneficiaries to prescription drugs.
`M
`
`1 IMS Health website at www.imshealth.com and Census Bureau at
`www.census.gov. The 2003 number of prescriptions per capita (11.8)
`differs from the 10.8 on www.statehealthfacts.kff.org because the data
`come from different sources (IMS Health vs. Verispan).
`2 National Association of Chain Drug Stores, “Industry Facts-at-a-Glance,”
`at www.nacds.org, using data from IMS Health.
`3 Bureau of Labor Statistics at www.bls.gov.
`l 4 Pharmaceutical Research and Manufacturers of America, Pharmaceutica
`
`Industy Pofile, various years, at www.phrma.org/publications.
`r r
`5 US Food and Drug Administration at www.fda.gov/cder.
`6 Forune, April 5, 2004.
`t
`7 IMS Health website at www.imshealth.com. Physician promotion
`excludes amounts for professional meetings and events.
`8 US Department of Health and Human Services, Prescription Drug
`t t
`Coverage, Spending, Uilizaion, and Prices: Report to the President, April
`2000.
`9 Kaiser Family Foundation, Trends in Medicare Supplemental Insurance
`r
`and Presciption Drug Benefits, 1996-2001, M. Laschober, June 2004.
`10 Kaiser 2003 Health Insurance Survey, 2003.
`11 Kaiser Family Foundation/The Commonwealth Fund/Tufts-New England
`Medical Center, Seniors and Pescription Drugs Findings Fom a 2001
`r
`:
`r
`t
`r
`Survey of Senios in Eight Staes, July 2002, p.25.
`12 Kaiser Family Foundation and Health Research and Educational Trust,
`Employer Health Benefits: 2004 Annual Survey, September 2004.
`13 Kaiser Commission on Medicaid and the Uninsured, The Coninuing
`t
`t
`
`Medicaid Budget Challenge: Stae Medicaid Spending Growth and Cost
`r
`t
`Containment in Fiscal Years 2004 and 2005: Results fom a 50-Stae
`Survey, October 2004.
`14 Health Affairs, “Health Spending Projections Through 2013,” Feb. 11,
`2004, at www.healthaffairs.org. Note that this projection does not
`take into account the impact of the Medicare Modernization Act of 2003.
`15Health Affairs, “Health Spending Projections Through 2013,” Feb. 11,
`2004, at www.healthaffairs.org.
`
`
`
`For More Information
`This Fact Sheet (#3057-03) and the following reports are available on
`the Kaiser Family Foundation’s website at www.kff.org: Trends and
`Indicators in the Changing Health Care Marketplace, 2004 Update
`
`(#7031), Prescription Dug Trends—A ChartbookUpdate (#3112), r
`
`
`Medicare and Prescipion Drugs (#1583-06), Medicaid Prescription Drugr t
`
`Spending and Use (#7111), Medicaid and Presciption Drugs (#1609-02), r
`
`
`Federal Policies Affecing the Cost and Availability o New t f
`
`Pharmaceuticals (#3254), Employer Health Benefits, 2004 (#7148),
`
`Retiree Health Benef s Now and in the Future, (#6105). See also it
`www.statehealthfacts.kff.org for state-specific prescription drug
`utilization, sales, and average prices (under Health Costs & Budgets).
`
`
`
`
`From 1995-2002, pharmaceutical manufacturers were the
`nation’s most profitable industry. In 2003, they ranked third,
`with profits (return on revenues) of 14% compared to 5% for
`all Fortune 500 firms.6
`
`Both prescription use and shifts to higher-priced drugs are
`affected by advertising. Manufacturers spent $25.3 billion for
`advertising in 2003, with $22.1 billion (87%) directed toward
`physicians (including $16.4 billion for the retail value of drug
`samples), and $3.2 (13%) billion directed toward consumers.
`Spending for direct-to-consumer advertising -- typically to
`advertise newer, higher-priced drugs – was over 8 times
`greater in 2003 than in 1995.7
`Insurance Coverage for Prescription Drugs
`In 1996, 23% of nonelderly Americans had no drug coverage
`(more recent data are not available), including those without
`any health insurance for some or all of the year.8
`Additionally, more than a third (36%) of Medicare
`beneficiaries had no prescription drug coverage in the Fall of
`2001.9 Under the Medicare Prescription Drug, Improvement,
`and Modernization Act of 2003, Medicare will offer a
`voluntary prescription drug benefit beginning in 2006.
`
`Lack of drug insurance can have adverse effects. A recent
`survey found that 37% of the uninsured said they did not fill
`a prescription because of cost, compared to 13% of the
`insured.10 A 2001 survey of seniors in 8 states (42% of US
`adults age 65+) found that in the last 12 months, 35% of
`seniors without prescription drug coverage either did not fill a
`prescription 1 or more times or skipped doses of medicines to
`make the prescription last longer, compared to 18% with
`drug coverage.11
`
`Private and Public Responses
`Employer-sponsored health plans have responded to
`increasing prescription drug costs by establishing tiered cost-
`sharing formulas and increasing drug copayments. In 2004,
`a majority (68%) of workers with employer-sponsored
`coverage have at least 3 tiers of cost-sharing arrangements,
`two and a half times the proportion in 2000 (27%).
`Copayments for nonpreferred drugs (those not included on a
`formulary or preferred drug list) have increased 94% during
`the same time period, from an average of $17 per
`prescription in 2000 to $33 in 2004. Copayments for
`preferred drugs (those included on a formulary or preferred
`drug list, such as a brand name drug with a generic
`substitute) increased by 62%, from $13 in 2000 to $21 in
`2004.12
`
`Cost containment initiatives in the area of prescription drugs
`were implemented by 47 states and the District of Columbia
`in FY2004 for Medicaid, the public program that plays a key
`role in providing outpatient pharmacy services to the low-
`income population. These initiatives included making more
`drugs subject to prior authorization (33 states) and having
`preferred drug lists (27 states). For FY2005, 43 states have
`indicated they would implement new or additional pharmacy-
`related initiatives, including preferred drug lists (29 states),
`
`
`
`
`
`
`Page 00002
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket