Direct-to-Consumer (DTC) Advertising
Amaldoss, W., He, Chuan. 2009. Direct-to-Consumer Advertising of Prescription Drugs: A Strategic Analysis. Marketing Science 28(3): 472-487
This paper proposes and tests a competitive model of DTC advertising. Potential implications of DTC advertising for generic drugs and over-the-counter drugs are also discussed.
Donohue, J.M., M. Cevasco, and M.B. Rosenthal. August 16, 2007. A Decade of Direct-to-Consumer Advertising of Prescription Drugs. New England Journal of Medicine 357(7):673-681.
This article examines industry-wide trends in spending by pharmaceutical companies on direct-to-consumer advertising and promotion to physicians during the past decade. It characterizes the drugs for which such advertising is used and assesses the timing of advertising after a drug is introduced. Finally, it examines trends in the FDA's regulation of drug advertising.
Frosch, D.L., P.M. Krueger, R.C. Hornik, et al. 2007. Creating Demand for Prescription Drugs: A Content Analysis of Television Direct-to-Consumer Advertising. Annals of Family Medicine 5(1):6-13.
This paper examines how television prescription drug advertisements attempt to influence consumers. Researches analyzed ads for factual claims they made about the target condition, how they attempted to appeal to consumers, and how they portrayed the medication and lifestyle behaviors in the lives of ad characters.
Government Accountability Office, Prescription Drugs: Improvements Needed in FDA’s Oversight of Direct-to-Consumer Advertising, November 2006.
This report examines the frequency of extraordinary price increases for brand-name prescription drugs from 2000 to 2008, the characteristics of the brand-name prescription drugs that had increases, and contributing factors.
Jeffords, J.M. April 28, 2004. Direct-to-Consumer Drug Advertising: You Get What You Pay For. Health Affairs Web Exclusive.
This article discusses drug manufacturers’ expenditures on direct-to-consumer advertising. It discusses the role of the federal government regulating DTC and proposes how to balance commercial free speech and consumer protection.
Kelly, P. April 28, 2004. Perspective: DTC Advertising’s Benefits Far Outweigh Its Imperfections. Health Affairs Web Exclusive.
Written by the president of a drug manufacturing company, this paper discusses the benefits of direct-to-consumer advertising. It focuses on consumer education and patient-physician interactions, while addressing key criticisms of prescription advertising.
Kravitz, R.L., R.M. Epstein, M.D. Feldman, et al. April 27, 2005. Influence of Patients’ Requests for Direct-to-Consumer Advertised Antidepressants. Journal of the American Medical Association 16(293):1992–2002.
The authors present their findings from a study of major depression and adjustment disorder and the effect of patients’ requests on doctor prescribing.
National Conference of State Legislatures, Marketing and Direct-to-Consumer Advertising (DTCA) of Pharmaceuticals, February 20, 2007.
This report is a compendium of state laws, filed bills not enacted, and related resources describing or affecting the marketing and advertising of pharmaceuticals, including disclosure of information relating to the practices.
Palumbo, F., and C. Mullins. 2002. The Development of Direct-to-Consumer Prescription Drug Advertising Regulation. Food and Drug Law Journal 57(3):423–444.
This article provides a historical overview on advertising prescription drugs directly to consumers.
Riggs, D.L., S.M. Holdsworth, and D.R. McAvoy. April 28, 2004. Direct-to-Consumer Advertising: Developing Evidence-Based Policy To Improve Retention And Comprehension. Health Affairs Web Exclusive.
This paper discusses potential methods to use direct-to-consumer advertising of prescription drugs to educate consumers about medications. It also proposes how evaluate the effectiveness and appropriateness of ads.
Weissman, J.S., D. Blumenthal, A.J. Silk, et al. April 28, 2004. Physicians Report On Patient Encounters Involving Direct-to-Consumer Advertising. Health Affairs Web Exclusive.
Based on a survey of over 600 physicians, this paper reports both positive and negative impacts of direct-to-consumer advertising on physician interactions with their patients and health outcomes of patients.
Cost Sharing and Cost Containment
Fairman, K.A. 2008. The Future of Prescription Drug Cost-Sharing: Real Progress or Dropped Opportunity? Journal of Managed Care Pharmacy 14(1): 70-82.
This paper presents a meta-analysis on prescription drug cost-sharing efforts, and makes recommendations for approaches and policies in the future.
Gibson, T.B., Ozminkowski, R.J., Goetzel, R. Z. 2005. The Effects of Prescription Drug Cost Sharing:A Review of the Evidence. The American Journal of Managed Care 11 (7): 730-740.
This study analyzes whether patients respond to increased cost sharing by substituting less expensive alternatives for medications with higher levels of copayments or coinsurance, and examines the evidence between cost sharing and use of essential or maintenance medications, health outcomes, process-of-care measures (such as medication adherence and discontinuation), and costs.
Goldman, D.P., G.F. Joyce, Y. Zheng. July 4, 2007. Prescription Drug Cost Sharing: Associations with Medication and Medical Utilization and Spending and Health. Journal of the American Medical Association 298(1):61-69.
This paper synthesizes evidence on the associations between cost-sharing features of prescription drug benefits and use of prescription drugs, use of nonpharmaceutical services, and health outcomes.
Hoadley, J., Georgetown University Health Policy Institute for the Kaiser Family Foundation, Cost Containment Strategies for Prescription Drugs: Assessing the Evidence in the Literature, March 2005.
This report provides descriptions and examples of over 30 prescription drug cost-control strategies used by markets and government, including utilization, pricing, and regulatory strategies.
RAND, Prescription Drug Cost Sharing: A Powerful Policy Lever to Use with Care, 2009.
This study examined the effect of prescription drug cost-sharing arrangements on drug costs and use, overall health care costs, and patient health.
Solomon MD, Goldman DP, Joyce GF, and Escarce JJ. 2009. Cost Sharing and the Initiation of Drug Therapy for the Chronically Ill. Archives of Internal Medicine 169 (8): 740–748.
This retrospective cohort study sought to identify cost sharing factors that contributed to reductions in the utilization of prescription drugs.
Thomas, C.P. 2008. How Prescription Drug Use Affects Health Care Utilization and Spending by Older Americans: A Review of the Literature. AARP Public Policy Institute.
This paper assesses the professional literature on the impact of prescription drug insurance and the use of prescription drugs on utilization and spending by the elderly on prescription drugs and non-drug health care services.
Importation
IMS Cambridge, The Future of Price Regulation in the U.S. Pharmaceutical Market, 2005.
This paper summarizes the pharmaceutical industry’s concerns about prescription drug importation, particularly as it pertains to pricing concerns and the Medicare Part D benefit.
Outterson, K., Kesselheim A. S. 2009. How Medicare Could Get Better Prices On Prescription Drugs. Health Affairs 28(5): w832-w841.
This study examines various options to reduce prescription drug spending without direct government price negotiations, including the expansion of generic and therapeutically equivalent substitution, increased formulary diversity, importation, and limited antitrust waivers.
Saatsoglou, P. 2004. Pharmaceutical Reimportation: Magnitude, Trends, and Consumers. Managed Care 13(3 Supp): 7-9.
This paper discusses differences in pharmaceutical prices between countries and quantities of drugs imported from Canada, and the demographic characteristics of individuals choosing to import their medications.
U.S. Department of Health and Human Services Task Force on Drug Importation, Report on Prescription Drug Importation, December 2004.
This report summarizes the federal government’s findings on the prospect of drug importation, based on meetings, written comments, and testimonies from constituents and experts.
Industry Trends
Express Scripts, Express Scripts 2008 Drug Trend Report, 2008.
This annual report from pharmacy benefit manager Express Scripts, discusses trends in prescription costs and utilization, as well as benefit design.
Express Scripts, Geographic Variation Trends in Prescription Use: 2000-2006, 2008.
This report provides state-specific information for prescription use for seven major therapy classes: antihyperlipidemics (for high cholesterol), antidiabetics, antihypertensives (for high blood pressure), gastrointestinal (for stomach and intestinal problems), antidepressants, analgesics/anti-inflammatories (painkillers), and estrogen.
FamiliesUSA, Big Dollars, Little Sense: Rising Medicare Prescription Drug Prices, June 2006.
This report examines the change in Part D drug prices for the most frequently prescribed drugs during the period November 2005 to April 2006 and how Part D drug prices currently compare to the prices secured by the VA.
FamiliesUSA, Big Dollars, Little Sense: Rising Medicare Prescription Drug Prices, June 2006.
This report examines the change in Part D drug prices for the most frequently prescribed drugs during the period November 2005 to April 2006 and how Part D drug prices currently compare to the prices secured by the VA.
Families USA, Profiting from Pain: Where Prescription Drug Dollars Go, July 2002.
Based on the financial reports of major U.S. pharmaceutical companies submitted to the Securities Exchange Commission in 2001, this report documents the spending of major U.S. drug manufacturers, focusing on company profits, expenditures on research, development, and marketing.
Government Accountability Office, Prescription Drugs: Price Trends for Frequently Used Brand and Generic Drugs from 2000 through 2004, August 2005.
This report examines the change in retail prices and other pricing benchmarks for drugs frequently used by Medicare beneficiaries and other individuals with health insurance from 2000 through 2004.
Government Accountability Office, Brand-Name Prescription Drug Pricing: Lack of Therapeutically Equivalent Drugs and Limited Competition May Contribute to Extraordinary Price Increases, 2009.
This report looks at the frequency of drug price increases from 2000-2008, the types of drugs that had price increases, and the factors that may have contributed to these increases.
Gross, D., American Association of Retired Persons Policy & Research, Prescription Drug Prices in Canada, June 2003.
This issue brief compares and contrasts key characteristics of pharmaceutical markets and prescription drug coverage in Canada and the United States and identifies factors that may contribute to any real differences in the financial burden of prescription drugs for older consumers.
Health Strategies Consultancy LLC for the Kaiser Family Foundation, Follow the Pill: Understanding the U.S. Commercial Pharmaceutical Supply Chain, March 2005.
This report explains the pricing and distribution path of prescription medications, and the major players affecting prices as drugs move from manufacturing sites through wholesale to distributors, to different pharmacies and finally reaching patients.
Herrick, D., National Center for Policy Analysis, Shopping for Drugs: 2004, October 2004.
The author presents and explains several techniques used by individual consumers to afford medicines, such as comparing prices, drug substitution, bulk buying, pill-splitting, generic drug substitution, and over-the-counter drug use.
Kaiser Family Foundation, Prescription Drug Trends Fact Sheet - September 2008 Update, 2008.
This updated fact sheet provides trend information about prescription drug expenditures and coverage, key factors that contribute to rising prescription spending, and efforts to contain certain rising drug costs.
Scherer, F.M. August 26, 2004. The Pharmaceutical Industry – Prices and Progress.The New England Journal of Medicine 351:927–932.
The author presents a history of the pharmaceutical industry, touching on research and development, patents, pricing, profits, and international price differentials.
Strunk, B., P. Ginsburg, and J. Cookson. June 2005. Tracking Health Care Costs: Declining Growth Trend Pauses in 2004. Health Affairs Web Exclusive.
This paper reports a deceleration in health spending, looking at the components underlying this pattern, including prescription drug spending.
Zuvekas, S.H. and J.W. Cohen. January/February 2007. Prescription Drugs and the Changing Concentration of Health Care Expenditures. Health Affairs 26(1):249-257.
This paper uses data from the 1996–2003 Medical Expenditure Panel Survey (MEPS) to explore why the concentration of health care expenditures has changed over time. It concludes that rapid growth in prescription drug spending, which is diffused over a large fraction of the population, versus slower growth in spending for inpatient care largely accounts for the recent change. The paper then discusses the potential implications for current cost containment and reform efforts.
Intellectual Property Rights and Patent Law
Frank, R.G. 2007. The Ongoing Regulation of Generic Drugs. New England Journal of Medicine 357(20): 1993-1997.
This study discusses the affect that governmental regulation of generic prescription drugs has on health care costs.
Gluck, M., Georgetown University Institute for Health Care Research and Policy for the Kaiser Family Foundation, Federal Policies Affecting the Cost and Availability of New Pharmaceuticals, July 2002.
This paper examines the federal government’s laws and policies in intellectual property protection, drug research and development, and prescription importation. It focuses on the laws and policies that regulate and influence patents and generic competition.
Kesselheim, A. S., Fischer, M. A., and Avorn, J. 2006. Extensions Of Intellectual Property Rights And Delayed Adoption Of Generic Drugs: Effects On Medicaid Spending. Health Affairs 25(6): 1637-1647.
This study examines potential savings based on the timing of availability of generic drugs.
National Institute for Health Care Management, Prescription Drugs and Intellectual Property Protection,August 2000.
This issue brief provides an overview of intellectual property protection and prescription drug spending, discussing prescription drug access and innovation.
Stein, P., and E. Valery. July/August 2004. Competition: An Antidote to the High Price of Prescription Drugs. Health Affairs 23(4):151–158.
This article analyzes the role of competition in prescription drug pricing and development. The authors discuss patent protections held by the private sector, and posit that government ownership of patents could significantly reduce prescription drug prices.
Strongin, R.J., National Health Policy Forum, Hatch-Waxman, Generics, and Patents: Balancing Prescription Drug Innovation, Competition, and Affordability, June 2002.
This background paper discusses intellectual property protection, competition, and access to prescription drugs as it pertains to patent law reform. It also reviews American intellectual property laws and the generic drug approval process.
Medicaid
Bruen, B.K., Miller, L.M. 2008. Changes In Medicaid Prescription Volume And Use In The Wake Of Medicare Part D Implementation. Health Affairs 27(1): 196-202.
This brief examines the major shift of prescription drug spending from Medicaid to Medicare following the implementation of the Medicare drug benefit program, as well its effect on enrollee prescription usage and generic drug production.
Cunningham, P.J. May/June 2005. Medicaid Cost Containment and Access to Prescription Drugs. Health Affairs 24(3):780–789.
This author uses state enrollment and cost containment strategy to show the efforts of these strategies on enrollees’ access to prescription drugs.
Frank, R.G., Newhouse, J.P. 2008. Should Drug Prices Be Negotiated Under Part D Of Medicare? And If So, How? Health Affairs 27(1): 33-43
This report assesses the cost-effectiveness of prescription drug pricing following the implementation of Medicare drug benefit program.
Gencarelli, D.M., National Health Policy Forum, Medicaid Prescription Drug Coverage: State Efforts to Control Costs, May 2003.
The author summarizes the Medicaid prescription drug benefit, explaining how states control prescription drug spending within Medicaid and the concerns associated with these strategies.
Government Accountability Office, Medicaid Outpatient Prescription Drugs: Estimated 2007 Federal Upper Limits for Reimbursement Compared with Retail Pharmacy Acquisition Costs, December 2006.
This report explores the potential effects of the average manufacturer price (AMP)-based federal upper limits (FULs) on retail pharmacies. It compares AMP-based FULs with the retail pharmacy acquisition costs, by estimating what the AMP-based FULs would have been if they had applied in 2006 and compared them with average retail pharmacy acquisition costs from 2006 for frequently used and high expenditure multiple-source outpatient prescription drugs in Medicaid.
Kaiser Family Foundation, An Update on the Clawback: Revised Health Spending Data Change State Financial Obligations for the New Medicare Drug Benefit, March 2006.
This issue update provides an overview of the state financing of the Medicare drug benefit. Revisions by the federal government due to updated health spending data has resulted in an estimated net decline in the amount states will send to the federal government in 2006 through the clawback of more than $700 million.
Kaiser Family Foundation, Resources on Dual Eligibles and Issues Related to Their Transition to the New Medicare Drug Benefit, December 2005.
This is a collection of information and publications on dual eligibles, their current drug coverage, and issues related to their transition to the new Medicare benefit.
Madden et al. 2008. Cost-Related Medication Nonadherence and Spending on Basic Needs Following Implementation of Medicare Part D. The Journal of the American Medical Association 299(16): 1922-1928.
This study sought to measure changes in cost-related medication nonadherence and forgoing basic needs to pay for drugs following Medicare Part D implementation.
Mello, M., D.M. Studdert, and T.A. Brennan. February 5, 2004. The Pharmaceutical Industry versus Medicaid- Limits on State Initiatives to Control Prescription-Drug Costs. New England Journal of Medicine 350:608–613.
The authors describe state cost-curbing and cost-saving strategies, using examples and data about cost and access to prescription drugs.
National Conference of State Legislatures, Recent Medicaid Prescription Drug Laws and Strategies, 2001-2007, August 2007.
This page describes legislative initiatives states are considering or have enacted to change their Medicaid programs in response to the challenges arising from increased demand for and higher costs of prescription drugs.
Safran et al. 2009. Prescription Coverage, Use and Spending Before and After Part D Implementation: A National Longitudinal Panel Study. Journal of General Internal Medicine 25(1): 10-17.
This study evaluates changes in Medicare beneficiaries’ prescription coverage, use and spending before and after Medicare Part D implementation.
Medicare
Frakt, A.B. and S.D. Pizer. July/August 2006. A First Look at the New Medicare Prescription Drug Plans. Health Affairs 25(4):w252-w261.
Using nationwide data, this article examines the availability, costs, and benefits of regional and local plans offering prescription drug benefits to beneficiaries. It focuses on stand-alone prescription drug plans and compares them with other Medicare health plans offering drug coverage.
Hoadley, J., The Commonwealth Fund, Medicare’s New Adventure: The Part D Drug Benefit, March 28, 2006.
This issue brief considers the types of prescription drug plans that initially entered the market; the shape the market and the benefit are taking; the drugs initially available through the plans offering the benefit; the success in enrolling beneficiaries; whether beneficiaries will have improved access to needed drugs; and the impact on the larger marketplace for prescription drugs.
Kaiser Family Foundation, Resources on the Medicare Prescription Drug Benefit
The Kaiser Family Foundation has a vast array of resources on the Medicare Drug Benefit (Part D), which was adopted in 2003 and implemented in January 2006. Highlights include:
Kaiser Family Foundation, The Medicare Prescription Drug Benefit - An Updated Fact Sheet, November 2009.
This updated fact sheet includes the latest information and data about the Medicare Drug Benefit, including a breakdown of the standard benefit, enrollment data and an update on additional low-income assistance.
Kaiser Family Foundation, The Federal Government's Authority To Regulate Advertising in Medicare, September 2008.
This policy brief explains the Centers for Medicare & Medicaid Services’ legal authority to regulate advertising and other information issued by the private companies that contract with the government to provide Medicare benefits.
Kaiser Family Foundation, Low-Income Assistance Under the Medicare Drug Benefit, December 2009.
This fact sheet provides an overview of the Medicare drug benefit and the additional subsidies available to certain eligible low-income beneficiaries.
Kaiser Family Foundation, Medicare Part D Spotlight: Part D Plan Availability in 2010 and Key Changes Since 2006, December 2009.
This spotlight uses information released by the Centers for Medicare and Medicaid Services (CMS) about Medicare Part D prescription drug plans that will be available in 2010. The brief provides an overview of the different options available in 2010 and highlights key changes from previous years.
Kaiser Family Foundation, Medicare Spending and Financing Fact Sheet, May 2009.
This updated fact sheet provides an overview of spending on the Medicare program, how the program is financed, and Medicare’s future financial outlook. It includes the latest available data on Medicare financing.
Lopert, R., Moon, M. 2007. Toward a Rational, Value-Based Drug Benefit for Medicare. Health Affairs 26(6): 1666-1673.
This study examines suggested changes to Medicare plan D to produce a more sustainable drug benefit program.
The National Committee to Preserve Social Security and Medicare, Price Negotiation for the Medicare Drug Program: It Is Time to Lower Costs for Seniors, October 2009.
This brief explores the impact of the prohibition on Medicare negotiating for lower drug prices for beneficiaries.
Shea, D.G., J.V. Terza, B.C. Stuart, et al. June 2007. Estimating the Effects of Prescription Drug Coverage for Medicare Beneficiaries. Health Services Research 42(3):933-949.
This study uses drug utilization data from the Medicare Current Beneficiary Survey from 1999—before coverage was available through Part D—to examine the relationship between insurance coverage and prescription drug utilization. It confirms that Medicare beneficiaries with coverage used more prescription drugs than those without.
Summer, L., P. Nemore, and J. Finberg, The Commonwealth Fund, Improving the Medicare Part D Program for the Most Vulnerable Beneficiaries, May 2007.
This report discusses some of the challenges vulnerable Medicare beneficiaries face in using Part D and makes specific recommendations to strengthen the program, including eliminating or amending the resource test, changing the rules for individuals needing long-term care services, and ensuring that funds for counseling are appropriately available.