Direct-to-Consumer (DTC) Advertising
Congressional Budget Office. 2011. Potential Effects of a Ban on Direct-to-Consumer Advertising of New Prescription Drugs.
This brief examines some of the effects of such a moratorium, drawing on data documenting direct-to-consumer advertising and other promotional activities used by pharmaceutical producers as well as academic analyses of how advertising has affected the market for drugs.
Dieringer N, L Kukkamma, G Somes, & R Shorr. 2011. Self-Reported Responsiveness to Direct-to-Consumer Drug Advertising and Medication Use: Results of a National Survey. BMC Health Services Research 11(1): 232.
This survey explores the relationship relating patterns of medication use to patient responsiveness to direct-to-consumer marketing.
Frosch D, D Grande, D Tarn, & R Kravitz. 2010. A Decade of Controversy: Balancing Policy With Evidence in the Regulation of Prescription Drug Advertising. American Journal of Public Health 100(1): 24-32.
The authors reviewed empirical evidence addressing the claims made in the policy debate for and against DTCA.
Greene J & D Herzberg. 2010. Hidden in Plain Sight: Marketing Prescription Drugs to Consumers in the Twentieth Century. American Journal of Public Health 100(5): 793-803.
The authors examine the continuity of efforts to promote prescription drugs to consumers and the public health significance of contemporary pharmaceutical marketing practices.
Huh J, D DeLorme, L Reid & S An. 2010. Direct-to-Consumer Prescription Drug Advertising: History, Regulation, and Issues. Minnesota Medicine 93(3): 50-52.
This article traces the history of direct-to-consumer advertising of prescription and over-the-counter medications and describes how drug advertising is regulated and by whom. It also discusses the controversies that surround direct-to-consumer marketing of prescription drugs.
National Conference of State Legislatures, Marketing and Direct-to-Consumer Advertising (DTCA) of Pharmaceuticals, 2009.
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.
Cost Sharing and Cost Containment
Costa F & M Gemmill Toyama. 2011. Does Cost Sharing Really Reduce Inappropriate Prescriptions Among the Elderly? Health Policy 101(2): 195-208.
This paper examines the effect of cost sharing for prescription drugs in some dimensions of medication-related quality, namely the probability of inappropriate prescription drug use.
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, C Mclaughlin, & D Smith. 2010. Generic Utilization and Cost-Sharing for Prescription Drugs. Advances in Health Economics and Health Services Research 22: 195-219.
This study estimates the own- and cross-price elasticity of brand-name out-patient prescription drug cost-sharing for maintenance medications and estimates the effects of changes in the price differential between generic and brand-name prescription drugs.
Goldman, D.P., G.F. Joyce, Y. Zheng. 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.
Hartung D, M Carlson, D Kraemer, D Haxby, K Ketchum, & M Greenlick. 2008. Impact of a Medicaid Copayment Policy on Prescription Drug and Health Services Utilization in a Fee-for-Service Medicaid Population. Medical Care 46(6): 565-572.
The authors researched the impact of a copay policy for prescription drugs on medication and health services utilization overall and among subjects with several common chronic diseases enrolled in a state Medicaid program.
Hoadley, J. 2012. Adapting tools from other nations to slow U.S. prescription drug spending. National Institute for Healthcare Reform.
This policy analysis examines two approaches from other countries that can be applied in the U.S. to reduce spending on prescription drugs.
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.
Reiss S, D Ross-Degnan, F Zhang, S Soumerai, A Zaslavsky & J Wharam. 2011. Effect of Switching to a High-Deductible Health Plan on Use of Chronic Medications. Health Services Research 46(5): 1382-1401.
This study examines whether high-deductible health plans (HDHPs) that exempt prescription drugs from full cost sharing preserve medication use for major chronic illness, compared with traditional HMOs with similar drug cost sharing.
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.
Tu H & D Samuel. 2012. Limited Options to Manage Specialty Drug Spending
. Center for Studying Health System Change.
This analysis examines why prescription drug costs are so high for specialty drugs, and what can and cannot be done to reduce these costs.
Boukus E & E Carrier. 2011. Americans’ Access to Prescription Drugs Stabilizes, 2007- 2010. Tracking Report- Center for Studying Health Systems Change 27: 1-5.
The authors review access to prescription medications during the recession for uninsured Americans, as well as Medicaid and Medicare beneficiaries.
Gellad W, J Donahue, X Zhao, Y Zhang & J Banthin. 2012. The Financial Burden from Prescription Drugs has Declined Recently for the Nonelderly, Although it is Still High for Many. Health Affairs 31(2): 408-416.
The authors examined ten years of nationally representative data from the Medical Expenditure Panel Survey and describe trends in two measures of financial burden for prescription drugs: out-of-pocket drug costs as a function of family income and the proportion of all out-of-pocket health care expenses accounted for by drugs.
Gonce A & U Schrader. 2012. Plantopia? A Mandate for Innovation in Pharma Manufacturing. McKinsey Quarterly.
The authors explore how pharmaceutical manufacturing must change to adapt to the post-blockbuster markets and find ways to maintain profitability.
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.
Gu Q, C Dillon, & V Burt. 2010. Prescription Drug Use Continues to Increase: U.S. Prescription Drug Data for 2007-2008. NCHS Data Brief 42.
This report examines national trends in prescription drug use, and provides data on who uses prescription medications and commonly used types of drugs.
PwC. 2011. Introducing the Pharma 2020 Series.
This series of reports published since 2007 looks into the future of the Pharmaceuticals and Life Sciences’ value chain and an analysis of the strategies available to companies.
Scherer, F.M. 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.
Zuvekas, S.H. & J.W. Cohen. 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
Clozel M. 2011. Between Confidentiality and Scientific Exchange: The Place of Publication in Drug Discovery and Pharmaceutical Research. Science Translational Medicine 3(67).
Publications in the field of pharmaceutical drug discovery should take into account the confidentiality inherent to the protection of the intellectual property rights of a discovery, but they are fundamentally important because they can enhance scientific knowledge, improve the care and safety of patients, provide information for prescribers, and educate the public about the pharmaceutical industry.
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, 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., & 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, 1999-2002.
This series of publications addresses intellectual property right and patents of pharmaceutical research and developments.
Rai A. 2012. Use Patents, Carve-Outs, and Incentives- A New Battle in the Drug-Patent Wars. New England Journal of Medicine 367: 491-493.
This opinion piece discusses the changing nature of the pharmaceutical industry after a recent Supreme Court decision, specifically relating to brand-name drugs versus generics.
Sokal A & B Gerstenblith. 2010. The Hatch-Waxman Act: Encouraging Innovation and Generic Drug Competition. Current Topics of Medical Chemistry 10(18): 1950-1959.
This article addresses the Act’s goals of encouraging new development and greater public access to generic drugs in the context of issues pertaining to patent rights and in light of the congressional goals.
Stein, P., and E. Valery. 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.
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.
Domino M et al. 2011. Increasing Time Costs and Copayments for Prescription Drugs: An Analysis of Policy Changes in a Complex Environment. Health Services Research 46(3): 900-919.
The authors estimate the effect of two separate policy changes in the North Carolina Medicaid program: (1) reduced prescription lengths from 100 to 34 days' supply, and (2) increased copayments for brand name medications.
Mascardo L, K Spading, & P Abramowitz. 2012. Implementation of a Comprehensive Pharmaceutical Care Program for an Underserved Population. American Journal of Health-Systems Pharmacy 69(14): 1225-1230.
This article describes the implementation of a prescription benefit program for low-income patients emphasizing clinical pharmacist services and strict formulary control, with a review of program expenditures and cost avoidance.
Basalo G & R Weiss. 2012. Impact of Final Short-Fill Rule on Medicare Part D Costs and Long-Term Care Pharmacy Dispensing. The Consultant Pharmacist 27(4): 269-273.
This study evaluated the impact of the final Centers for Medicare & Medicaid Services' (CMS) "short-fill" rule regarding the appropriate dispensing of prescription drugs in long-term care facilities and determined rates of unconsumed medication and the net-cost impact on Medicare Part D prescription drug plans based on the proposed and final CMS rule and other scenarios under consideration by CMS.
Briesacher B et, al. (2011). Medicare Part D and Changes in Prescription Drug Use and Cost Burden: National Estimates for the Medicare Population, 2000 to 2007. Medical Care 49(9):834–841.
This study estimates nationally representative changes in prescription drug use and out-of-pocket drug costs 2 years after implementation of Part D.
Congressional Budget Office. 2011. Spending Patterns for Prescription Drugs Under Medicare Part D.
This issue brief reviews patterns of Medicare Part D utilization and spending among the non-low-income subsidy (LIS) and LIS populations.
Congressional Budget Office. 2010. Effects of Using Generic Drugs on Medicare’s Prescription Drug Spending.
This study assessed how successful Medicare plans have been in encouraging the use of generic drugs and how much additional savings could arise from the wider use of such 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.
Goedken A, J Urmie, K Farris & W Doucette. 2010. Impact of Cost Sharing on Prescription Drugs Used by Medicare Beneficiaries. Research in Social & Administrative Pharmacy 6(2): 100-109.
This study compares prescription drug cost sharing across prescription insurance type for Medicare beneficiaries after Medicare Part D, assesses the impact of that cost sharing on the number of medications used, and examines how generic utilization rates differ before and after Medicare Part D and across the type of insurance.
Government Accountability Office. (2012). Medicare Part D Coverage Gap: Discount Program Effects and Brand-Name Drug Price Trends.
This report reviews findings from the first two years of the ACA’s efforts to close the coverage gap in Medicare Part D drug coverage.
Khan N & R Kaestner. (2009). Effect of Prescription Drug Coverage on the Elderly's Use of Prescription Drugs.Inquiry 46(1):33-45.
This paper evaluates the effect of prescription drug insurance coverage on prescription drug use among the elderly.
Kaiser Family Foundation, Explaining Health Care Reform: Key Changes to the Medicare Part D Drug Benefit Coverage Gap, 2010.
This explainer walks through how provisions included in the Affordable Care Act would impact Medicare Part D, including changes to reduce enrollee’s out-of-pocket liability when they reach the doughnut hole.
Kaiser Family Foundation, Understanding the Effects of the Medicare Part D Coverage Gap in 2008 and 2009, 2011.
This study examines how the coverage gap in Medicare’s drug benefit known as the “doughnut hole” affects Medicare beneficiaries and their prescribing patterns.
Kaiser Family Foundation, How Does the Benefit Value of Medicare Compare to the Benefit Value of Typical Large Employer Plans? A 2012 Update, 2012.
This study compares the value of Medicare's fee-for-service benefits last year with the value of benefits in two large employer health plans -- a large health plan serving federal employees and a typical large employer Preferred Provider Organization (PPO) plan.
Kaiser Family Foundation, Analysis of Prescription Drug Plans in 2012 and Key Trends Since 2006, 2012.
This report presents findings from an analysis of the Medicare Part D marketplace in 2012 and changes in drug coverage and costs since 2006. It presents key findings related to Medicare drug plan plan availability, premiums, cost-sharing, the coverage gap and availability for low-income beneficiaries, the coverage gap, benefit design and cost sharing, formularies, and utilization management, based on data from CMS for all plans participating in Part D.
Kaiser Family Foundation, The Federal Government's Authority To Regulate Advertising in Medicare, 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.
Medicare Today, KRC Research, Seniors’ Opinions About Medicare Rx: 7th Year Update, 2012.
This annual survey examines seniors’ current opinions on the Medicare Part D Prescription Drug program, as well as overall satisfaction trends since its creation in 2006.
Lau D & J Stubbings. 2012. Medicare Part D Research and Policy Highlights, 2012: Impact and Insights. Clinical Therapeutics 34(4): 904-914.
The purpose of this article was to highlight the latest key peer-reviewed research findings on Medicare Part D and major public policy initiatives for Part D for 2012.
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.
Moon, M. 2012. Medicare and the Affordable Care Act. Journal of Aging & Social Policy 24(2): 233-247.
This article explores how the ACA will impact the Medicare Drug Benefit, as well as other aspects of Medicare.
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.
Outterson, K., Kesselheim A. S. 2009. How Medicare Could Get Better Prices On Prescription Drugs. Health Affairs28(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.
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.
Shrank W, & N Choudhry. (2011). Time to Fill the Doughnuts — Health Care Reform and Medicare Part D. New England Journal of Medicine 364(7):598-601.
This perspective examines how the Affordable Care Act plans to close the “doughnut hole” through rebates and drug discounts.
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.