WASHINGTON -- Consumer access to effective and affordable medicines is an imperative for public health, social equity, and economic development, but this need is not being served adequately by the biopharmaceutical sector, says a new report from the National Academies of Sciences, Engineering, and Medicine. The report offers eight recommendations with 27 actions for their implementation (a sample of actions in each area appears below) to improve the affordability of prescription drugs without discouraging the development of new and more effective drugs for the future.
"Over the past several decades, the biopharmaceutical sector in the United States has been successful in developing and delivering effective drugs for improving health and fighting disease, and many medical conditions that were long deemed untreatable can now be cured or managed effectively," said Norman Augustine, former chairman and CEO of Lockheed Martin Corp., former chairman of the National Academy of Engineering, and chair of the committee that conducted the study and wrote the report. "However, high and increasing costs of prescription drugs coupled with the broader trends in overall medical expenditures, which now equals 18 percent of the nation's gross domestic product, are unsustainable to society as a whole. Our report seeks to address the market failures that currently permeate the biopharmaceutical sector, such as lack of competition due to distortions in the application of the patent protection process, the imbalance between the negotiating power of suppliers and purchasers, and the convoluted structure of the supply chain. Although changes within the current system will be demanding, they are likely to better serve the nation."
As defined in the report, the "biopharmaceutical sector" encompasses a wide range of participants including researchers, physicians and other care providers who can prescribe medications, public and private payers, intermediaries such as pharmacy benefit managers, health care organizations, and patient advocacy organizations.
DRUG PRICING AND FORMULARY DESIGNConsolidate and apply governmental purchasing power, strengthen formulary design, and improve drug valuation methods.
Congress should modify existing legislation to allow the U.S. Department of Health and Human Services (HHS) to directly negotiate prices with producers and suppliers of medicines, including acting on behalf of any relevant state agency that elects to participate in the process. Because prices tend to be lower when the purchaser has bargaining power that is at least comparable to that of the seller, the U.S. could achieve lower prices for prescription drugs by consolidating its bargaining power and providing greater flexibility in formulary design. A formulary describes which drugs a health care payer will cover for which disease indications, and at what cost. Formulary control in the U.S. relies heavily on tiering, which has mixed consequences because placement of a drug in a higher tier can reduce adherence to a treatment plan, with potential harm to patient health, but the tiered price mechanism can also be used by insurers to negotiate lower prices for branded drugs. Congress should authorize HHS, related federal agencies, and associated private payers to expand flexibility in formulary design, including very selective exclusion of drugs, such as when less costly drugs provide similar clinical benefit.
GENERICS AND BIOSIMILARS
Accelerate the market entry and use of safe and effective generics as well as biosimilars and foster competition to ensure the continued affordability and availability of these products.
The U.S. Department of Justice (DOJ) and the Federal Trade Commission (FTC) should vigorously deter manufacturers from paying other producers for the delayed entry into the market -- known as "pay-for-delay agreements" -- of generics and biosimilars (products that are demonstrated to be interchangeable with branded, FDA-approved products). DOJ and FTC also should expand the enforcement of policies that preclude mergers and acquisitions of firms among companies possessing significant competing generics and biosimilars and possessing a significant share of the market, as these strategies reduce access to reasonably priced drugs. State legislatures should develop policies to restrict the use of the "dispense as written" practice by prescribers that may unnecessarily impede the use of generics and biosimilars, the report says. In addition, Congress should authorize the U.S. Food and Drug Administration (FDA) to seek reciprocal drug approval arrangements for generics and biosimilars between the regulatory agencies of the U.S. and countries such as the U.K., Germany, Canada, Australia, and Japan because in the absence of evidence of harm, importation of these drugs could provide cost savings.
FINANCIAL TRANSPARENCY IN THE BIOPHARMACEUTICAL SUPPLY CHAIN
Assure greater transparency of financial flows and profit margins in the biopharmaceutical supply chain.
Various participants in the biopharmaceutical supply chain point to other participants as the main contributors to high and rising drug costs, the report says, so to help understand the root causes of price increases and when they are appropriate, Congress should require disclosure of information from insurance plans about the average net prices paid for prescription drugs, including patients' cost-sharing among plans, and from biopharmaceutical companies about average net volume of and prices paid for drugs across each active sales channel. HHS should curate, analyze, and publicly report the data, collected at the level of National Drug Codes, on a quarterly basis to the public and congressional committees, and the FTC should examine the data to identify and act upon any anti-competitive practices.
Promote the adoption of industry codes of conduct, and discourage direct-to-consumer advertising of prescription drugs as well as direct financial incentives for patients.
Large biopharmaceutical companies spend substantially more on marketing and administration than on research and development that could lead to new drugs, the report says, and direct-to-consumer advertising of prescription drugs can adversely influence consumer choices. Therefore, Congress should disallow direct-to-consumer advertising of prescription drugs as a tax-deductible business expense. In addition, manufacturers and suppliers should adopt industry codes of conduct that reduce or eliminate direct-to-consumer advertising of prescription drugs and should increasingly support efforts to enhance public awareness of disease prevention and management. Clinicians, medical practices, and hospitals also should substantially tighten restrictions on pharmaceutical companies' direct visits to clinicians, the acceptance and use of free drug samples, special payments, and other inducements paid by biopharmaceutical companies.
Modify insurance benefit designs to mitigate prescription drug cost burdens for patients.
Current insurance benefit designs for prescription drugs often expose consumers to considerable financial risk and can unfavorably affect patients' medication adherence, the report says. Congress should establish limits on the total annual out-of-pocket costs paid by enrollees in Medicare Part D plans that cover prescription drugs by removing the cost-sharing requirement for patients who reach the catastrophic coverage limit. Congress also should direct the Centers for Medicare & Medicaid Services to modify the designs of plans offered through Medicare Part D and government health insurance exchanges to limit patients' out-of-pocket payments for drugs when there is clear evidence that treatment adherence for a particular indication can reduce the total cost of care, as determined by HHS.
FEDERAL DISCOUNT PROGRAMS
Eliminate misapplication of funds and inefficiencies in federal discount programs that are intended to aid vulnerable populations.
Congress should expand the authority of the HHS to provide increased oversight and regulation of the 340B program to ensure that participation by covered entities, contract pharmacies, and drug manufacturers is consistent with the original intent of the program -- to improve the access of low-income populations to medicines at discounted rates.
Ensure that financial incentives to develop drugs for the prevention and treatment of rare diseases are not extended to widely sold drugs.
Congress should revise the Orphan Drug Act -- designed to foster the development of innovative drugs for rare conditions -- to ensure that financial incentives for the prevention and treatment of rare diseases are not diverted to widely sold drugs, by promoting agreements between biopharmaceutical companies and HHS that enable HHS to obtain favorable concessions on launch prices, annual price increases, and other practices important to public health. In addition, FDA should be directed to limit the market exclusivity awarded to orphan drugs to one seven-year extension.
Increase available information and implement reimbursement incentives to more closely align clinicians' prescribing practices with treatment value.
Current insurer reimbursement policies for clinician-administered drugs in the outpatient setting minimize incentives for medical providers to select treatments and settings for patient care that are the most cost-effective. These policies may serve to inflate the prices of these drugs charged by manufacturers and other members of the supply chain who profit from the current system, and put patients at clinical and financial risk. Therefore, payers should establish payment policies for drugs administered by clinicians in medical practices and hospitals that do not differentiate for the site of care, the report says. Hospitals, vendors of electronic health records, insurers, and professional societies should ensure that clinicians have readily accessible and routinely updated information regarding drug cost and efficacy, including relative clinical benefits of alternative treatment regimens and the relative financial costs of treatment settings to both patients and payers, to support sound prescribing decisions at the point of care.
The report also contains a dissenting viewpoint, which says the report's set of recommendations as a whole would reduce prices too much and diminish future investments in innovation, and a minority perspective, which says that even stronger actions are needed to make prescription drugs more affordable.
The study was sponsored by the Laura and John Arnold Foundation, the Breast Cancer Research Foundation, the Commonwealth Fund, the Milbank Memorial Fund, the California Health Care Foundation, the American College of Physicians, and the Presidents' Committee of the National Academies of Sciences, Engineering, and Medicine. The National Academies of Sciences, Engineering, and Medicine are private, nonprofit institutions that provide independent, objective analysis and advice to the nation to solve complex problems and inform public policy decisions related to science, technology, and medicine. They operate under an 1863 congressional charter to the National Academy of Sciences, signed by President Lincoln. For more information, visit nationalacademies.org. A committee roster follows.
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Copies of Making Medicines Affordable: A National Imperative are available from the National Academies Press on the Internet at http://www.nap.edu or by calling 202-334-3313 or 1-800-624-6242. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).
THE NATIONAL ACADEMIES OF SCIENCES, ENGINEERING, AND MEDICINE
Health and Medicine Division
Board on Health Care Services
Committee on Ensuring Patient Access to Affordable Drug Therapies
Norman Augustine 1, 2 (chair)
Former Chairman and CEO
Lockheed Martin Corp.
Former Chairman, National Academy of Engineering
Former U.S. Senator (D-N.M.)
Associate Professor of Health Policy
Department of Pediatrics and Department of Public Health Sciences
University of Chicago
Division of Pharmaceutical Outcomes and Policy
Eshelman School of Pharmacy
University of North Carolina
Founder and Director
Center for Patient Partnerships
Schools of Law, Medicine & Public Health, Nursing, and Pharmacy
University of Wisconsin
Rebekah Gee 3
Louisiana Department of Public Health
Victoria Hale 3
Founder and Chair Emeritus
Michelle Mello 3
Professor of Law
Stanford Law School, and
Professor of Health Research and Policy
School of Medicine
Eliseo Pérez-Stable 3
National Institute on Minority Health and Health Disparities
National Institutes of Health
Charles Phelps 3
University Professor and Provost Emeritus
University of Rochester
Chief Medical Officer
Former Chief Medical Officer, Merck & Company
Diane Rowland 3
Executive Vice President
Henry J. Kaiser Family Foundation, and
Kaiser Commission on Medicaid and the Uninsured
Vinod Sahney 1,3
Distinguished University Professor of Industrial Engineering and Operations Research
Former Senior Vice President, Blue Cross Blue Shield of Massachusetts and Henry Ford Health System
Mossavar-Rahmani Center for Business and Government
Harvard John F. Kennedy School of Government
Former CEO, Standard Chartered Bank
Former Chairman, President, and CEO
Reed Tuckson 3
Tuckson Health Connections LLC
Former Executive Vice President and Chief of Medical Affairs, UnitedHealth Group
Alan Weil 3
Health Affairs, and
Vice President for Public Policy
1 Member, National Academy of Engineering
2 Member, National Academy of Sciences
3 Member, National Academy of Medicine