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U.S. Healthcare Reform: Impact on the Pharmaceutical Industry
Decision Resources, Inc., June 2010, Pages: 35
Healthcare reform is coming to the United States and everyone is asking, “What’s in it for me?” The debate to pass healthcare reform into law was long and contentious, and no one got exactly what he or she wanted. In this report, we discuss the tactics and manoeuvres that were used to get healthcare reform passed in the United States.
Understanding the process is valuable in appreciating how a major piece of legislation that will impact approximately 17.6% of the U.S. gross domestic product (GDP) was shepherded through one of the most bipartisan Congresses in recent decades. The pharmaceutical and healthcare industries played their part in the unfolding healthcare reform drama that took place throughout 2009 to March 2010. We assess how the new healthcare reform laws will impact the pharmaceutical industry and evaluate potential winners and losers.
Questions Answered in this Report
- The New York Times reported, “Never in modern memory has a major piece of legislation passed without a single Republican vote.” How did healthcare reform come about in the United States in 2010? What were the legislative proposals, and which ones became public law?
- The generic drug industry’s greatest disappointment was the 12-year exclusivity period granted to innovators of original biologics—a period of time that prompted one industry observer to say that generics companies will be allowed to sell only outdated biologics. What are the provisions of the new regulatory approval pathway for biosimilars in the United States? Why does the Generic Pharmaceutical Association
(GPhA) consider it a biogenerics pathway in name only? What significant authority was punted to the FDA and why? How will the dynamics of the biologics sector be affected?
- The newly established Independent Payment Advisory Board (IPAB) is designed to slow the growth of Medicare spending and improve the quality of care. Why did Peter Orszag, director of the Office of Management and Budget, say this board represents “the largest yielding of sovereignty from the Congress since the creation of the Federal Reserve?” Why does the Pharmaceutical Research and Manufacturers of America (PhRMA) have concerns about “the overly broad powers” of this board?
- Although many stakeholders dislike provisions in the final healthcare laws, most would probably admit that it could have been much worse. What are the major provisions in the new healthcare reform laws? What financial impact will they have on the pharmaceutical industry? What, according to a lobbyist interviewed for this report, has been the pharmaceutical industry’s greatest fear related to healthcare reform? What specific areas of healthcare reform are most vulnerable to attack?
Scope:
- Primary data: An interview with a health policy lobbyist who is active in government affairs in Washington, D.C. He spoke on background concerning recent negotiations on healthcare reform legislation, biosimilars, and new responsibilities for the FDA.
- Legislative manoeuvres: Legislative dead ends, filibuster, cloture, supermajority, transparency, reconciliation, conference committee, Stupak amendment, special election, S.Amdt.2786, amendment “in the nature of a substitute,” lobbyists, special interest groups, sweetheart deals, “cornhusker kickback,” Louisiana purchase, President Barack Obama’s healthcare summit, “deemed and passed” rule.
- Players: Senate Committee on Health, Education, Labor, and Pensions (HELP); Senate Committee on Finance; House Committee on Ways and Means; House Committee on Energy and Commerce; House Committee on Education and Labor; Blue Dog Democrats; Tri-Committee; Congressional Budget Office (CBO); anti-abortion Democrats; the Gang of Six; President Barack Obama; Biotechnology Industry Organization (BIO); Generic Pharmaceutical Association (GPhA); Federal Trade Commission (FTC); Special Committee on Aging; House Rules Committee; Pharmaceutical Research and Manufacturers of America (PhRMA).
- Bills and Laws: H.R.3962, Affordable Health Care for America Act; H.R.3200, America’s Affordable Health Choices Act of 2009; S.1679, Affordable Health Choices Act; S.1796, America’s Healthy Future Act of 2009; H.R.3590, Service Members Home Ownership Tax Act of 2009; H.R.3590, Patient Protection and Affordable Care Act; Public Law 111-148, Patient Protection and Affordable Care Act; Public Law 111-152, Health Care and Education Reconciliation Act; Biologics Price Competition and Innovation Act, Veterans Health Care Act of 1992.
- Topics negotiated: Cost containment, number of people insured, impact on federal deficit, anticipated savings, public plan, individual mandate, national insurance exchange, nonprofit insurance cooperatives, Cadillac plans, government-run public option, buying into Medicare, opting out, biosimilars, interchangeability, pay-for-delay deals, patent litigation settlement agreements, market exclusivity of biologics, evergreening, authorized generics, patent disputes, closing the Medicare Part D coverage gap (donut hole), expansion of Medicaid, expansion of the 340B program, comparative effectiveness research, personalized medicine, $80 billion pharmaceutical industry fee, generics substitution, clinical superiority.
- Anticipated trends: Impact of healthcare reform on non-elderly people in the United States, financial impact on the pharmaceutical industry, period of exclusivity for biologics, the FDA’s significant role, patent litigation under the new biosimilars act, pricing and reimbursement, a new pharmaceutical business development strategy.
- Analyst insights: Expert insights from Decision Resources analysts who specialize in pricing and reimbursement and in central nervous system disorders.
Featuring expert contributions from:
- A health policy lobbyist who is active in government affairs in Washington, D.C.
- Neil Grubert, M.A., Decision Resources director of pricing and reimbursement research, and program manager for the Spectrum Pharmaceutical Pricing, Reimbursement, and Market Access portfolio.
- Sandra Chow, M.Sc., a Decision Resources analyst who specializes in central nervous system disorders.
Key Terms for this Report:
Biologics, Biosimilar, Comparative effectiveness, Cost containment, Evergreening, Exclusivity, H.R.3590, H.R.4872, Healthcare reform, Interchangeability, Legislation, Lobbying, Patent litigation settlement agreements, Pricing and reimbursement, Reconciliation
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