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Pharmaceutical Market Access, Pricing, and Reimbursement News in the Second Quarter of 2009
Decision Resources, Inc., Aug 2009, Pages: 40
The second quarter of 2009 saw steady progress toward healthcare reform in the United States and action in several of the world’s other major pharmaceutical markets to curb pharmaceutical expenditures. Cost-containment strategies vary considerably from one country to another, but governments and other payers increased their emphasis on strategies such as increased use of generics, price cuts, and health technology assessment (HTA).
Questions Answered in This Report
President Barack Obama has declared his intention to pass healthcare reform legislation in the United States before the end of 2009.
- What are the key features of legislation under review by Congress?
- How much would healthcare reform cost?
- What are the implications for the pharmaceutical industry?
The European Court of Justice (ECJ) recently issued two judgments that could have significant repercussions for drug manufacturers.
- How much freedom do European governments have to impose price cuts or freezes on prescription drugs?
- Can generics manufacturers use drugs licensed many years ago in recently acceded EU member states as reference products for abridged applications for generic drugs?
The German government has earned a reputation for strict control of healthcare costs.
- What changes are pending for certain widely prescribed cardiometabolic drugs?
- What barriers to market access will new drugs likely face in the future?
The Japanese government has recently begun preparations for a new round of pricing and reimbursement reforms in 2010.
- What is the government considering with regard to the regular price revision process?
- What are the prospects for long-listed drugs subject to generics competition?
Scope
- Issues affecting the pharmaceutical industry in the United States: healthcare reform; pharmacy benefit management trends; comparative effectiveness research; regulatory pathway for biosimilars; flexible pricing arrangements.
- Issues affecting the pharmaceutical industry in Europe: market trends; generic drug use; health economic evaluation; proposed prescribing and reimbursement restrictions; shifting patterns of parallel trade; flexible pricing arrangements.
- Issues affecting the pharmaceutical industry in Japan: disagreement on pricing reform; continued resistance to the use of generics; approval of the first biosimilar.
- Outlook and implications for the pharmaceutical industry: potential impact of U.S. healthcare reform; increased focus on cost cutting; potential impact of the recession on healthcare spending; continued growth of generics markets; challenges for biosimilars; market access barriers for new drugs; prescribing and reimbursement restrictions; growth of flexible pricing arrangements.
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