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Pharmaceutical Pricing, Reimbursement, and Prescribing News in the Third Quarter of 2007
Decision Resources, Inc., Dec 2007, Pages: 32
Introduction
The third quarter of 2007 was a quiet period in terms of legislation and other major developments in pricing and reimbursement in the major pharmaceutical markets, but recent trends in cost containment continued. In this report, we focus on Q3 measures that health care payers are using to curb their drug expenditures and to improve patient access to medications. We conclude with an assessment of the outlook and implications for the pharmaceutical industry.
Questions Answered in This Spectrum Report
- Although biosimilars are licensed at the EU level, manufacturers of branded biologics will need to adapt to national reimbursement and prescribing policies on biosimilars. What policies are European countries taking with regard to biologics and biosimilars? What impact will reference pricing have on biologics manufacturers?
- The Italian Medicines Agency will pay increased attention to pharmaceutical innovation as a key criterion in reimbursement decision making. What requirements will the Italian government place upon manufacturers regarding their products’ degree of innovation? How will Italy define its various levels of pharmaceutical innovation? What methods will it use to assess this innovation?
- The pharmaceutical industry will soon have to adapt to a new pricing and reimbursement system in the United Kingdom. What pricing and reimbursement reforms are under consideration in the United Kingdom? What will the short- and long-term impacts be on industry players working in this country?
Scope
- Overview: major events in Q3 2007 in the pricing, reimbursement, and prescribing environment in the major pharmaceutical markets under study.
- United States: 2008 changes to Medicare Part D; FDA Amendments Act and its reforms to the FDA; payers’ enthusiasm toward the emergence of biogenerics; the impact of Wal-Mart on low-priced generics.
- European Union: the first approval of biosimilar epoetin alfa products.
- France: emergency pharmaceutical cost-containment measures to address booming costs; use of the 2008 social security budget as a tool to curb spending.
- Germany: overview of general spending trends; pressures on generics manufacturers; continued growth in negotiated rebate contracts between manufacturers and health insurance funds; growing demand for copayment-exempt medicines; abolition of the Bonus-Malus rule.
- Italy: increased focus on innovation in reimbursement decision making.
- Spain: continued concerns of the pharma industry over the impact of Spain’s 2006 Medicines Law on mature agents; official establishment of what constitutes an innovation; restrictions on generics substitution.
- United Kingdom: plans to replace the circa-1957 Pharmaceutical Price Regulation Scheme; outcome of judicial review of financial incentives in place to encourage brand-to-generic drug switching.
- Japan: proposals for reform of the pricing and reimbursement system; growing public demand for generics in the face of physician reservations.
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