Abstract
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 defi ne 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 fi rst 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; offi cial 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 fi nancial 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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