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Pharmaceutical Pricing, Reimbursement and Market Access News in the First Quarter of 2010

Decision Resources, Inc., May 2010, Pages: 37


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The first quarter of 2010 was one of the most eventful in recent years with regard to pharmaceutical market access. Several governments introduced major reforms that will impact the pharmaceutical industry, and governments in other countries continued their efforts to contain spending on prescription drugs. The international pharmaceutical industry is under enormous - and growing - financial pressure.

Questions answered in this report:

- After many months of stormy debate and negotiation, the U.S. government fi - nally passed major healthcare reform legislation in March 2010. What are the key elements of the reform package, and what is the timeline for implementation of these measures? What will be the main costs and benefits to the research-based pharmaceutical industry?

- The pharmaceutical industry is appalled by recently announced changes to the German pricing and reimbursement system. What will be the extent and duration of a planned price freeze and an increase in mandatory rebates? How is pricing freedom for new drugs under threat in Germany? What data will companies be required to gather for new drugs?

- The Spanish government recently unveiled two packages of stringent new cost-containment measures. How does the government intend to make the reference pricing system more aggressive? What price cuts are planned for drugs outside the reference pricing system? How will these measures impact drug manufacturers?

- The Japanese government implemented its most recent biennial price adjustments on April 1, 2010. How have prices been revised in response to market prices? What cuts have been imposed on long-listed drugs? How have some drugs been re-priced in response to market expansion? How does the government intend to use a new premium to promote the launch of new drugs in Japan?

Scope of the report:

- Issues affecting the pharmaceutical industry in the United States: key elements of healthcare reform legislation; prospects for improved access to health insurance; changes to Medicare; initiatives to improve public health and the quality of healthcare provision; impact of healthcare reform on the pharmaceutical industry.

- Issues affecting the pharmaceutical industry in Europe: new collaboration between the European Medicines Agency and the European Network for Health Technology Assessment; reimbursement restrictions for drugs of limited effectiveness in France; overhaul of the German pricing and reimbursement system; market trends in Italy; introduction of stringent new cost-containment measures in Spain; measures to stimulate greater use of generics in the United Kingdom.

- Issues affecting the pharmaceutical industry in Japan: biennial price revision based on market prices; price cuts for long-listed drugs; repricing in response to market expansion; introduction of a price premium to promote the launch of new drugs in Japan.

- Legislation: Patient Protection and Affordable Care Act; Health Care and Education Reconciliation Act of 2010; Real Decreto Ley 4/2010 (Royal Decree Law 4/2010).

- Outlook and implications for the pharmaceutical industry: challenges to the implementation of U.S. healthcare reform and impact on drug manufacturers; future emphasis of French government’s cost-containment strategy; possible relaxation of some longstanding cost controls in Germany; growing financial pressures in Italy; increasing anxiety among drug manufacturers in Spain; potential shift in U.K. health policy; pressure on the Japanese pharmaceutical industry to meet government requirements.

Key terms for this report:

Comparative effectiveness research, Cost-containment, Cost-effectiveness evaluation, Generics, Generics substitution, Health economic evaluation, Health technology assessment, Healthcare reform, Market access, Parallel trade, Price premiums, Pricing, Rebates, Reference pricing, Reimbursement



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