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Pharmaceutical Pricing, Reimbursement, and Market Access News in the Fourth Quarter of 2010
Decision Resources, Inc, Feb 2011, Pages: 28
The fourth quarter of 2010 saw governments in the United States, Europe, and Japan continue their recent efforts to contain healthcare expenditures. This report analyzes measures that healthcare payers are using to curb their drug expenditures and improve patient access to medications, and assesses the outlook and implications for the pharmaceutical industry.
Questions answered in this report:
- The Patient Protection and Affordable Care Act (PPACA) and the Health Care and Education Reconciliation Act of 2010 (HCERA) promise to deliver the most radical reform of the U.S. healthcare system since the creation of the Medicare and Medicaid programs in 1965. What has been the response thus far to the creation of new high-risk insurance pools? What reforms took effect on January 1, 2011? How are opponents mounting political and legal challenges to the legislation?
- In November 2010, the French Parliament passed the Loi de Financement de la Sécurité Sociale 2011 (LFSS; Social Security Finance Act 2011). How does the French government hope to reduce pharmaceutical expenditures by €860 million ($1.139 billion)? What ceiling has been set for the growth of pharmaceutical spending in 2011?
- The Arzneimittel-Neuordnungs-Gesetz (AMNOG; Pharmaceutical Restructuring Act), enacted in December 2010, contains some of the most radical and extensive changes to the German pricing and reimbursement system in recent years. What evidence will manufacturers be required to submit in support of pricing applications? What will be the procedure for pricing new drugs? What changes are being made to established cost-containment measures?
- The U.K. government intends to introduce a value-based pricing system when the current Pharmaceutical Price Regulation Scheme (PPRS) expires at the end of 2013. What objectives does the government have for the new system? How does the government intend to use variable price thresholds? What procedures will manufacturers likely have to follow in setting the prices of new branded drugs in the United Kingdom?
Scope of the report:
- Issues affecting the pharmaceutical industry in the United States: slowdown in the growth rate of national healthcare expenditures; unfavorable assessments of the U.S. healthcare system; early responses to healthcare reform; prospective constraints on healthcare spending.
- Issues affecting the pharmaceutical industry in Europe: substantial variations among major markets in the uptake of new drugs; new cost-containment measures in France; Pharmaceutical Restructuring Act in Germany; initiative to promote more-uniform access to innovative medicines across Italy; burden of new cost-containment measures in Spain; radical overhaul of the healthcare system and introduction of value-based pricing in the United Kingdom.
- Issues affecting the pharmaceutical industry in Japan: proposals for increased patient cost sharing.
- Legislation: Gesetz zur Neuordnung des Arzneimittelmarktes (AMNOG; Pharmaceutical Market Restructuring Act); Health and Social Care Bill 2011; Health Care and Education Reconciliation Act of 2010 (HCERA); Patient Protection and Affordable Care Act (PPACA); Loi de Financement de la Sécurité Sociale 2011 (LFSS; Social Security Finance Act 2011); Real Decreto Ley 4/2010 (Royal Decree Law 4/2010); Real Decreto Ley 8/2010 (Royal Decree Law 8/2010).
- Outlook and implications for the pharmaceutical industry: increasing pressure to curb runaway healthcare costs and continued political division over healthcare reform; aggressive limits on pharmaceutical sales growth in France; prospective transformation of the pricing landscape in Germany and the United Kingdom; impact of austerity measures in Italy and Spain; need for continued government intervention to stimulate the Japanese generics market.
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