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Pharmaceutical Market Access in Europe: The Barriers Keep On Rising
Decision Resources, Inc, Oct 2011
The leading European markets are among the most testing in terms of the barriers to market access that they erect. France, Italy, and Spain have complex pricing and reimbursement procedures: prices are benchmarked and strictly controlled, innovation is a key factor in determining price and reimbursement status, and launch delays can be substantial. By comparison, Germany and the United Kingdom were historically free pricing markets, characterized by relatively high prices and minimal delays in launching new drugs. However, Germany is in the process of implementing a radical overhaul of its pricing system, and the United Kingdom plans to introduce major reforms in January 2014.
Questions answered in this report:
- The EU Transparency Directive states that pharmaceutical pricing procedures must be completed within 90 days, with the possibility of a further 90 days for reimbursement decision making. What are the average delays to market access in price-regulated markets? What are the pharmaceutical industry’s concerns and aspirations with regard to a prospective reform of the Transparency Directive?
- The French government has recently announced plans to reform its national pharmaceutical regulatory system. What conditions will be set for the reimbursement of new drugs? What sanctions will manufacturers face if they do not comply with deadlines for postmarketing research? What is the pharmaceutical industry’s initial reaction to the planned reforms?
- Germany introduced a radical overhaul of its pharmaceutical pricing system in January 2011. What are the key elements of the new system? How will pricing procedures vary according to a drug’s perceived level of innovation? What actions have manufacturers taken thus far in response to the reforms?
- Pharmaceutical innovation is a key criterion in reimbursement decision making in Italy. What evidence are manufacturers required to submit? How does the Agenzia Italiana del Farmaco (AIFA; Italian Medicines Agency) assess innovation? What measures have been introduced to promote more-uniform access to innovative drugs across Italy?
- The pricing of new pharmaceuticals in Spain is based on a cost-plus formula. What is the basic procedure for setting prices? What other factors can have a particularly important bearing on a new drug’s price in Spain? What is the scope for postmarketing price increases?
- The U.K. government intends to introduce a value-based pricing (VBP) system when the current Pharmaceutical Price Regulation Scheme (PPRS) expires at the end of 2013. Which drugs are expected to be included in the VBP system? How is value likely to be assessed? What procedures will be applied to drugs that require postmarketing research? What concerns has the pharmaceutical industry expressed with regard to the proposed reforms?
Scope:
Markets covered: France, Germany, Italy, Spain, United Kingdom.
Processes reviewed: price setting, admission to reimbursement, health technology assessment.
Legislation assessed: Arzneimittel-Neuordnungs-Gesetz (AMNOG; Pharmaceutical Restructuring Act); Arzneimittel-Nutzenbewertungsverordnung (Pharmaceutical Benefit Assessment Order); EU Transparency Directive (89/105/EEC); Gesetz zur Stärkung des Wettbewerbs in der Gesetzlichen Krankenversicherung (Act for the Improvement of Competition in the Statutory Health Insurance System, abbreviated to the GKV-Wettbewerbsstärkungsgesetz, or GKV-WSG); Real Decreto Ley 4/2010 (Royal Decree Law 4/2010).
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