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Orphan Drugs in Europe: Pricing, Reimbursement, Funding and Market Access Issues, 2011 Edition
Just Pharma Reports, June 2011, Pages: 143
The cost of treating rare disease in an age when austerity measures are hitting total healthcare funding across Europe is a highly controversial, even emotive subject. There is a clear and pressing clinical need, a strong patient voice and the treatments themselves sometimes offer the only hope. But is this enough to assure premium prices and special status in an era of budget limitations, and growing demands for evidence of clinical and cost effectiveness?
The orphan drug Regulation 141/2000, resulting in 724 designated products and 62 marketing approvals in the first 10 years, has certainly been one of the most successful legislative measures by the EU. Encouraging development and accelerating regulatory approval are very important, but alone do not ensure orphan drugs are actually available for use. Rare disease patients need timely access to therapies that are fully funded by social health insurance/national health services. Hurdles are found at national, regional and local level. Discover what these are and the strategies employed by successful orphan drug companies.
Orphan Drugs in Europe: Pricing, Reimbursement, Funding & Market Access, 2011 Edition is a fully revised and greatly enlarged version of the best-selling 2008 report, and the author’s fifth major title on orphan drugs.
Updated to May 2011, it includes:
- Availability, price and reimbursement status for all 60 EU-designated orphan drugs with centralised marketing authorisations up to end-2010.
- How orphan drug policies differ across Europe. Expanded sections on each EU-5 country. Situation in 20 countries described in total.
- Key role of special ‘high cost’ funding systems explained.
- Impact of health technology assessment.
- The myths and realities of orphan drug costs.
- How risk sharing schemes and patient registries can help bridge the data gap.
- Ways to provide pre-approval early access.
- 12 case studies.
- The potential for EU collaboration on clinical added value of orphan drugs.
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