Eight years earlier, EU Regulation 141/2000 was enacted to encourage R&D in rare diseases and increase orphan drug output. By any standard the Regulation has been a major success. Almost 800 designation applications have been made, with 44 orphan medicines from 31 sponsoring companies receiving pan-European marketing approval. An estimated 1.6 million patients with 38 different rare diseases have potentially benefited, and the surge of interest in the area has offered hope to many more. Orphan drugs accounted for 23% of all new marketing applications to the EMEA in 2006 alone.
Rare diseases and their treatments may still be emotive territory, with a strong patient voice and genuine unmet need, but the pendulum is swinging from a guarantee of ‘special status’ when it comes to public reimbursement to issues of budgetary impact and cost effectiveness – not only because of the high cost of orphan drugs themselves, but the growing number of target diseases and treatments, associated new costs of medical education and diagnosis, and the need for chronic disease management.
Questions answered by this report include:
What is the actual in-market status of all EU designated orphan drugs with marketing authorisations up to the beginning of 2008?
Which drugs are covered by reimbursement, which are not?
Are special funds available for orphan drugs?
Where is health technology assessment required?
How large is the European price corridor for orphan drugs?
Is there a relationship between target patient population and price?
How do orphan drug policies differ across the leading European countries?
Do payers view all orphan drugs as unique?
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