Access to orphan drugs in Spain falls

A study by AELMHU reveals that of the 94 orphan drugs approved by the EMA since 2002, with orphan drug designation in effect, only been marketed so far 51 in Spain, in a downward trend has been particularly marked in recent 4 years.

It was observed that between 2002 and 2011, of the 42 orphan drugs approved by the EMA, financing and pricing were authorised for 38 drugs, i.e. 90.5%, while 2 of them (4.7%) did not, and another 2 were pending financing decision during that period.

However, this trend has changed dramatically, and between 2012 and 2015, of the 44 orphan drugs approved by the EMA, only 13 (29.5%) have been approved for funding in Spain, 11 (25%), the company itself has not requested funding, and 20 (45.4%) were under the decision process. Of these, 9 (45%) have had their application rejected for funding and 11 (55%) are still pending that funding is authorised.

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Published 11. August 2016 in News Spain