Pfizer withdraws Bosulif in Germany
Published on Friday, November 15, 2013
Pfizer Inc. (NYSE:PFE) broke off pricing negotiations with Germany's Statutory Health Insurance Funds Association (GKV-Spitzenverband) for Bosulif bosutinib and said it will no longer market the Orphan cancer drug in Germany.
Pfizer said there was "no prospect of reaching an agreement" on Bosulifs price after the first round of negotiations. Last month, Germany's Federal Joint Committee (G-BA) said Bosulif has an "unquantifiable" additional benefit for adults with chronic, accelerated or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) -- the indication for which the dual inhibitor of BCR-ABL and Src kinase has conditional approval in the EU (see BioCentury Extra, Oct. 17).
Pfizer said this is the first time an Orphan drug has been taken off the market in Germany because of drug pricing law AMNOG. In August, Pfizer and the country's Institute for Quality and Efficiency in Healthcare (IQWiG) estimated that Bosulif would cost the German statutory health insurance funds (GKV) up to EUR 34.4 million ($46 million) per year.
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FT article on the subject of drug pricing here:
The orphan drug R&D landscape needs drastic changes, as the industry’s approach to gaining market access is unsustainable, particularly in the EU, healthcare experts and executives told this news service.
Orphan drugs are developed to treat rare, or orphan, diseases, which in the US is defined as less than 200,000 patients and in the EU is defined as affecting five or less people out of every 10,000. They have access to fast-tracked regulatory timelines, financial incentives and extended exclusivity periods. As legislation around the globe has been established and amended in recent years, the pharmaceutical industry has seen a surge in orphan focussed companies, pipelines and new drugs on the market.
Yet, the orphan drug industry has come under fire for its steep pricing, which is blocking patient access to therapies, particularly in Europe and emerging markets, and the situation has escalated over recent years.
http://www.ft.com/cms/s/2/78bddb5a-5388-11e3-b425-00144feabdc0.html#axzz...
(Please note that although the above article says NICE rejected bosutinib, it IS still available through the CDF in England)