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BeneluxA collaboration joint pricing negotiations fail

The first joint pricing negotiations for a medicinal product in the context of the BeneluxA collaboration with respect to health technology assessment and pricing and reimbursement have failed. On 23 May 2017, the Belgian Minister of Health announced that the Belgian National Institute for Health and Disability Insurance (RIZIV), joined by the Dutch competent authorities, and Vertex Pharmaceuticals Europe Ltd. (Vertex), could not agree on an acceptable price to market Vertex's medicine Orkambi® (lumacaftor/ivacaftor) for the treatment of cystic fibrosis (also known as mucoviscidosis).

According to the Minister of Health's press release, Vertex requested a sales price level that was not cost-effective and there was “no prospect of an acceptable price”.  The Dutch and Belgian authorities therefore terminated talks with Vertex and, as a consequence, the medicine will not be listed or reimbursed in either country.

Orkambi is used for the treatment of a specific type of cystic fibrosis, which affects approximately 500 patients in Belgium and 750 patients in the Netherlands. Both Belgian and Dutch officials therefore would like to make the medicinal product available, and expressed their hopes that Vertex would come back with an acceptable proposal.  The Belgian organisation for mucoviscidosis patients has announced that it will keep pressuring different political parties in parliament with the aim at reversing the decision of the Minister of Health.

Orkambi obtained a marketing authorisation in the EU for the treatment of cystic fibrosis in November 2015 and, according to Vertex, is currently readily available in Austria, Denmark, France, Germany, Italy, Luxembourg, and the US.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, June 2017 Issue (Thomson Reuters).

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