In January 2014, Sativex received marketing authorization (AMM) granted by the National Agency for the Safety of Medicines and Health Products (ANSM). This cannabis-based oral spray is only indicated for patients with multiple sclerosis to relieve severe contractures (spasticity), resistant to other treatments.
After the evaluation by the High Authority of Health, the drug was to arrive in French pharmacies in April 2015. But this marketing seems today threatened, because the negotiations on the prices are struggling to succeed. According to the daily The world, Almirall, the Spanish laboratory which markets Sativex in Europe, and the Economic Committee for Health Products (CEPS), the body which sets the price of reimbursable drugs in France, have not managed to come to an agreement.
The laboratory would like to sell the Sativex 350 euros per box whereas the CEPS had, initially, set the bar at 60 auros. “The average price of Sativex in Europe is 440 euros for a month of treatment. We have proposed 20 % less in France. The Economic Committee for Health Products is asking us to drop another 17 to 20%. There, I can’t! ” said Christophe Vandeputte, general manager of the Almirall laboratory in France.
The laboratory is now requesting arbitration from the Minister of Health, Marisol Touraine. If no agreement is reached on the sale price, the drug may not be sold in France.
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