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 for Health, the drug was to arrive in French pharmacies in April 2015. But this marketing now seems threatened, because the negotiations on prices are struggling to succeed. According to the daily The worldAlmirall, the Spanish laboratory that markets Sativex in Europe, and the Economic Committee for Health Products (CEPS), the body that sets the price of reimbursable drugs in France, failed to reach an agreement.
The laboratory would like to sell Sativex for 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 one month of treatment. % 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 was reached on the selling price, the medicine might not be sold in France.
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