Spanish drugmaker Almirall has said it may decide to withdraw multiple sclerosis spasticity treatment Sativex from the German market after a breakdown in talks with the country's reimbursement authorities.
Sativex (nabiximols) is available in eight markets around the world - including six countries in Europe - but the pricing mandated by the German authorities undercuts the product's price elsewhere, according to its original developer GW Pharmaceuticals.
Neither Almirall nor GW Pharma has disclosed the price mandated by Germany's Federal Joint Committee (G-BA) for Sativex after months of negotiations and arbitration proceedings, although GW Pharma said it was "unacceptable" and "significantly lower than the reimbursed Sativex price in other European countries".
The Spanish company's German subsidiary Almirall Hermal GmbH has now indicated it may suspend or withdraw Sativex in Germany while it tries to reach an agreement with the authorities.
Sativex is a cannabinoid treatment for moderate to severe spasticity in MS patients who cannot be treated with other drugs, and was deemed to offer an added benefit over existing therapies when the G-BA reviewed the product last year.
The drug is reported to cost a little over 4 euros a day in other European markets, and to date is available in the UK, Spain, Germany, Denmark, Norway, Sweden, Canada and Israel. It is also approved for sale in Austria, Czech Republic, Belgium, Finland, Iceland, the Netherlands, Luxembourg, Poland, Portugal, Slovakia, New Zealand and Australia, with launches in the latter markets expected in the coming months. (Más)
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