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.
"Sativex is one of several recent examples of new medicines that have not been appropriately valued by the new German reimbursement system," said GW Pharma in a statement.
For instance, earlier this month Eisai said it was appalled by a G-BA decision that its epilepsy drug Fycompa (perampanel) was no better than existing drugs and should not qualify for reimbursement, while Boehringer Ingelheim and Eli Lilly have so far failed to agree a reimbursement price for their diabetes treatment Trajenta (linagliptin) because of similar claims by the federal authorities.
"The recently introduced pricing and reimbursement system in Germany has been presented as a means of recognising innovative new medicines that provide added value over existing treatment options," said Justin Gover, GW's chief executive.
"Despite Sativex being a clear example of such a medicine, as recognised in other markets, the German system appears to be neglecting the interests of patients and jeopardising pharmaceutical companies' ability to provide German patients with access to new treatments," he added.