GW Pharmaceuticals and partner Almirall have said they may pull Sativex from the market in Germany after failing to agree a price for the drug with the national authority.
Sativex (nabiximols) is an oromucosal spray containing active ingredients from the cannabis sativa plant used to treat moderate to severe spasticity in multiple sclerosis patients who have not responded to other drugs . It is available in eight countries, with 12 others due to roll out the drug over the next year.
In Germany – where the drug has been available since June 2011 and already been prescribed for upwards of 3,000 patients – pricing negotiations between Almirall and the German Federal Joint Committee (G-BA) have been dragging on for months.
In the latest development, an arbitration board has set a price “significantly lower than the reimbursed Sativex price in other European countries”, according to GW Pharma. Aside from Germany, Sativex is also available in the UK, Spain, Denmark, Norway, Sweden, Canada, and Israel, and in European markets the drug typically sells for between €4 and €5 per day.
“Sativex is one of several recent examples of new medicines that have not been appropriately valued by the new German reimbursement system,” said the company in a statement, noting that the decision comes despite the G-BA concluding in mid-2012 that Sativex provides added benefit over current treatment options for spasticity in MS patients.
Germany has come under fire for new pricing controls introduced in 2010 that included mandatory rebates and a reference pricing system that refers to the lowest-cost markets in Europe. The European Federation of Pharmaceutical Industries and Associations (EFPIA) said that last year that the system is jeopardising German patients’ access to new drugs.
Other companies that have fallen foul of Germany’s reimbursement system in recent months include Eisai with its epilepsy drug Fycompa (perampanel), Boehringer Ingelheim for diabetes treatment Trajenta (linagliptin) and GSK with Benlysta (belimumab) for lupus.
“The new price decision in Germany is inappropriate for an innovative treatment option for severely suffering patients who currently do not have other options and no longer covers the financing of the product,” said Farid Taha, the managing director of Almirall Hermal in Germany.
“We will evaluate all possible options and further steps for Sativex as Almirall believes Germany should continue as a relevant country for innovative medicines,” he added.
GW said it would take an £800,000 charge this fiscal year in connection with the German pricing decision, as product sales will be lower than previously expected.
In addition to MS spasticity, Sativex is also in phase III development as a treatment for cancer-related pain, which will be the initial target indication for the product in the US.