Sativex (international non-proprietary name: nabiximols) is a medicine based on cannabis extracts developed by GW Pharmaceuticals, now a subsidiary of Jazz Pharmaceuticals. It is the first cannabis-derived medicine to be granted marketing authorization worldwide - in the UK in 2010 - and the most widely approved cannabis medicine internationally, with a presence in over 30 countries.
It comes in the form of a mouth spray. Its composition is unique: it contains approximately equal amounts of THC and CBD - a 1:1 ratio - extracted from two different varieties of cannabis grown by GW Pharmaceuticals. This ratio, far from being arbitrary, is inspired by the composition of cannabis-based medicines used in the 19th and 20th centuries, as established by GW founder Geoffrey Guy's study of historical medical literature.
Sativex is indicated for the symptomatic treatment of moderate to severe spasticity due to multiple sclerosis (MS), in adult patients who have not responded adequately to other antispasticity treatments.
Spasticity (involuntary muscle contractions, rigidity, pain) affects up to 80% of advanced MS patients. It is one of the most disabling symptoms of the disease, affecting walking, sleeping, dressing and all daily activities. In France, around 5,000 patients could potentially benefit from Sativex.
Clinical data on Sativex show real efficacy, but limited to a sub-population of patients. Studies identify around 10% of «responder» patients - those in whom Sativex brings a significant reduction in spasticity after 4 weeks of therapeutic trial. For these patients, the improvement may be substantial and lasting. For others, the benefit is insufficient to justify continued treatment.
It is precisely this limited effectiveness in a minority of patients that led the HAS to judge the Medical Service Rendered as «low» and the improvement in SMR as «non-existent», two conclusions that weighed heavily in the French blockade.
The story of Sativex in France is a textbook case of the bureaucratic and economic obstacles to access to medical cannabis medicines in this country.
2014: Marketing authorization granted, but... On January 8, 2014, the ANSM granted Sativex its marketing authorization in France for MS-related spasticity. The HAS issued a favorable reimbursement opinion for 15% in October 2014. Everything seems to be in order.
2015: the tariff freeze Marketing was blocked even before launch: French distributor Almirall asked for a price of around 350 euros per month (20% below the average European price of 440 euros). The CEPS is proposing around 60 to 70 euros per month. The gap is insurmountable.
2016-2021: negotiations stall Despite repeated calls from patients, associations and members of parliament, no agreement was reached. Patients on hunger strike attract media attention. The drug remains on the market in 17 then 23 European countries, while French patients have to buy it abroad at their own expense.
2022: a new attempt In July 2022, Almirall submitted a new request for assessment to the HAS, supported by new clinical data. The Transparency Commission maintained its conclusions: low SMR, no improvement in SMR. Pricing discussions resume, without success.
Today Sativex still has its marketing authorization in France, but is still not marketed or reimbursed. No French pharmacy dispenses it. Patients wishing to access it must travel abroad or try to obtain an import authorization - a complex process that only the most informed and affluent patients manage to accomplish.
Sativex is approved and marketed in over 30 countries, including the UK (first country, 2010), Spain, Germany, Italy, Denmark, Sweden, the Czech Republic, Canada, Australia and many US states. In Germany, it is reimbursed by health insurance companies. In the UK, it is available on prescription, but is not recommended by NICE because of its cost-effectiveness.
deemed unfavorable.
France and Slovenia are the only two countries in the European Union to have granted marketing authorization for Sativex without actually marketing it.
→ See also: GW Pharmaceuticals, the British company behind Sativex and Epidiolex
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