09 Jun 2017

SMA: European marketing authorisation for SpinrazaTM (nusinersen)

Illustration for article: SMA: European marketing authorisation for SpinrazaTM (nusinersen)
SpinrazaTM (nusinersen), the first and only treatment for spinal muscular atrophy (SMA), is now available in Europe.
Biogen has just announced that it has obtained marketing authorisation for SpinrazaTM (nusinersen) in Europe. This is the first drug for the treatment of SMA.
Now, every European country will have to evaluate the value of this drug for patients, decide to cover it and negotiate a price.
In France, two different committees of the Haute Autorité de Santé (HAS, the French National Authority for Health) must first deliver their opinions to assess the therapeutic and economic value of the medicinal product. Then, the Economics Committee for Health Products will negotiate a price allowing standard access to the drug. It is a long process that could take a year or more. The time required for negotiation will indeed depend on the price that Biogen will request.
During this period, an “authorisation for temporary use” status, following the temporary use authorisation cohort obtained two weeks ago for SMA type 1 and 2, will allow doctors to prescribe nusinersen while waiting to be marketed in France. To allow the maximum number of patients to benefit from nusinersen in this transitional period, the AFM-Telethon has asked Biogen to request this authorisation for temporary use status for all types of SMA that will benefit from the marketing authorisation.