Biogen Community Update – December 22, 2017
Dear members of the SMA community,
In response to your request for information, we would like to provide you with an update on the health technology assessment reviews for SPINRAZA™ (nusinersen) conducted by the
Common Drug Review (CDR) and L’Institut national d’excellence en santé et en services sociaux in Québec (INESSS).
After clinical and pharmacoeconomic reviews of published and unpublished clinical data, INESSS and the Canadian Agency for Drugs and Technologies in Health (CADTH) have now
published their reimbursement recommendations for nusinersen. Both INESSS and the Canadian Drug Expert Committee (CDEC) recognize the therapeutic value
and benefits of nusinersen however only for a subset of the population affected with SMA, notably within the Type 1 population.
Biogen recognizes that the INESSS and CDEC recommendations are important initial steps in providing formulary listing recommendations to provincial drug plans. We are disappointed at
the restrictive nature of these recommendations given the clinical value that nusinersen can provide to individuals living with SMA in Canada.
We believe that the medical and patient communities, as well as Biogen and the provincial
authorities share a common goal of bringing nusinersen to families impacted by SMA as quickly and as broadly as possible. We remain committed to finding the best way forward to achieve
broad and timely access. Nusinersen is the first and only Health Canada-approved therapy indicated for the treatment of SMA in pediatric and adult patients. The efficacy and safety of nusinersen
for the treatment of 5q SMA has been demonstrated in patients across the spectrum of the disease.
The nusinersen clinical program, the largest in SMA to date, is comprised of multiple studies across a range of SMA patients, including presymptomatic and symptomatic patients who had, or were likely to
develop Type 1, 2, or 3 SMA. The certainty of the benefits seen early on in these clinical trials resulted in accelerated and prioritized regulatory approvals across the globe.
Now that CDEC has issued its recommendation, the participating drug plans can act upon the recommendation and begin negotiations on a provincial level or via the pan-Canadian
Pharmaceutical Alliance (pCPA). Currently, it is not known how long pCPA negotiations will take nor which Provinces will engage in negotiations. Biogen is committed to working with the pCPA
and provincial governments to achieve public reimbursement as soon as possible. Biogen is dedicated to further improve the futures of patients and families living with SMA.
Biogen will continue to provide nusinersen for existing and new eligible infantile-onset (Type 1) patients through its expanded access program.
In addition to the already available extensive evidence proving clinical value of nusinersen across the spectrum of SMA patients, Biogen and the physician community will continue to
further expand the evidence available by collecting and analyzing data notably through SHINE, an open-label extension study across different SMA populations. These efforts will continue to
provide a deeper understanding of SMA and nusinersen. More information on studies in SMA can be obtained at www.clinicaltrials.gov.
We remain a dedicated partner to the SMA community and will continue to work tirelessly to ensure that patients who may benefit from nusinersen receive access as quickly as possible.
The Biogen Team
For further questions, please contact Medical Information at:
1 866 477 3462 or firstname.lastname@example.org