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Biogen Announcement In Regards To Spinraza

July 20th, 2018 – FOR IMMEDIATE RELEASE

Toronto, Ontario

 

Biogen to re-submit Spinzara for SMA Type 1, 2 and 3

 

We are pleased to announce that Biogen will be re-submitting Spinzara to CADTH and INNESSS.

Muscular Dystrophy Canada will be coordinating a patient submission as part of this process. Staff will be reaching out to our registered clients or should you wish to participate please contact Marie-Hélène Bolduc at marie-helene.bolduc@muscle.ca

To read our last submission to CADTH – click here

Statement from Biogen (below)

 

Dear Members of the SMA Community

In response to your requests for information, please see below a brief update on the progress towards bringing SPINRAZA (nusinersen) to Canadian patients affected by Spinal Muscular Atrophy (SMA).

On June 29, 2017, Health Canada approved SPINRAZA as the first treatment for SMA.  Six months later, in December 2017, recommendations for  the public reimbursement of SPINRAZA were released by the Canadian Association of Drugs and Technology in Health (CADTH) and Quebec’s Institut national d’excellence en santé et en services sociaux (INESSS).  Although positively reviewed and recommended for a small subset of type 1 patients, these recommendations greatly limit access to care for the population of patients that could benefit from SPINRAZA.

Since the CADTH and INESSS recommendations, Biogen Canada has been involved in discussions with the pan-Canadian Pharmaceutical Alliance (pCPA) aimed at ensuring that patients with SMA have access to SPINRAZA.  In support of this goal, Biogen has agreed to re-submit to CADTH and INESSS – requesting reimbursement for 5q SMA in presymptomatic patients and patients with types 1, 2 and 3. The pCPA is actively engaged with Biogen, with the intent to come to an agreement as soon as possible.

Biogen urges  CADTH/INESSS to consider ALL of the SPINRAZA data,  from both placebo-controlled and open label studies, so as to reach a similar decision as most health authorities around the world that currently recommend SPINRAZA and have agreed to fund its clinical value for a broad population of patients.  Thirty seven (37) countries are now funding SPINRAZA based on the same data as that submitted in Canada.

The faster this new review concludes, the sooner Canadian patients will have hope against deterioration from SMA.

Biogen’s commitment to the SMA community remains steadfast. There is still much work to do and Biogen will continue to work tirelessly to ensure that all patients who may benefit from Spinraza will receive access as quickly as possible in Canada. We remain committed to transparent and timely communications and will continue to be available to provide any requested updates.

About Muscular Dystrophy Canada

Muscular Dystrophy Canada’s mission is to enhance the lives of those affected with neuromuscular disorders by continually working to provide ongoing support and resources while relentlessly searching for a cure through well-funded research. To learn more about Muscular Dystrophy Canada, please visit www.muscle.ca or call our toll-free number at 1-866-MUSCLE-8 (1-866-687-2538). 

Further information

For further information, images and interviews please contact Barbara Stead-Coyle at Muscular Dystrophy Canada by phone at 902-440-1257.

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