Dear Cure SMA Canada Community,
We’d like to bring you up to date on some developments of the Spinraza approval process here in Canada.
Due to the lack of compatible agreement between Biogen and the pCPA/provincial governments, Biogen has resubmitted their application with CADTH. This resubmission was necessary because of the need for the provinces to adhere to the drug approval process. Because of the very narrow recommendation from CADTH from the first submission, it put the provinces/pCPA in a position where they would have to override that recommendation or approve the very narrow margin of patients.
We have made a strong impact on the decision makers, we are very sure that the re-submission will result in a broader recommendation from CADTH. And we feel hopeful and confident that the approval process will move more timely than the previous application.
That Canada covers the treatment our most severe patients, the type 1, immediately.
That Biogen offers a wider scope of treatment to patients in their EAP, including type 2 and 3 patients, effective immediately.
That CADTH expedites the recommendation process and returns with a favorable response that encompasses our type 1,2 and 3 patients.
Cure SMA Canada will continue to advocate for the access to treatment for all of our patients. We will continue to support CORD (Canadian Organization for Rare Diseases) to press the Canadian government to implement a Rare Disease Strategy so patients do not have to sit and wait for a life saving and life changing treatment. It is unacceptable that the SMA community has been left waiting, our patients progressing, watching other countries gain access.
Cure SMA Canada will be providing patient input on Biogen’s new submission. We will be informing you, the community, of the support and input we will need from you to support this submission.
Thank you for your continued support, together we will get what we’ve all been waiting and hoping for. We must remain vigil and we will!
Susi Vander Wyk
Cure SMA Canada
Please see below for Biogen’s Community Statement
Biogen’s Community Statement
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.
Managing Director Biogen Canada