Biogen Canada Provides Update on CDA Draft Recommendation Supporting Expanded Public Reimbursement of SPINRAZA™ for Canadians with SMA

• The draft recommendation from Canada's Drug Agency (CDA) is a major step toward more equitable treatment access for Canadians with spinal muscular atrophy (SMA).
• It supports expanding public reimbursement of SPINRAZA™ for adults with type 2 and 3 SMA as well as patients with two, three and four SMN2 gene copies.
• This represents an important first step toward broader public treatment access, with further negotiations and provincial funding decisions forthcoming.

TORONTO, Oct. 26, 2026 /CNW/ -- Biogen Canada Inc. acknowledges the draft recommendation from Canada's Drug Agency (CDA) that supports a significant expansion of public reimbursement for SPINRAZA™ (nusinersen) for Canadians with spinal muscular atrophy (SMA). The recommendation marks a long-awaited milestone for Canada's SMA community and represents an important step toward addressing disparities in treatment access across the country.

The draft recommendation supports public reimbursement of SPINRAZA for patients with genetically confirmed 5q SMA with 2, 3 or 4 SMN2 gene copies including adults, provided certain conditions are met.¹ This represents a meaningful advancement for patient populations that historically faced barriers to publicly funded treatment.

SPINRAZA has been approved in Canada since 2017 for treating a broad range of patients with SMA. Despite this, access through public drug plans continues to vary across the country according to age and province of residence. Quebec has provided public reimbursement for all types of SMA and across all age groups since 2018.²

This outcome for the SMA community follows reviews that started in March 2026 through the CDA's Formulary Management Expert Committee (FMEC) pilot reimbursement reassessment initiative. The innovative pilot project considered new and evolving evidence to help determine whether changes should be made to existing public reimbursement recommendations for certain approved SMA treatments.

"The CDA's draft recommendation is a significant turning point for many in the Canadian SMA community. Ever since SPINRAZA's Canadian approval in 2017, adults with SMA and individuals with four copies of SMN2 have aspired to access treatment, and we're thrilled to welcome this milestone announcement," said Eric Tse, General Manager of Biogen Canada. "We salute Canada's SMA community for its remarkable perseverance over the years and applaud the CDA's FMEC process that helped make this outcome possible – it is reflective of their commitment to putting patients at the centre of healthcare decision-making."

Although the draft recommendation is a significant step forward, it does not result in immediate changes to provincial drug coverage, as provincial funding decisions are still required. Biogen Canada remains committed to working collaboratively with governments and government agencies to support timely and sustainable access to treatment for eligible patients across Canada.

"Canada's SMA community is celebrating the progress that has been made toward equitable care access, and I'm overjoyed for the adults and individuals living with four SMN2 copies who now have a clearer path to treatment," said Susi Vander Wyk, Executive Director of Cure SMA Canada. "The CDA's draft recommendation follows years of advocacy by SMA community members who bravely stepped forward to share their experiences, and I appreciate the CDA's commitment to hear their voices and re-examine the evidence as our understanding of SMA evolves. More work is ahead, but right now we mark a truly meaningful advancement for the SMA community."

"The draft recommendation is a landmark moment for the SMA community and a testament to the incredible determination of patients and families who have tirelessly worked to ensure their voices were heard," said Stacey Lintern, Chief Executive Officer of Muscular Dystrophy Canada. "We are particularly delighted for adults and those living with type 4 SMA who are now a step closer to accessing treatment. While this outcome was hard-won by the community, we would like to recognize the CDA for its openness to emerging evidence and undertaking a novel approach to its evaluation of SMA treatments."

 The CDA's draft recommendation is open to stakeholder feedback from October 22 to October 29, 2026, with a final recommendation expected on December 1, 2026. A link to the draft recommendation is available here.

About Biogen

Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment, to deliver long-term growth.

Biogen has been proudly serving Canadian patients for more than 25 years. For information about Biogen Canada, please visit www.biogen.ca.

References:

1. Canada's Drug Agency. CDA Draft Reimbursement Recommendation. October 2026.
2. Province of Quebec. Amyotrophie spinale 5q – La ministre McCann annonce que les personnes atteintes des types II et III de la maladie auront accès au médicament Spinraza (MC). December 2018.

SOURCE Biogen Canada Inc.