Canada’s Drug Agency Has Drafted a Yes on Spinraza for Adults With SMA, Four Years After Telling Provinces Not to Pay

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Canada’s Drug Agency Has Drafted a Yes on Spinraza for Adults With SMA, Four Years After Telling Provinces Not to Pay

Athithi Verma· 27 October 2026· 2 min read· Synopulse

Biogen Canada said on 26 October that Canada’s Drug Agency has issued a draft recommendation supporting public reimbursement of Spinraza (nusinersen), provided certain conditions are met, for adults with type 2 and type 3 spinal muscular atrophy and for patients with two, three or four copies of the SMN2 gene, including adults. The review began in March under the agency’s Formulary Management Expert Committee pilot of reimbursement reassessments. Feedback closes on 29 October and the final recommendation is expected on 1 December. Provincial plans must still decide on funding after negotiations. Spinraza has been approved in Canada since 2017, and Quebec has reimbursed it for all SMA types and ages since 2018.

2022
Year the agency’s committee said do not reimburse for adults with type 2 and 3 SMA
4
SMN2 copies now inside the draft, alongside two and three, including adults
C$354,000
Yearly maintenance cost per patient at the C$118,000 vial price submitted in 2022
1 Dec
Final recommendation due, after feedback closes on 29 October
Access read

The agency that told provinces not to fund Spinraza for adults in July 2022 now backs it, through a reassessment route it opened itself. In 2022 its committee found no randomised evidence in treatment-naive adults and could not attribute the observational gains to the drug. At the price then submitted, adult treatment costs about C$708,000 in the first year and C$354,000 a year after that.

  • Provincial drug plans: adults add years of maintenance to the budget. The draft changes no coverage on its own, and the release does not list the conditions. Any price condition will surface in the final recommendation and in the pan-Canadian Pharmaceutical Alliance negotiation that follows, and adult patients on maintenance dosing are the budget line it will be sized against.
  • Sponsors with a past CDA rejection: the reassessment pilot is a second route. The 2022 rejection rested on thin, short observational data, and Muscular Dystrophy Canada credits the agency’s openness to emerging evidence for the new draft. Sponsors holding real-world data on a population the agency once turned down will test whether that openness extends to them.
  • Signposts: the final text, the conditions and the provinces. Watch whether the 1 December recommendation keeps the adult and four-copy criteria, which conditions attach, including any price reduction, and how fast provinces outside Quebec list Spinraza after negotiation.

Read the original source (Biogen Canada) →
Read the 2022 recommendation (CADTH) →

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