Wednesday, August 6, 2025

Conditions of CDA’s recommendations

Canadian Journal of Health Technologies. July 2025 Volume 5 Issue 7. Reimbursement Recommendation: Omaveloxolone (Skyclarys).Indication: For the treatment of Friedreich’s ataxia in patients 16 years of age and older. 

Sponsor: Biogen Canada Inc. 

Final recommendation: Reimburse with conditions Canada’s Drug Agency (CDA-AMC) is a pan-Canadian health organization. Canada’s Drug Agency (CDA-AMC) recommends that Skyclarys be reimbursed by public drug plans for the treatment of Friedreich’s ataxia (FA) if certain conditions are met. 

Based on the sponsor’s submission, omaveloxolone-SOC is not cost-effective at a WTP of $50,000 per QALY gained when either the public health care payer or a societal perspective is adopted. Price reductions of 95% to 97% would be required for omaveloxolone-SOC to be cost-effective compared to SOC from the societal and public payer perspectives, respectively, at this threshold.

 

Conditions of CDA’s recommendations