Canadian drug agency declines to recommend reimbursement for Biogen SMA drug Spinraza
Dr_Microbe


Biogen (NASDAQ:BIIB) said the Canadian Agency for Drugs and Technologies in Health (CADTH) recommended against public reimbursement of the company's drug Spinraza to treat spinal muscular atrophy (SMA).
The company said that CADTH acknowledged the real-world evidence (RWE) generated from observational studies but discounted the RWE as it deemed it inconclusive without randomized clinical trial data for adult patients.

"We are absolutely devastated for the SMA community and the adult patients who have been relentlessly advocating for years for their right to access potentially life-changing treatment," said Eric Tse, General Manager of Biogen Canada.
Biogen noted that Spinraza was the first treatment approved in Canada for SMA â an inherited neurodegenerative disorder characterized by loss of nerve cells causing progressive loss of muscle, mobility over time.
Provinces will ultimately decide on CADTHâs reimbursement recommendation, the company said in an Aug. 30 press release.
Quebec is currently the only province that commits to funding treatment for Canadian patients with SMA.