The Canadian province of Saskatchewan has joined that of Quebec in granting access to Spinraza (nusinersen) therapy to a wider range of people with spinal muscular atrophy (SMA), Biogen Canada announced in a press release.
Only those with type 1 SMA, the disease’s most severe form, had access to Spinraza. Now, the Saskatchewan Ministry of Health has decided to expand coverage to pre-symptomatic patients who have two or three copies of the SMN2 gene, and patients up to age 18 who developed symptoms after they were 6 months old and who have never walked independently.
Patients who have gained the ability to walk independently (type 3), and those over age 18 with type 2 or type 3 SMA, are encouraged to speak with their physicians about coverage on a case-by-case basis.
”We are delighted to learn that Canadian patients living with SMA in the province of Saskatchewan will gain access to the only medicine that can treat SMA,” Susi Vander Wyk, executive director of Cure SMA Canada, said in a statement. “This news will bring new hope for SMA patients, and we look forward to hearing from the other Canadian provinces.”
Biogen Canada said it is pleased by Saskatchewan’s decision. Biogen developed and markets Spinraza, the first SMA therapy approved by the U.S. Food and Drug Administration, and the only one that treats all SMA types.
“This decision is additional proof that authorities in Canada and around the world see the benefits and efficacy profile of Spinraza for SMA patients,” said Marina Vasilou, Biogen Canada’s vice president and managing director. “Biogen Canada continues to pursue its discussions with all other provincial jurisdictions in Canada in order for them to join Quebec and Saskatchewan in granting broad access to SMA patients to the first and only medicine in the world to treat SMA.”
The Institut national d’excellence en sante et en services sociaux (INESSS) — Quebec’s exclusive entity for evaluating new treatments for reimbursement — recommended in December 2018 that Spinraza be funded for a wide population of SMA patients.
But the Canadian Association of Drugs and Technologies in Health (CADTH) issued an opinion in March limiting public-funded treatment to patients age 12 and younger who never walked, and to presymptomatic infants with disease-causing mutations. It recommended accessibility to the treatment for others with SMA.
CADTH advises the country’s provinces and territories whether to fund therapies, based on its cost-benefit analyses. While provinces don’t have to adhere to CADTH’s advice, they usually do.
Provinces outside Quebec, now including Saskatchewan, cover Spinraza for patients up to seven months old who are experiencing muscle weakness.
Health Canada approved Spinraza as an SMA treatment in June 2017. The disease is characterized by loss of motor neurons in the spinal cord and lower brain stem, causing severe and progressive muscular atrophy and weakness.