Amid the high-profile flop of Biogen’s Alzheimer’s treatment Aduhelm, another of the company’s key products is suffering a slower decline.
After a successful launch in 2017 and quick uptake of spinal muscular atrophy drug Spinraza, the blockbuster has been losing market share to newer rivals.
Early this week, Spinraza took another hit as the Canadian Agency for Drugs and Technologies in Health (CADTH) recommended against reimbursement for adults.
The independent organization, which advises the government on treatments and medical matters, cited a lack of clinical evidence supporting the efficacy and safety of Spinraza in people 18 and older.
“There is a need for treatments in adult patients with type II and type III SMA that stabilize disease progression, including the avoidance of using machines to help breathing, improve strength in the upper limbs, and improve health-related quality of life,” CADTH wrote in its report. “However, the evidence reviewed did not show that Spinraza would meet any of these needs.”
In Canada, Spinraza—which is taken through spinal injection—costs $708,000 for patients in the first year and $354,000 annually in subsequent years.
In a statement, Biogen Canada said it was “deeply saddened" by the decision. The recommendation "reinforces access inequities across the country and keeps an urgently needed medication out of reach for the vast majority of adult patients,” Biogen wrote.
The decision doesn’t necessarily exclude the possibility of reimbursement for Spinraza for adults as provinces can individually opt to fund the treatment. Quebec is the only province that currently reimburses for Spinraza regardless of a patient’s age or severity of disease.
The treatment was the first in Canada for SMA and has been readily available to children since 2017.
“The SMA community is in stunned disbelief and feels devastated that government agencies are not able to see the value in saving Canadian patients' lives,” Susi Vander Wyk, executive director of Cure SMA Canada, said in Biogen’s release. “We as a country cannot possibly accept healthcare based on age and postal code, where in one jurisdiction you are able to access treatment, while in another you can’t.”
Spinraza was an immediate success upon its launch. In its second full year on the market, sales reached $2.10 billion. But its been a slow erosion since, with sales coming in at $2.05 billion in 2020 and $1.9 billion last year. In the second quarter, Spinraza generated $431 million, a 14% decline from the same period last year.
Competition has taken the shine of Spinraza. Novartis’ one-time gene therapy for SMA, Zolgensma, which launched in 2019, generated sales of $1.35 billion last year. Another competitor, Roche’s Evrysdi, has gained momentum since its launch in 2020, bringing in sales of 226 million Swiss francs ($235 million) in the first quarter of this year.
Meanwhile, Biogen’s Aduhelm—once hailed as a game-changing remedy for Alzheimer’s—has been brought down by scrutiny surrounding its data and regulatory process. With marginal sales, the company has been forced to downsize and has undergone a CEO change.