The discussion will likely begin in earnest this month to expand reimbursement criteria for Spinraza (nusinersen), Biogen’s treatment for spinal muscular atrophy (SMA).

Accordingly, market watchers pay attention to whether the authorities will put Roche’s oral SMA treatment, Evysdi (risdiplam), on the reimbursement list, which has been shelved due to the review of Spinraza’s reimbursement criteria.

The Health Insurance Review and Assessment Service (HIRA) will review detailed operational plans of Spinraza’s reimbursement criteria this month.

Related officials will decide whether to ease the conditions for insurance benefits because it is difficult to prove the current reimbursement criteria of the “expression of related clinical symptoms and signs in patients aged three or less” in adult SMA patients. The issue was also mentioned last year at the National Assembly Health and Welfare Committee’s administrative audit.

HIRA also plans to conduct the review of Evrysdi in connection with that Spinraza’s reimbursement criteria. Evrysdi applied for insurance benefits in July 2021, but its application has yet to be tabled even on the Drug Benefit Assessment Committee, the first stage in registration for reimbursement.

More specifically, the current beneficiaries from the reimbursement for Spinraza are 5q SMA patients who meet all three conditions: Genetic diagnosis of 5q SMN-1 gene deficiency or mutation; the expression of SMA-related symptoms and signs in patients aged three or less, and those who do not use permanent ventilators.

Among the current reimbursement standards, Biogen has reportedly requested HIRA to expand the “patients aged three or less” to “patients aged 18 or less.”

“The discussion on expanding reimbursement standards for Spinraza and Evrysdi will likely become visible to some extent within this month,” said a HIRA official. “Talks are getting longer because we need to be cautious as these drugs can exert heavy influence on insurance’s finance.”

Noting that the agency will reasonably streamline the standards through experts’ advisory meetings, the official said, “We are also discussing Evrysdi’s standards because once determined, they will have a big impact.”

Currently, Spinraza and Novartis’ Zolgensma (onasemnogene abeparvovec) are on the reimbursement list as SMA treatments. Spinraza is directly injected into spinal cords, and Zolgensma is intravenous injection.

On the other hand, Evrysdi is an oral treatment that has the advantage of reducing social and economic burdens on patients and their guardians, such as the suspension of study or work, transportation costs, and caregiving, while saving drug costs for babies and infants with doses customized by age and weight.

Evrysdi is a super-expensive medicine costing about 300 million won ($231,445) for its first and annual treatment.