For Spinal Muscular Atrophy (SMA) patients to get reimbursement when they use Spinraza (nusinersen), it has become essential to prove the maintenance of the drug’s motor function, according to an insurance reviewing agency.

The Health Insurance Review and Assessment Service (HIRA) recently released the results of a case reviewing the eligibility of Spinraza, which was deliberated by the Medical Review and Assessment Committee in June, on its website.

Possible beneficiaries of its insurance coverage are patients with 5q spinal muscular atrophy (SMA), provided they are genetically diagnosed with a defect or mutation in the 5q SMN-1 gene, develop SMA-related clinical symptoms and signs at the age of 3 or younger, and are not on a permanent ventilator, it said.

According to disclosed cases, for instance, a 14-year-old girl with type 2 applied for nursing care benefits for continued treatment following the completion of a clinical study, which decreased 4 points from her previous motor function assessment score.

The committee approved insurance benefits but required the patient to prove twice in a row that her motor function score was maintained or improved by linking the motor function score at the time of taking Spinraza before the medical benefit application.

Failure to do so for two consecutive years could lead to discontinued benefits.

An 8-year-old boy with type 2 also met the eligibility criteria for Spinraza and was approved for its use. However, he was asked to submit a report on his motor function decline at the subsequent monitoring. The boy’s HFMSE (Hammersmith Functional Motor Scale Expanded) dropped from 19 points in July 2020 to 8 in June 2022.

Besides, 30 of the 31 cases submitted as monitoring reports for Spinraza treatment were approved for nursing care benefits because the submitted motor function assessment confirmed that motor function was maintained or improved compared to the previous assessment.

However, in one case, the committee requested to supplement it with additional video data to confirm the maintenance of motor function.

On the other hand, it rejected the appeal of a 26-year-old woman disqualified from the Spinraza benefit.

The committee concluded that the majority opinion justified the decision to deny after evaluating the video evidence submitted by the woman. The panel said that the motor skills claimed to have been gained could not be confirmed and, therefore, could not be considered improved by Spinraza treatment.

Further details of the committee's deliberations can be found on HIRA’s website.