Biogen’s Spinraza (ingredient: nusinersen), a treatment for spinal muscular atrophy (SMA), started to receive insurance benefits as the first treatment for 5q SMA in Korea from Monday.
|Biogen’s spinal muscular atrophy treatment Spinraza|
SMA is a rare neuromuscular disorder in which muscles gradually contract due to damage in motor neurons in the spinal cord and brain stem. Cognitive function stays normal, but all muscles grow weak, making it difficult to perform basic tasks for life such as breathing or eating.
If left untreated, a patient with SMA is highly likely to die.
Under the reimbursement plan, the patient can receive insurance benefits if they have the three criteria: diagnosis confirming survival motor neuron 1 gene deletion or mutation, developed SMA-related clinical symptoms and signs at 3 years of age or younger, and are not using a permanent ventilator (more than 16 hours per day or more than 21 days in a row).
To be eligible for the benefit of Spinraza medication, patients must submit a preliminary application to the Health Insurance Review and Assessment Service for approval, while going through the clinical evaluation, including developmental stage, exercise function, and respiratory function, before receiving additional doses after the initial treatment dosage(four doses).
The health authorities quickly approved Spinraza due to SMA’s seriousness and the drug’s innovative efficacy.
However, procedures for reimbursement for the drug have not been smooth.
The biggest hurdle was Spinraza’s astronomical list price, which was known to cost over 92.3 million won ($81,000) a vial.
Biogen applied for reimbursement to the Health Insurance Review and Assessment Service (HIRA) in April last year, but the pharmaceutical reimbursement assessment committee has repeatedly refused to discuss the issue. In November, the committee ruled that Spinraza needed a reassessment. In December, Spinraza passed the committee’s approval for reimbursement. Biogen was able to start price negotiations with the HIRA on Jan. 29. The two sides failed to reach an agreement in three rounds of talks but finally set the reimbursement price in the additional and final negotiations on March 15.
“Spinraza is the world's first and the only approved SMA medicine to date,” Biogen Korea CEO Hwang Se-eun said. “We are delighted to be able to offer new treatment options to medical staff and patients who have been waiting for the insurance benefits since the drug received approval in December 2017.”
Biogen will do its best to make early diagnoses and overcome SMA through Spinraza, which has proved its excellent therapeutic effect with many clinical and overseas prescription experiences, she added.
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