Biogen Korea "SMA Treatment Spinraza, Coverage Expanded to Over 3 Years Old"

Spinraza Coverage Since 2019 for Patients Diagnosed Under Age 3
Coverage Criteria Relaxed for Patients Diagnosed After Age 3
"More SMA Patients Will Have Access to Drug Treatment"

Hwang Se-eun, CEO of Biogen Korea

"More domestic patients with spinal muscular atrophy (SMA) will have the opportunity for drug treatment in the future."

Biogen Korea held its first press conference on the 2nd at the Conrad Seoul Hotel to mark the expansion of the domestic reimbursement criteria for Spinraza (active ingredient: nusinersen), the first treatment for SMA. Hwang Se-eun, CEO of Biogen Korea, stated, "The health insurance reimbursement criteria for Spinraza (active ingredient: nusinersen) have been relaxed," and added, "We will continuously seek ways to improve the treatment environment for SMA." Since last month, the Ministry of Health and Welfare has allowed infantile SMA patients who developed symptoms after the age of 3 to receive reimbursement when administered Spinraza.

SMA is a rare genetic disease in which the loss of motor neurons in the spinal cord and pituitary gland leads to a deficiency of survival motor neuron (SMN) protein, causing gradual weakening of muscles throughout the body. It is classified into four types (1 to 4) based on the onset time and physical development indicators. SMA, once considered an incurable disease, became a treatable condition when Biogen developed Spinraza in December 2016. Spinraza works by continuously increasing the amount of SMN protein and is administered via direct injection into the spinal canal to deliver the drug to the central nervous system, the root cause of the disease. It is typically administered 4 to 5 times a year. Spinraza has been approved as an SMA treatment in over 60 countries, and more than 14,000 patients worldwide have been treated with it.

In Korea, Spinraza was approved by the Ministry of Food and Drug Safety in December 2017 and was covered by health insurance in April 2019. Until now, only infants and young children under the age of 3 with symptom onset were eligible for reimbursement. However, with the recent relaxation of reimbursement criteria, patients with SMA type 3b (onset after age 3) are now included. Since Spinraza is an ultra-expensive drug costing about 100 million KRW per dose when not covered by insurance, reimbursement coverage was urgently needed for SMA patients outside the coverage. Under reimbursement, patients only need to pay the health insurance co-payment ceiling of 5.98 million KRW.

Professor Park Hyung-joon of the Department of Neurology at Gangnam Severance Hospital, who has experience administering Spinraza to SMA patients, said, "Type 3b SMA patients experience declining motor function over time, leading to walking difficulties and muscle weakness. However, until now, they could not receive reimbursement for Spinraza and had to rely only on supportive treatments such as physical and rehabilitation therapy." He emphasized, "With the expansion of reimbursement criteria, type 3b patients can expect improved quality of life by combining fundamental drug treatment." In fact, overseas studies from countries like Germany have shown improvements in various motor function indicators after administering Spinraza to late-onset SMA patients.

Biogen Korea stated that it will continue various efforts to improve the quality of life for SMA patients. Choi Jung-nam, Executive Director of Biogen Korea, said, "We will continue to propose various solutions that help SMA patients in their daily lives and contribute to the emotional stability of their caregivers." Biogen Korea currently operates the digital medical information platform 'TISMA' and educational content 'Smile Home Training' to improve patients' motor function and daily living.

Meanwhile, the oral SMA treatment Evrysdi (active ingredient: risdiplam, developed by Roche) was covered by health insurance for the first time last month, expanding treatment options for patients. Adult patients who have suffered from SMA for a long time often have scoliosis, making spinal canal injections difficult, so Evrysdi has become an alternative. However, due to its previous non-reimbursement status and high cost, access to the treatment was limited.

This content was produced with the assistance of AI translation services.