'2.8 Billion' Zolgensma, Available for 6 Million Won Starting Next Month

Passed by the Health Insurance Policy Deliberation Committee on the 20th

Following the '360 million' Kimria,
High-cost treatment drugs covered by insurance

SMA, a rare disease affecting 1 in 10,000
Actual out-of-pocket expenses range from 830,000 to 5,980,000 KRW

Novartis's Spinal Muscular Atrophy (SMA) Treatment 'Zolgensma'

[Asia Economy Reporter Lee Chun-hee] The National Health Insurance coverage for Novartis's spinal muscular atrophy (SMA) treatment 'Zolgensma' (active ingredient onasemnogene abeparvovec), known as the 'world's most expensive drug' with a dosage cost of about 2.8 billion KRW in the United States, will be implemented next month.

On the 20th, the Ministry of Health and Welfare announced that it held the 16th Health Insurance Policy Deliberation Committee meeting and approved the revision of the drug reimbursement list and reimbursement ceiling table, which includes this matter. The revision will be applied from next month after going through related procedures.

Through this revision, five drugs including Zolgensma, 'Sonazoid Injection', 'Dopacheck Injection', 'Donerion Patch', and 'Donesib Patch' will newly be covered by health insurance. The coverage scope of already insured anticancer drugs 'Keytruda Injection' and 'Xtandi Soft Capsules' has been expanded. Keytruda's coverage, which was previously limited to second-line treatment for non-small cell lung cancer and melanoma, was expanded in March to include first-line treatment for non-small cell lung cancer and second-line treatment for Hodgkin lymphoma, and now has been further extended to second-line treatment for urothelial carcinoma.

Extremely High-Cost Treatment at 2.8 Billion KRW in the US, but a Miraculous 'One-Shot Therapy'

SMA is a disease caused by mutations in the SMN1 gene leading to the loss of motor neurons, resulting in muscle weakness or loss. It is known to occur in about 1 in every 6,000 to 10,000 newborns. This means that 20 to 30 patients are diagnosed annually in South Korea alone. Although there was no treatment method until recently, the possibility of treatment through gene therapy is increasing. In particular, Zolgensma is known as a 'one-shot therapy' that achieves near-complete cure with just a single administration, raising great expectations among patients.

However, the high cost of administration has been a factor causing hesitation in treatment. The dosage cost of Zolgensma is $2.125 million USD (about 2.788 billion KRW) in the US and 167.07 million yen (about 1.586 billion KRW) in Japan. The domestic price was set at 1.981 billion KRW, similar to the Japanese price level applying the exchange rate before the start of price negotiations.

However, once covered by health insurance, the burden on patients receiving Zolgensma will drastically decrease. With a 10% copayment applied under the rare disease special calculation exception, the out-of-pocket expense reduces to 198.17 million KRW. Considering the out-of-pocket maximum payment system, the actual patient burden decreases further to between 830,000 KRW and 5.98 million KRW.

The leukemia chimeric antigen receptor (CAR)-T cell therapy 'Kymriah', which has been covered by health insurance since April, also has a price of 360.04 million KRW, but with related exceptions applied, the patient burden is limited to between 830,000 KRW and 5.98 million KRW.

Especially as President Yoon Seok-yeol promised during the presidential election to extend health insurance coverage for rare and severe diseases, the reimbursement of high-cost treatments is expected to continue. Treatments such as the amyloid cardiomyopathy drug 'Vyndamax' (annual cost 200 million KRW), neurofibromatosis drug 'Koselugo' (annual cost 200 million KRW), and hereditary retinal disease drug 'Luxturna' (1 billion KRW) are also aiming for reimbursement. All are high-cost treatments costing several hundred million KRW.