Insurance Coverage Expanded for Rare and Severe Disease Treatments; New Dravet Syndrome Drug Listed in 126 Days

The Ministry of Health and Welfare is expanding National Health Insurance coverage for treatments for rare and severe diseases. Fintepla oral solution, a treatment for Dravet syndrome, completed the coverage process in 126 days, about half the time previously required.

The ministry said coverage for medicines would be expanded starting Sept. 1 to reduce treatment costs for people with rare and intractable diseases and patients with severe cancers. It will also support the stable supply of essential medicines at risk of shortages.

National Health Insurance will cover Fintepla oral solution, a treatment for Dravet syndrome, a rare and intractable form of epilepsy that begins within the first year of life and causes severe seizures and developmental delays. The number of patients in South Korea is estimated at about 150.

With the new coverage, annual medical costs per patient, previously about 100 million won, will fall to about 10 million won. Fintepla oral solution was selected for a pilot program that runs approval, assessment and price negotiations in parallel, completing the coverage process in 126 days, about half of the previous 240 days.

Polivy, a new treatment for initial therapy of diffuse large B-cell lymphoma, will also receive National Health Insurance coverage. It will provide a new treatment option for patients who have suffered from limited treatment options and reduce the burden of high drug costs.

Coverage for Blincyto, a treatment for precursor B-cell acute lymphoblastic leukemia, will be expanded. Previously, coverage was available only when the cancer had relapsed or existing treatments had failed.

Going forward, coverage will also be available at an earlier stage, immediately after initial chemotherapy has eliminated cancer cells, to clear any remaining microscopic cancer cells. The ministry expects the expanded indication to help reduce the risk of early relapse and increase the chance of a cure for young patients, as the disease has a high incidence in children younger than 5.

Support for the stable supply of medicines designated for withdrawal prevention will continue. Jungwe Protamines 6% Injection, which is essential for regulating blood pressure and stabilizing circulation in newborns and premature infants, will be newly designated as a withdrawal-prevention medicine, with a stable cost-reimbursement system established.

The import price of Tuberculin PPD A.J.V. Injection, a tuberculosis diagnostic reagent whose supply was expected to be disrupted because of rising import costs, will be promptly reflected in its drug price this year to address concerns about supply instability.

Yoo Ju-heon, director general of the Health Insurance Policy Bureau at the Ministry of Health and Welfare, said, "We will continue to pursue prompt National Health Insurance coverage for treatments for severe and rare diseases, while actively supporting the stable supply of medicines essential for medical care."