New reimb criteria established for growth hormone Sogroya

MOHW Pushes for revision of Drug Standards Notice... Effective May 1

Criteria revised with the listing of combination drugs such as diabetes medications... sulglycotide removed from the list

The government is establishing new reimbursement criteria following the new listing of growth hormone treatments. Additionally, self-injectable formulations of severe asthma treatments have been newly added to the list, allowing for switching between formulations.

On the 16th, the Ministry of Health and Welfare issued an administrative notice regarding the amendment to the “Detailed Provisions on the Application Criteria and Methods for Medical Care Benefits.” The amendment is scheduled to take effect on May 1.

Novo Nordisk’s Sogroya prefilled pen (somapacitan) will have new reimbursement criteria established for growth hormone deficiency in both pediatric and adult patients.

The drug is administered at a maximum of 8 mg per week in accordance with the approved indications, and patients must bear the full cost if they exceed specific height criteria (153 cm for females, 165 cm for males). Coverage may be extended if growth hormone deficiency is confirmed after 3 years of treatment. Self-injection prescriptions are also permitted.

Reimbursement criteria have also been newly established for emergency imported drugs supplied through the Korea Orphan & Essential Drug Center. The skeletal muscle relaxant Takeda Lysthenon Inj is now covered for use during general anesthesia to alleviate spasms associated with endotracheal intubation or electroconvulsive therapy (ECT).

For the anti-atherosclerotic agent Epic Cholestyramine Powder for Susp, coverage criteria have been established solely for the purpose of 'Reducing serum cholesterol levels’ within the scope of approval by the Ministry of Food and Drug Safety. However, patients must bear the full cost when the drug is administered for other purposes, such as treating pruritus.

Reimbursement criteria have been established for the vasodilator Viatris Isoptin Inj for the treatment of angina and arrhythmia, and Centa 5-HT-P Cap is now covered for the treatment of patients with BH4-deficient phenylketonuria.

 

For GSK’s severe asthma treatment Nucala, the self-injectable autoinjector formulation Nucala Autoinjector was added, allowing switching with the existing formulation.

Additionally, for Nucala Autoinjector, long-term prescriptions of up to 24 weeks are permitted for patients who have shown stable disease activity and no side effects 6 months after the initial dose.’

With the listing of new combination drugs for diabetes and hypertension/dyslipidemia, general reimbursement principles have been partially revised. The empagliflozin + linagliptin combination has been added for diabetes with the new listing of K-Glito Tab, and the fimasartan + atorvastatin + ezetimibe combination has also been added for hypertension and hyperlipidemia with the new listing of Kanarbzet Tab.

Gliptide Tab, which failed to demonstrate usefulness during the Ministry of Food and Drug Safety’s clinical reevaluations, will be removed from the reimbursement list.