Immuno-oncology drug 'Keytruda', Expectations Rise for Expanded National Health Insurance Coverage

Additional Reimbursement Criteria Established for 11 Indications

A green light has been turned on for the expansion of health insurance coverage for the representative immuno-oncology drug 'Keytruda.'

The Health Insurance Review and Assessment Service (HIRA) announced on the 12th that the Cancer Disease Deliberation Committee reviewed the expansion of the reimbursement criteria for Keytruda injection and established reimbursement criteria for a total of 11 indications (efficacy and effects).

Once it passes the Drug Reimbursement Evaluation Committee of HIRA, it will undergo price negotiations with the National Health Insurance Service and deliberation by the Health Insurance Policy Deliberation Committee, after which additional health insurance coverage will be applied.

Keytruda is an immuno-oncology drug developed by the American pharmaceutical company MSD (Merck). It was ranked the top-selling drug worldwide in 2023. Unlike conventional anticancer drugs that directly attack cancer cells, immuno-oncology drugs help immune cells attack cancer cells.

Keytruda received approval from the U.S. Food and Drug Administration (FDA) in 2014 and from the Ministry of Food and Drug Safety (MFDS) in 2015. The initially approved indication was unresectable or metastatic melanoma, and since then, the indications have expanded to 16 cancers with a total of 34 approved indications.

However, among these, health insurance coverage is currently applied only to 7 indications across 4 cancer types: non-small cell lung cancer, Hodgkin lymphoma, melanoma, and urothelial carcinoma. The pharmaceutical company requested an expansion of reimbursement for other indications in 2023, but during five meetings of the Cancer Disease Deliberation Committee held until the end of last year, the decision to 'reconsider' was repeatedly made, and approval was not granted.

At the sixth meeting this time, the indications for which reimbursement criteria were finally established include gastric or gastroesophageal junction adenocarcinoma, esophageal cancer, endometrial cancer, colorectal cancer, head and neck squamous cell carcinoma, cervical cancer, triple-negative breast cancer, small intestine cancer, and cholangiocarcinoma.

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