Starting in Jan., the scope of Korea's national health insurance coverage for Keytruda (ingredient pembrolizumab), an immuno-oncology drug from U.S. pharmaceutical company Merck (MSD), will be expanded.
Until now in Korea, Keytruda coverage applied only to four cancer types—melanoma, non-small cell lung cancer (NSCLC), Hodgkin lymphoma, and urothelial carcinoma—but starting next year, nine cancer types have been added to the coverage list. Newly added cancers are head and neck cancer, stomach cancer, esophageal cancer, endometrial cancer, small intestine cancer, biliary tract cancer, colorectal cancer, triple-negative breast cancer, and cervical cancer.
The Ministry of Health and Welfare said it approved an agenda item to expand Keytruda's reimbursed indications at the 24th meeting of the Health Insurance Policy Deliberation Committee (HIPDC) held at 2 p.m. on the 23rd in Seocho-gu, Seoul. The decision comes about two years after a request to expand coverage in 2023. The expansion of Keytruda's reimbursement in Korea was applied for by Korea MSD, Merck's Korean subsidiary, and went through the health authorities' review process.
It is meaningful in that patients with those cancer types, who had to be treated without coverage, will now be able to receive national health insurance benefits.
A Ministry of Health and Welfare official said, "In cancer types with expanded use, when patients meet the reimbursement criteria, the annual per-person drug expense that patients have borne is expected to decrease significantly from about 73.02 million won to 3.65 million won (monotherapy, with a 5% copayment)."
Keytruda is an immuno-oncology drug developed by MSD that first received U.S. Food and Drug Administration (FDA) approval in 2014 as a treatment for melanoma, a skin cancer, and has since expanded its indications. As it has shown treatment effects across multiple cancers, it became the world's top-selling pharmaceutical in 2023.
Unlike first- and second-generation anticancer drugs that directly attack cancer cells, immuno-oncology drugs work by activating the immune response of T cells, which are immune cells, to recognize and induce attacks on cancer cells. It is also known that former U.S. President Jimmy Carter received Keytruda treatment.
In Korea, it received its first approval from the Ministery of Food and Drug Safety in 2015. At the time, the approved indication was melanoma that was inoperable or metastatic. Since then, indications have been steadily expanded, and a total of 34 indications have been approved across 16 cancer types.
However, health insurance coverage has applied only to four cancer types (seven indications): non-small cell lung cancer (NSCLC), Hodgkin lymphoma, melanoma, and urothelial carcinoma. Annual domestic claims amount to about 400 billion won.
With this HIPDC decision, coverage will be further expanded to nine cancer types, broadening the previously limited range of coverage compared with the number of approved indications. In particular, with endometrial cancer and breast cancer included, coverage will now be available for women's cancers that previously had a high share of noncovered treatment.
Coverage has also been expanded for Dupixent (ingredient dupilumab), a medicine from French global pharmaceutical company Sanofi. Previously, in Korea, coverage applied only to chronic severe atopic dermatitis, but through this HIPDC decision, coverage will also apply to treatment of severe type 2 inflammatory asthma.
The Ministry of Health and Welfare said that with the expansion, the annual per-person drug cost for Dupixent in severe asthma, which patients had borne, will decrease from about 15.88 million won to 4.76 million won (with a 30% copayment).
Meanwhile, among eight ingredients re-evaluated this year, for olopatadine hydrochloride, Weiryeongseon-Gwallugeun-Hagocho, bepotastine, and L-aspartate-L-ornithine injection 0.5 g/mL, whose clinical utility was confirmed, coverage will be maintained, while for the remaining drugs, the HIPDC raised the need for further review, and they will be discussed again later.