The Ministry of Health and Welfare announced that, effective October 1, it will cover the costs of “Retevmo Capsules,” a treatment for lung cancer caused by rare genetic mutations; “Viloiyu,” a treatment for unresectable advanced or metastatic gastric cancer; and the combination therapy of “Padsep” and “Keytruda” for the first-line treatment of urothelial carcinoma. This measure, aimed at improving access to treatment for patients with rare and underserved cancers, was approved following deliberation by the Health Insurance Policy Deliberation Committee.
Retevmo Capsules are used to treat non-small cell lung cancer and medullary thyroid cancer caused by a rare genetic mutation known as RET fusion. RET is a gene that regulates cell growth; when mutated, it disrupts normal cell growth and differentiation, leading to cancer. Non-small cell lung cancer caused by this genetic mutation occurs in only 1–2% of lung cancer patients, and the number of patients in South Korea is estimated to be fewer than 300. Unlike existing cytotoxic anticancer drugs, Retevmo Capsules are a targeted anticancer drug that selectively attacks only the specific cancer cells, thereby reducing side effects and increasing efficacy. As it is an oral medication, it is expected to alleviate the inconvenience experienced by patients who previously had to wait long periods at hospitals to receive injections.
Viloiz is a new drug for the treatment of unresectable advanced or metastatic gastric cancer. According to the 2023 National Cancer Registry Statistics, while the 5-year relative survival rate for all gastric cancers from 2019 to 2023 reached 78.6%, the median survival period for unresectable advanced or metastatic gastric cancer is 6 to 10 months, and the 5-year relative survival rate hovers around 10%, highlighting the difficulty of treatment. Biloyju has been proven to reduce the risk of developing resistance by 41% compared to existing treatments and to approximately double overall survival, and is expected to help alleviate patients’ financial burden and extend their lives.
Urothelial carcinoma is a neglected cancer type, accounting for about 2.5% of all cancer cases. Because it progresses more rapidly than other cancers, early intervention is crucial; however, for the existing drug Keytruda, health insurance coverage has been limited to second-line treatment only—after failure of first-line therapy. With this new policy, patients can now use Keytruda from the very first line of treatment and are also eligible for health insurance coverage when using it in combination with the next-generation drug Padsep.
Padscep precisely targets cancer cells, while Keytruda strengthens the patient’s immune cells to aid treatment. Because their mechanisms of action differ, the combination therapy is expected to be highly effective; key clinical trials have reported that overall survival was approximately doubled compared to existing treatments.
This decision marks effectively the first instance in which health insurance coverage has been extended to a combination therapy involving new drugs patented by different pharmaceutical companies. Under current laws and regulations, health authorities must negotiate separately with Astellas Pharma Korea and MSD Korea, and while the two companies’ interests may differ, a compromise was reached with the goal of addressing gaps in treatment for patients with rare and severe diseases. The government plans to use this as a precedent to push for institutional reforms aimed at expanding health insurance coverage for combination therapies involving different new drugs.
Lee Hyung-hoon, Second Vice Minister of Health and Welfare, stated, “We hope that this expansion of health insurance coverage will alleviate the burden on patients and their families who have delayed or abandoned treatment due to high medication costs,” adding, “We will continue to strive to strengthen health insurance coverage for treatments for rare and severe diseases.”
