Patients with urothelial cancer will be able to receive Padcev and Keytruda together as a first-line treatment under national health insurance. It is effectively the first case in which Korea has extended coverage to a regimen combining new drugs from two different pharmaceutical companies.
The Ministry of Health and Welfare said on the 30th that, following a review by the Health Insurance Policy Deliberation Committee, it will expand insurance coverage from Oct. 1 to the Padcev-Keytruda combination therapy, the rare lung cancer drug Retevmo capsules and Vyloy injection for advanced and metastatic gastric cancer.
The core of the measure is coverage for first-line urothelial cancer treatment that combines Padcev from Astellas Pharma Korea with Keytruda from MSD Korea. Until now, Keytruda was not reimbursed when used as an initial treatment for urothelial cancer, with coverage available only from second-line treatment after the first course failed. Starting Oct. 1, however, patients can receive benefits when the two drugs are used together at the first stage of treatment.
The two drugs attack cancer cells in different ways. Padcev delivers anticancer agents by targeting cancer cells, while Keytruda works by helping immune cells attack them. In a Phase 3 trial of the combination therapy, median overall survival was 31.5 months, roughly double the 16.1 months for patients who received conventional chemotherapy.
To apply health insurance to the regimen, the government had to negotiate separately with each of the two companies that own Padcev and Keytruda. The agreement is effectively the first case of reimbursement for a treatment that combines new drugs from different pharmaceutical companies. The ministry plans to review ways to improve the system to expand coverage for other combinations of new drugs on that basis.
Retevmo, a treatment for rare lung cancer, is also included in the coverage expansion. It is an oral targeted anticancer drug used for non-small cell lung cancer caused by RET gene fusion and for medullary thyroid cancer. RET fusion non-small cell lung cancer occurs in 1% to 2% of all lung cancer patients, and the number of domestic patients is estimated at fewer than 300.
Vyloy, a treatment for advanced and metastatic gastric cancer that cannot be removed by surgery, will also be covered. According to the ministry, the five-year relative survival rate for all gastric cancer is 78.6%, but for unresectable advanced and metastatic gastric cancer it stands at around 10%. Lee Hyung-hoon, second vice minister of health and welfare, said, "Through this expansion of health insurance coverage, we hope to ease the burden on patients and families who delay or give up treatment because of high drug costs," adding, "We will continue working to strengthen coverage for treatments for rare and serious diseases."
