South Korea to extend national health insurance coverage to treatments for rare, neglected cancers

Starting Thursday, a combination therapy using urothelial cancer drugs Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) will receive national health insurance coverage for the first time.

Two other treatments will also gain coverage: Retevmo (selpercatinib) capsules for rare gene-mutation lung cancer, and Vyloy (zolbetuximab) for advanced or metastatic gastric cancer.

The Ministry of Health and Welfare announced Wednesday that the Health Insurance Policy Deliberation Committee had approved the expansion of national health insurance coverage.

For urothelial cancer — a neglected cancer type accounting for about 2.5 percent of all cancer cases — coverage will apply to a first-line combination therapy pairing the new drug Padcev with the existing drug Keytruda.

Urothelial cancer progresses faster than many other cancers, making early intervention critical. Previously, Keytruda was covered under national health insurance only from the second line of treatment onward, after first-line therapy had failed.

Under the new measure, urothelial cancer patients will be able to use Keytruda from the first stage of treatment and receive coverage for the combination therapy with Padcev as well.

The ministry said the approval marks what is in effect the first time national health insurance has been extended to a combination therapy involving new drugs patented by different pharmaceutical companies. "Under relevant regulations, each pharmaceutical company must negotiate individually with health authorities, and their interests can diverge," the ministry said. "Nevertheless, a compromise was reached under the overarching goal of eliminating treatment blind spots for patients with rare and serious diseases."

The government said it plans to use this case as a precedent and pursue further regulatory improvements to expand national health insurance coverage for combination therapies involving different new drugs.

Retevmo capsules, now covered under national health insurance, are a targeted anticancer drug for non-small cell lung cancer and medullary thyroid cancer caused by rare gene mutations. Unlike conventional cytotoxic anticancer drugs, Retevmo targets only the relevant cancer cells.

Because it comes in oral capsule form rather than as an injection, patients will also be spared the inconvenience of repeated hospital visits and long waits for infusion.

Non-small cell lung cancer caused by rare gene mutations affects only 1 to 2 percent of lung cancer patients and is estimated to affect fewer than 300 patients in South Korea.

Vyloy, a new drug for unresectable advanced or metastatic gastric cancer, has demonstrated clinical efficacy — reducing the risk of treatment resistance by 41 percent compared with existing therapies and extending overall survival by approximately twofold.

Gastric cancer of this type is notoriously difficult to treat, with a five-year relative survival rate of only around 10 percent. The ministry said it expects national health insurance coverage for Vyloy to ease the financial burden on patients and contribute to prolonging their lives.

"I hope this expansion of national health insurance coverage will ease the burden on patients and their families who have been delaying or forgoing treatment because of the high cost of medication," Deputy Minister of Health and Welfare Lee Hyeong-hun said. "We will continue to strengthen national health insurance protection for treatments targeting rare and serious diseases."