The immuno-oncology drug "Keytruda," considered a representative, has passed the first hurdle for expanded health insurance coverage.
The Health Insurance Review and Assessment Service noted on the 12th that the Cancer Disease Advisory Committee evaluated whether to expand the coverage criteria for Keytruda (generic name pembrolizumab) and established coverage standards for a total of 11 indications.
If Keytruda passes the Health Assessment Service's drug reimbursement evaluation committee, it will undergo price negotiations with the National Health Insurance Service and review by the Health Insurance Policy Review Committee before receiving additional insurance coverage.
Keytruda, an immuno-oncology drug developed by the U.S. pharmaceutical company MSD (Merck), was also ranked as the top-selling drug worldwide in 2023. Immuno-oncology drugs help immune cells attack cancer cells, unlike existing chemotherapy drugs that directly target cancer cells.
Keytruda received approval from the U.S. Food and Drug Administration (FDA) in 2014, followed by approval from the Ministry of Food and Drug Safety in South Korea in 2015. The initially approved indication was for unresectable or metastatic melanoma, and the indications have since expanded to a total of 34 approvals across 16 cancers. However, health insurance coverage currently applies to only 7 indications for 4 types of cancer: non-small cell lung cancer, Hodgkin's lymphoma, melanoma, and urothelial carcinoma.
The pharmaceutical company requested expanded coverage for other indications in 2023, but the decision for "re-discussion" was repeatedly made over a total of 5 Cancer Disease Advisory Committee meetings until the end of last year, and this meeting was the 6th.
The indications for which coverage criteria have been established this time 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 ▲ biliary cancer.
If the expansion of health insurance coverage for Keytruda is finalized, it is expected to significantly reduce the financial burden on many cancer patients.
Ahead of the meeting, the Korean Patient Coalition urged for a swift expansion of coverage, stating, "As discussions for the expansion of Keytruda's coverage have been delayed for two years, patients are missing out on appropriate treatment opportunities."