Merck’s Tepmetko wins reimbursement in Korea after 3.5 years, expanding access for lung cancer patients with rare MET mutation

Merck’s targeted lung cancer therapy Tepmetko (ingredient: tepotinib) has finally secured reimbursement from the National Health Insurance Service, three years and six months after it was approved by the Ministry of Food and Drug Safety (MFDS) in November 2021. The milestone opens the door for broader patient access to the first reimbursed MET exon 14 skipping mutation-targeting therapy in the country.

Tepmetko’s reimbursement, which took effect on April 1, is expected to significantly improve treatment accessibility for patients with non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations — a rare oncogenic driver found in just 1.8 to 3.1 percent of Korean non-small cell lung cancer (NSCLC) cases.

These patients typically face poor prognosis due to high rates of metastasis to the brain and bones, resistance to standard chemotherapy or immunotherapy, and limited response to immune checkpoint inhibitors due to advanced age and frailty.

"Tepmetko is a much-needed treatment option that many physicians in the field have been waiting to use under insurance coverage," said Professor Han Ji-youn, a medical oncologist at the National Cancer Center. "Now that both NGS-based testing and this targeted therapy are reimbursed, real-world use will increase dramatically."

Tepmetko’s health insurance listing was based on the phase 2 VISION study, which included both tissue and liquid biopsy-confirmed cases of MET exon 14 skipping NSCLC.

In patients who were treatment-naïve and diagnosed by tissue biopsy, the drug demonstrated an objective response rate (ORR) of 58.6 percent, with a median progression-free survival (PFS) of 15.9 months and overall survival (OS) of 29.7 months. The median duration of response (DoR) reached an impressive 46.4 months.

Importantly, the trial results showed consistent efficacy regardless of prior treatment, biopsy method, or patient demographics. Among 106 Asian patients analyzed as a sub-cohort, Tepmetko showed an ORR of 64 percent, with a PFS of 16.5 months and OS of 32.7 months.

Despite its clinical benefits, the path to reimbursement was fraught with challenges.

Tepmetko faced multiple rejections by Korea’s cancer drug reimbursement advisory board — the Cancer Disease Review Committee — in 2023, raising concerns it might never be covered. Only after a third application in December 2024 did the drug finally receive a positive recommendation, culminating in the April reimbursement.

"Although I was part of the review committee, physicians with specific expertise in the therapy are not allowed to participate in those meetings, which made it difficult to advocate for the drug," Professor Han said. "Still, we are grateful that Merck never gave up on pursuing reimbursement. Their persistence paid off, and now patients can access this essential treatment without financial burden."

Tepmetko now joins the ranks of standard-of-care options for MET-driven NSCLC and arrives ahead of its rival, Novartis’ Tabrecta (capmatinib), which was approved at the same time but has yet to receive reimbursement.

The drug has already passed formulary reviews at over 30 major hospitals in Korea, including the country's five largest tertiary medical centers, indicating it is well-positioned for rapid clinical adoption.

“Precision medicine is only possible when both biomarker testing and targeted therapies are accessible,” Han said. “Thankfully, Korea remains one of the very few countries where next-generation sequencing (NGS) for detecting biomarkers like MET exon 14 skipping mutations is already covered by the national health insurance.”

Now, with Tepmetko also included in the reimbursement scheme, the nation has achieved a rare situation where both the diagnostic tool and the corresponding therapy are fully reimbursed, she added.

This dual reimbursement is particularly significant given that in most countries, including those with advanced healthcare systems, either the test or the drug — and sometimes both — remain outside the scope of national coverage, limiting access for many patients.

In contrast, Korea’s system now allows patients with this rare mutation to undergo comprehensive genomic testing and begin appropriate treatment without shouldering prohibitive out-of-pocket costs.

“According to the NCCN guidelines, biomarker testing is strongly recommended for patients with metastatic non-small cell lung cancer — including rare types such as MET exon 14 skipping — as it enables early identification of targetable mutations and appropriate first-line therapy selection,” Han said. “The reimbursement of both NGS and Tepmetko ensures that Korean patients can receive a diagnosis and start targeted therapy in a timely manner, which is critical given the aggressive nature of MET-altered lung cancer.”

Christoph Hamann, General Manager of Merck Biopharma Korea, also emphasized the broader implications of this milestone.

"We hope Tepmetko’s reimbursement will help redefine standards of care for difficult-to-treat lung cancers in Korea,” Hamann said. “As a company, Merck is committed to pushing the boundaries of oncology innovation and ensuring that patients get timely access to transformative therapies."