Merck’s Tepmetko, BeOne Medicines’ Tevimbra to be covered by insurance starting April

Merck's MET inhibitor, Tepmetko (tepotinib), and BeOne Medicines' (formerly BeiGene) anti-PD-1 immuno-oncology drug, Tevimbra (tiselizumab), will be covered by Korea's national health insurance starting next month.

In addition, the combination therapy of abiraterone plus prednisolone for metastatic castration-resistant prostate cancer will be reclassified from an optional insurance benefit (covering 30 percent of costs) to a mandatory benefit (covering 95 percent of costs).

The Health Insurance Review and Assessment Service (HIRA) announced on Thursday the “Amendment to the Notification on Drugs Prescribed and Administered to Cancer Patients” and opened it for expert opinions until March 26. The amendment is set to take effect on April 1.

Tepmetko will be covered for the “first-line treatment of patients with locally advanced or metastatic NSCLC with confirmed MET exon 14 deletion (skipping).”

Tepmetko, approved by the Ministry of Food and Drug Safety in November 2021, secured reimbursement on its third attempt. This reimbursement comes three and a half years after its introduction in Korea.

“Tepmetko is approved for the treatment of patients with locally advanced or metastatic NSCLC with a confirmed MET exon 14 deletion and was reviewed with reference to textbooks, guidelines, and clinical articles,” HIRA stated. The applicant drug is mentioned in major textbooks and is recommended as “preferred, category 2A” by the U.S. National Comprehensive Cancer Network (NCCN) and “II.A, MCBS Score 3” by the European Society for Medical Oncology (ESMO). 

HIRA further noted that in a phase 2 trial with an expanded confirmatory arm, Tepmetko demonstrated an objective response rate (ORR) of 51.4 percent, a median progression-free survival (mPFS) of 11.2 months, and a median overall survival (mOS) of 19.6 months.

“The reimbursement criteria for the applicant agent are based on the fact that it is a well-targeted therapy that offers another treatment option for patients and is considered a clinically necessary benefit,” HIRA stated.

Tevimbra is also covered for “the second or later treatment of patients with unresectable, recurrent, locally advanced, or metastatic esophageal squamous cell carcinoma that has recurred or progressed during or after prior platinum-based chemotherapy.”

This includes recurrence within six months of completing prior chemotherapy or post-surgical adjuvant therapy and is covered only if the patient has not previously been treated with an immune checkpoint inhibitor, such as a PD-1 inhibitor.

Currently, immunotherapies with the same mechanism of action, such as Keytruda (pembrolizumab) and Opdivo (nivolumab), are approved for the first- and second-line treatment of esophageal cancer in Korea, but they have not been reimbursed.

Tevimbra is the only immuno-oncology drug to be reimbursed for the treatment of esophageal cancer and was successful in just its second attempt since its approval in November 2023.

“The NCCN guidelines recommend Tevimbra as a ‘category 1’ agent,” HIRA said, “and the randomized, open-label, multicenter Phase 3 trial confirmed an improvement in median overall survival (mOS) of 8.6 months vs. 6.3 months (hazard ratio 0.70) for Tevimbra compared to the control chemotherapy regimen (paclitaxel, docetaxel, irinotecan), which establishes the reimbursement criteria.”

Meanwhile, the abiraterone plus prednisolone combination, which has been covered as an optional benefit with a 30 percent patient copayment, will be converted to a mandatory benefit with a 5 percent patient copayment for the first-line treatment of metastatic castration-resistant prostate cancer. 

Recently, next-generation hormonal agents (ATRAs) such as Erleada (apalutamide) and Xtandi (enzalutamide) have been applied as mandatory benefits in the hormone-sensitive stage prior to castration resistance. Additionally, the patent expiration of Zytiga has led to the launch of generics, such as Hanmi Pharmaceutical's Abiteron and Ace Pharma's Aviron, significantly reducing the price of abiraterone-based drugs.

In addition, last year, Hanmi Pharm launched Abiteron Duo, a combination of abiraterone and prednisolone, at a lower price than the original single drug Zytiga.