Will Retevmo complete its reimbursement race in Korea?

Passed DREC after failing price negotiations in 2023

No alternative RET-targeted anticancer therapies… listing outcome remains key

Retevmo has revived the fading prospects for reimbursement of RET-targeted anticancer drugs in Korea.

The drug recently passed the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service (HIRA), approximately 5 years after receiving domestic approval in Korea. This achievement comes eight months after it passed the Cancer Disease Deliberation Committee in September last year.

Retevmo has faced significant challenges throughout the reimbursement process. It received approval from the Ministry of Food and Drug Safety in March 2022.

Subsequently, reimbursement criteria were established in November 2022, and the drug passed the Drug Reimbursement Evaluation Committee in May 2023, confirming its cost-effectiveness.

However, in August 2023, the listing was derailed when price negotiations with the National Health Insurance Service (NHIS) broke down. Later, in October 2023, data demonstrating an improvement in overall survival (OS) from Phase III clinical trials was released. Based on this evidence, the company reapplied for reimbursement and has now successfully completed the second round of HIRA-level evaluations.

Attention now turns to whether Retevmo can achieve a positive outcome in price negotiations and secure final reimbursement listing.

RET mutation is a rare genetic alteration found in approximately 1–2% of patients with non-small cell lung cancer.

Currently, Retevmo is the only approved RET-targeted therapy in Korea. Conventional chemotherapy and immunotherapy have shown limitations in terms of response rates and duration of response in this patient population.

The US National Comprehensive Cancer Network (NCCN) guidelines recommend Retevmo as a “Preferred Category 1” option for first-line treatment of RET-mutated metastatic NSCLC. This is the highest grade, meeting the highest level of evidence and expert consensus. While it is considered a standard of care immediately upon diagnosis, it remains non-reimbursed in Korea.

Of course, even within the global standard of care, many are not reimbursed in Korea. However, the case of Retevmo stands out in that it had already demonstrated cost-effectiveness once yet failed at the negotiation stage, and even after additional clinical evidence, the re-evaluation process has been prolonged.

Among the A7 reference pricing countries, Retevmo is reimbursed and used in clinical practice in 6 countries (the US, Germany, Italy, the UK, Switzerland, and Japan), excluding France.