Will Retevmo finally be reimbursed 5yrs post-approval?

Follow-up procedures prolonged even after submission of economic evaluation data

No word after passing the CDDC review... concerns mount that the only treatment option may become useless

Attention is once again turning to whether the RET-targeted anticancer therapy Retevmo can finally conclude its reimbursement listing process.

Despite domestic regulatory approval, reimbursement coverage has yet to be granted nearly 5 years later, extending the wait for eligible patients.

According to industry sources, Eli Lilly Korea resubmitted its reimbursement application for Retevmo (selpercatinib), indicated for RET-mutated non-small cell lung cancer (NSCLC), in April of last year. The therapy subsequently passed the Health Insurance Review and Assessment Service (HIRA) Cancer Disease Review Committee again in September. Follow-up procedures, including pharmacoeconomic evaluation, are reportedly in progress.

The company has already submitted the required documentation, including the pharmacoeconomic evaluation data. However, specific timelines for review or details regarding price negotiations remain difficult to ascertain at this stage.

Retevmo endured a truly arduous journey through the listing process. The drug received approval from the Ministry of Food and Drug Safety in March 2022. Subsequently, reimbursement criteria were established by the Health Insurance Review and Assessment Service in November 2022, and it passed the Drug Reimbursement Evaluation Committee in May 2023, gaining recognition for its cost-effectiveness.

However, its listing fell through in August 2023 when price negotiations with the National Health Insurance Service broke down. Then, in October 2023, Phase III clinical trial data showing improved overall survival (OS) were announced, prompting the company to reapply based on this evidence.

RET mutations represent rare genetic alterations identified in approximately 1–2% of NSCLC patients.

Currently, Retevmo remains the only RET-targeted therapy approved in Korea. Conventional chemotherapy and immunotherapy have historically shown limitations in response rates and durability within this patient population.

Meanwhile, 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 level of evidence and expert consensus. While it is considered a treatment option immediately upon diagnosis in global standards, it remains non-reimbursed in Korea.

Of course, many anticancer drugs designated as global standard treatments remain non-covered in Korea. However, Retevmo differs in that, despite having already been recognized for cost-effectiveness once and securing additional clinical evidence after negotiations stalled, discussions for its coverage have been prolonged.

Among the A7 reference pricing countries, Retevmo is reimbursed and actively used in clinical practice across six nations (the United States, Germany, Italy, the United Kingdom, Switzerland, and Japan), with France being the sole exception.