RET-targeted Retevmo reattempts reimb listing in Korea

Will be deliberated by HIRA CDDC on Nov. 2

Attention focused on its 2nd review after CDDC’s deliberations were criticized at the NA audit

The RET-targeted anticancer therapy ‘Retevmo’ will reattempt reimbursement listing in Korea.

 

According to industry sources, Lilly Korea’s Retevmo (selpercatinib) will be deliberated by the Health Insurance Review and Assessment Service’s Cancer Disease Review Committee (CDRC) tomorrow on November 2nd.

 

Retevmo received marketing authorization in March this year and was deliberated by CDDC for reimbursement in May.

 

After deliberation, the CDDC decided not to set reimbursement standards for the drug.

 

Whether a different conclusion will be made this time remains to be seen.

 

The CDDC’s review process was raised as an issue at the recent NA Audit.

 

Rep.

 

Gi-Yoon Kang of the People Power Party pointed out the lack of rationale for the CDDC’s not setting reimbursement standards within HIRA’s reimbursement process.

 

According to Rep.

 

Kang, the CDDC made the decision not to set reimbursement standards for anticancer drugs that had applied for reimbursement with Phase II clinical trials due to their absence of Phase III trial data, but this undermines the purpose of drugs that received approval under the condition of conducting Phase III trials in the future.

 

However, HIRA said what it requested was additional data, not Phase III trial data, that could explain the clinical efficacy of the drugs, as it lacks data comparing its efficacy with existing treatments (indirect comparative data with existing treatments, real-world data, reimbursement evaluation results abroad, etc.) In 2020, Retevmo was approved as the first treatment option for cancer patients with RET gene alternations in the US after the FDA reviewed the drug through the Accelerated Approval and Priority Review pathway and granted the Breakthrough Therapy & Orphan Drug Designation.

 

The drug demonstrated its efficacy through the LIBRETTO-001 trial that was conducted on 702 patients with advanced or metastatic solid cancer with RET mutations.

 

In the trial, the overall response rate (ORR) of patients with RET fusion-positive NSCLC without prior platinum-based treatment experience that was treated with Retevmo was 85%.

 

Although the median duration of response (DoR) was not yet reached, 79% of the patients showed continued response during the follow-up period (median 7.4 months).

 

In patients with platinum-based treatment experience, the ORR was 64%, and the median DoR was 17.5 months.