Lilly retries to make RET-targeted therapy accessible

Has re-applied for reimbursement of 'Retevmo' for lung cancer

Whether Retevmo's third bid would succeed gains attention

Product photo of Retevmo Cap

Patients are hopeful again for RET-targeted cancer therapy, a treatment option once deemed 'pie in the sky.' According to industry sources, Lilly Korea has recently submitted an application for insurance reimbursement listing for its RET (REarranged during Transfection) inhibitor 'Retevmo (selpercatinib),' indicated for the treatment of non-small cell lung cancer (NSCLC).

 

Retevmo, which was approved in South Korea in March 2022, had not passed the Cancer Disease Review Committee (CDRC) of the Health Insurance Review and Assessment Service (HIRA) in May of the same year.

 

The drug passed the CDRC in November and the Drug Reimbursement Evaluation Committee (DREC) in May 2023.

 

Upon clearing the DREC review, Retevmo was anticipated to be reimbursed as the company entered a pricing negotiation with the National Health Insurance Service (NHIS) in June.

 

However, an agreement had not been met.

 

It was the sole unsuccessful drug pricing negotiation of that year.

 

Consequently, it was expected that RET cancer therapy would not be readily accessible in South Korea.

 

Two RET cancer therapies are domestically approved.

 

In addition to Retevmo, 'Gavreto (pralsetinib),' introduced by Roche Korea from Blueprint Medicines Corp, exists.

 

However, Gavreto's inclusion in the reimbursement list became difficult due to Roche withdrawing the sales rights.

 

Lilly's Korean subsidiary has recently made progress.

 

However, it remains uncertain whether the company will finalize the reimbursement listing process.

 

Retevmo was conditionally approved for agreement to meet the Phase 3 trial requirement.

 

However, the company's application for listing process lacked a Phase 3 study and was asked to submit a document equivalent to the requirement.

 

For this reason, criticism arose regarding the evaluation criteria for the drug that had been conditionally approved to expedite its introduction.

 

This was because the company had quickly applied for listing under the approval–evaluation linkage system, underwent discussions on reimbursement for about a year and a half but ultimately failed.

 

There is still room for a turnaround.

 

Proper Phase 3 trial results are now in hand.

 

What now matters is Lilly's and the government's commitment to introducing a RET-targeted cancer therapy.

 

At the 2023 European Society for Medical Oncology (ESMO 2023) annual meeting, the results of Retevmo's Phase 3 trials, LIBRETTO-431 and LIBRETTO-531, were each disclosed.

 

Those results were published in the New England Journal of Medicine (NEJM).

 

The LIBRETTO-431 study presented at the conference compared Retevmo with platinum-based chemotherapy±pembrolizumab in the first-line treatment of patients with progressive or metastatic RET fusion–positive NSCLC.

 

The key result was that, in the ITT-pembrolizumab cohort, the median progression-free survival (PFS) assessed by the blinded independent central review (BICR) was 24.8 months in the Retevmo-treated group versus 11.2 months in the control group, with a hazard ratio of 0.465.

 

The overall response rate (ORR) by BICR was also significantly higher in the Retevmo group at 83.7% compared to 65.1% in the control group.

 

Meanwhile, Retevmo was granted accelerated approval, priority review, and Breakthrough Therapy & Orphan Drug Designation in the United States in 2020.

 

Then, it was approved as the first treatment option for the treatment of cancer patients with RET gene mutations.