‘Lilly will reapply for Retevmo’s reimbursement in Korea’

We ask for help on the government’s part

Lilly Korea expresses will to receive reimbursement for Retevmo in Korea

Agenda remains pending after failing drug pricing negotiations last time

“We will do our best to receive reimbursement for Retevmo in Korea.

 

However, the will of the health authorities is as important” The company has expressed its will to list a RET-targeted therapy option in Korea.

 

The question that remains now is when.

 

Lilly's RET inhibitor Retevmo (selpercatinib) remains non-reimbursed since the company’s pricing negotiations with the National Health Insurance Service broke down last year There are only two RET-targeted therapies - ‘Gavreto (pralsetinib),’ which Roche Korea introduced from Blueprint Medicines, and ‘Retevmo (selpercatinib)’ by Lilly Korea – currently approved in Korea.

 

Of the two, it would be hard for Gavreto to be listed for reimbursement in Korea as Roche gave up rights to the drug.

 

The situation is not so better off for Retevmo either.

 

Retevmo, which was approved in Korea in March 2022, failed to pass the Health Insurance Review and Assessment Service Cancer Disease Review Committee (CDDC) review in May of the same year, but then passed CDDC review in November and finally passed the Drug Reimbursement Evaluation Committee in May last year.

 

After passing the DREC review, the company entered into drug price negotiations with the National Health Insurance Service in June, raising expectations on Retevmo’s reimbursement.

 

However, the two ultimately failed to reach an agreement.

 

In fact, it was the only news of a drug pricing negotiation failure reported in the past year.

 

Retevmo was granted marketing authorization under the condition of conducting a Phase III trial, so it had trouble during the reimbursement listing process as the authorities requested the company for data equivalent to a Phase III trial to accommodate for the lack of its Phase III trial data.

 

At the time, this led to criticism about the reimbursement evaluation criteria for conditionally approved drugs that were granted fast-track review.

 

The reimbursement of Retevmo, which applied for fast-track status under the approval-reimbursement evaluation linkage system, had been in discussions for about a year and a half, but to no avail.

 

But it now has additional results from a proper Phase III trial.

 

Now it's a matter of Lilly and the government’s willingness to bring RET drugs to the market.

 

Results from Phase III trials on Retevmo - LIBRETTO-431 and LIBRETTO-531 - were presented at the European Society for Medical Oncology Annual Congress (ESMO 2023) last year.

 

The results were published in the internationally recognized New England Journal of Medicine (NEJM) along with the congress presentation.

 

The LIBRETTO-431 trial presented at the meeting compared Retevmo with platinum-based chemotherapy±pembrolizumab as a first-line treatment in patients with advanced or metastatic RET fusion-positive NSCLC.

 

Key findings in the trial showed that in the ITT-pembrolizumab population, the median progression-free survival (PFS) by an independent centralized review committee (BICR) was 24.8 months in the Retevmo arm, and 11.2 months in the control arm, with a hazard ratio of 0.465.

 

The overall response rate (ORR) by BICR was 83.7% in the Retevmo arm, which was statistically significantly higher than the 65.1% in the control arm.

 

“Lilly intends to reapply for reimbursement of Retevmo,” said a Lilly representative.

 

However, for us to quickly reapply for reimbursement, not only the company's efforts but also discussions with health authorities are required.

 

So we cannot provide a specific timeline for the reapplication yet.

 

We remain committed to improving access to Retevmo for cancer patients with RET gene mutations in Korea.” In 2020, Retevmo was approved as the first treatment option for cancer patients with RET 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.