'Retevmo' also seeks thyroid cancer reimbursement

Lilly Korea has applied for listing of two indications

Growing attention to the potential reimbursement expansion of Korea's only treatment option

Product photo of Retevmo

The RET-targeted cancer therapy 'Retevmo' seeks insurance reimbursement listing of its medullary thyroid cancer indication.

 

According to sources, Lilly Korea recently submitted reimbursement applications simultaneously for the non–small cell lung cancer indication and medullary thyroid cancer indication of the RET (REarranged during Transfection) inhibitor Retevmo (selpercatinib).

 

Having failed in its previous two attempts to secure reimbursement listing for lung cancer, the company is now showing its determination to gain listing by adding a new indication.

 

The prevalence of medullary thyroid cancer is only 1–2% of all thyroid cancers worldwide and just 0.6% in South Korea.

 

However, 60% of cases harbor RET gene mutations.

 

In other words, RET-targeted therapies can be used to treat medullary thyroid cancer.

 

First-line treatments for medullary thyroid cancer currently consist of multitargeted kinase inhibitors such as vandetanib and cabozantinib, which inhibit multiple kinases non-selectively and can therefore be associated with higher rates of adverse events.

 

In contrast, Retevmo is a highly selective RET inhibitor.

 

Retevmo demonstrated efficacy in medullary thyroid cancer in the Phase 3 LIBRETTO-531 study.

 

The LIBRETTO-531 study is a Phase 3 open-label trial comparing Retevmo against the approved first-line multikinase inhibitors (cabozantinib or vandetanib) in patients with progressive or metastatic RET-mutant medullary thyroid cancer.

 

A total of 291 medullary thyroid cancer patients with no prior multikinase inhibitor therapy were randomized (193 Retevmo treatment group, 98 control group).

 

At the investigators' discretion, patients in the control group received cabozantinib in 73 cases and vandetanib in 25 cases.

 

The progression-free survival (PFS) comparison yielded positive data in the interim analysis.

 

At a median follow-up of approximately 12 months, the Retevmo treatment group had not yet reached median PFS by blinded independent central review (BICR), while the control group had a median PFS of 16.8 months.

 

The hazard ratio was 0.280.

 

In preplanned subgroup analyses, BICR-assessed and investigator-assessed PFS were longer with Retevmo than with the control.

 

Meanwhile, although Retevmo was approved in South Korea in March 2022, it failed to pass the National Health Insurance Service (NHIS) Cancer Disease Review Committee (CDRC) in May of the same year.

 

Still, it cleared the CDRC in November and passed the Drug Reimbursement Evaluation Committee (DREC) in May 2023.

 

After passing the reimbursement committee, negotiations with the NHIS on pricing began in June, raising hopes for listing, but ultimately, no agreement was reached.

 

The case was the only failed price negotiation of that year.

 

A Lilly representative said, "The company has been continuously preparing for the reapplication process and has submitted all required documents to the NHIS.

 

The government is currently reviewing the application.

 

We will do our best to ensure that more patients can benefit as soon as possible."