Eli Lilly’s Retevmo Gains 1st-Line Reimbursement for RET-Positive NSCLC and Thyroid Cancer in South Korea

Retevmo Secures National Health Insurance Coverage for Lung and Thyroid Cancers in South Korea

South Korean health authorities have granted National Health Insurance reimbursement to Korea Lilly’s RET-targeted therapy Retevmo, expanding access for patients with specific gene mutations, medigatenews.com reported. The reimbursement covers Retevmo capsules in 40mg and 80mg strengths, containing the active ingredient selpercatinib, following a public notice from the Health Insurance Review and Assessment Service that took effect on December 1.

Eligible Patient Populations and Approved Indications

The insurance coverage applies to two distinct patient groups requiring first-line or subsequent palliative care. The first group includes adults with RET fusion-positive local advanced or metastatic non-squamous non-small cell lung cancer at stage IIIB or higher. The second group covers adults and adolescents aged 12 and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy following disease progression.

Before this decision, patients who identified RET gene variants faced a coverage gap that left them reliant on standard chemotherapy regimens. Korea Lilly expects the reimbursement to close that gap and provide eligible patients with direct access to targeted treatment from the early stages of diagnosis.

Clinical Trial Results Supporting Lung Cancer Reimbursement

Evidence supporting the lung cancer indication comes from the Phase 3 LIBRETTO-431 study, which evaluated patients with treatment-naive RET fusion-positive advanced non-small cell lung cancer. The trial compared Retevmo against a control group receiving pembrolizumab combined with chemotherapy.

Data from the trial showed a median progression-free survival of 24.8 months for patients receiving Retevmo, compared to 11.2 months for the control group. The therapy reduced the risk of disease progression or death by 54 percent. The objective response rate reached 84 percent in the Retevmo arm, compared to 65 percent in the comparator arm.

Clinical Trial Results for Medullary Thyroid Cancer

The therapy demonstrated similar efficacy in treating medullary thyroid cancer during the Phase 3 LIBRETTO-531 trial. Researchers evaluated the drug in advanced RET-mutant medullary thyroid cancer patients who had no prior exposure to kinase inhibitors.

The 12-month progression-free survival rate reached 86.8 percent in the Retevmo group, compared to 65.7 percent in the control group, which received either cabozantinib or vandetanib. Treatment with Retevmo lowered the risk of disease progression or death by 72 percent.

Park expressed hope that the reimbursement will lower financial barriers and expand access to appropriate treatment for more patients.

Industry Outlook on Precision Oncology

Kwon Mi-ra, executive director of the Oncology Business Unit at Korea Lilly, characterized Retevmo as a prime example of precision medicine that targets specific genetic variants rather than tumor locations. Kwon added that the company remains committed to delivering innovative treatment options for rare and difficult-to-treat cancers with high unmet medical needs in South Korea.

Frequently Asked Questions About Retevmo Coverage

What exact strengths and active ingredients are covered by the new insurance policy?

The reimbursement applies to Retevmo capsules in 40mg and 80mg strengths, which contain the active ingredient selpercatinib.

Which specific lung cancer stages qualify for the reimbursed treatment?

Patients diagnosed with RET fusion-positive local advanced or metastatic non-squamous non-small cell lung cancer at stage IIIB or higher are eligible.

What age restrictions apply to the medullary thyroid cancer indication?

The coverage for advanced or metastatic RET-mutant medullary thyroid cancer applies to adults and adolescents aged 12 and older who require systemic therapy.

How much did Retevmo reduce the risk of disease progression in the lung cancer trial?

In the Phase 3 LIBRETTO-431 study, Retevmo reduced the risk of disease progression or death by 54 percent compared to the control group.