[Reporter’s View] Reimbursing the only RET-targeted therapy

Do not dampen the company’s reimbursement attempt for Retevmo, the only RET-targeted therapy available in Korea

News of a new drug failing to be listed for insurance reimbursement always upsets patients.

 

The blow is even harder when it is the only treatment option available.

 

Such was the case in 2023 when the National Health Insurance Service and Lilly failed to reach an agreement on the price of the RET-targeted anticancer drug Retevmo (selpercatinib).

 

This was the only case of a drug price negotiation failure that year.

 

This drug was the first treatment option for patients with RET fusion-positive non-small cell lung cancer and thyroid cancer, and the only drug that was being reviewed for reimbursement in Korea.

 

With the reimbursement listing of Retevmo falling through, patients were left to endure an indefinite wait.

 

Then, this year, the developer, Lilly Korea, finally reaffirmed its commitment.

 

Lilly recently submitted a reimbursement application for non-small cell lung cancer along with an indication for thyroid cancer.

 

This is the company’s third attempt.

 

Prior to the approval of Retevmo, there were no targeted treatment options available for patients with RET-mutated NSCLC or thyroid cancer.

 

Therefore, the Ministry of Food and Drug Safety approved Retevmo through a fast-track review for the treatment of:▲ adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC); ▲adults and pediatric patients 12 years of age or older with advanced or metastatic RET-mutated medullary thyroid cancer who require systemic therapy; and ▲ adult patients who are refractory to radioactive iodine therapy and who have prior sorafenib and/or lenvatinib treatment, with advanced or metastatic RET-fusion benign thyroid cancer who require systemic therapy.

 

Among the A7 countries that are used as Korea’s drug price reference countries, Retevmo is covered and used in 6 countries (US, Germany, Italy, UK, Switzerland, and Japan) other than France.

 

However, despite the considerable time that has passed, it is still not reimbursed in South Korea.

 

The MFDS has been operating an expedited review system to promptly launch and supply highly innovative drugs for life-threatening or serious conditions to the market and patients.

 

However, only a handful of the 23 approved through the fast track is currently being reimbursed by insurance.

 

This means that even after the drugs receive accelerated approval through fast-track review, it is difficult for cancer patients to receive treatment benefits without reimbursement.

 

While regulatory authorities often determine that rapid introduction is necessary, it is frequently the case that insurance authorities remain cautious and conservative.

 

When it comes to the introduction and improvement of systems, ‘effectiveness’ is always a top priority.

 

This reporter hopes that policies aimed at improving patient access to innovative new drugs can achieve the intended effect.