RET-targeted anticancer drugs fail reimb…no promise

on when they will be covered in Korea

Only 1 of the 23 drugs that were granted expedited review was successfully listed through the fast track system

Gene therapies that benefit a very few have difficulty receiving coverage

With RET-targeted anticancer drugs failing to receive reimbursement, patients are now left to wait indefinitely for coverage of their drugs.

 

Lilly Korea's RET inhibitor Retevmo (selpercatinib) failed to be listed for reimbursement last month due to the final breakdown in drug price negotiations with the National Health Insurance Service.

 

This drug was the first treatment option for patients with RET gene mutated non-small cell lung cancer and thyroid cancer and was the only drug that continued on evaluations for reimbursement in Korea.

 

Only two RET-targeted therapies – Retevmo and Gavreto – are currently approved in Korea.

 

In the case of Gavreto, the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee and the Drug Reimbursement Evaluation Committee determined the drug inadequate for reimbursement and made a final ‘non-reimbursement’ decision.

 

Only Retevmo passed the DREC meeting Before Retevmo, no other option had been available for RET-mutated NSCLC or thyroid cancer in Korea.

 

This is why the Ministry of Food and Drug Safety had approved Retevmo 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.

 

The company had attempted to receive reimbursement for the thyroid cancer and NSCLC indications.

 

In other words, Retevmo was accepted as a drug that requires urgent introduction in recognition of its innovation and clinical value in Korea.

 

In fact, 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, Japan) other than France.

 

This was why Retevmo had applied for expedited reimbursement listing through the approval-evaluation linkage system and engaged in discussions with the relevant authorities for a year and a half but to no avail.

 

Although the authorities acknowledged the innovativeness of the drug, they deemed that there remained uncertainty about the efficacy of the specific gene-targeting drug as it was approved through a single-arm study without a comparator rather than a Phase II trial.

 

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 1 out of 23 approved through the fast track is currently being covered by insurance.

 

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

 

This is why non-small cell lung cancer and thyroid cancer specialists who have been longing for Retevmo’s listing are expressing the most disappointment.

 

Se-Hoon Lee, Professor of Hematology-Oncology at Samsung Medical Center, said, “Retevmo is recommended as a first-line treatment for patients with RET fusion-positive NSCLC in the NCCN guidelines.

 

It is very unfortunate that our patients have no opportunity to receive the proven therapeutic benefits of Retevmo.” Dong-Jun Lim, Professor of Endocrinology and Metabolism at the Catholic University of Korea Seoul St.Mary’s Hospital, said, “Although thyroid cancer is generally known to be an easy-to-treat cancer with a high survival rate, patients with medullary thyroid cancer with RET mutations have a poor prognosis and low survival rate.

 

It is a very difficult situation for both the patients and doctors, being unable to use treatments with proven, significant clinical results on patients with RET-mutated medullary thyroid cancer due to the lack of treatment access, or in other words, coverage.”