Will the non-reimbursed Gavreto vanish in Korea?

Roche to sell the drug until February next year...will return the rights to Blueprint

The drug failed to receive reimbursement after Roche gave up sales rights...reapplication plan for reimbursement unclear

Retevmo expected to dominate the RET inhibitor market...lowering Gaverto’s expected profit

The possibility that the new RET-targeted anticancer therapy ‘Gavreto (pralsetinib)’ will vanish without ever being released in Korea has been rising.

 

With Roche giving up sales rights for Gavreto, the prospects of its reimbursement listing in Korea had also gone up in smoke.

 

As Blueprint Medicines, the original developer of Gavreto, does not have a branch in Korea, the company would need to find a new partner to market the drug in Korea, which is more easily said than done.

 

According to the Health Insurance Review and Assessment Service, the Drug Reimbursement Evaluation Committee determined Gavreto inadequate for reimbursement and made a ‘non-reimbursement’ at its 7th 2023 DREC meeting that was held on the 6th.

 

Drugs that receive a non-reimbursement decision, not a conditional pass or re-discussion decision, must reapply for reimbursement with supplementary materials.

 

As such drugs need to undergo all the steps for reimbursement again, the time to their reimbursement listing becomes delayed indefinitely.

 

Also, it is unclear which pharmaceutical company will reapply for Gavreto’s reimbursement in the future.

 

Before, Roche Korea was in charge of its approval and distribution in Korea.

 

Roche had paid $775 million upfront for Gavreto’s global sales right in all countries excluding China.

 

However, in March, only 2 years and 7 months after signing the agreement, the company returned the rights for Gavreto to Blueprint due to lower sales expectations.

 

With the termination of the collaboration, Roche will be supplying Gavreto until February next year.

 

To continue supply, the original developer Blueprint Medicines will need to directly supply the drug or find a new partner.

 

Without its own Korean subsidiary, the realistic alternative for Blueprints would be to resume supply through a new partner.

 

So far, there has been no word on Gavreto’s new partner.

 

Roche Korea submitted an application for the reimbursement of Gavreto in November last year.

 

However, its discussions fell through after the global termination of the collaboration was announced ahead of its CDDC review.

 

Roche Korea was unable to continue the drug pricing negotiations for the drug in a situation where it was unclear which company would continue marketing the drug.

 

As a result, Gavreto’s reimbursement standards were not set at the CDDC meeting, resulting in its non-reimbursement by DREC.

 

The market conditions are also working against Gavreto.

 

Its competitor, Lilly's 'Retevmo (selpercatinib)', passed DREC review in May and is set to be reimbursed soon.

 

The reimbursement listing timing for Retevmo and Gavreto, both of which received domestic approval in the same month, widened significantly in the reimbursement listing process.

 

Unlike Retevmo, which passed the Drug Committees (DCs) of major general hospitals in January of this year, Gavreto was unable to even be registered for prescriptions.

 

At this rate, it is highly likely that Retevmo will dominate the domestic RET mutation-targeting therapy market.

 

In addition, Gavreto recently voluntarily withdrew its thyroid cancer indication in the U.S.

 

With Retevmo already owning the indication, Gavreto lost the opportunity to extend its indication to the area.

 

This signifies the lower profit expected for Gavreto in Korea.

 

Previously, sales of Retevmo surpassed Gabretto in global sales, reducing the sales expectations for Gavreto.

 

It seems that it will not be easy to find a pharmaceutical company that will sell Gavreto in this situation, as the patient group is small, sales expectations are low, and reapplications need to be made for its reimbursement.

 

If Gavreto goes through the withdrawal process at this pace, Retevmo will become the only targeted anti-cancer drug that can treat RET mutation-positive cancer in Korea.

 

RET is one of the major emerging biomarkers that induce cancer.

 

It causes malignant tumors through fusion mutations or point mutations.

 

RET mutations are partially found in several cancer types, including lung cancer, breast cancer, and colorectal cancer.

 

The rate of RET mutations in non-small cell lung cancer is about 2 to 6%, and RET fusion mutations have been reported in up to 40% of thyroid cancers.