First batch of drugs gain reimb through AEN pilot project

Second batch of drugs, including Winrevair, is also expected to gain reimbursement soon

Bylvay’s reimbursement listing in October concludes the listing of the first phase of drugs under the ‘approval-evaluation-negotiation’ project

Reimbursement applications for Winrevair·Fintepla·Limcato were filed in Jan-Feb this year

With the first drugs under the Approval-Evaluation-Negotiation pilot program all securing reimbursement, the timing for the second batch of drugs currently under review to enter reimbursment listing is also approaching.

 

Expectations are building for the possibility of their sequential insurance coverage as early as the first half of next year.

 

With Bylvay Cap (odevixibat) gaining reimbursement coverage last month, all first-phase drugs under the Approval-Evaluation-Negotiation (AEN) project have now entered Korea’s reimbursement system, joining the previously covered Qarziba Inj (dinutuximab beta).

 

The second batch of products under review are Winrevair (sotatercept) by MSD Korea for pulmonary arterial hypertension, Fintepla (fenfluramine) by UCB Korea for Dravet syndrome, and Limcato (anbal-cel) by the domestic company Curocell for large B-cell lymphoma.

 

According to industry sources on the 16th, approximately 9 to 10 months have passed since the companies applied for reimbursement of these second-batch drugs.

 

They are currently receiving cost-effectiveness reviews.

 

Except for Winrevair, which received marketing authorization in July, the other two are also near approval.

 

Among the three, Limcato was the first to apply for reimbursement in January, followed by Winrevair and Fintepla in February.

 

Winrevair and Fintepla are being reviewed for cost-effectiveness, while Limcato is being reviewed for its clinical usefulness.

 

Looking at the precedent set by the first batch of drugs that went through the reimbursement listing process, reimbursement for the second batch is expected early next year.

 

As Qarziba was listed about 6 months after approval, if Winrevair, the only second batch drug approved as of now, follows a similar process, its reimbursement listing could occur as early as late this year or early next year.

 

However, both Qarziba and Bylvay encountered hurdles at the Drug Reimbursement Evaluation Committee (DREC) stage, facing twists and turns before achieving reimbursement.

 

Qarziba, which was approved by the Ministry of Food and Drug Safety (MFDS) in June last year, was initially deemed non-reimbursable at its first DREC review.

 

It was subsequently granted for reimbursement in December last year after reapplying.

 

It took approximately two years from Bylvay’s first reimbursement application in October 2023 to listing.

 

Even at the point of its re-application last August, it had already been 14 months.

 

This underscores the need to pass the DREC review without rejection and secure recognition of its reimbursement appropriateness, to achieve swift reimbursement listing.

 

If a re-review process is required, reimbursement may be delayed beyond expectations.

 

Meanwhile, the AEN linkage project is a pilot initiative aimed at enhancing access to high-priced treatments for severe diseases by shortening the period to listing of new drugs—which previously exceeded 300 days, including 120 days for MFDS (Ministry of Food and Drug Safety) approval, 150 days for HIRA (Health Insurance Review and Assessment Service) reimbursement evaluation, and 60 days for NHIS (National Health Insurance Service) drug price negotiations.

 

During this year's National Assembly audit, the Ministry of Health and Welfare stated it would review plans to institutionalize the expedited listing system based on an analysis of the AEN pilot project's outcomes and feedback from the field.