Fintepla enters pricing negotiations through parallel review

Selected alongside Rimqarto and Winrevair for the second Approval–Evaluation–Negotiation pilot program in December last year

Approved in December 2025… approaches reimbursement listing following DREC review in June

Fintepla (fenfluramine), one of the drugs selected for the government's second pilot program for the parallel operation of approval, reimbursement evaluation, and price negotiation (parallel Approval–Evaluation–Negotiation pilot program), has recently entered reimbursement price negotiations with the National Health Insurance Service (NHIS).

Fintepla was selected for the second pilot program in December 2024, alongside Winrevair and Rimqarto. Following its Korean marketing authorization in December 2025, the drug entered price negotiations approximately seven months later.

According to industry sources on July 13, UCB Korea's antiepileptic drug ‘Fintepla,’ Astellas Korea's targeted cancer therapy ‘Vyloy (zolbetuximab),’ and Janssen Korea's ‘Rybrevant (amivantamab)’ all began pricing negotiations with the NHIS this month.

All three products were reviewed by the Drug Reimbursement Evaluation Committee (DREC) in June and were deemed eligible for reimbursement.

Fintepla received a positive reimbursement recommendation as ‘adjunctive therapy for the treatment of seizures associated with Dravet syndrome in patients aged two years and older,’ approximately 18 months after being selected for the second pilot program.

The parallel Approval–Evaluation–Negotiation pilot program allows the Ministry of Food and Drug Safety (MFDS), the Health Insurance Review and Assessment Service (HIRA), and the NHIS to conduct regulatory approval, reimbursement assessment, and price negotiations concurrently, shortening the overall time required for reimbursement listing. Eligible products include therapies for cancer and rare diseases with limited life expectancy, particularly those that address unmet medical needs by demonstrating superior clinical benefit or for which only a few alternative treatments exist.

Fintepla received marketing authorization in Korea in December 2025 and has also been designated an orphan drug. With only the completion of reimbursement price negotiations remaining, the product is one step closer to reimbursement listing. Among the drugs included in the second parallel review pilot program, Fintepla has progressed the furthest toward reimbursement.

Another product in the second pilot program, Curocell's CAR-T therapy Rimqarto (anbalcabtagene autoleucel), recently had its reimbursement criteria established by the Cancer Drug Deliberation Committee (CDDC) and is expected to undergo DREC review.

Meanwhile, Jassen Korea’s Rybrevant (amivantamab) is currently in price negotiations after receiving a positive reimbursement recommendation from DREC as monotherapy for ‘adults with locally advanced or metastatic non-small cell lung cancer harboring EGFR exon 20 insertion mutations whose disease has progressed during or after platinum-based chemotherapy.’

Likewise, Astellas' Vyloy 100 mg and 300 mg received a positive reimbursement recommendation for first-line treatment, in combination with fluoropyrimidine- or platinum-based chemotherapy, for ‘patients with CLDN18.2-positive, HER2-negative, unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma,’ leaving only price negotiations before reimbursement listing.

Because all of these products are high-priced oncology drugs, they are expected to be listed through the Risk Sharing Agreement (RSA) scheme. Accordingly, negotiations will focus not only on reimbursement pricing and budget impact, but also on determining the appropriate RSA type and refund rate.