Fintepla to receive rapid reimbursement listing in Korea

Drug price negotiations with NHIS concluded in just 30 days

New treatment option for seizure control rises for the rare intractable Dravet syndrome

‘Fintepla,’ one of the drugs included in the second phase of Korea's Approval–Assessment–Negotiation Parallel Review Pilot Program, is expected to enter the National Health Insurance reimbursement system at an accelerated pace.

According to industry sources, UCB Korea recently reached a final agreement with the National Health Insurance Service (NHIS) on the reimbursement price for Fintepla (fenfluramine), a treatment for Dravet syndrome. Given that negotiations began in early July, the process has been completed within the program's targeted 30-day timeline.

The only remaining step is deliberation by the Health Insurance Policy Deliberation Committee (HIPDC). Barring any unexpected developments, Fintepla is expected to be listed for reimbursement in September.

After being approved in Korea in December last year, Fintepla was designated an orphan drug and selected for the second phase of the government's Approval–Assessment–Negotiation Parallel Review Pilot Program. The statutory timeline for NHIS drug price negotiations (60 days) is reduced to 30 days for drugs subject to the program.

Dravet syndrome is an ultra-rare, intractable childhood epilepsy that typically begins during infancy. According to experts, approximately 80% of cases are caused by mutations in the SCN1A gene.

The disease usually develops around 12 months of age, and up to 15% of patients die during infancy or adolescence. Patients face an increased risk of numerous neurological and developmental comorbidities, including tonic-clonic seizures, delayed language development, autism, intellectual disability, and attention-deficit/hyperactivity disorder (ADHD).

The disease also places a substantial burden on caregivers, as they are required to provide around-the-clock care while coping with career disruption and loss of income, resulting in high caregiving stress and reduced quality of life.

Frequent seizures occurring over a long period in patients with Dravet syndrome not only degrade the quality of life for patients and caregivers but also carry the risk of sudden unexpected death in epilepsy (SUDEP), making reducing or stopping seizures the primary treatment goal.

However, substantial unmet medical needs remain in Korea as there are limitations in controlling seizures with currently used antiepileptic drugs alone, and some therapies even exacerbate seizures. Fintepla is regarded as a valuable treatment option because it not only reduces seizure frequency but also has the potential to achieve seizure freedom in some patients.

Meanwhile, Fintepla demonstrated its clinical value through three randomized Phase III trials (STUDY 1–3).

In a pooled analysis of Study 1, which enrolled 119 patients, and Study 3, which included subsequently enrolled patients, treatment with Fintepla reduced monthly convulsive seizure frequency (MCSF) by 62.3% and 64.8%, respectively. Notably, near-complete seizure freedom was observed only in patients treated with Fintepla.

In Study 2, patients receiving standard therapy with stiripentol (plus clobazam and/or valproate) were randomized 1:1 to receive either Fintepla or placebo during a 15-week study consisting of a six-week baseline period, a three-week titration period, and a 12-week maintenance period. The study showed that 54% of patients receiving Fintepla achieved at least a 50% reduction in monthly convulsive seizure frequency from baseline, compared with 5% in the placebo group.