Fintepla’s reimbursement listing process draws attention

Discussions ongoing after the Health Insurance Review and Assessment Service’s Pharmacoeconomic Evaluation Subcommittee meeting...the pilot program’s effectiveness faces a test

Rises as a new option for seizure control in patients with Dravet syndrome

Attention is focused on the insurance reimbursement process for ‘Fintepla’, a drug included in Korea’s approval-evaluation-negotiation parallel pilot program.

The reimbursement application for UCB Pharma Korea’s Dravet syndrome drug Fintepla (penfluramine) has been submitted to the Health Insurance Review and Assessment Service's (HIRA) Pharmacoeconomic Evaluation Subcommittee and is currently undergoing subsequent procedures.

Approved domestically last December, Fintepla was designated as an orphan drug and was selected as a candidate for the second phase of the government's ‘Approval-Evaluation-Negotiation Parallel Pilot Program’. Amid ongoing debates about the effectiveness of the pilot program, it remains to be seen whether Fintepla can smoothly complete the listing procedures, including review by the Drug Reimbursement Evaluation Committee.

Dravet syndrome is an ultra-rare, pediatric, intractable disorder that typically manifests in infancy. According to experts, approximately 80% of cases are associated with SCN1A mutations.

It typically manifests around 12 months of age, with up to 15% of patients dying during infancy or adolescence. Patients face elevated risks of both physical and neurodevelopmental comorbidities, including motor impairment, language delay, autism spectrum disorders, intellectual disability, and ADHD.

Caregivers also endure high caregiving stress and low quality of life, including the burden of 24-hour care, career disruptions, and loss of income.

Frequent, long-term seizures in Dravet syndrome patients not only degrade the quality of life for both patients and caregivers but also carry a risk of sudden unexpected death in epilepsy (SUDEP). Therefore, seizure reduction or elimination is the central treatment objective for the condition.

However, conventional antiepileptic drugs often show limited efficacy, and certain therapies may even exacerbate seizures, leaving considerable unmet medical need in the domestic treatment landscape. Fintepla is being evaluated as a treatment option that not only reduces seizure frequency but may also achieve near-complete seizure control in some patients.

Fintepla’s clinical value has been demonstrated through 3 randomized Phase III trials (Study 1–3).

An integrated analysis combining data from 119 patients enrolled in Study 1 and participants recruited in Study 3 showed that the Fintepla treatment group showed a reduction in monthly convulsive seizure frequency (MCSF) by 62.3% and 64.8%, respectively. Notably, near-complete seizure elimination was observed exclusively in the Fintepla treatment groups.

Study 2, a 15-week trial consisting of a six-week baseline, three-week titration, and 12-week maintenance phase, randomized patients 1:1 to receive Fintepla or placebo alongside standard therapy with stiripentol (plus clobazam and/or valproate). Results showed that 54% of patients in the Fintepla combination group achieved at least a 50% reduction in MCSF from baseline, compared with only 5% in the placebo group.