Citrelin clears insurance panel’s hurdle 10 years after getting drug approval

Citrelin (taltirelin), a treatment for spinocerebellar degeneration (SCD), a neurological disease, has crossed the threshold of health insurance reimbursement 10 years after winning approval from the Ministry of Food and Drug Safety (MFDS).

However, the passage was “conditional” on the developer's acceptance of a price below the government-suggested ceiling, and further negotiations on the drug price are expected to be the final key.

On Thursday, the Health Insurance Review and Assessment Service (HIRA) held this year’s seventh Pharmaceutical Reimbursement Evaluation Committee (PREC) meeting and released the results of the deliberations.

SCD is a group of progressive neurodegenerative diseases caused by degenerative changes in the cerebellum and its connecting pathways, resulting in ataxia, dysarthria, and gait disorders. It includes hereditary and non-hereditary forms, and depending on its progress, the disease leads to significant functional impairment and decreased quality of life.

To date, there is no optimal pharmacologic treatment for SCD-induced ataxia. The efficacy of riluzole and valproic acid has been suggested, but their clinical effectiveness has not yet been established. In most cases, adjunctive treatments, such as balance and coordination training, strength training, and gait training, are used to maintain function.

Citrelin is a thyrotropin-releasing hormone (TRH) derivative-based drug that the MFDS approved on Feb. 6, 2015, for treating ataxia caused by SCD.

HLB applied for reimbursement in 2017, but was denied it in 2018 at the year’s second hearing of the PREC. At the time, the panel ruled that it was “non-reimbursable” due to a lack of evidence of clinical utility and low cost-effectiveness compared to alternative drugs.

However, Citrelin recently completed a phase 4 clinical trial in Korean patients with SCD, and the results were published in the Journal of Movement Disorders this year, which has helped to overcome the clinical uncertainty.

In addition, the PREC granted limited recognition of Citrelin's cost-effectiveness, with the condition that it be reimbursed at or below the government price.

The remaining procedure is to negotiate the drug price with the National Health Insurance Service. If the negotiations are finalized, the final reimbursement registration will likely become possible through the decision of the Health Insurance Policy Review Committee.

Meanwhile, the committee also approved Bylvay (odevixibat), a drug for the treatment of pruritus in patients with progressive familial intrahepatic cholestasis (PFIC), approved in 2023 as the first drug for the “Pilot Project for Paralleled Approval, Salary Evaluation, and Drug Price Negotiation,” on the agenda for reconsideration.