Recordati Korea’s Isturisa and HLB Pharm’s Citirelin Added to Reimbursement List

Recordati Korea’s Isturisa Film-Coated Tablet and HLB Pharm’s Citirelin Orally Disintegrating Tablet will be listed for reimbursement beginning December 1. Isturisa was accepted under a risk-sharing agreement, while Citirelin bypassed price negotiations by agreeing to a price at or below the weighted average of alternatives.

According to industry sources, the Health Insurance Policy Review Committee has confirmed the reimbursement ceilings for both products.

Isturisa is approved for adults with Cushing’s disease, a form of endogenous Cushing’s syndrome caused by ACTH-secreting pituitary adenomas, which account for 60–70% of endogenous cases. The drug is intended for patients who are not candidates for pituitary surgery or who fail to achieve adequate control after surgery.

The evaluation committee acknowledged clinical need based on significant mUFC reductions seen in studies, though limited sample sizes made cost-effectiveness analysis challenging. Nevertheless, considering the rarity of the disease, lack of therapeutic alternatives, international reimbursement status, and the company’s agreement to a risk-sharing mechanism, reimbursement was deemed appropriate. Final prices were set at $23.47 (1 mg) and $89.45 (5 mg). The average annual treatment cost is estimated at $25,610, with patient out-of-pocket spending around $2,550 under 10% coinsurance.

HLB Pharm’s Citirelin ODT is indicated for improving ataxia associated with spinocerebellar degeneration, which causes balance impairment, gait disturbance, and reduced hand coordination. Spinocerebellar ataxia is a rapidly progressive adult-onset neurodegenerative disease with limited treatment options.

While the committee initially questioned Citirelin’s cost-effectiveness and reimbursement suitability, the manufacturer accepted a price of $1.13 per 5 mg tablet, equivalent to the weighted average of existing alternatives. This met evaluation criteria and allowed the drug to proceed without price negotiations. With reimbursement and 10% coinsurance, patient out-of-pocket costs are expected to be approximately $82.33.