HIRA Reviews Reimbursement Applications for Enhertu-Semblix and Dazalex in South Korea

HIRA Reviews Reimbursement Applications for Enhertu-Semblix and Dazalex in South Korea

The Health Insurance Review and Assessment Service recently released the results of the 2023 Cancer Disease Review Committee's deliberation on reimbursement standards for cancer treatment drugs. Among the drugs discussed, Enhertu, a breast cancer treatment by Daiichi Sankyo and AstraZeneca, drew attention due to achieving 50,000 consents through national petitions.

Enhertu, which contains Trastuzumab deluxtecan, has been requested for reimbursement by patients with unresectable or metastatic HER2-positive breast cancer who have previously received two or more anti-HER2-based therapies, locally advanced or metastatic HER-2 patients who have previously received two or more therapies including anti-HER2 therapy, and treatment of benign gastric or gastroesophageal junction adenocarcinoma. However, reimbursement standards for Enhertu have yet to be established, as further data supplementation has been requested from the company.

On the other hand, the reimbursement standard for Novartis' Semblix, which is used for the treatment of adult patients with Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) in the chronic phase who have been previously treated with two or more tyrosine kinase inhibitors (TKIs), has been established.

Meanwhile, Janssen's multiple myeloma treatment, Dazalex Inj. (ingredient daratumumab), aimed to expand its reimbursement standard, but the next opportunity was promised. The drug is currently reimbursed as monotherapy for patients with relapsed or refractory multiple myeloma who have received at least three treatments, including proteasome inhibitors and immunomodulators.

Despite applying for an expansion of the reimbursement standard for combination therapy with carfilzomib and dexamethasone for patients with multiple myeloma who have received one or more prior therapies, reimbursement standards for all three indications have not been established. Further reviews on the adequacy of reimbursement will be conducted by the Pharmaceutical Reimbursement Evaluation Committee.