3 new blood disease drugs eligible for health insurance coverage in Korea

The Korean health insurance agency has opened the door for polycythemia vera treatment Besremi (ropeginterferon alfa-2b), third-generation Bruton's tyrosine kinase (BTK) inhibitor Jaypirca (pirtobrutinib), and multiple myeloma antibody Darzalex (daratumumab) to gain national health insurance coverage.

The Health Insurance Review and Assessment Service (HIRA) held its fifth Pharmaceutical Reimbursement Evaluation Committee (PREC) meeting for 2025 on Thursday and announced the results of its deliberations.

First, the PREC recognized the appropriateness of Besremi's proposed reimbursement. Although the drug has been available in Korea for three and a half years, this marks a major step forward in securing reimbursement.

Besremi, approved by the Ministry of Food and Drug Safety (MFDS) in October 2021 after being designated an orphan drug, has been used to treat polycythemia vera (PV). It has attracted attention as an alternative for patients who fail first-line hydroxyurea therapy.

As a third-generation mono-pegylated interferon, Besremi eliminates the JAK2 mutant cells that cause PV. It is designed for long-term treatment, offering longer dosing intervals and fewer side effects than traditional interferons. The drug acts directly on hematopoietic stem cells to address the disease at its root.

Following the PREC’s approval, Besremi is expected to gain reimbursement coverage after pricing negotiations with the National Health Insurance Service (NHIS) and final approval by the Health Insurance Policy Evaluation Committee.

Jaypirca, a third-generation BTK inhibitor developed by Lilly, was also recognized for reimbursement adequacy, conditional on the future submission of supporting evidence by the manufacturer.

Jaypirca, an orphan drug for relapsed or refractory mantle cell lymphoma (MCL), received MFDS approval in August 2024 and crossed the PREC threshold about nine months later.

Unlike first- and second-generation BTK inhibitors (e.g., ibrutinib and zanubrutinib), which bind irreversibly to the C481 cysteine of the BTK protein, Jaypirca is the first non-covalent (reversible) BTK inhibitor. This unique mechanism allows Jaypirca to retain efficacy against tumors with BTK mutations such as C481S, which reduce the effectiveness of earlier treatments.

With PREC’s approval and potential for expedited reimbursement negotiations, Jaypirca could offer new hope to Korean patients who have developed resistance to earlier-generation BTK inhibitors.

On the same day, the PREC also approved Janssen’s Darzalex reimbursement expansion proposal. The committee acknowledged the appropriateness of expanding its use, which is currently reimbursed through a risk-sharing arrangement (RSA).

Darzalex, an anti-CD38 monoclonal antibody, was first approved in November 2017 as a fourth-line monotherapy for relapsed or refractory multiple myeloma. Its indications were expanded in 2019 and 2020 to include five additional second-line and first-line treatment uses.