Whether the polycythemia vera (PV) treatment BESREMi (ropeginterferon alfa-2b) will be considered for the Drug Reimbursement Evaluation Committee (DREC) review gains attention.

According to the pharmaceutical industry sources, the 5th DREC of the Health Insurance Review & Assessment Service (HIRA) is scheduled to convene on the 8th.

BESREMi is a next-generation interferon that targets the JAK2 mutation gene, which causes polycythemia vera. It was developed with improved purity and tolerability over existing interferons so that it can be administered every two weeks for the first 1.5 years and then every four weeks thereafter.

However, despite having its reimbursement criteria set by the Cancer Drug Reimbursement Committee in March of last year, BESREMi has not yet been submitted to the Drug Reimbursement Evaluation Committee (DREC) even after 14 months, and it remains unclear whether it will be on the agenda for the upcoming 5th committee meeting.

On May 2, the Korea Leukemia Patients Association called for a discussion of BESREMi's reimbursement to provide a treatment option for polycythemia vera patients with no alternatives.

The Association explained, "The only treatment currently reimbursed by national health insurance is hydroxyurea. However, approximately 10–20% of all patients are either refractory or cannot continue to take the drug due to side effects. For these patients, BESREMi is virtually the only treatment alternative."

As of 2023, there are 4,995 polycythemia vera patients in South Korea, who are classified into low- and high-risk groups.

Professor Seong-Yun Lee of the Division of Hematology-Oncology at Ilsan Paik Hospital remarked, "Although polycythemia vera may seem small in patient pool as a rare haematologic malignancy, the patient population continues to grow. Over time, low-risk patients transition to the high-risk category, increasing the likelihood of resistance or intolerance, so the scale should not be underestimated."

Notably, during the parliamentary petition in February last year to urge BESREMi's reimbursement, the initiative collected 50,552 signatures in just 30 days, demonstrating broad social consensus on the need for treatment, and the Association insists that the system and administration must respond swiftly.

The Association stated, "The fact that BESREMi has not been submitted to the DREC even 14 months after the Cancer Drug Reimbursement Committee's decision reflects that the government and the pharmaceutical company are ignoring the desperate reality of patients without treatment options," and demanded, "BESREMi must be placed on the committee's agenda, approved, and quick price negotiations must follow."

Nevertheless, there is reason to hope that BESREMi will be on the 5th DREC's agenda, as the HIRA's Economic Evaluation Committee has already confirmed its cost-effectiveness.

The next steps will proceed based on whether the company accepts the government's proposal, and industry sources say that PharmaEssentia Korea, which has BESREMi, has agreed to the proposal after persuading its global headquarters.

Although further discussions remain, some predict that BESREMi's bid for reimbursement will advance rapidly now that some compromises have been reached.

The key will be the specific price-setting since, with global interferon shortages continuing and more cases of BESREMi adoption emerging, the price set in Korea may serve as a reference.

It is also anticipated that PharmaEssentia Korea may propose a risk-sharing agreement (RSA) during negotiations, meaning that even after DREC approval, negotiations with the HIRA on pricing will remain a challenge for the company.

Professor Lee said, "It would be ideal for all patients to receive treatment without financial burden, but considering the limits of national health insurance finances, priority reimbursement for patients who are resistant or intolerant to hydroxyurea is urgently needed. These patients have no other treatment options if they cannot be treated with hydroxyurea."