Patient group urges quick reimbursement of Besremi for polycythemia vera

The Korea Leukemia Patients Organization (KLPO) has called for the reimbursement of Besremi Inj. (ropeginterferon alfa-2b), the only treatment alternative for patients with polycythemia vera (PV), ahead of the upcoming reimbursement review committee meeting on Thursday this week.

The patient group issued a statement last Friday, urging the government and pharmaceutical companies to expedite the reimbursement process for Besremi.

PV is a myeloproliferative tumor that causes the chronic overproduction of red blood cells in the bone marrow and is classified as a rare blood cancer. The disease also leads to increased white blood cells and platelets, which can cause cardiovascular complications such as thrombosis and embolism or progress to myelofibrosis and acute leukemia. As of 2023, the number of PV patients in Korea was estimated at 4,995.

Currently, only one PV treatment -- hydroxyurea -- is covered by national health insurance in Korea. According to the KLPO, approximately 10 to 20 percent of patients are either unresponsive to the drug or unable to continue treatment due to side effects. For these patients, Besremi is virtually the only available alternative, the organization emphasized.

Besremi is a third-generation mono-pegylated proline interferon that selectively eliminates JAK2-mutated hematopoietic stem cells, the underlying cause of PV. It can be administered once every two weeks initially, and once every four weeks with long-term use. However, the drug is not covered by insurance and costs 4.25 million won (approximately $3,054) per dose, resulting in annual treatment expenses amounting to tens of millions of won.

Besremi was approved by the European Medicines Agency (EMA) in 2019, the U.S. Food and Drug Administration (FDA) and the Korean Ministry of Food and Drug Safety (MFDS) in 2021. In July 2024, Korea set reimbursement criteria for the treatment of low-risk PV patients requiring cytoreductive therapy and high-risk PV patients with symptoms but without splenomegaly.

Emphasizing the urgency of reimbursement, the KLPO noted that a public petition submitted to the National Assembly from February to March last year gathered 55,552 online signatures in just 30 days.

"The patient's time moves faster than the pace of the system and administration. Waiting brings pain and threatens life -- it is a desperate time. We must not allow that time to be wasted," the KLPO stated.