Hope for polycythemia vera, Besremi, makes reimb progress

Whether the company will accept the Pharmceoeconomic Evaluation Subcommittee results gain attention

The only third-generation interferon treatment available in Korea

Industry attention is gathering on the insurance reimbursement progress for the polycythemia vera treatment, Besremi.

 

According to industry sources, PharmaEssentia Korea's new drug for polycythemia vera, Besremi (ropeginterferon alfa-2b-njft), has been determined cost-effective by the Health Insurance Review and Assessment Service's Pharmacoeconomic Evaluation Subcommittee.

 

Accordingly, the procedure will proceed depending on whether the company accepts the government's proposal.

 

As Besremi will gain a unique status in the field when listed, the industry expects the company and the government to derive positive results.

 

This is the second attempt for Besremi’s reimbursement listing in Korea.

 

In March 2023, the drug underwent the reimbursement process for refractory or intolerant polycythemia vera but failed to pass the Cancer Disease Review Committee in July of the same year.

 

At the time, the Cancer Disease Review Committee determined that there was insufficient evidence to judge the clinical utility of Besremi as a second-line treatment.

 

In response, PharmaEssentia resubmitted its application for reimbursement in March after adding domestic clinical data on Besremi and supplementing the evidence on the drug’s efficacy as second-line therapy, and the application passed CDDC review in July of the same year.

 

At that time, the Cancer Disease Review Committee established the reimbursement standards for Besremi as a treatment for patients with polycythemia vera without splenomegaly accompanied by symptoms in low-risk groups (limited to patients requiring cytoreductive therapy) and high-risk groups.

 

Besremi is a next-generation interferon treatment that selectively removes JAK2 mutations that cause polycythemia vera.

 

It was developed to improve the purity and tolerability of existing interferons so that it can be administered every two weeks for the first 1.5 years and every four weeks thereafter.

 

It is currently recommended for the treatment of PV in the National Comprehensive Cancer Network (NCCN) and European Leukemia Network (ELN) guidelines, regardless of prior treatment history.

 

Polycythemia vera is a rare blood disorder where a somatic cell mutation in the bone marrow abnormally activates bone marrow function and produces excessive red blood cells.

 

                                                                                                According to HIRA data, about 5,000 patients are affected with PV in Korea, and hydroxyurea is mainly used for the majority of patients.

 

However, as the current reimbursed drugs are not curative and there are no new alternatives for patients who fail hydroxyurea treatment, there remains a high unmet need for the disease.