Reimb of polycythemia vera drug 'BESREMi' likely in Sept

Have reached a final agreement on the drug price negotiation with the National Health Insurance Service (NHIS)

The only third-generation interferon treatment option

The polycythemia vera treatment 'BESREMi' is expected to be listed on the national health insurance list.

 

The National Health Insurance Service (NHIS) and PharmaEssentia Korea have recently reached a final agreement on the drug price negotiation for BESREMi (ropeginterferon alfa-2b).

 

As a result, if it passes the Health Insurance Policy Review Committee, it can be officially listed in September.

 

BESREMi's company had previously proceeded with the reimbursement process for hydroxyurea-refractory or intolerant polycythemia vera in March 2023.

 

It failed to pass the Health Insurance Review & Assessment Service (HIRA)'s Cancer Disease Review Committee in July of the same year.

 

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

 

PharmaEssentia subsequently supplemented the evidence for this drug's efficacy as a second-line therapy by adding domestic clinical data.

 

It resubmitted the reimbursement application in March of last year, passed the Cancer Disease Review Committee in July of the same year, passed the Drug Reimbursement Evaluation Committee in May, and has now completed the negotiation stage.

 

BESREMii is a next-generation interferon that selectively eliminates the JAK2 mutant gene, which is the cause of polycythemia vera.

 

It was developed to improve the purity and tolerability of existing interferons, allowing for once-every-two-week administration for the initial 1.5 years and once every four weeks thereafter.

 

BESREMi is currently recommended in the National Comprehensive Cancer Network (NCCN) and European LeukemiaNet (ELN) guidelines for the treatment of polycythemia vera, regardless of prior treatment history.

 

Meanwhile, polycythemia vera is a rare blood cancer in which a somatic mutation in the bone marrow abnormally activates bone marrow function, leading to excessive production of red blood cells.

 

According to HIRA data, the number of prevalent patients in Korea is around 5,000, and hydroxyurea is primarily used for more than half of these patients.

 

However, the currently reimbursed drugs are not a fundamental treatment.

 

For patients who fail hydroxyurea treatment, there is no new alternative, making it a disease with high unmet needs.