PharmaEssensia, reimbursement rechallenge of the new drug Besremi for polycythemia vera

Taiwanese pharmaceutical company PharmaEssentia Korea recently submitted an insurance coverage application for the polycythemia vera treatment drug "Besremi (Ropeginterferon alfa-2b)." This drug had applied for insurance coverage last year but did not receive approval due to the decision of the Health Insurance Review and Assessment Service (HIRA) 's Cancer Disease Subcommittee. However, PharmaEssentia has resubmitted the application after supplementing local clinical data.

Besremi is a next-generation interferon that selectively removes the JAK2 mutation gene, which is the cause of polycythemia vera. It is an improved medication compared to conventional interferons. This medication has been developed to be administered once every two weeks for the initial 1.5 years and then once every four weeks.

Currently, guidelines from the National Comprehensive Cancer Network (NCCN) and the European LeukemiaNet (ELN) recommend Besremi as a treatment for polycythemia vera.

Polycythemia vera is a rare blood cancer characterized by excessive production of red blood cells due to mutations in bone marrow stem cells. The number of patients with this disease in South Korea is estimated to be around 5,000. However, currently available medications lack fundamental treatment options, and in cases where hydroxyurea treatment fails, there is a high unmet demand for alternative treatments among patients. As a result, there is growing interest in the insurance coverage results for Besremi.