GSK reattempts reimb for myelofibrosis drug Omjjara

After failing to be presented for DREC review, company rapidly expressed a strong intent to attempt relisting

Korea lacks anemia-management options…reaching an agreement on comparator drugs key

GSK’s myelofibrosis drug Omjjara (momelotinib), which failed reimbursement on its first attempt, is once again seeking insurance reimbursement in Korea.

 

According to industry sources, GSK Korea recently resubmitted its reimbursement application for Omjjara.

 

Despite its recent failure to be presented to the Health Insurance Review and Assessment Service (HIRA) Drug Coverage Evaluation Committee, the company is showing renewed determination.

 

Omjjara passed the Cancer Disease Deliberation Committee review last March, but reimbursement procedures were halted after disagreements arose between GSK and HIRA regarding comparator drug selection for price calculation.

 

Consequently, it remains to be seen whether GSK and the government can reach a consensus this time.

 

Omjjara has a triple mechanism of action that inhibits JAK1 and JAK2 as well as ACVR1 (activin A receptor type 1).

 

In myelofibrosis treatment, JAK1 and JAK2 inhibition helps relieve systemic symptoms and reduce splenomegaly, while ACVR1 inhibition decreases hepcidin expression and thereby alleviates anemia.

 

Anemia management remains one of the major unmet needs in treating myelofibrosis.

 

Transfusion-dependent anemia brings more than just the commonly perceived issue of dizziness - depending on its severity, it can be life-threatening.

 

Phase III trials SIMPLIFY-1 and MOMENTUM demonstrated that Omjjara significantly improved key symptoms such as splenomegaly and reduced transfusion dependence in anemic myelofibrosis patients regardless of prior JAK-inhibitor exposure.

 

In SIMPLIFY-1, which compared Omjjara to ruxolitinib (Jakavi) in JAK-inhibitor-naïve myelofibrosis patients, Omjjara demonstrated non-inferiority to ruxolitinib in the primary endpoint of spleen volume response at week 24.

 

The proportion of transfusion-independent patients was 66.5 % in the Omjjara group versus 49.3 % in the ruxolitinib group, showing a statistically significant reduction in transfusion dependence in the Omjjara arm.

 

Professor Seo-yeon Ahn of Chonnam National University Hwasun Hospital’s Department of Hematology stated, “Existing JAK inhibitors relieve splenomegaly and systemic symptoms but often worsen anemia or increase transfusion needs, leaving an unmet clinical need.

 

Omjjara demonstrated significant clinical value in improving anemia, which is closely tied to prognosis in myelofibrosis patients.”