Can the myelofibrosis drug Ojjara pass CDDC review in KOR?

Whether the drug’s benefits of reducing transfusion dependence in anemic patients gain attention

Was released without reimbursement recently... demonstrated effect in alleviating splenomegaly and systemic symptoms in a Phase III trial

Industry attention is rising on whether GSK’s new drug for myelofibrosis, Ojjara, will be able to make progress in its reimbursement journey and be listed in Korea.

 

According to industry sources, GSK's myelofibrosis treatment Ojjara (momelotinib) will be presented for review to the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee tomorrow (19th).

 

Specifically, the indication being reviewed is its use as a ‘treatment for adults with anemia at intermediate or high risk of myelofibrosis.’ The drug is currently indicated for primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis.

 

GSK recently launched Ojjara as a non-reimbursed drug.

 

It remains to be seen whether the application will lead to the introduction of a covered treatment option that will significantly improve anemia, which has remained an unmet need in the treatment of myelofibrosis in Korea.

 

Ojjara has a unique triple-inhibition mechanism that blocks JAK1, JAK2, and ACVR1 (Activin A Receptor Type 1).

 

In the treatment of myelofibrosis, inhibition of JAK1 and JAK2 can contribute to the improvement of systemic symptoms and reduction of splenomegaly in patients, while inhibition of ACVR1 can help alleviate anemia by inducing a reduction in hepcidin expression.

 

Managing anemia is one of the unmet needs in the treatment of existing patients with myelofibrosis.

 

Anemia, which increases the need for blood transfusions, causes more than just dizziness, and depending on the severity, it can lead to a serious condition that can be life-threatening.

 

The Phase III SIMPLIFY-1 and MOMENTUM studies have shown that, regardless of prior treatment with JAK inhibitors, Ojjara can significantly improve the main symptoms of splenomegaly and transfusion dependence in the treatment of patients with myelofibrosis with anemia.

 

In the SIMPLIFY-1 study, which confirmed the clinical efficacy and safety of Ojjara compared to that of JAK inhibitors in the first-line treatment of patients with myelofibrosis who had no prior experience with JAK inhibitors, Ojjara demonstrated non-inferiority to JAK inhibitors in the primary endpoint of spleen volume response at Week 24 of treatment.

 

The proportion of transfusion independence in each patient group was 66.5% for the Ojjara arm and 49.3% for the ruxolitinib arm, indicating that Ojjara showed significantly less transfusion dependency.

 

“While JAK inhibitors, which were used in the treatment of myelofibrosis, showed effects in alleviating splenomegaly and systemic symptoms, they worsened anemia or increased the need for blood transfusions, which left an unmet need,” said Seo-Yeon Ahn, Professor of Hematology & Oncology at Chonnam National University Hwasun Hospital, “Ojjara has confirmed its significant clinical value in managing anemia, which is closely related to the prognosis of patients with myelofibrosis, and we expect that its launch in Korea will contribute to improving the treatment outcomes and quality of life of more patients.”