Novartis Korea’s Revolade (ingredient: eltrombopag) will receive reimbursement for treating people with severe aplastic anemia who have not shown sufficient response to immunosuppressive therapy, from next Monday.
|Novartis' thrombocytopenia treatment Revolade|
Revolade treats thrombocytopenia, a rare condition where the patient has low blood platelet count.
Novartis Korea has also reduced the insurance price of Revolade 25mg and 50 mg by 3.6 percent.
The insurance benefit will cover patients who do not show response to a combination treatment of anti-human thymocyte immunoglobulin (ATG) and cyclosporine therapy for at least six months. However, those patients who have difficulty in administering ATG due to age or infection may receive the reimbursement after showing no response to a cyclosporine monotherapy for at least six months.
Severe aplastic anemia is a blood disease where the bone marrow does not produce enough blood cells for the body, leading to complications such as fatigue, dyspnea, and abnormal bruising or bleeding.
Currently, the standard therapy for severe aplastic anemia is immunosuppressive therapy or hematopoietic stem cell transplantation. Novartis Korea noted that one-third of patients do not respond to immunosuppressive treatment, requiring new options.
The insurance benefit comes after the Ministry of Food and Drug Safety gave the go-ahead for the additional indication in May of last year.
The approval for the expanded indication was based on a phase 2 trial that demonstrated the hematological response of Revolade in patients with severe aplastic anemia who do not respond adequately to immunosuppressive therapy.
The study was a single-group, single-institution, open-label study of 43 patients with severe aplastic anemia who had platelet counts below 30x109/L and showed an insufficient response to one or more immunosuppressive treatments. Findings showed that around 40 percent of patients treated with Revolade showed a hematologic response at 12 to 16 weeks of treatment.
The most common adverse reactions were nausea, cough transaminase increased, diarrhea, and headache.
“The treatment options for severe anemia were limited to immunosuppressive therapy, and there was no alternative for relapse or recurrence making the survival prognosis poor,” said Christoph Lorez, general manager of Novartis Korea’s oncology unit.
The company hopes that the new reimbursement plan will allow Revolade to become a new treatment option for patients, Lorez added.