AbbVie Korea’s Venclexta Tab. (ingredient: venetoclax), a drug for recurrent or refractory chronic lymphocytic leukemia (CLL), has passed the first stage to benefit from insurance coverage.
The Health Insurance Review and Assessment Service (HIRA) held a meeting of the Pharmaceutical Reimbursement Evaluation Committee on Thursday and concluded that Venclexta 10mg, 50mg, and 100mg were eligible for reimbursement.
AbbVie applied for the insurance benefit for the treatment after getting the Venclexta license from the Ministry of Food and Drug Safety on May 29.
The regulator granted the nod for Venclexta as monotherapy for the treatment of CLL patients who relapsed or who were refractory to chemotherapy and B cell receptor pathway inhibitors.
AbbVie said Venclexta tablets suppress the excessive expression of BCL-2 protein, which inhibits apoptosis in CLL in which lymphocytes in the blood increase significantly.
The drug has a new mechanism of treatment that selectively binds to BCL-2 protein, inhibits its function, and induces apoptosis, thereby preventing abnormal growth of cancer cells and the progress of the disease.
CLL is blood cancer caused by abnormally increased lymphocytes in the blood. It is the most common leukemia in the West, but only 0.4-0.5 percent of all leukemia patients have CLL in Korea.
Primary symptoms include fatigue, weight loss, fever and night sweats. Most of CLL are known to occur in people aged over 60.
Under the criteria for the national health insurance benefits, the government’s final decision could change if the drug’s detailed reimbursement scope is changed. Also, if the approval conditions of the drug change or if the government nullifies the license, the final decision is subject to change.
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