Pfizer’s CD33-positive acute myeloid leukemia (AML) treatment, Mylotarg (gemtuzumab ozogamicin), has failed to receive national health insurance benefits.
Lilly Korea’s ulcerative colitis treatments, including Omvoh Injection 20 mg/ml (mirikizumab), Omvoh Prefilled Pen Inj. 100 mg/ml, and Omvoh Prefilled Syringe Inj. 100 mg/ml, were reviewed. Roche Korea’s multiple sclerosis treatment, Ocrevus (ocrelizumab), was given a conditional pass, sending the decision back to pharmaceutical companies.
The Health Insurance Review and Assessment Service (HIRA) made this decision during its Pharmaceutical Reimbursement Evaluation Committee (PREC) meeting on Thursday.
As a result of the deliberations, Pfizer’s Mylotarg was determined to be non-reimbursable.
Mylotarg is the first and only antibody-drug conjugate (ADC) approved by the Ministry of Food and Drug Safety (MFDS) in November 2021 for treating newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults.
Pfizer applied for its reimbursement to HIRA concurrently with the domestic approval of Mylotarg and passed the Cancer Disease Review Committee (CDRC) after several attempts. However, it received a final non-reimbursement decision.
Ocrevus, Roche Korea’s treatment for relapsing-remitting multiple sclerosis (MS), was deemed eligible for benefits if the company agrees to a price below the appraised amount.
MS is a chronic disease of the central nervous system, consisting of the brain, spinal cord, and optic nerves. It is an autoimmune disease in which the patient’s immune system attacks healthy cells and tissues.
Ocrevus is a recombinant humanized monoclonal antibody (mAb) that selectively targets the B-cells expressing CD20 to inhibit MS by reducing their number and function. CD20 is a cell surface antigen expressed on pre-B cells, mature and memory B cells, but not lymphocyte stem cells and plasma cells.
Lilly Korea’s active ulcerative colitis drugs Omvoh Inj. 20mg/ml, Omvoh Prefilled Pen Inj. 100mg/ml and Omvoh Prefilled Syringe Inj. 100mg/ml’ will also have to accept the price proposed by the HIRA for the drugmaker to move on to the next stage.
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