Reblozyl (luspatercept-aamt) — Medical Mutual

Initial criteria

• Patient is age ≥ 18 years
• Fulfill universal criteria
• Patient has anemia with symptomatic splenomegaly and/or constitutional symptoms AND used in combination with ruxolitinib OR
• Patient has anemia with no splenomegaly or constitutional symptoms AND used as a single agent OR
• Patient has anemia with splenomegaly and constitutional symptoms well controlled on current JAK inhibitor AND used in combination with JAK inhibitor

Reauthorization criteria

• Continues to meet universal and indication criteria
• No dosing <21 days
• Absence of unacceptable toxicity
• Patient is experiencing disease response (e.g., decrease in RBC transfusions, ≥1.5 g/dL Hb increase without transfusions, reduction in anemia-related fatigue) OR
• For new starts: no disease response after ≥2 consecutive initial doses (6 weeks) and requires dose increase one level up (not >1.75 mg/kg) OR
• Patient experienced response followed by loss of response and requires dose increase up one dose level (not >1.75 mg/kg)

Approval duration

initial 24 weeks; renewal 6 months