Reblozyl (luspatercept-aamt) — Medical Mutual

Initial criteria

• Patient is age ≥ 18 years
• Fulfill universal criteria (negative pregnancy test if applicable, no recent DVT/stroke, other causes ruled out, Hb<11.5g/dL, not substituting transfusions)
• Used as a single agent
• Treatment of symptomatic anemia with MDS lower-risk disease (IPSS-R very low, low, or intermediate) without del(5q) mutation
• If ring sideroblasts <15% (or <5% with SF3B1 mutation): serum erythropoietin ≤500 mU/mL AND used as initial treatment OR following no response/relapse after ESA despite adequate iron
• If ring sideroblasts ≥15% (or ≥5% with SF3B1 mutation): may be initial treatment OR following no response/relapse after imetelstat
• For MDS/MPN overlap neoplasm with SF3B1 mutation, or for MDS/MPN-RS-T: patient required ≥2 RBC units/8 weeks AND patient is ESA ineligible (serum EPO >200 and not treated with ESA) OR had inadequate response to adequate ESA therapy OR documented contraindication/intolerance to ESA

Reauthorization criteria

• Patient continues to meet universal and indication-specific criteria
• No doses <21 days apart
• Absence of unacceptable toxicity
• Patient experiencing disease response as evidenced by a decrease in RBC transfusions OR
• For new starts: did not achieve reduction in transfusion burden after ≥2 consecutive 1 mg/kg doses (6 weeks) → requires dose increase to 1.33 mg/kg OR
• Did not achieve reduction after ≥2 consecutive 1.33 mg/kg doses (6 weeks) → requires dose increase to 1.75 mg/kg OR
• Patient experienced response followed by loss of response → requires dose increase by one dose level (not >1.75 mg/kg)

Approval duration

initial 21 weeks; renewal 6 months