Reblozyl (luspatercept-aamt) — Medical Mutual

Beta thalassemia

Initial criteria

Patient is age ≥ 18 years unless otherwise specified
Females of reproductive potential have a negative pregnancy test prior to start of therapy and will use an effective method of contraception during treatment and for at least 3 months after treatment
Patient has not had a deep vein thrombosis or thrombotic stroke requiring medical intervention within 6 months prior to therapy
Other causes of anemia (e.g., hemolysis, bleeding, recent major surgery, vitamin deficiency) have been ruled out
Reblozyl is not being used as a substitute for RBC transfusions in patients requiring immediate correction of anemia
Patient has pre-dose Hemoglobin < 11.5 g/dL obtained within 7 days of administration
Confirmed diagnosis of beta thalassemia (excludes isolated alpha-thalassemia and hemoglobin S/ß-thalassemia variants) either by HBB gene analysis or clinical/hematologic findings
Patient is RBC transfusion dependent defined as requiring 6–20 RBC units per 24 weeks
Patient does not have major end organ damage including: liver disease ALT > 3xULN or cirrhosis; heart failure NYHA ≥3, significant arrhythmia requiring treatment, or MI within 6 months; lung disease pulmonary fibrosis/pulmonary hypertension ≥Grade 3; creatinine clearance < 60 mL/min

Patient continues to meet universal and indication-specific criteria
Patient will not receive doses < 21 days apart
Absence of unacceptable toxicity (e.g., thromboembolic events, severe hypertension, extramedullary hematopoietic masses)
Patient is experiencing disease response as evidenced by a decrease in number of RBC transfusions from baseline OR
For new starts: Patient did not achieve reduction in transfusion burden after ≥2 consecutive initial doses (6 weeks) at 1 mg/kg and requires dose increase to 1.25 mg/kg OR
Patient experienced response followed by loss of response and requires dose increase to 1.25 mg/kg from 1 mg/kg

initial 15 weeks; renewal 1 year