REBLOZYL (luspatercept)

REBLOZYL (luspatercept) 

OFFICE ADMINISTRATION

Indications for Prior Authorization:

• Indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions

Patients must meet the following criteria for the indication(s) above:

• Patient is 18 years of age or older, AND
• Patient has a diagnosis of beta thalassemia, AND
• Prescribed by or in consultation with a hematologist, AND
• Chart note documenting baseline transfusion burden within the past 6 months, AND
• Patient has been receiving regular RBC transfusions (6-20 RBC units per 6 months), AND
• Had no transfusion-free period >35 days within the past 6 months
• Please note: may cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception. Advise not to breastfeed

Reauthorization criteria:

• Patient is responding positively to Reblozyl® (e.g. patient received at least 33% reduction in transfusion burden from baseline), OR

• Patient is requesting dose increase (maximum dose is 1.25 mg/kg every 3 weeks) and chart notes show an inadequate response to 1 mg/kg dose

Dosing:

• Starting dose: 1 mg/kg once every 3 weeks by subcutaneous injection
• If the patient does not achieve a reduction in RBC transfusion burden after at least 2 consecutive doses (6 weeks) at the 1 mg/kg starting dose, increase the Reblozyl® dose to 1.25 mg/kg
• Maximum dose of 1.25 mg/kg
• Discontinue Reblozyl® if a patient does not experience a decrease in transfusion burden after 9 weeks of treatment (administration of 3 doses) at the maximum dose level or if unacceptable toxicity occurs at any time

Approval:

• Initial: 2 months
• 1st renewal: 6 months
• 2nd renewal: 1 year