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Limited coverage criteria – luspatercept

Last updated on March 24, 2025

 

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Generic name

 luspatercept                                                                                                                                    
Strength & form

25 mg vial and 75 mg vial lyophilized powder to be reconstituted for subcutaneous injection

Special Authority criteria

Approval period

Initial

  • Adults with red blood cells (RBC) transfusion-dependent anemia associated with beta-thalassemia
  • Patients must be receiving regular transfusions, defined as: 6 to 20 RBC units in the 24 weeks prior to initiating treatment with luspatercept, and no transfusion-free period greater than 35 days in the 24 weeks prior to initiating treatment with luspatercept

6 months

Renewal

  • The patient should attain and maintain a minimum reduction of 33% in transfusion burden (number of RBC units over the most representative 12 week period from within the 6 months immediately preceding this request) when compared to the pre-treatment baseline RBC transfusion burden (measured over the 24 weeks prior to initiating treatment with luspatercept)
 6 months

Practitioner exemptions

  • No practitioner exemptions

Special notes

  • Patients should be assessed for a response to luspatercept every 6 months
  • The patient should be under the care of a hematologist with experience in managing patients with beta-thalassemia. All requests must be made by a hematologist
  • The maximum dose of luspatercept should not exceed 1.25 mg/kg (or 120 mg total dose) per administration
  • Please note: luspatercept is not eligible for PharmaCare coverage for the treatment of myelodysplastic syndrome
  • PharmaCare coverage is limited to up to 125 mg of luspatercept daily

Special Authority request form(s)