More topics

Limited coverage drugs – luspatercept

Last updated on September 27, 2024

Generic name

 luspatercept                                                                                                                                    
Strength

25 mg vial and 75 mg vial

Form

 Lyophilized powder to be reconstituted for subcutaneous injection

Special Authority criteria

Approval period

Initial coverage

  • 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

  1. Patients should be assessed for a response to luspatercept every 6 months
  2. 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
  3. The maximum dose of luspatercept should not exceed 1.25 mg/kg (or 120 mg total dose) per administration
  4. Please note: luspatercept is not eligible for PharmaCare coverage for the treatment of myelodysplastic syndrome
  5. PharmaCare coverage is limited to up to 125 mg of luspatercept daily

Special Authority requests