Product Details

Reblozyl

Luspatercept
75 mg/Vial
Powder for Solution for Subcutaneous Injection
Single-Use 75-mg Vial Pack (Preservative-Free)

DIN/PIN/NPN

02505568

Manufacturer

Celgene Inc.

Formulary Listing Date

2023-02-27  

Unit Price

6567.0000

Amount MOH Pays

6567.0000

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

B03XA06

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Anemia

Luspatercept

  • Brand(s): Reblozyl
  • Dosage Form/Strength: 25 mg, 75 mg vials
  • Effective date: February 27, 2023

Initiation Criteria

For the treatment of red-blood cell (RBC) transfusion-dependent anemia associated with beta-thalassemia in patients who meet ALL the following criteria:

  1. 18 years of age and older; AND

  1. Has ‘transfusion-dependent’ beta-thalassemia associated anemia defined as:
    a) Requiring 6 to 20 RBC units in the 24 weeks prior to initiating luspatercept;
    AND
    b)     Has not had a transfusion-free period greater than 35 days in the 24 weeks prior to initiating treatment with luspatercept;

    AND

  1. Treatment is prescribed by a clinician with expertise in the management of beta- thalassemia.

Notes:

  1. The patient’s RBC transfusion record within the 24 weeks prior to treatment initiation with luspatercept must be provided.

  1. Renewal requests must include the patient’s RBC transfusion record within the 6 months (approximately 24 weeks) of the coverage period in order to compare baseline and on-treatment RBC transfusion burden and other relevant laboratory/bloodwork results.

Exclusion criteria:

  1. Patients with a diagnosis of Hemoglobin S/beta-thalassemia.

  1. Patients with a diagnosis of alpha-thalassemia.

Discontinuation criteria:

Luspatercept should be discontinued in patients who have not achieved a reduction in RBC transfusion burden after using 3 consecutive escalated doses (9 weeks) at 1.25 mg/kg in accordance with the product monograph.

Renewal criteria:

Renewals will be considered for patients who are able to achieve or maintain at least a 33% reduction of RBC transfusion burden compared to the pre-luspatercept baseline RBC transfusion burden AND who do not meet the discontinuation criteria AND who have not developed unacceptable toxicities from treatment with luspatercept

At each renewal, the RBC transfusion burden over 24 weeks of treatment will be compared against the baseline RBC transfusion burden measured in the 24 weeks prior to initiation of treatment with luspatercept. 

Approved dosage:

Usual starting dose of 1mg/kg to a maximum of 1.25 mg/kg or 120 mg per dose (whichever is reached first) administered subcutaneously every 3 weeks

Duration of Approvals (initial and renewals): 6 months

Initiation criteria

For the treatment of red-blood cell (RBC) transfusion-dependent anemia associated with myelodysplastic Syndromes (MDS) in patients who meet ALL the following criteria:

  1. 18 years of age or older; AND

  1. Diagnosed with very low- to intermediate-risk MDS with ringed sideroblasts in accordance with the Revised International Prognostic Scoring System (IPSS-R); AND

  1. Has ‘transfusion-dependent’ MDS associated anemia defined as requiring an average of 2 RBC units over 8 weeks in the 16 weeks prior to initiating luspatercept ; AND

  1. Failed or not appropriate to be treated with an erythropoietin stimulating agent (ESA) for their MDS-associated anemia (see Notes 3 and 4); AND

  1. Good performance status of 0 to 2; AND

  1. Treatment is prescribed by a clinician with expertise in the management and treatment of MDS.

Notes:

  1. The patient’s RBC transfusion record within the 24 weeks prior to treatment initiation with luspatercept must be provided.

  1. Renewal requests must include the patient’s RBC transfusion record within the 6 months (approximately 24 weeks) of the coverage period in order to compare baseline and on-treatment RBC transfusion burden and other relevant laboratory/bloodwork results.

  1. Initial applications should include details of the ESAs that have been used (i.e., Name of treatment, dose(s), duration of use, response.)

  1. Patients considered inappropriate for ESA therapy may include those who are predicted to have less than a 25% chance of responding to an ESA, or those with contraindications, or have a history of unacceptable toxicities to an ESA.

  1. Patients must not have had a thrombotic event (e.g., stroke, deep venous thrombosis, pulmonary or arterial embolism) in the 6 months prior to treatment initiation with luspatercept.

Exclusion criteria:

  1. Patients with a diagnosis of MDS-associated anemia due to Isolated 5q deletion.

  1. Patients with high-risk categories of MDS.

  1. Patients diagnosed with Acute Myeloid Leukemia (AML) or whose disease has transformed to AML.

Discontinuation Criteria:

  1. Luspatercept should be discontinued in patients who have not achieved a reduction in RBC transfusion burden after using 3 consecutive escalated doses (9 weeks) at 1.75 mg/kg in accordance with the product monograph.

  1. Progression of MDS to a higher risk category or transformation to AML.

Renewal Criteria:

Initial renewals will be approved for patients who achieve RBC transfusion independence over a minimum of 16 consecutive weeks within the first 24 weeks of treatment initiation with luspatercept AND who do not meet the discontinuation criteria AND who have not developed unacceptable toxicities to luspatercept.

Subsequent renewals will be approved for patients who maintain their transfusion independence while on treatment and who have not developed unacceptable toxicities to luspatercept.

Patients who are not transfusion independent at the time of the initial or subsequent renewal but who have experienced a 50% or more reduction in RBC transfusion burden over a period of 16 weeks compared to the pre-luspatercept baseline RBC transfusion burden during the period of coverage (i.e. approximately 24 weeks), will be considered on a case-by-case basis.

(CBCs, other relevant bloodwork, and transfusion records during the coverage period should be included with the application.)

Approved dosage:

Usual starting dose of 1mg/kg to a maximum of 1.75 mg/kg or 168 mg per dose (whichever is reached first) administered subcutaneously every 3 weeks

Duration of Approvals (initial and renewals): 6 months

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

View Monograph