CASGEVY (exagamglogene autotemcel)

Medical Administration – intravenous

Diagnosis considered for coverage:
  • Sickle Cell Disease (SCD): Indicated for the treatment of sickle cell disease (SCD) in patients 12 years and older with recurrent vaso-occlusive crises.
Coverage Criteria:

For the treatment of sickle cell disease:

  • Diagnosis of sickle cell disease, AND
  • Patient has genotype βS/βS, βS/β0, or βS/β+, AND
  • Patient is 12 years of age or older, AND
  • Provider attests that patient is clinically stable and eligible to undergo hematopoietic stem cell transplant (HSCT), AND
  • Patient has a history of at least 4 vaso-occlusive events (VOEs) in the past 24 months as defined by one of the following scenarios:
    • Acute pain event requiring a visit to a medical facility and administration of pain medications (opioids or intravenous [IV] non-steroidal anti-inflammatory drugs [NSAIDs]) or RBC transfusions 
    • Acute chest syndrome
    • Priapism lasting > 2 hours and requiring a visit to a medical facility 
    • Splenic sequestration, AND
  • Patient has obtained a negative test result for all of the following prior to cell collection:
    • Hepatitis B virus (HBV) 
    • Hepatitis C virus (HCV) 
    • Human immunodeficiency virus (HIV), AND
  • Patient is anticipated to provide an adequate number of cells to meet the minimum recommended dose of 3 x 10^6 CD34+ cells/kg, AND
  • Patient will receive both of the following:
    • Full myeloablative conditioning with busulfan prior to treatment with Casgevy
    • Anti-seizure prophylaxis with agents other than phenytoin prior to initiating busulfan conditioning, AND
  • Prescriber attests that patient will discontinue disease modifying therapies for sickle cell disease (e.g., hydroxyurea, crizanlizumab, voxelotor) 8 weeks before the planned start of mobilization and conditioning, AND
  • Both of the following:
    • Patient has never received any previous sickle cell gene therapy treatment in their lifetime (i.e., Casgevy, Lyfgenia) 
    • Patient has never received prior allogeneic transplant, AND
  • Prescribed by a provider at an SCD Treatment center with expertise in gene therapy, AND
  • Prescribed by one of the following:
    • Hematologist/Oncologist 
    • Specialist with expertise in the diagnosis and management of sickle cell disease
Coverage Duration: 
  • Initial: 1 Time Authorization in Lifetime
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 
  • Per prescribing information, Casgevy is for one-time, single dose intravenous use only.
Policy Updates:
  • 6/1/2024 (policy effective date) - New Casgevy Criteria (P&T 5/21/2024) (P&T Meeting May)
References:
  1. Casgevy Prescribing Information. Vertex Pharmaceuticals Incorporated. Boston, MA. December 2023.
  2. Exa-Cel and Lovo-Cel: Final Policy Recommendations Policy Recommendations. Accessed January 11, 2024. https://icer.org/wp-content/uploads/2023/08/ICER_Sickle-Cell-Disease_Final-Policy-Recommendations.pdf 
  3. Per clinical consult with hematologist/oncologist on 1/19/2024. 

Last review date: June 1, 2024

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