CASGEVY (exagamglogene autotemcel)

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.