Pharmacy Prior Authorization Criteria

Casgevy (exagamglogene autotemcel injection)

Indications for Prior Authorization

Casgevy (exagamglogene autotemcel injection)

• For diagnosis of Sickle Cell Disease (SCD)
  Indicated for the treatment of patients aged 12 years and older with sickle cell disease (SCD) with recurrent vaso-occlusive crises

• For diagnosis of Transfusion-dependent β-thalassemia (TDT)
  Indicated for the treatment of patients aged 12 years and older with transfusion-dependent β-thalassemia (TDT)

Criteria

Casgevy

*Per prescribing information, Casgevy is for one-time, single dose intravenous use only

Prior Authorization

Length of Approval: 1 Time Authorization in Lifetime*
For diagnosis of Sickle Cell Disease

• Diagnosis of sickle cell disease
AND
• Patient has genotype βS/βS, βS/β0, or βS/β+ [2][3]
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: [3]
• 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
AND
• 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 a 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

Casgevy

*Per prescribing information, Casgevy is for one-time, single dose intravenous use only

Prior Authorization

Length of Approval: 1 Time Authorization in Lifetime*
For diagnosis of Transfusion-dependent β-thalassemia (TDT)

• Diagnosis of transfusion-dependent β-thalassemia (TDT)
AND
• Presence of a mutation at both alleles of the β-globin gene (i.e., β0/β0, β0/β+, β+/β+, β0/βE)
AND
• One of the following:
• Patient has a history of requiring at least 100 mL/kg/year of RBC transfusions in the prior 2 years
• Patient requires 10 units/year of RBC transfusions in the prior 2 years
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 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 does not have any of the following:
• Severely elevated iron in the heart (e.g., patients with cardiac T2* less than 10 msec by MRI)
• Advanced liver disease
• MRI results of the liver demonstrating liver iron content greater than or equal to 15 mg/g (unless biopsy confirms absence of advanced disease)
AND
• Both of the following:
• Iron chelation therapy (e.g., deferoxamine, deferasirox) will be discontinued for at least 7 days prior to initiating myeloablative conditioning therapy
• Hydroxyurea, Oxbryta (voxelotor), and Adakveo (crizanlizumab) will be discontinued at least 8 weeks prior to start of mobilization and conditioning
AND
• Patient will receive both of the following:
• Full myeloablative conditioning with busulfan prior to treatment with Casgevy
AND
• Anti-seizure prophylaxis with agents other than phenytoin prior to initiating busulfan conditioning
AND
• Both of the following:
• Patient has never received any previous transfusion dependent beta-thalassemia gene therapy treatment in their lifetime (i.e., Casgevy, Zynteglo)
• Patient has never received prior allogeneic transplant
AND
• Prescribed by a provider at a treatment center with expertise in gene therapy
AND
• Prescribed by one of the following:
• Hematologist/Oncologist
• Stem transplant specialist

P & T Revisions

2024-03-06, 2024-02-15

References

1. Casgevy Prescribing Information. Vertex Pharmaceuticals Incorporated. Boston, MA. January 2024.
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.

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Revision History

• 2024-03-06: New indication for beta thalassemia
• 2024-02-15: New Program for Casgevy

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