CurrentEmblemHealthPolicy MG.MM.PH.409

Casgevy (exagamglogene autotemcel) intravenous infusion

Clinical coverage criteria and authorization requirements for Casgevy gene therapy for sickle cell disease and beta thalassemia for EmblemHealth members; governs providers requesting preauthorization and billing for this one-time autologous HSC-based gene therapy.

Policy Summary

PayerEmblemHealth

PolicyCasgevy (exagamglogene autotemcel) intravenous infusion

Policy CodePolicy MG.MM.PH.409

Change TypeAdministrative (coding updates)

Effective Date

Next Review DateMar 7, 2025

Key ActionPrior authorization is required and the provider must submit clinical evidence that the member meets all coverage criteria before billing J3392.

SourceLink

POLICY UPDATE CHANGES

Updated applicable NDCs/procedure codes with descriptions.

one-timedose frequency (once per lifetime)

>=12minimum patient age for coverage

J3392procedure HCPCS code

>=2/yrsickle cell VOCs requirement

Coverage Criteria

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Initial Therapy

Covered when ALL of the following are met

General eligibility: 1. Patient is at least 12 years of age; 2. Provider has considered use of prophylaxis therapy for seizures prior to initiating myeloablative conditioning; 3. Patient has been screened and found negative for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus 1 & 2 (HIV-1/HIV-2) prior to leukapheresis; 4. Must not be administered concurrently with live vaccines while immunosuppressed; 5. Patient does not have a history of hypersensitivity to dimethyl sulfoxide (DMSO) or dextran 40; 6. Patient has not received other gene therapies; 7. Patient will not receive concomitant therapy with specified agents and must observe required washout periods (a. no iron chelators for 7 days prior to mobilization and for 6 months post‑treatment [3 months for non‑myelosuppressive chelators]; b. disease‑modifying agents such as hydroxyurea, voxelotor, or crizanlizumab withheld for at least 8 weeks prior to mobilization and conditioning); 8. Patient is a candidate for autologous hematopoietic stem cell transplant (HSCT) and has not had prior HSCT; 9. Patient does not have a known 10/10 HLA matched related donor willing to participate in an allogeneic HSCT; 10. Requests for subsequent use of exagamglogene after prior receipt of other gene therapies will be evaluated on a case‑by‑case basis.

General preconditions and exclusions for therapy

Sickle cell disease specific: A. Confirmed diagnosis of sickle cell disease by one of the following: (i) identification of significant quantities of HbS with or without an additional abnormal β‑globin chain variant by hemoglobin assay; OR (ii) identification of biallelic HBB pathogenic variants with at least one p.Glu6Val allele on molecular genetic testing; AND B. Symptomatic disease despite treatment with hydroxyurea and add‑on therapy (e.g., crizanlizumab, voxelotor); AND C. Patient experienced two or more vaso‑occlusive events/crises (VOE/VOC) in the previous year while adherent to the above therapy; AND D. Patient will be transfused prior to apheresis to a total hemoglobin ≤ 11 g/dL and HbS < 30% and will be transfused at least 8 weeks prior to initiation of myeloablative conditioning (with the stated Hb and HbS goals); AND E. Patient will not receive granulocyte‑colony stimulating factor (G‑CSF) for HSC mobilization.

Sickle cell diagnostic and treatment‑response criteria

Beta thalassemia specific: A. Documented diagnosis of homozygous or compound heterozygous beta thalassemia by one of the following: (i) HBB sequence analysis showing biallelic pathogenic variants; OR (ii) severe microcytic hypochromic anemia with absence of iron deficiency, anisopoikilocytosis with nucleated RBCs on smear, and hemoglobin analysis showing decreased/absent HbA with increased HbA2 ± increased HbF; AND B. Transfusion‑dependent disease defined as ≥100 mL/kg/year or ≥10 units/year of packed RBCs in the 2 years preceding therapy; AND C. Patient will be transfused prior to apheresis to a total hemoglobin ≥ 11 g/dL for 60 days prior to myeloablative conditioning; AND D. Patient does not have severely elevated cardiac iron (cardiac T2* < 10 ms or LVEF < 45%) OR advanced liver disease (AST/ALT > 3× ULN, direct bilirubin > 2.5× ULN, or biopsy showing bridging fibrosis/cirrhosis).

Beta thalassemia diagnostic, transfusion, and organ function criteria

Coverage excludes members with a history of hypersensitivity to dimethyl sulfoxide (DMSO) or dextran 40. For members with beta thalassemia, coverage is excluded when there is evidence of severe cardiac iron overload (defined as cardiac T2* < 10 msec by MRI or left ventricular ejection fraction < 45%) or advanced liver disease (defined as AST or ALT > 3× ULN, direct bilirubin > 2.5× ULN, or biopsy demonstrating bridging fibrosis or cirrhosis).

Requests for repeat or subsequent treatment with exagamglogene after prior receipt of other gene therapies (for example, lovotibeglogene or betibeglogene products) will be reviewed on a case-by-case basis and are not routinely covered under the standard criteria.

Casgevy must not be administered concurrently with live vaccines while the member is immunosuppressed; live vaccines are prohibited during that period per preconditioning and post‑treatment immunosuppression guidance.

For hematopoietic stem cell mobilization, G‑CSF mobilization is not permitted for sickle cell disease patients per the policy; additionally, specified washout and avoidance periods apply to concomitant therapies — for example, iron chelators must be withheld for 7 days prior to mobilization and for 6 months after treatment (3 months for non‑myelosuppressive chelators), and disease‑modifying agents (such as hydroxyurea, voxelotor, or crizanlizumab) must be stopped for at least 8 weeks prior to mobilization and conditioning.

Coding and Clinical Parameters

Applicable HCPCS Procedure CodesHCPCSCovered

J3392

Injection, exagamglogene autotemcel, per treatment; 1 billable unit = 1 treatment

Applicable NDCsNDCCovered

51167-0290-xx

Casgevy containing a minimum of 3.0 × 10^6 CD34+ cells/kg of body weight, in one or more vials packaged in carton(s)

Applicable ICD-10 DiagnosesICD-10

D56.1	Beta thalassemia
D56.5	Hemoglobin E-beta thalassemia
D57.0	Hb-SS disease with crisis
D57.00	Hb-SS disease with crisis, unspecified
D57.01	Hb-SS disease with acute chest syndrome
D57.02	Hb-SS disease with splenic sequestration
D57.03	Hb-SS disease with cerebral vascular involvement
D57.04	Hb-SS disease with dactylitis
D57.09	Hb-SS disease with crisis with other specified complication
D57.1	Sickle-cell disease without crisis

1–10 of 51

1/6

inv-07: Minimum CD34+ cell dose

Minimum CD34+ cell dose>= 3 x 10^6 CD34+ cells/kg

Dose frequencyOne-time (single IV infusion, once per lifetime)

Dose basisPer kg of body weight

inv-08: Transfusion requirements

Sickle cell — pre-apheresis transfusion targetsTransfuse to total hemoglobin ≤ 11 g/dL and HbS < 30%; transfusion must occur at least 8 weeks prior to initiation of myeloablative conditioning

Beta thalassemia — pre-apheresis transfusion targetsTransfuse to total hemoglobin ≥ 11 g/dL for 60 days prior to myeloablative conditioning

Mobilization restrictionDo not use G-CSF for HSC mobilization in sickle cell patients

inv-09: Transfusion-dependence definition for beta thalassemia

Transfusion‑dependence definition (beta thalassemia)History of transfusions of at least 100 mL/kg/year or ≥10 units/year of packed red blood cells in the 2 years preceding therapy

Assessment period2 years prior to therapy

Measurement unitsmL/kg/year or units/year of pRBCs

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. The provider must obtain preauthorization before billing J3392 and ensure the submitted documentation demonstrates the member meets all policy criteria.

Affected code: J3392
Preauthorization must be obtained before scheduling or billing for therapy

Documentation Required

Clinical Evidence Required for Preauthorization

The treating provider must submit clinical evidence that the member meets ALL applicable policy criteria to support preauthorization. Evidence should include, as relevant: diagnostic test results, genetic testing reports, hemoglobin assays, transfusion history, documentation of prior and concomitant therapies (including trials of hydroxyurea and add-on agents), VOE/VOC event history, and planned transfusion details and goals.

Diagnostic proof of genotype or hemoglobin assay results
Molecular genetic testing reports where applicable
Documentation of symptomatic disease despite hydroxyurea and add-on therapy (e.g., crizanlizumab, voxelotor)
Transfusion records showing volumes and timing relative to planned apheresis/myeloablation

Denial Risk

Documentation Submission Requirement

Failure to submit the required clinical records and supporting documentation may result in denial of preauthorization, inability to complete a timely review, or post-payment claim recovery. Providers are responsible for retaining and providing records upon request.

Incomplete or absent documentation may lead to denial or delay
Post-payment recovery possible if documentation is insufficient

OpenPayer

Casgevy (exagamglogene autotemcel) intravenous infusion

Coverage Criteria

Coding and Clinical Parameters

Provider Actions and Authorization

Background

Definitions