Exagamglogene autotemcel (Casgevy®) 'Notification'
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Policy defines medical necessity criteria, documentation requirements, and duration/administration details for exagamglogene autotemcel (Casgevy) intravenous single-dose gene therapy for patients aged ≥12 years with either sickle cell disease (SCD) with recurrent VOCs or transfusion-dependent β-thalassemia (TDT). It includes eligibility, exclusion, preparatory therapy, and transplant-related requirements and billing codes.
April 2026: Added revenue codes 0891 and 0892 associated with policy HCPCS code(s); policy notification 2/1/2026 for effective date 4/1/2026.
January 2026: For TDT indication, added requirement to discontinue disease-modifying therapies for TDT (e.g., mitapivat) prior to initiating treatment.
December 2025: For SCD and TDT indications, revised diagnostic confirmation criteria, genotype handling, transplant fitness and organ function requirements, and removed/adjusted several prior exclusions (e.g., Karnofsky/Lansky, CKD, pulmonary hypertension).
January 2025: Coding change — added HCPCS code J3392 to dosing reference table effective 1/1/2025; deleted C9399, J3490, and J3590 termed 12/31/2024.
February 2024: Original medical policy criteria issued.
Coverage Summary
Policy purpose: to define medical necessity criteria, documentation, and billing for exagamglogene autotemcel (Casgevy), an FDA-approved, single-dose autologous gene therapy for patients aged ≥ 12 years with either sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) or transfusion-dependent β-thalassemia (TDT). The policy aligns coverage with FDA labeling, requires confirmation of diagnosis and genotype, assessment of transplant fitness and organ function, clearance of active infections and malignancy, and specified timeframes for discontinuation of preparatory/disease-modifying therapies prior to hematopoietic stem cell (HSC) mobilization and myeloablative conditioning.
Coverage stance: Covered with criteria when all stated eligibility and exclusion criteria are met. Dosing and administration: therapy is a single intravenous dose with a minimum recommended dose of 3 x 10^6 CD34+ cells per kg (single-dose), and the policy follows the FDA-labeled maximum of 1 unit (one-time, single-dose per lifetime). Duration of approval is 365 days; distribution from a specialty pharmacy provider may be required and prior authorization/medical-record documentation is required to confirm eligibility and meet billing rules.
Medical Necessity (Eligibility and Exclusions)
General eligibility
Covered when ALL of the following are met:
Coding
| J3392 | Exagamglogene autotemcel (Casgevy) intravenous infusion |
| 0891 | Special Processed Drugs - FDA Approved Cell Therapy |
| 0892 | Special Processed Drugs - FDA Approved Gene Therapy |
Provider Actions & Prior Authorization
Prior authorization / medical necessity documentation required
Medical record documentation is required to support diagnosis confirmation, genotype/molecular testing, clinical history of VOCs or transfusions, relevant labs, specialist attestation, and verification of discontinuation of disease-modifying therapies prior to mobilization/conditioning for coverage approval.
- Diagnosis confirmation (hemoglobin assay showing significant HbS and/or biallelic HBB pathogenic variants) [medical record documentation required]
- Molecular genetic testing results (genotype such as βS/βS, βS/β0, βS/β+ or biallelic HBB variants for TDT) [medical record documentation required]
- History of VOCs (≥4 severe VOCs in past 24 months) or transfusion history for TDT (≥100 mL/kg/year or ≥10 units/year over past 2 years) [medical record documentation required]
- Relevant labs (bone marrow function, HIV, HBV, HCV, eGFR, cardiac T2*/LVEF where applicable) within past 3 months where specified [medical record documentation required]
- Specialist attestation: prescriber is a specialist or has consulted a specialist (hematologist/SCD or TDT specialist/transplant specialist) [medical record documentation required]
- Documentation of discontinuation of disease-modifying therapies prior to HSC mobilization and myeloablative conditioning (SCD: at least 8 weeks; TDT: discontinue agents such as mitapivat) [medical record documentation required]
- Other eligibility/exclusion documentation (no prior allogeneic HSCT, no prior gene therapy for the requested indication, absence of active infections, hepatic/iron overload criteria, etc.) [medical record documentation required]
Single-dose, one-time lifetime; maximum units
Approval duration is 365 days (1 year); therapy is a one-time, single-dose treatment per lifetime (maximum units = 1).
- maximum units = 1
- HCPCS code = J3392
- Distribution from a specialty pharmacy provider may be required due to cost; contact Blue Cross NC to coordinate
Required labs and testing timeframe
Labs and other specified documentation must be recent and included in the prior authorization submission; where noted, results should be from within the past 3 months.
- Bone marrow function: WBC ≥ 3,000/µL OR platelet count ≥ 50,000/µL (labs within past 3 months)
- HIV-1 and HIV-2 testing (patient must NOT be HIV positive; labs within past 3 months)
- Hepatitis B (HBsAg negative OR HBV surface Ab-positive with negative other HBV markers OR negative HBV DNA) (labs within past 3 months)
- Hepatitis C (HCV antibody negative OR HCV antibody positive with undetectable viral load) (labs within past 3 months)
- Renal assessment: eGFR > 60 mL/min/1.73 m2 (medical record documentation required)
- Cardiac iron/func tion where applicable: cardiac T2* not < 10 msec by MRI or LVEF not < 45% by echocardiogram (for TDT)
Exclusion conditions lead to non-coverage
Claims may be denied if the patient meets any of the listed exclusions or contraindications documented in the medical record.
- Prior allogeneic hematopoietic stem cell transplantation
- Prior gene therapy for the requested and/or approved indications (including the requested agent)
- Any clinically significant and active bacterial, viral, fungal, or parasitic infection
- HIV-1 or HIV-2 positivity
- Advanced liver disease (e.g., cirrhosis, active hepatitis, significant fibrosis)
- Evidence of iron overload for TDT (cardiac T2* < 10 msec or LVEF < 45%)
- Contraindications to plerixafor or to busulfan/myeloablative conditioning agents (including hypersensitivity)
- Any prior or current malignancy or immunodeficiency disorder (except non-melanoma skin cancers) or history of Familial Cancer Syndrome
Background, Evidence, and Definitions
Exagamglogene autotemcel (Casgevy) is an FDA-approved, single-dose autologous gene therapy for patients ≥ 12 years with either sickle cell disease with recurrent VOCs or transfusion-dependent β-thalassemia. The policy is aligned with FDA labeling and specifies that dosing follows the FDA-referenced minimum of 3 x 10^6 CD34+ cells per kg as a single intravenous dose. HCPCS coding for the product is listed as J3392, and applicable revenue codes for specially processed cell and gene therapies include 0891 and 0892.
| Reference | Notes |
|---|---|
| Frangoul H et al., NEJM 2021; CRISPR-Cas9 gene editing for SCD and β-thalassemia | Primary clinical reference listed in policy evidence; supports clinical trial evidence for gene editing approach |
| FDA label referenced — indication, dosing (3 x 10^6 CD34+ cells/kg), HCPCS J3392, maximum units = 1 | Policy cites FDA label for indication, minimum recommended dose (3 x 10^6 CD34+ cells/kg), HCPCS J3392, and maximum units = 1; revenue codes 0891 and 0892 also noted elsewhere in policy |
Definitions
Revision History
Added revenue codes 0891 (Special Processed Drugs - FDA Approved Cell Therapy) and 0892 (Special Processed Drugs - FDA Approved Gene Therapy) associated with policy HCPCS code(s); policy notification 02/01/2026 for effective date 04/01/2026.
For the TDT indication, added requirement to discontinue any disease-modifying therapies for TDT (e.g., mitapivat) prior to initiating treatment due to recent FDA approval of a new therapy for TDT.
Multiple clinical criteria clarified and restructured: revised diagnostic confirmation criteria and genotype handling for SCD and TDT, refined transplant fitness and organ function requirements (e.g., added LVEF <45% as iron overload indicator for TDT, removed Karnofsky/Lansky performance status, removed CKD and pulmonary hypertension exclusions, specified Moyamoya-related cerebral vasculopathy), and reformatted TDT-specific alpha-thalassemia criterion; policy notification 10/15/2025 for effective date 12/15/2025.
Coding change: Added HCPCS code J3392 to dosing reference table effective 01/01/2025; deleted C9399, J3490, and J3590 (termed 12/31/2024).
Original medical policy criteria issued (initial policy publication).
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