Casgevy (exagamglogene autotemcel) Medical Drug Criteria
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Defines prior authorization, eligibility, and coverage conditions for a single-dose autologous gene therapy (Casgevy) for patients with sickle cell disease or transfusion-dependent beta thalassemia under BCBSKS.
Length of authorization changed from 'may not' to 'will not' be renewed; coverage limited to one treatment course (one dose).
Requirement that patient has not had a prior HSCT and for patients under 18, no known suitable 10/10 HLA matched related donor willing to participate in allogeneic HSCT.
Sickle cell disease criteria updated to require uncontrolled disease despite hydroxyurea OR crizanlizumab (or intolerance) or need for repeat transfusions; VOC threshold changed to two or more events in the previous year.
HCPCS code J3392 (exagamglogene autotemcel) added effective 01/01/2025 and J3590 removed.
Coverage Criteria for Casgevy (exagamglogene autotemcel)
inv-01: Initial Therapy — General and administrative criteria
Covered when ALL of the following are met
General eligibility
- Concomitant therapy restrictions: No iron chelators for at least 7 days prior to myeloablative conditioning and for 6 months post-treatment for myelosuppressive iron chelators (e.g., deferiprone) OR 3 months post-treatment for non-myelosuppressive iron chelators; disease-modifying agents (e.g., hydroxyurea, crizanlizumab) withheld for at least 8 weeks prior to mobilization and conditioning.
inv-02: Initial Therapy — Sickle Cell Disease
AND for Sickle Cell Disease patients, ALL of the following must be met
inv-03: Initial Therapy — Beta Thalassemia
AND for Beta Thalassemia patients, ALL of the following must be met
inv-04: Administration timing
AND procedural timing requirements
Exclusions: Patients who have received prior gene therapies (for example, Lyfgenia® [lovotibeglogene autotemcel] or Zynteglo® [betibeglogene autotemcel]) are excluded from standard authorization for Casgevy. For Beta Thalassemia patients, exclusion criteria additionally include severely elevated cardiac iron (cardiac T2* < 10 msec), left ventricular ejection fraction < 45%, or evidence of advanced liver disease (AST or ALT > 3× ULN, direct bilirubin > 2.5× ULN, or biopsy showing bridging fibrosis or cirrhosis).
Requests for additional doses or repeat courses beyond the single authorized treatment course are not covered. Coverage will be provided for one treatment course (1 dose of Casgevy) and will not be renewed.
Coding and Product Identification
| J3392 | Injection, exagamglogene autotemcel, per treatment; 1 billable unit = 1 treatment (Effective 01/01/2025) |
| 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) |
Provider Requirements and Prior Authorization
Prior Authorization / Documentation Required
Prior authorization is required. Submit all relevant medical records/chart notes documenting diagnosis, prior therapies, transfusion history, and clinical markers supporting medical necessity. Failure to submit required medical records may result in denial of the prior authorization request.
- Submission of medical records (chart notes) related to the medical necessity criteria is REQUIRED on all requests for authorizations.
- Provide documentation related to diagnosis, step therapy, genetic/mutational testing, and transfusion history via direct upload through the PA web portal or by fax.
Failure to Submit Required Records — Denial Risk
Failure to submit the required records (e.g., documentation of prior therapies, transfusion dependence, genotype confirmation, and pre-collection infectious disease screening) may result in administrative denial or delay. Ensure records include evidence of prior use or intolerance of hydroxyurea or crizanlizumab (for sickle cell) or documentation of transfusion dependence (for beta thalassemia).
- Evidence of prior therapies: hydroxyurea or crizanlizumab trial OR documentation of intolerance or need for repeat transfusions (sickle cell).
- Evidence of transfusion dependence: ≥100 mL/kg/year or ≥10 units/year pRBCs in the 2 years preceding therapy (beta thalassemia).
- Pre-collection screening: HBV, HCV, and HIV-1/2 test results.
Billing and Product Identification
Billing must use HCPCS code J3392 for exagamglogene autotemcel. Confirm patient identity matches vial labeling prior to infusion; do not infuse if patient-specific vial label does not match the intended patient.
- HCPCS: J3392 - Injection, exagamglogene autotemcel, per treatment; 1 billable unit = 1 treatment (Effective 01/01/2025).
- Casgevy is provided as a single-dose autologous infusion — administer all vials to achieve the patient-specific dose.
- Before infusion, confirm the patient's identity matches the unique patient identifiers on the Casgevy vial(s). Do not infuse if labels do not match.
Required Prior Therapies / Disease Status (Documentation)
Documentation of required prior therapies and disease status must be provided with the PA request. For sickle cell disease, include genotype confirmation and evidence of uncontrolled disease despite hydroxyurea or crizanlizumab, or documentation of transfusion use/intolerance. For beta thalassemia, include HBB sequencing or hematologic/hemoglobin analysis and documentation of transfusion dependence.
- Sickle cell: genotype (βS/βS, βS/β0, βS/β+) confirmation by hemoglobin assay or molecular testing; documentation of prior hydroxyurea or crizanlizumab use or intolerance, or repeat transfusions.
- Beta thalassemia: HBB sequence gene analysis showing biallelic pathogenic variants OR hemoglobin analysis consistent with severe disease; documentation of transfusion dependence (≥100 mL/kg/year or ≥10 units/year).
- Note mobilization requirements: Sickle cell mobilization with plerixafor only; Beta thalassemia mobilization with plerixafor + G-CSF.
Provider Actions — Submission Requirements
Providers must ensure all specified documentation is included at time of submission to avoid administrative denials or delays in treatment authorization.
- Include diagnosis, prior therapy history, transfusion records, genotype/testing results, infectious disease screening, and any relevant supportive care measures.
- Provide documentation via the PA web portal upload or fax as instructed.
Key Definitions and Thresholds
Background — Therapy Description
Casgevy is an autologous, single-dose, ex vivo CRISPR-based gene-editing therapy administered as a CD34+ cell suspension for patients with sickle cell disease or transfusion-dependent beta thalassemia. Candidate patients must meet general safety and screening requirements prior to leukapheresis (including age ≥ 12 years, screening negative for HBV, HCV, and HIV-1/2, and no history of hypersensitivity to DMSO or dextran 40). Product handling requires confirmation of vial-to-patient identity prior to infusion, and conditioning/mobilization timing and concomitant therapy restrictions must be observed as specified in the clinical criteria.
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