Exagamglogene autotemcel (Casgevy) coverage and prior authorization
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Medical coverage policy governing prior authorization and medical necessity criteria for exagamglogene autotemcel (Casgevy) for treatment of Sickle Cell Disease (SCD) and Transfusion-dependent β-thalassemia (TDT) for Baylor Scott & White Health Plan members.
Added TDT (transfusion-dependent β-thalassemia) indication (FDA approved) and TDT specific criteria.
Added CPT code 96409 and updated HCPCS code from J3590 to J3392.
Updated treatment center criteria to attestation only and reformatted to include 'Universal Criteria' and 'Indication Specific Criteria'.
Coverage and Medical Necessity Criteria
Universal Criteria
Covered when ALL of the following universal criteria are met
All items required
Sickle Cell Disease (SCD) Coverage
Covered for SCD when ALL of the following are met
All items required
Transfusion-dependent β-thalassemia (TDT) Coverage
Covered for TDT when ALL of the following are met
All items required
Limits
Transfusion-dependent β-thalassemia (TDT) efficacy criteria
Coverage informed by clinical trial outcomes for TDT; primary efficacy endpoint is TI12
Primary efficacy endpoint in Trial 2
Context for efficacy expectations
BSWHP considers exagamglogene autotemcel (Casgevy®) for the treatment of all other indications to be experimental and investigational because the effectiveness of this strategy has not been established.
Due to the wide range of applicable diagnosis codes and potential updates to coding, the policy does not present an exhaustive inclusive list of ICD-10 diagnosis codes; inclusion of a code in the examples does not guarantee reimbursement and members must meet the medical necessity criteria in the policy language.
BSWHP considers repeat administration of exagamglogene autotemcel (Casgevy®) to be experimental and investigational and therefore not medically necessary, as the effectiveness of administering the therapy more than once has not been established.
The policy notes that there are ICD-10 entries identified as not covered, but the specific not-covered ICD-10 entries are not listed in this portion of the document.
Procedure, Drug, and Diagnosis Codes
| J3392 | Injection, exagamglogene autotemcel, per treatment |
| D56.1 | Beta thalassemia |
| 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 |
| D57.20 | Sickle-Cell/Hb-C Disease Without Crisis |
| D57.211 | Sickle-Cell/Hb-C Disease With Acute Chest Syndrome |
Authorization, Documentation, and Operational Requirements
Prior authorization required; clinical review
Prior authorization is required for exagamglogene autotemcel (Casgevy®). All requests will be reviewed by a clinical pharmacist and medical director and must meet the universal criteria and the indication-specific medical necessity criteria in this policy.
Use listed HCPCS/CPT codes on prior authorization; codes do not guarantee payment
Submit a prior authorization request using the applicable HCPCS and CPT codes listed in the policy; inclusion of a code does not ensure reimbursement — member must meet the policy criteria. Applicable codes include HCPCS J3392 for exagamglogene autotemcel and CPT administration codes 96413 and 96409 for related administration services.
Document hydroxyurea failure/intolerance/contraindication for SCD
For SCD indications, document hydroxyurea failure, intolerance, or a contraindication prior to approval; this is a required element of the SCD indication-specific criteria.
- Hydroxyurea failure, intolerance, or contraindication must be clearly documented in the record.
Required documentation to support prior authorization
Include documentation that the therapy is prescribed by or in consultation with a board-certified hematologist and that the member will receive treatment at an activated authorized treatment center. Also document eligibility for autologous HSCT, absence of an available HLA‑matched related donor, no prior HSCT/gene therapy/investigational cellular therapy, and fulfillment of the appropriate indication-specific criteria (including confirmed genotype and performance status).
- Prescribing clinician is a board-certified hematologist or consultation is documented.
- Attestation that treatment will occur at an activated authorized treatment center.
- Evidence of eligibility for autologous HSCT and lack of an available HLA‑matched related donor.
- No prior HSCT, exagamglogene or other gene therapy, or investigational cellular therapy.
- Indication-specific items (e.g., confirmed genotype, age and performance status thresholds).
Provide clinical outcome data (TI12) and related documentation
When assessing TDT outcomes and continued coverage, provide baseline transfusion requirements, dates of infusion, and hemoglobin measurements to support evaluation of transfusion independence (TI12 defined as weighted average Hb ≥9 g/dL without RBC transfusions for at least 12 consecutive months, evaluated starting 60 days after last RBC transfusion).
- Baseline transfusion volume and frequency during the 2-year pre‑treatment period.
- Dates of exagamglogene infusion.
- Serial hemoglobin values to calculate weighted average Hb and document TI12.
Incomplete criteria or excluded conditions may cause denial
Requests that do not meet ALL universal criteria or the indication-specific criteria — including the listed laboratory and physiologic cutoffs, genotype and performance status requirements, history exclusions (prior HSCT/gene therapy), or prior therapy requirements — risk denial.
- Failure to meet lab or physiologic thresholds (e.g., WBC <3×10^9/L, platelets <50×10^9/L, LVEF <45%, eGFR <60 mL/min/1.73 m2) may trigger denial.
- Requests with prior HSCT, prior gene therapy, investigational cellular therapy, or an available HLA‑matched related donor are not eligible.
Coding alone does not guarantee coverage
Inclusion of an applicable CPT/HCPCS/ICD code on a request or claim does not guarantee coverage or reimbursement; the patient must meet the policy's medical necessity criteria for approval.
Clinical Background and Rationale
Sickle Cell Disease (SCD) is an autosomal recessive disorder characterized by polymerization of hemoglobin S that leads to red blood cell sickling, chronic hemolytic anemia, recurrent vaso-occlusion with acute painful crises and severe vaso-occlusive episodes, and progressive multi-organ damage. Curative therapy can include hematopoietic stem cell transplant (HSCT) from a matched donor, but matched donors are often unavailable; exagamglogene autotemcel (Casgevy®) is an autologous, CRISPR/Cas9 genome-edited CD34+ hematopoietic stem cell therapy developed to increase fetal hemoglobin and reduce disease manifestations in eligible patients.
Key Definitions and Terms
Policy Revision and Updates
Added Transfusion-dependent β-thalassemia (TDT) indication and TDT-specific coverage criteria; added CPT code 96409; updated HCPCS code from J3590 to J3392; added ICD-10 code D56.1; updated treatment center criteria to attestation only; other policy formatting and standard language updates.
Policy created (new policy effective 06/10/2024).
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