Exagamglogene autotemcel (Casgevy) gene therapy coverage
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Defines Meridian Health Plan medical necessity and authorization criteria for Casgevy (exagamglogene autotemcel) for patients with sickle cell disease or transfusion-dependent β-thalassemia, including required documentation and committee review. Affects providers submitting prior authorization for Medicaid line of business.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Therapy — Sickle Cell Disease
Covered when ALL of the following are met:
Initial Therapy — Transfusion-Dependent β-Thalassemia (TDT)
Covered when ALL of the following are met:
Non–FDA approved indications not specifically addressed in this policy are not authorized unless the provider supplies sufficient supporting documentation consistent with the plan's off‑label use requirements (see policy CP.PMN.53 and related evidence of coverage guidance).
The inclusion or exclusion of any procedure or diagnosis code in this policy does not guarantee coverage. Providers must follow applicable plan coverage rules, current coding guidance, and submit claims using the most up‑to‑date code sets and professional coding resources.
Casgevy (exagamglogene autotemcel) is authorized as a one‑time administration only; continued therapy or repeat dosing will not be authorized.
Initial Therapy
Initial therapy — Initial authorization granted when all specific indication criteria are met
Initial authorization is granted when ALL specific indication criteria are met (see indication-specific criteria below).
Dosing and product availability — Dosing and product availability details
Dosing and product availability details:
Continuation Criteria
Continuation — All Indications
All Indications
Coding and Code-based Criteria
| J3392 | Injection, exagamglogene autotemcel, per treatment |
Definitions
Provider Actions and Prior Authorization
PDAC utilization management review required
All requests reviewed under this policy require Precision Drug Action Committee (PDAC) Utilization Management Review; prior authorization and supporting clinical documentation must be submitted per CC.PHAR.21.
- Refer to CC.PHAR.21 for PDAC process details.
Prior authorization required for HCPCS J3392
Prior authorization is implied by inclusion of HCPCS code J3392 (Injection, exagamglogene autotemcel, per treatment); providers must follow the plan’s prior authorization submission processes for this code.
- HCPCS J3392 is referenced in the policy coding implications.
Step therapy: not applicable (authorization based on criteria)
Step therapy is not applicable as authorization is contingent on meeting the listed indication-specific criteria (e.g., documented trial/failure/intolerance to hydroxyurea for SCD or required transfusion history for TDT).
- Authorization requires meeting the coverage criteria rather than prior step therapy sequences.
No step therapy rules stated
The policy does not specify any step therapy rules in this section.
Submit complete supporting clinical documentation
Providers must submit documentation (office chart notes, lab results, or other clinical information) demonstrating the member meets all approval criteria, including confirmatory genetic testing, VOC/transfusion history, transplant eligibility attestation, hydroxyurea trial/failure/intolerance (if applicable), body weight when required, and minimum harvested cell dose.
- Documentation of negative HIV, hepatitis B and C within last 6 months is required for TDT.
- Include provider attestation of clinical stability and HSCT eligibility.
- Document minimum CD34+ cell dose (≥ 3 x 10^6 cells/kg).
Supporting references and plan notice
Use the Casgevy Prescribing Information (Jan 2024) and the clinical literature cited in the policy (e.g., Frangoul et al., ClinicalTrials.gov listings, NHLBI guidance) to support clinical documentation; the plan reserves the right to change policy and providers must adhere to coverage terms, limitations, and applicable state Medicaid provisions.
- Prescribing Information: Casgevy Prescribing Information. Boston, MA: Vertex Pharmaceuticals, Inc.; January 2024.
- Cited literature and clinical trial references listed in policy Appendix/References should be included as supporting evidence.
Documentation-based denials possible
Requests that lack required documentation showing the member meets approval criteria, or requests for non–FDA‑approved indications without sufficient off‑label evidence per applicable off-label use policies, may be denied.
- Non‑FDA indications require sufficient documentation per off‑label use policy CP.PMN.53 for Medicaid.
Coding inclusion does not guarantee coverage/payment
Inclusion of HCPCS J3392 or any other code in this policy is informational and does not guarantee coverage or payment; providers should reference current professional coding guidance before claim submission.
- Codes referenced are for informational purposes only; inclusion/exclusion does not guarantee coverage.
Site of Care and Specialist Requirements
Specialist prescribing and transplant involvement required
Therapy must be prescribed by or in consultation with hematology and transplant specialists experienced in sickle cell disease or transfusion‑dependent β‑thalassemia; transplant specialist involvement and assessment of transplant eligibility is required as part of the criteria.
- Medication prescribed by or in consultation with a board‑certified hematologist or transplant specialist (SCD criteria)
- Prescribed by or in consultation with a hematologist and transplant specialist and transplant attestation (TDT criteria)
No site‑of‑care restrictions stated
No site‑of‑care restrictions are specified in this portion of the document.
Quantity Limits
Background
Exagamglogene autotemcel (Casgevy) is an autologous CD34+ hematopoietic stem and progenitor cell–based gene therapy approved for patients aged ≥ 12 years with either sickle cell disease with recurrent vaso‑occlusive crises or transfusion‑dependent β‑thalassemia. Treatment requires confirmatory genetic testing, transplant eligibility assessment, and a minimum harvested dose of ≥ 3 x 10^6 CD34+ cells/kg. The product is supplied as a single‑dose cell suspension and may be provided in up to nine vials for the single infusion; dosing and safety details are described in the Casgevy Prescribing Information (Jan 2024) and supporting clinical references.
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