ModifiedmhnPolicy CP.PHAR.603

Exagamglogene autotemcel (Casgevy) coverage

Defines medical necessity criteria, documentation, and approval conditions for one-time administration of exagamglogene autotemcel (Casgevy) for patients aged ≥12 with sickle cell disease with recurrent VOCs or transfusion-dependent β-thalassemia. Applies to providers submitting requests to the payer lines of business listed.

Policy Summary

Payermhn

PolicyExagamglogene autotemcel (Casgevy) coverage

Policy CodePolicy CP.PHAR.603

Change TypeCriteria and coding updatesindication expansion

Effective DateDec 8, 2023

Next Review Date

Key ActionObtain prior authorization and submit clinical documentation including genetic confirmation, infection screening, body weight, and transplant specialist attestation.

SourceLink

POLICY UPDATE CHANGES

HCPCS code J3392 was added for exagamglogene autotemcel and codes J3590 and C9399 were removed.

Criteria updated to require genetic confirmation of genotype and additional exclusions such as active HIV, hepatitis B, hepatitis C, advanced liver disease, current malignancy, and immunodeficiency disorders.

Initial approval duration was revised to 6 months to allow adequate time for gene therapy manufacture; minimum Casgevy dose clarified and body weight documentation required for weight-based dosing verification.

Policy updated with newly approved indication for transfusion-dependent β-thalassemia (TDT) and an additional transfusion-dependence option of ≥8 pRBC transfusions per year for the previous two years.

≥12Minimum patient age

3 x10^6 CD34+/kgCell dose requirement

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Coverage Criteria for Exagamglogene Autotemcel (Casgevy)

Initial Therapy - Sickle Cell Disease

Covered when ALL of the following are met for Sickle Cell Disease:

SCD Initial Approval: 1. Diagnosis of sickle cell disease with genetic confirmation of one of the following genotypes: a) βS/βS or b) βS/β0; 2. Prescribed by or in consultation with a hematologist and a transplant specialist; 3. Age ≥ 12 years; 4. Documentation of ≥ 2 severe vaso-occlusive crises (VOCs) per year during the previous two years, where severe VOC is defined as: a) an acute pain event requiring a visit to a medical facility and administration of pain medications or packed red blood cell (pRBC) transfusion, b) acute chest syndrome (ACS), c) priapism >2 hours requiring a facility visit, d) splenic sequestration, or e) hepatic sequestration; 5. Failure of hydroxyurea at up to the maximally indicated dose for ≥ 6 months unless contraindicated or clinically significant adverse effects are experienced (myelosuppression alone does not qualify as treatment failure); 6. Attestation from a transplant specialist that the member: a) understands risks and benefits of alternative options such as allogeneic HSCT, and b) is clinically stable and eligible to undergo myeloablative conditioning and HSCT; 7. No prior allogeneic HSCT; 8. No prior gene therapy; 9. Documentation within the last 6 months of negative testing for active HIV, hepatitis B virus, and hepatitis C virus; 10. No advanced liver disease; 11. No current malignancy or immunodeficiency disorder; 12. Documentation of member body weight in kg; 13. Dose to be administered contains a minimum of 3 x 10^6 CD34+ cells/kg.all listed criteria

Approval duration: 6 months (one-time infusion per lifetime)

Initial Therapy - Transfusion-Dependent β-Thalassemia

Covered when ALL of the following are met for Transfusion-Dependent β-Thalassemia (TDT):

TDT Initial Approval: 1. Diagnosis of transfusion-dependent β-thalassemia (TDT) with genetic confirmation; 2. Prescribed by or in consultation with a hematologist and a transplant specialist; 3. Age ≥ 12 years; 4. Documentation of one of the following for the previous two years: a) receipt of ≥100 mL/kg or ≥10 units of pRBC per year, OR b) receipt of ≥8 transfusions of pRBC per year; 5. Attestation from a transplant specialist that the member: a) understands risks and benefits of alternative options such as allogeneic HSCT, and b) is clinically stable and eligible to undergo myeloablative conditioning and HSCT; 6. Member does not have any of the following: a) associated α-thalassemia with >1 alpha chain deletion, b) alpha multiplications, c) associated sickle cell β-thalassemia; 7. No prior allogeneic HSCT; 8. No prior gene therapy; 9. Documentation within the last 6 months of negative testing for active HIV, hepatitis B virus, and hepatitis C virus; 10. No advanced liver disease; 11. No current malignancy or immunodeficiency disorder; 12. Documentation of member body weight in kg; 13. Dose to be administered contains a minimum of 3 x 10^6 CD34+ cells/kg.all listed criteria

Approval duration: 6 months (one-time infusion per lifetime)

Covered with criteria (summary)

Policy criteria were updated to align with FDA approval for SCD and TDT; examples of updated criteria included:

Updated coverage requirements (summary): Genetic confirmation of genotype; addition of defined severe VOC criteria and a hydroxyurea failure requirement for SCD; requirement for negative testing within 6 months for active HIV, hepatitis B, and hepatitis C; exclusion of advanced liver disease, current malignancy, and immunodeficiency disorders; added TDT transfusion-dependence option of ≥8 pRBC transfusions/year for the previous two years; added exclusions for associated α-thalassemia with >1 alpha chain deletion, alpha multiplications, and associated sickle cell β-thalassemia; clarification of minimum Casgevy dose requirement and documentation of member body weight for verification of weight-based dosing; initial approval duration revised to 6 months to allow gene therapy manufacture.

See full policy sections for complete nesting and precise age/genotype thresholds.

Non-FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the request is supported by the payer's off-label use policies (CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, CP.PMN.53 for Medicaid) or other evidence of coverage documentation demonstrating sufficient efficacy and safety.

The policy now excludes certain phenotypes associated with α-thalassemia and related hemoglobinopathies. Specifically, coverage is not authorized for cases with associated α-thalassemia with >1 alpha chain deletion, alpha multiplications, or for disease categorized as associated sickle cell β-thalassemia, consistent with specialist feedback and alignment to the FDA-labeling–aligned updates.

Casgevy is approved to be administered as a single, one-time infusion. Accordingly, continued therapy will not be authorized under this policy; approval duration for initial authorization is operationalized to permit therapy manufacture but the therapy itself is one-time per member.

Requests for Casgevy must document recent infectious disease and comorbidity status. Members with active HIV, hepatitis B virus, hepatitis C virus, advanced liver disease, current malignancy, or a current immunodeficiency disorder are excluded from coverage per the updated criteria and will not meet policy approval unless documentation demonstrates these conditions are resolved and criteria are otherwise satisfied.

Coding and Product Characteristics

HCPCS codes referencedHCPCS

J3392	Injection, exagamglogene autotemcel, per treatment
J3590	Not listed (removed from policy)
C9399	Not listed (removed from policy)

Minimum CD34+ cell dose

Minimum CD34+ cell dose3 x 10^6 CD34+ cells/kg (minimum recommended dose for SCD and TDT)

Maximum doseNot applicable (no maximum dose specified)

Dose basisDose calculated per kilogram of body weight (documentation of body weight in kg required)

CD34+ cells per mL

Cell concentration per vial4-13 x 10^6 CD34+ cells/mL per vial

Vial suspension volume rangeEach vial suspended in 1.5 to 20 mL cryopreservative medium

Product presentation

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

PA and billing code

Prior authorization is required. Provider must obtain prior authorization before infusion and include HCPCS J3392 for exagamglogene autotemcel billing.

Prior authorization required for Casgevy (exagamglogene autotemcel).
Use HCPCS code J3392 for billing; do not bill J3590 or C9399 for this product.

Documentation Required

Documentation and medical director review

Provider must submit clinical documentation showing all approval criteria are met. All requests require medical director review.

Attach office chart notes, relevant consult notes (hematology and transplant specialist), and attestation from transplant specialist.
Include documentation of age, diagnosis, genotype confirmation, and prior therapies tried.

Background on Therapy

Casgevy (exagamglogene autotemcel) is an autologous, CD34+ hematopoietic stem and progenitor cell–based gene-editing therapy indicated for patients aged ≥12 years with either sickle cell disease (SCD) with recurrent vaso-occlusive crises or transfusion-dependent β-thalassemia (TDT). The therapy is provided as a one-time, multidisciplinary-managed cell infusion requiring hematology and transplant specialist involvement; policy updates align criteria with FDA labeling (including genotype confirmation, infectious disease screening, hydroxyurea failure for SCD when applicable, and minimum cell dose requirements) and operational considerations for manufacture and dosing verification.

Definitions and Measurement Conversions

Severe VOC

DefinitionSevere vaso-occlusive crisis (VOC): an acute pain event requiring a visit to a medical facility and administration of pain medications (e.g., opioids or IV NSAIDs) or pRBC transfusions; acute chest syndrome; priapism lasting >2 hours requiring facility visit; splenic sequestration; or hepatic sequestration.

Documentation timeframe for severity criterionDocumentation of ≥2 severe VOCs per year during the previous two years is required for SCD initial approval

Source of definition updateVOC definitions were added to the policy to align with FDA labeling and specialist input

pRBC unit

Approximate volume per RBC unit1 RBC unit refers to approximately 200–350 mL of pRBC

Conversion for standard bags (≥350 mL)