ModifiedHealth NetPolicy CP PHAR.603

Exagamglogene autotemcel (Casgevy) — Coverage Criteria

Policy governing medical necessity and prior authorization requirements for one-time autologous gene therapy Exagamglogene autotemcel (Casgevy) for patients with sickle cell disease or transfusion-dependent beta-thalassemia age ≥12, for Health Net lines of business noted.

Policy Summary

PayerHealth Net

PolicyExagamglogene autotemcel (Casgevy) — Coverage Criteria

Policy CodePolicy CP PHAR.603

Change TypeCriteria, coding, dosing, and authorization updates

Effective DateDec 8, 2023

Next Review Date

Key ActionSubmit prior authorization with required clinical documentation, confirm genetic genotype and negative HIV/hepatitis testing, document body weight, and request medical director review.

SourceLink

POLICY UPDATE CHANGES

HCPCS code J3392 was added and codes J3590 and C93991 were removed.

Criteria were updated to require genetic confirmation of genotype and definitions of severe VOC; hydroxyurea failure criterion added; negative testing for active HIV, hepatitis B and C, advanced liver disease, current malignancy, and immunodeficiency added.

Minimum Casgevy dose requirement clarified and minimum recommended dose specified as 3 x 10^6 CD34 cells/kg body weight IV.

Initial approval duration revised to 6 months to allow for gene therapy manufacture and preparation.

For TDT, added transfusion-dependence requirement of ≥8 transfusions of pRBCs per year for the previous two years and certain alpha-globin genotypic exclusions.

Requirement to document member body weight for verification of weight-based dosing added.

≥12minimum patient age for coverage

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Coverage Criteria for Exagamglogene autotemcel (Casgevy)

Initial Therapy — Sickle Cell Disease

Covered when ALL of the following are met for SCD patients:

SCD initial eligibility: Diagnosis of sickle cell disease with genetic confirmation of the appropriate genotype; age ≥ 12 years; prescribed by or in consultation with a hematologist and transplant specialist; documentation of ≥2 severe vaso-occlusive crises (VOC) per year during the previous 2 years (severe VOC defined per policy as an acute event requiring medical facility visit and administration of analgesics or parenteral therapy, transfusion, or other medical intervention including acute chest syndrome, priapism ≥2 hours requiring medical visit, hepatic or splenic sequestration); failure of hydroxyurea at maximally tolerated dose for ≥6 months unless contraindicated or clinically intolerant; attestation from a transplant specialist that the member understands risks/benefits of alternative therapies including allogeneic HSCT and that the member is clinically stable and eligible to undergo myeloablative conditioning and HSCT; member has not received prior allogeneic HSCT or prior gene therapy; documentation within the last 6 months that the member is negative for active HIV, hepatitis B, and hepatitis C; no advanced liver disease; no current malignancy or immunodeficiency disorder; documentation of member body weight in kg; dose contains a minimum of 3 x 10^6 CD34+ cells/kg.see child nodes

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

Initial Therapy — Transfusion-Dependent Beta‑Thalassemia

Covered when ALL of the following are met for transfusion-dependent beta-thalassemia (TDT):

TDT initial eligibility: Diagnosis of transfusion-dependent beta-thalassemia with genetic confirmation; age ≥ 12 years; prescribed by or in consultation with a hematologist and transplant specialist; documentation of transfusion dependence defined as either receipt of ≥100 mL/kg (or ~10 units) of packed red blood cells per year for the previous 2 years OR receipt of ≥8 pRBC transfusions per year for the previous 2 years; member understands risks/benefits of alternative therapies including allogeneic HSCT; attestation from a transplant specialist that the member is clinically stable and eligible to undergo myeloablative conditioning and HSCT; absence of specified alpha-globin exclusions (e.g., associated alpha-thalassemia with >1 alpha chain deletion, alpha multiplications) and exclusion of associated sickle cell beta-thalassemia per policy note; member has not received prior allogeneic HSCT or prior gene therapy; documentation within the last 6 months that the member is negative for active HIV, hepatitis B, and hepatitis C; no advanced liver disease; no current malignancy or immunodeficiency disorder; documentation of member body weight in kg; dose contains a minimum of 3 x 10^6 CD34+ cells/kg.see child nodes

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

Initial therapy — SCD and TDT eligibility — key updated criteria

Covered when ALL of the following are met (summary of key updated criteria):

SCD/TDT indication and testing: Genetic confirmation of the appropriate genotype is required; member must be negative for active HIV, hepatitis B, and hepatitis C and have no advanced liver disease, current malignancy, or current immunodeficiency disorder; for SCD, documented definitions of severe VOC and documented failure of hydroxyurea (when applicable) are required; for TDT, documentation of transfusion dependence (≥8 pRBC transfusions per year for the prior two years or ≥100 mL/kg or ~10 units per year for prior two years) is required.

Derived from policy updates aligning to FDA labeling and pivotal trial criteria.

Dosing and weight verification: Minimum recommended dose is 3 x 10^6 CD34+ cells/kg IV; provider must document member body weight in kg to verify weight-based dosing.3 x 10^6 CD34 cells/kg

Approval duration set to 6 months to permit manufacture/preparation.

Pre-treatment safety screening: Required pre-treatment screening includes documentation within the last 6 months that the member is negative for active HIV, hepatitis B, and hepatitis C; confirmation of absence of advanced liver disease, current malignancy, or immunodeficiency disorder.

Requests for indications that are not FDA‑approved and not specifically addressed in this policy are not authorized unless the provider supplies sufficient supporting documentation consistent with the plan's off‑label use policies. See referenced off‑label policies (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53) for required evidence of efficacy and safety; absent that documentation, requests for non‑FDA indications may be denied.

Per the policy update, certain alpha‑globin genotypes are excluded from coverage. Associated alpha‑thalassemia with >1 alpha chain deletion, alpha multiplications, and associated sickle cell beta‑thalassemia were added as exclusions based on specialist input and to align with the product’s labeled and trial populations.

Casgevy is intended as a single‑dose, one‑time autologous gene therapy. Continued therapy will not be authorized; the product is dosed one time only and additional dosing is not covered.

Coverage is conditional on completion and documentation of required pre‑treatment testing and absence of excluded conditions. The policy requires documentation that the member is negative for active HIV, hepatitis B, and hepatitis C and has no advanced liver disease, current malignancy, or current immunodeficiency disorder; failure to provide these negative test results or evidence of exclusion criteria (including the alpha‑thalassemia genotypes noted) may render the member ineligible and result in denial. Additionally, non‑FDA indications lacking required off‑label documentation are not authorized.

Billing and Coding

HCPCS codes referencedHCPCS

J3392	HCPCS code added for this clinical policy (product-specific billing code).
J3590	HCPCS code removed per policy note.
C93991	HCPCS code removed per policy note.

Minimum CD34+ cell dose

Minimum CD34+ cell dose (numeric)3 x 10^6 CD34+ cells/kg body weight (IV)

ContextMinimum recommended dose specified for both SCD and TDT indications; maximum dose not applicable.

Documented requirementProvider must document member body weight to verify weight-based dosing.

Minimum CD34+ cell dose (alternate phrasing)

Minimum CD34+ cell dose (alternate wording)Minimum recommended dose: 3 x 10^6 CD34 cells/kg IV

Applies toBoth sickle cell disease (SCD) and transfusion‑dependent beta‑thalassemia (TDT)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Medical Director Review and Prior Authorization Required

All requests reviewed under this policy require medical director review. Prior authorization (PA) is required before dispensing or administration; provider must submit clinical documentation supporting that the member meets all approval criteria for review.

All requests require medical director review prior to final determination.
PA is required for Casgevy (Exagamglogene Autotemcel); submit complete clinical documentation (office notes, lab results, specialist consults).

Prior Authorization

Prior Authorization and Approval Duration

Initial approval duration is 6 months to allow time for manufacture and preparation of therapy. Approval is for a one-time infusion per lifetime when criteria are met.

Initial approval period: 6 months (to allow for gene therapy manufacture and preparation).
Therapy is a one-time infusion per lifetime if approved.

Definitions and Clinical Terms

VOC — vaso-occlusive crisis

TermVaso-occlusive crisis (VOC)

Definition (policy appendix)VOC listed as abbreviation in policy: vaso-occlusive crisis; used in criteria describing acute painful vaso-occlusive events requiring medical attention.

Usage in criteriaRequired documentation: ≥2 severe VOCs per year during the previous 2 years for SCD eligibility (see severe VOC definition).

ACS — acute chest syndrome

TermAcute chest syndrome (ACS)

Definition (policy appendix)ACS listed as abbreviation in policy: acute chest syndrome.

Relevance

Background

Exagamglogene autotemcel (Casgevy) is an autologous CD34+ hematopoietic stem and progenitor cell‑based gene therapy indicated for patients with sickle cell disease with recurrent vaso‑occlusive crises and for transfusion‑dependent beta‑thalassemia aged ≥12 years. The policy requires genetic confirmation of the appropriate genotype, pre‑treatment infection and comorbidity screening, and verification of weight and cell dose to support manufacturing and safe administration. The minimum recommended cell dose is 3 x 10^6 CD34+ cells/kg administered as a single IV infusion; initial authorization is provided for 6 months to allow time for product manufacture and preparation.

Revision History and Policy Changes

2024-11-18criteria_update

Added requirement to document member body weight for verification of weight‑based dosing and updated dose references for SCD and TDT.

2024-11-06coding_update

HCPCS code J3392 was added and codes J3590 and C93991 were removed for product-specific billing.

2024-03-12criteria_updateLatest

Policy Summary

PayerHealth Net

PolicyExagamglogene autotemcel (Casgevy) — Coverage Criteria

Policy CodePolicy CP PHAR.603

Change TypeCriteria, coding, dosing, and authorization updates

Effective DateDec 8, 2023

Next Review Date

Key ActionSubmit prior authorization with required clinical documentation, confirm genetic genotype and negative HIV/hepatitis testing, document body weight, and request medical director review.

SourceLink

On This Page

Documentation Required

Required Documentation and Review

Provider must submit documentation supporting all approval criteria, including but not limited to chart notes, transplant specialist attestation, and lab/test results. Acceptable documentation includes office chart notes, specialist consult notes, laboratory reports, and imaging or transfusion records as applicable.

Transplant specialist attestation confirming member understands risks/benefits of HSCT and eligibility for myeloablative conditioning.
Genetic confirmation of genotype for SCD or TDT as applicable.
Documentation of prior gene therapy or allogeneic HSCT status.

Documentation Required

Infection Screening and Body Weight Documentation

Documentation from within the last 6 months is required showing the member is negative for active HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV). Provider must also document the member's current body weight in kilograms for verification of the weight‑based minimum CD34+ cell dose.

Negative testing for HIV, HBV, and HCV within 6 months prior to infusion.
Documentation of body weight in kg for dose calculation (minimum 3 x 10^6 CD34+ cells/kg).

Step Therapy

Hydroxyurea Trial Requirement for SCD

For sickle cell disease (SCD) indications, documentation of hydroxyurea treatment failure or intolerance is required prior to approval unless contraindicated. Hydroxyurea should have been tried at the maximally indicated or maximum tolerated dose for at least 6 months unless clinically contraindicated or significant adverse effects occurred.

Documented trial of hydroxyurea up to maximally indicated/maximum tolerated dose for >= 6 months, OR documented contraindication or intolerance.
Myelosuppression from hydroxyurea (dose-dependent and reversible) does not alone qualify as treatment failure without meeting failure criteria per NHLBI guidance.