CurrentViva Health PlanPolicy IC-0744

Casgevy (exagamglogene autotemcel) Coverage Criteria

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Prior authorization and coverage criteria for one treatment course of Casgevy for eligible members with severe symptomatic sickle cell disease or transfusion-dependent beta thalassemia.

Policy Summary

PayerViva Health Plan

PolicyCasgevy (exagamglogene autotemcel) Coverage Criteria

Policy CodePolicy IC-0744

Change TypeNo material change

Effective DateN/A

Last ReviewAug 4, 2026

Next Review DateN/A

Key ActionSubmit supporting clinical documentation with every prior authorization request for the one-dose Casgevy treatment course.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 doseAuthorization course

1Maximum billable units

≥2 yearsMinimum age

≥12 kgMinimum weight

J3392HCPCS code

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CurrentViva Health PlanPolicy IC-0744

Casgevy (exagamglogene autotemcel) Coverage Criteria

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Sign up for vivahealthplan Policy IC-0744 alerts

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Prior authorization and coverage criteria for one treatment course of Casgevy for eligible members with severe symptomatic sickle cell disease or transfusion-dependent beta thalassemia.

Policy Summary

PayerViva Health Plan

PolicyCasgevy (exagamglogene autotemcel) Coverage Criteria

Policy CodePolicy IC-0744

Change TypeNo material change

Effective DateN/A

Last ReviewAug 4, 2026

Next Review DateN/A

Key ActionSubmit supporting clinical documentation with every prior authorization request for the one-dose Casgevy treatment course.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 doseAuthorization course

1Maximum billable units

≥2 yearsMinimum age

≥12 kgMinimum weight

J3392HCPCS code

44Covered diagnosis codes

Coverage Criteria

General initial approval criteria

Covered when all general initial-approval requirements and supporting documentation requirements are met.

General initial approval

Required clinical documentation: Supporting medical records, chart notes, laboratory results, confirmatory diagnostics, diagnosis documentation, step-therapy history, and applicable genetic or mutational testing are submitted to establish medical necessity.
Documentation may be submitted by direct upload through the prior authorization web portal or by fax.
Age and treatment preparation: The member is at least 2 years of age, and the provider has considered seizure prophylaxis with an agent other than phenytoin before myeloablative conditioning.Age ≥2 years
Infection screening: Before leukapheresis, the member has been screened and found negative for hepatitis B virus, hepatitis C virus, and HIV-1/HIV-2 in accordance with clinical guidelines.
Vaccination and hypersensitivity: The provider confirms that the member will not receive live vaccines concurrently while immunosuppressed, and the member has no history of hypersensitivity to dimethyl sulfoxide or dextran 40.
Prior gene therapy: The member has not received another gene therapy for sickle cell disease or beta thalassemia.
Subsequent exagamglogene autotemcel use after another applicable gene therapy may be evaluated case by case.
Required medication interruptions: Iron chelators are withheld for at least 7 days before myeloablative conditioning and for the required post-treatment interval; disease-modifying agents such as hydroxyurea or crizanlizumab are withheld for at least 8 weeks before mobilization and conditioning.Iron chelators: ≥7 days before conditioning; 6 months after treatment for myelosuppressive chelators or 3 months for non-myelosuppressive chelators. Disease-modifying agents: ≥8 weeks before mobilization and conditioning
Transplant candidacy: The member is a candidate for autologous hematopoietic stem-cell transplant and has not had a prior hematopoietic stem-cell transplant.
Allogeneic donor consideration: For a member younger than 18 years, there is no known and available suitable 10/10 HLA-matched related donor willing to participate in allogeneic hematopoietic stem-cell transplant.

Initial therapy: sickle cell disease

For sickle cell disease, all diagnosis, treatment-history, transfusion, mobilization, and severity requirements must be met.

Sickle cell disease

Diagnosis and genotype: The member has confirmed sickle cell disease with genotype βS/βS, βS/β0, or βS/β+, established by hemoglobin assay showing significant quantities of HbS or by molecular genetic testing showing biallelic pathogenic HBB variants with at least one p.Glu6Val variant.
Additional genotypes may be considered case by case based on disease severity.
Mobilization eligibility: The member weighs at least 12 kg before the start of mobilization.Weight ≥12 kg
Prior treatment or transfusion history: The member has uncontrolled disease despite hydroxyurea or crizanlizumab at any point in the past, has experienced intolerance to such treatment, or has required repeat transfusions to treat symptomatic disease or reduce the risk of stroke.

Initial therapy: beta thalassemia

For beta thalassemia, all diagnosis, transfusion, and organ-function requirements must be met.

Beta thalassemia

Diagnosis: The member has documented homozygous beta thalassemia or compound heterozygous beta thalassemia, including β-thalassemia/hemoglobin E, confirmed by HBB sequence analysis showing biallelic pathogenic variants or by qualifying clinical and hemoglobin findings: severe microcytic hypochromic anemia without iron deficiency, anisopoikilocytosis with nucleated red blood cells, and hemoglobin analysis showing decreased or absent HbA with increased HbA2, with or without increased HbF.
Transfusion dependence: The member has transfusion-dependent disease, defined by a history of transfusions of at least 100 mL/kg/year or at least 10 units per year of packed red blood cells during the 2 years preceding therapy.≥100 mL/kg/year or ≥10 units/year of pRBCs in the 2 years preceding therapy
Preconditioning transfusion: The member will be transfused before apheresis to a total hemoglobin of at least 11 g/dL for 60 days before myeloablative conditioning.

Renewal criteria

Renewal is not available.

Renewal limitation: Prior authorization may not be renewed after the single authorized treatment course.One treatment course consisting of one dose

Continuation or renewal authorization is not available.

For initial authorization, the member must have no history of hypersensitivity to dimethyl sulfoxide (DMSO) or dextran 40, must be a candidate for autologous hematopoietic stem-cell transplantation, and must have no prior HSCT. Live vaccines must not be administered concurrently while the member is immunosuppressed. The member also must not have received another gene therapy for sickle cell disease or beta thalassemia, except that subsequent exagamglogene autotemcel use may be reviewed case by case. Required medication interruptions must also be observed, including withholding iron chelators for at least 7 days before myeloablative conditioning and disease-modifying agents such as hydroxyurea or crizanlizumab for at least 8 weeks before mobilization and conditioning.

For beta thalassemia, coverage requires acceptable cardiac and hepatic status. Treatment is excluded when there is severe cardiac iron overload, defined as cardiac T2* less than 10 msec by MRI or LVEF less than 45% by echocardiogram. Coverage is also excluded for advanced liver disease, defined as AST or ALT greater than 3 times the ULN, direct bilirubin greater than 2.5 times the ULN, or liver biopsy showing bridging fibrosis or cirrhosis.

Billing and Coding

Covered HCPCS CodesHCPCSCovered

J3392

Injection, exagamglogene autotemcel, per treatment; 1 billable unit = 1 treatment

Covered NDC CodesNDCCovered

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)

Covered Diagnosis CodesICD-10Covered

D56.1	Beta thalassemia
D56.5	Hemoglobin E-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

1–10 of 21

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Covered Diagnosis CodesICD-10Covered

D56.1	Beta thalassemia
D56.5	Hemoglobin E-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

1–10 of 44

1/5

Casgevy dosing limit

Treatment courseOne dose of Casgevy

Maximum quantity1 billable unit

Unit basisPer dose

Minimum age

Minimum ageAt least 2 years

RequirementMember must be at least 2 years of age

Authorization context

Authorization and Provider Requirements

Prior Authorization

One-Course Prior Authorization

Prior authorization is required for Casgevy and, if approved, is valid for one treatment course consisting of one dose. Submit the request with the required clinical documentation before treatment.

Initial authorization is limited to one treatment course (1 dose).

Denial Risk

No Renewal

Authorization may not be renewed after the initial treatment course. Do not submit a renewal request for additional Casgevy treatment.

Casgevy authorization is not renewable.

Therapy Background

Casgevy (exagamglogene autotemcel) is an autologous gene-editing therapy in which the member’s hematopoietic stem cells are collected and treated before being returned. It is administered as a single intravenous treatment after stem-cell collection and myeloablative conditioning. This policy addresses its use for severe symptomatic sickle cell disease and transfusion-dependent beta thalassemia, with disease-specific requirements for diagnosis, prior therapy, transfusion management, mobilization, and organ function. Authorization covers one treatment course consisting of one dose.

Clinical Definitions

Vaso-occlusive event/crisis (VOE/VOC)

Encounter requirementVisit to a medical facility for evaluation

Documentation requirementA diagnosis of the event must be documented

Qualifying causesAcute pain, acute chest syndrome, acute splenic sequestration, acute hepatic sequestration, or priapism lasting >2 hours requiring subsequent intervention

Overt stroke

Neurologic changeSudden neurologic change lasting more than 24 hours

Imaging requirementAccompanied by cerebral MRI changes

Definition

Initial Casgevy Authorization

Initial Casgevy authorization

Initial therapy is authorized for one treatment course when all general criteria and the applicable disease-specific criteria are satisfied.

Initial Casgevy treatment

General requirements: The member meets all general initial approval requirements, including age, infection screening, transplant candidacy, medication interruptions, vaccination, hypersensitivity, prior gene-therapy, and documentation requirements.
ONE covered indication
- Severe symptomatic sickle cell disease: The member meets all applicable sickle cell disease criteria, including eligible genotype or confirmatory testing, minimum weight, qualifying treatment history or transfusion history, transfusion targets, mobilization requirements, and a qualifying severe symptomatic complication.Weight ≥12 kg; pre-apheresis total Hb ≤11 g/dL and HbS <30%; at least one qualifying severity complication

Continuation and Renewal

No renewal

No continuation or renewal authorization is available.

No renewal: Prior authorization validity may not be renewed after the single authorized treatment course.One treatment course; one dose

Renewal duration cannot be extended.

Treatment Sequence and Medication Holds

Step	Requirement	Duration	Applicable treatment history
1	For sickle cell disease, document prior hydroxyurea or crizanlizumab treatment history as applicable.	At any point in the past	Uncontrolled disease despite hydroxyurea or crizanlizumab, intolerance to treatment, or repeat transfusions required for symptomatic disease or stroke-risk reduction.

Step	Requirement	Duration	Applicable medication
2	Withhold disease-modifying agents such as hydroxyurea or crizanlizumab.	At least 8 weeks before mobilization and conditioning	Disease-modifying agents must be discontinued before treatment.

Step	Requirement	Duration	Applicable medication
3	Withhold iron chelators during the required pre- and post-treatment periods.	At least 7 days before myeloablative conditioning; after treatment, 6 months for myelosuppressive chelators or 3 months for non-myelosuppressive chelators	Iron chelators must be discontinued for the specified interval.

Casgevy Quantity Limit

Casgevy quantity limit

Treatment courseOne treatment course

DoseOne dose

Maximum quantity1 billable unit

Policy Summary

PayerViva Health Plan

PolicyCasgevy (exagamglogene autotemcel) Coverage Criteria

Policy CodePolicy IC-0744

Change TypeNo material change

Effective DateN/A

Last ReviewAug 4, 2026

Next Review DateN/A

Key ActionSubmit supporting clinical documentation with every prior authorization request for the one-dose Casgevy treatment course.

SourceLink

On This Page

A crizanlizumab trial is not applicable to members younger than 16 years.

Transfusion targets: The member will be transfused before apheresis to a total hemoglobin of ≤11 g/dL and HbS level of <30%, and will be transfused at least 8 weeks before initiation of myeloablative conditioning with the same hemoglobin and HbS goals.Pre-apheresis and preconditioning total Hb ≤11 g/dL and HbS <30%; preconditioning transfusion begins at least 8 weeks before conditioning

Stem-cell mobilization: The member will not receive granulocyte-colony stimulating factor for mobilization of hematopoietic stem cells.

Severe symptomatic disease

ONE or more qualifying complications
- Echocardiography shows a tricuspid regurgitant jet velocity greater than 2.5 m/s.TRJV >2.5 m/s
- The member has had or has a history of an overt stroke.
  An overt stroke is a sudden neurologic change lasting more than 24 hours accompanied by cerebral MRI changes.
- The member has experienced an acute chest syndrome episode within the previous 2 years.
  The episode includes pneumonia-like symptoms and a new pulmonary infiltrate.
- The member experienced at least 2 vaso-occlusive events or crises in the previous year.≥2 VOE/VOC in the previous year
  The event must require a medical-facility visit and documented diagnosis related to acute pain, acute chest syndrome, acute splenic or hepatic sequestration, or priapism lasting more than 2 hours requiring subsequent intervention.

Total Hb ≥11 g/dL for 60 days before conditioning

Cardiac and hepatic status: The member does not have severe cardiac iron overload or advanced liver disease.

Severe cardiac iron overload is cardiac T2* <10 msec by MRI or LVEF <45% by echocardiogram. Advanced liver disease is AST or ALT >3 times ULN, direct bilirubin >2.5 times ULN, or bridging fibrosis or cirrhosis on liver biopsy.

General initial approval criterion

Minimum weight before mobilization

Minimum weightAt least 12 kg

TimingBefore the start of mobilization

Applicable conditionSickle cell disease

Sickle cell transfusion before apheresis

Total hemoglobin≤11 g/dL

HbS level<30%

TimingBefore apheresis

Sickle cell transfusion before conditioning

TimingAt least 8 weeks before myeloablative conditioning

Total hemoglobin≤11 g/dL

HbS level<30%

Tricuspid regurgitant jet velocity

Required threshold>2.5 m/s

MeasurementEchocardiographic tricuspid regurgitant jet velocity

Clinical contextQualifying severe, symptomatic sickle cell disease despite supportive care

Sickle cell vaso-occlusive events

Required number of eventsAt least 2 vaso-occlusive events or crises

Lookback periodPrevious year

AbbreviationVOE/VOC

Beta thalassemia transfusion dependence

Annual transfusion volumeAt least 100 mL/kg/year of packed red blood cells

Alternative annual threshold≥10 units/year of packed red blood cells

Lookback period2 years preceding therapy

Beta thalassemia preconditioning transfusion

Total hemoglobin≥11 g/dL

DurationFor 60 days

TimingBefore myeloablative conditioning

Cardiac iron exclusion

Cardiac MRI exclusion thresholdCardiac T2* <10 msec

Echocardiographic exclusion thresholdLVEF <45%

ExclusionSevere cardiac iron overload

Advanced liver disease exclusion

Liver enzyme criterionAST or ALT >3 times the upper limit of normal (ULN)

Bilirubin criterionDirect bilirubin >2.5 times the ULN

Biopsy criterionBridging fibrosis or cirrhosis

Billing Rule

Follow Medicare Part B Policies

For Medicare members, follow applicable Medicare Part B coverage policies in addition to this policy. Review the Medicare Benefit Policy Manual, Chapter 15, §50, and any applicable NCDs, LCDs, and LCAs before submitting or processing the request.

Medicare Part B coverage for outpatient drugs is governed by applicable CMS manuals and coverage determinations.
Search applicable NCD, LCD, and LCA documents in the CMS Medicare Coverage Database: https://www.cms.gov/medicare-coverage-database/search.aspx.

Unsupported block type: step_therapy‎

Unsupported block type: step_therapy

Unsupported block type: documentation

Unsupported block type: denial_risk

Denial Risk

General Eligibility Not Met

Authorization may be denied when any general eligibility requirement is not met. Confirm and document all applicable requirements before submission.

Member is at least 2 years of age.
Member has negative HBV, HCV, and HIV-1/HIV-2 screening before leukapheresis.
Provider confirms no live vaccines will be administered concurrently while the member is immunosuppressed.
Member has no hypersensitivity to dimethyl sulfoxide or dextran 40.
Member has not received another sickle cell disease or beta thalassemia gene therapy, subject to case-by-case review of subsequent use.
Member will not receive prohibited concomitant iron chelators or disease-modifying agents during the required interruption periods.
Member is a candidate for autologous HSCT and has not had a prior HSCT.
For members younger than 18 years, no suitable available 10/10 HLA-matched related donor is willing to participate in allogeneic HSCT.

Denial Risk

Sickle Cell Disease Criteria Not Met

For sickle cell disease, denial may result when the required diagnosis, weight, treatment history, transfusion preparation, mobilization, or severity criteria are not documented or are not met.

Confirmed sickle cell disease must have genotype βS/βS, βS/β0, or βS/β+; additional genotypes may be considered case by case based on severity, with HbS or biallelic HBB molecular confirmation.
Member must weigh at least 12 kg before mobilization.
Document uncontrolled disease despite hydroxyurea or crizanlizumab, applicable intolerance, or repeat transfusions for symptomatic disease or stroke-risk reduction.
Before apheresis, transfuse to total hemoglobin ≤11 g/dL and HbS <30%; repeat transfusion at least 8 weeks before myeloablative conditioning with the same goals.
Do not use G-CSF for HSC mobilization.
Document severe symptomatic disease despite supportive care, including qualifying TRJV >2.5 m/s, prior overt stroke, acute chest syndrome within 2 years, or at least 2 VOE/VOC events in the prior year.

Denial Risk

Beta Thalassemia Criteria Not Met

For beta thalassemia, denial may result when diagnosis, transfusion dependence, pre-conditioning transfusion, or organ-function requirements are not documented or are not met.

Document homozygous or compound heterozygous beta thalassemia, including beta-thalassemia/HbE, by biallelic pathogenic HBB variants or qualifying hematologic and hemoglobin findings.
Document transfusion-dependent disease: at least 100 mL/kg/year or at least 10 units of pRBCs annually during the 2 years before therapy.
Document transfusion to total hemoglobin ≥11 g/dL for 60 days before myeloablative conditioning.
Member must not have cardiac T2* <10 msec, LVEF <45%, AST or ALT >3 times ULN, direct bilirubin >2.5 times ULN, bridging fibrosis, or cirrhosis.

Unsupported block type: denial_risk

Acute chest syndrome episode

Clinical presentationAcute event with pneumonia-like symptoms

Imaging findingNew pulmonary infiltrate

Lookback periodPrevious 2 years

Transfusion-dependent disease

Annual transfusion volumeAt least 100 mL/kg/year

Alternative annual thresholdAt least 10 units/year of packed red blood cells

Lookback period2 years preceding therapy

Transfusion-dependent beta thalassemia: The member meets all applicable beta thalassemia criteria, including confirmed homozygous or compound heterozygous disease, transfusion dependence, preconditioning transfusion requirements, and acceptable cardiac and hepatic status.≥100 mL/kg/year or ≥10 units/year of pRBCs; total Hb ≥11 g/dL for 60 days before conditioning