CurrentNew Hampshire Department of Health and Human ServicesPolicy N/A

Casgevy (exagamglogene autotemcel) Criteria

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This policy governs New Hampshire Medicaid Fee-for-Service coverage and authorization of Casgevy for patients aged 12 years and older with sickle cell disease and recurrent vaso-occlusive crises or transfusion-dependent beta-thalassemia. Coverage requires fulfillment of all applicable general and disease-specific clinical criteria.

Policy Summary

PayerNew Hampshire Department of Health and Human Services

PolicyCasgevy (exagamglogene autotemcel) Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 12, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing that all applicable general and disease-specific SCD or TDT criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12+ yearsMinimum patient age

2+SCD vaso-occlusive events in prior year

100 mL/kg/year or 10 units/yearTDT transfusion threshold

HbS <30%; Hb ≤11SCD pre-apheresis targets

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CurrentNew Hampshire Department of Health and Human ServicesPolicy N/A

Casgevy (exagamglogene autotemcel) Criteria

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Sign up for all New Hampshire Department of Health and Human Services policy alerts

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Policy Summary

PayerNew Hampshire Department of Health and Human Services

PolicyCasgevy (exagamglogene autotemcel) Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 12, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing that all applicable general and disease-specific SCD or TDT criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12+ yearsMinimum patient age

2+SCD vaso-occlusive events in prior year

100 mL/kg/year or 10 units/yearTDT transfusion threshold

HbS <30%; Hb ≤11SCD pre-apheresis targets

Denied if criteria unmetCoverage determination

Coverage Criteria

All indications

Covered when ALL of the following general criteria are met.

General criteria

Eligibility and safety requirements: The patient is at least 12 years of age; the provider has considered seizure-prophylaxis therapy before myeloablative conditioning; the patient screened negative for HBV, HCV, HIV-1, and HIV-2 in accordance with clinical guidelines before leukapheresis; the patient has no history of hypersensitivity to dimethyl sulfoxide (DMSO) or dextran 40; the patient has not received another gene therapy; the patient will observe the required restrictions on iron chelators and disease-modifying agents; the patient is a candidate for autologous hematopoietic stem cell transplant (HSCT) and has not had a prior HSCT; the patient does not have a willing 10/10 HLA-matched related donor for allogeneic HSCT; and Casgevy will not be administered concurrently with live vaccines while the patient is immunosuppressed.Age ≥12; negative HBV/HCV/HIV-1/HIV-2 screening; iron-chelator and disease-modifying-agent washout periods as specified by the policy

Sickle cell disease

Covered for sickle cell disease when ALL of the following criteria are met. Either diagnostic pathway satisfies the diagnostic-confirmation requirement.

SCD criteria

SCD diagnostic confirmation
- Hemoglobin assay pathway: Hemoglobin assay identifies significant quantities of HbS, with or without an additional abnormal β-globin chain variant.
- Molecular genetic testing pathway: Molecular genetic testing identifies biallelic HBB pathogenic variants, with at least one allele being the p.Glu6Val pathogenic variant.
Disease and treatment history: The patient has a confirmed diagnosis of sickle cell disease, has symptomatic disease despite treatment with hydroxyurea or add-on therapy such as crizanlizumab, and experienced at least 2 vaso-occlusive events or crises (VOE/VOC) in the previous year while adhering to that therapy.≥2 VOE/VOC events in the previous year while adherent to therapy
Transfusion requirements:

Coverage requires that the patient have no history of hypersensitivity to dimethyl sulfoxide (DMSO) or dextran 40, have received no other gene therapy, and have had no prior hematopoietic stem cell transplant (HSCT). The patient must be an autologous HSCT candidate and must not have a willing 10/10 HLA-matched related donor for allogeneic HSCT. The policy also requires the specified medication washout periods and prohibits concurrent live-vaccine administration while the patient is immunosuppressed.

For sickle cell disease, granulocyte-colony stimulating factor (G-CSF) must not be used to mobilize hematopoietic stem cells.

For transfusion-dependent beta-thalassemia, coverage is excluded when severe cardiac iron overload or cardiac dysfunction is present, including cardiac T2* less than 10 msec by MRI or LVEF less than 45% by echocardiogram. Coverage is also excluded for advanced liver disease, including AST or ALT more than 3 times the ULN, direct bilirubin more than 2.5 times the ULN, or bridging fibrosis or cirrhosis demonstrated by liver biopsy.

Clinical Thresholds and Exclusions

SCD recurrent VOC/VOE history

Required historyAt least 2 vaso-occlusive events or crises (VOE/VOC) in the previous year

Treatment statusEvents must occur while the patient is adhering to hydroxyurea or add-on therapy

Applicable conditionSymptomatic sickle cell disease despite hydroxyurea or add-on therapy

SCD pre-apheresis transfusion targets

Total hemoglobin≤11 g/dL before apheresis

HbS level<30% before apheresis

Conditioning interval

Authorization and Documentation Requirements

Prior Authorization

All Applicable Criteria Required

Prior authorization requires that all applicable general and indication-specific criteria be met. Casgevy must be administered in accordance with the requirements in this policy.

Documentation Required

General Clinical Documentation

Submit clinical documentation supporting general eligibility and treatment planning before cell collection and myeloablative conditioning.

Patient is 12 years of age or older.
Provider has considered seizure prophylaxis before initiating myeloablative conditioning.
Patient screened negative for HBV, HCV, and HIV-1/HIV-2 in accordance with clinical guidelines before leukapheresis.
Document that the patient is a candidate for autologous HSCT, has not had prior HSCT, and will not receive Casgevy concurrently with live vaccines while immunosuppressed.

Therapy Overview

Casgevy (exagamglogene autotemcel) is an autologous gene therapy for eligible patients aged 12 years and older with sickle cell disease and recurrent vaso-occlusive events or crises, or with transfusion-dependent beta-thalassemia. Treatment includes hematopoietic stem cell collection, myeloablative conditioning, and reinfusion of the patient’s genetically modified autologous cells. Coverage requires confirmation of the applicable disease and completion of the policy’s treatment-history, transfusion, safety, and treatment-exclusion requirements.

Policy Definitions

VOE/VOC definition

Evaluation requirementThe event requires a visit to a medical facility for evaluation

Documentation requirementThe visit results in a documented diagnosis of the event

Qualifying manifestationsAcute pain, acute chest syndrome, acute splenic sequestration, acute hepatic sequestration, or priapism lasting more than 2 hours

Subsequent interventionFor qualifying priapism, subsequent interventions may include opioid pain management, nonsteroidal anti-inflammatory drugs, or red blood cell transfusion

Transfusion-dependent beta-thalassemia definition

Packed red blood cell volumeTransfusions totaling 100 mL/kg/year or more

Initial Authorization

Initial authorization

Initial authorization is covered when all applicable general and disease-specific criteria are met.

Initial Casgevy therapy: The patient meets the general Casgevy criteria and either the sickle cell disease criteria or the transfusion-dependent beta-thalassemia criteria, including the required diagnostic confirmation, treatment history or transfusion dependence, transfusion targets, safety evaluation, and treatment exclusions.Age ≥12

The policy provides initial-authorization criteria and does not state a separate continuation regimen.

Required Prior Therapy

Step	Required prior treatment	Coverage requirement	Timing
1	Hydroxyurea or add-on therapy, such as crizanlizumab; disease-modifying agents listed by the policy also include voxelotor.	Symptomatic sickle cell disease despite therapy, with at least 2 vaso-occlusive events/crises in the preceding year while adherent to treatment.	Stop disease-modifying agents at least 8 weeks before hematopoietic stem-cell mobilization and myeloablative conditioning.

Policy Summary

PayerNew Hampshire Department of Health and Human Services

PolicyCasgevy (exagamglogene autotemcel) Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 12, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing that all applicable general and disease-specific SCD or TDT criteria are met.

SourceLink

On This Page

The patient will be transfused before apheresis to a total hemoglobin of ≤11 g/dL and an HbS level of <30%, and will be transfused at least 8 weeks before initiation of myeloablative conditioning with those hemoglobin and HbS goals.

Total Hb ≤11 g/dL; HbS <30%; transfusion at least 8 weeks before conditioning

Stem-cell mobilization: The patient will not receive granulocyte-colony stimulating factor (G-CSF) for mobilization of hematopoietic stem cells.

Transfusion must occur at least 8 weeks before initiation of myeloablative conditioning, with the stated hemoglobin and HbS goals

TDT transfusion dependence

Packed red blood cell volume100 mL/kg/year or more

Alternative unit threshold10 units/year or more of packed red blood cells

Lookback periodThe transfusion history must cover the 2 years preceding therapy

TDT preconditioning transfusion

Required total hemoglobin11 g/dL or more

Required durationFor 60 days before myeloablative conditioning

Treatment actionThe patient must be transfused to achieve the stated total hemoglobin level

Severe cardiac iron or cardiac dysfunction exclusion

Cardiac T2* thresholdCardiac T2* less than 10 msec by magnetic resonance imaging indicates severe cardiac iron overload

LVEF thresholdLVEF less than 45% by echocardiogram indicates reduced cardiac function

Coverage conditionThe patient must not have either severe cardiac iron overload or LVEF less than 45%

Advanced liver disease exclusion

AST or ALTMore than 3 times the upper limit of normal (ULN)

Direct bilirubinMore than 2.5 times the ULN

Liver biopsyBridging fibrosis or cirrhosis

Coverage conditionThe patient must not have advanced liver disease meeting any of these laboratory or biopsy criteria

Documentation Required

SCD Documentation

For SCD, submit documentation establishing the diagnosis, disease severity despite therapy, recurrent vaso-occlusive events, and required transfusion and mobilization plans.

Confirmed SCD diagnosis, including βS/βS, βS/β0, or βS/β+, established by hemoglobin assay or qualifying biallelic HBB molecular testing.
Symptomatic disease despite hydroxyurea or add-on therapy, such as crizanlizumab.
At least 2 VOE/VOC episodes in the prior year while adherent to therapy.
Transfusion plan before apheresis to total hemoglobin ≤11 g/dL and HbS <30%, with transfusion at least 8 weeks before myeloablative conditioning using the same goals.
Documentation that G-CSF will not be used for HSC mobilization.

Documentation Required

TDT Documentation

For TDT, submit documentation establishing the qualifying beta-thalassemia diagnosis, transfusion dependence, preconditioning transfusion plan, and cardiac and liver status.

Documented homozygous or compound heterozygous beta-thalassemia, including β-thalassemia/HbE, confirmed by biallelic pathogenic HBB variants or qualifying clinical, laboratory, and hemoglobin-analysis findings.
Transfusion-dependent disease documented by ≥100 mL/kg/year or ≥10 units of pRBCs per year during the 2 years preceding therapy.
Transfusion plan achieving total hemoglobin ≥11 g/dL for 60 days before myeloablative conditioning.
Cardiac evaluation showing no severely elevated cardiac iron, including cardiac T2* ≥10 msec and LVEF ≥45%.
Liver evaluation showing no advanced liver disease, including AST or ALT >3 times ULN, direct bilirubin >2.5 times ULN, bridging fibrosis, or cirrhosis.

Denial Risk

Failure to Meet Approval Criteria

Requests are denied when the applicable general or indication-specific approval criteria are not met.

Approval requires satisfaction of all applicable criteria for the patient’s indication.

Denial Risk

General Eligibility Exclusions

Casgevy is not authorized when any applicable general eligibility exclusion is present.

History of hypersensitivity to DMSO or dextran 40.
Prior treatment with another gene therapy, such as Lyfgenia or Zynteglo.
Concomitant therapy with iron chelators for 7 days or more before myeloablative conditioning or during the applicable post-treatment period: 6 months for myelosuppressive chelators and 3 months for nonmyelosuppressive chelators.
Concomitant disease-modifying agents, including hydroxyurea, voxelotor, or crizanlizumab, for 8 weeks or more before mobilization and conditioning.
Prior HSCT or failure to qualify as a candidate for autologous HSCT.
A known willing 10/10 HLA-matched related donor for allogeneic HSCT.
Concurrent administration with live vaccines while the patient is immunosuppressed.
Patient younger than 12 years of age or positive screening for HBV, HCV, or HIV-1/HIV-2.

Denial Risk

SCD-Specific Criteria Not Met

SCD-specific criteria are not met when the diagnosis, treatment response, event history, transfusion targets, or mobilization requirements are not documented or do not satisfy the policy.

Diagnosis is not confirmed by qualifying hemoglobin assay or molecular genetic testing.
Disease is not symptomatic despite hydroxyurea or add-on therapy, or the patient did not experience at least 2 VOE/VOC events in the preceding year while adherent to therapy.
Required pre-apheresis or preconditioning transfusion targets are not met: total hemoglobin ≤11 g/dL and HbS <30%, including transfusion at least 8 weeks before myeloablative conditioning.
G-CSF is planned or required for HSC mobilization.

Denial Risk

TDT-Specific Criteria Not Met

TDT-specific criteria are not met when the diagnosis, transfusion dependence, preconditioning transfusion plan, or cardiac and liver requirements are not satisfied.

Qualifying homozygous or compound heterozygous beta-thalassemia is not established by genetic or clinical and laboratory findings.
Transfusion dependence is not demonstrated by ≥100 mL/kg/year or ≥10 units of pRBCs per year in each relevant period during the 2 years preceding therapy.
The patient will not achieve total hemoglobin ≥11 g/dL for 60 days before myeloablative conditioning.
Severe cardiac iron, cardiac T2* <10 msec, or LVEF <45% is present.
Advanced liver disease is present, including AST or ALT >3 times ULN, direct bilirubin >2.5 times ULN, bridging fibrosis, or cirrhosis.

Alternative unit threshold10 units/year or more of packed red blood cells

Lookback periodThe transfusion history must cover the 2 years preceding therapy