Currenthusky_healthPolicy N/A

Casgevy (exagamglogene autotemcel) — Beta‑Thalassemia coverage criteria

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Prior authorization and medical necessity criteria for single-dose Casgevy gene therapy in individuals aged 12 and older with transfusion-dependent beta-thalassemia covered by HUSKY Health (Connecticut Medicaid). Applies to providers seeking coverage under CMAP.

Policy Summary

Payerhusky_health

PolicyCasgevy (exagamglogene autotemcel) — Beta‑Thalassemia coverage criteria

Policy CodePolicy N/A

Change TypeMaterial revision — separated Sickle Cell and Beta‑Thalassemia policies

Effective DateFeb 1, 2025

Last ReviewAug 27, 2025

Next Review DateN/A

Key ActionSubmit a completed CT DSS HUSKY Health Casgevy prior authorization form with genetic confirmation of β-thalassemia and a signed provider attestation of transfusion history and HSCT eligibility.

SourceLink

POLICY UPDATE CHANGES

The original Casgevy policy was divided into two separate policies for Sickle Cell Disease and Beta Thalassemia and all language regarding Sickle Cell was removed from this Beta-Thalassemia policy.

≥12minimum age for treatment

≥100 mL/kg or ≥10 unitsRBC transfusion history (2 yrs)

one-time

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Currenthusky_healthPolicy N/A

Casgevy (exagamglogene autotemcel) — Beta‑Thalassemia coverage criteria

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Policy Summary

Payerhusky_health

PolicyCasgevy (exagamglogene autotemcel) — Beta‑Thalassemia coverage criteria

Policy CodePolicy N/A

Change TypeMaterial revision — separated Sickle Cell and Beta‑Thalassemia policies

Effective DateFeb 1, 2025

Last ReviewAug 27, 2025

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

The original Casgevy policy was divided into two separate policies for Sickle Cell Disease and Beta Thalassemia and all language regarding Sickle Cell was removed from this Beta-Thalassemia policy.

≥12minimum age for treatment

≥100 mL/kg or ≥10 unitsRBC transfusion history (2 yrs)

one-time

authorized single-dose

J3392product billing code

12 monthsauthorization duration

Coverage and Medical Necessity Criteria

Medical Necessity Criteria — Initial Therapy

Covered when ALL of the following are met:

Eligibility criteria for Casgevy: A. Age ≥12 years; B. Diagnosis of β-thalassemia confirmed by genetic testing; C. History of ≥100 mL/kg/year or ≥10 units/year RBC transfusions in the previous 2 years; D. Treatment is prescribed by or in consultation with a hematologist; E. Treatment will be administered at an authorized treatment center; F. Individual is eligible for hematopoietic stem-cell transplant (HSCT) as determined by the hematologist; G. No available 10/10 HLA-matched related donor; H. No prior hematopoietic stem-cell transplant; I. No prior Casgevy or other gene therapy; J. Absence of the following exclusions: (a) Advanced liver disease as defined by: (1) ALT >3× ULN or direct bilirubin >2.5× ULN; OR (2) Baseline PT (INR) >1.5× ULN; OR (3) History of cirrhosis or evidence of bridging fibrosis or active hepatitis on liver biopsy; AND (b) Bacterial, viral, fungal or parasitic infection including HIV-1, HIV-2, hepatitis B or hepatitis C; AND (c) Any prior or current malignancy or myeloproliferative disorder or significant immunodeficiency disorder; K. Provider will follow all FDA recommendations for usage, dosage, preparation, administration, monitoring and patient education.

Casgevy (exagamglogene autotemcel) is considered investigational and not medically necessary for all indications other than Sickle Cell Disease and Beta Thalassemia. This policy addresses coverage for Casgevy when used for transfusion-dependent β-thalassemia under HUSKY Health; coverage for other indications is not provided under this policy.

Repeat administration of Casgevy (re-dosing) is not supported by FDA labeling or compendia and is therefore not considered medically necessary. Authorization, when granted, covers a one-time infusion only; subsequent doses are excluded from coverage.

Billing Codes and Transfusion History

Covered HCPCS CodeHCPCSCovered

J3392

Injection, exagamglogene autotemcel, per treatment

Required transfusion history — thresholds (inv-05)

Threshold (by weight)≥100 mL/kg/year of RBC transfusions in the previous 2 years

Threshold (by units)≥10 units/year of RBC transfusions in the previous 2 years

Time windowMeasured over the 2 years prior to authorization

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior authorization required; one-time infusion; 12-month authorization

Prior authorization is required for Casgevy. If approved, authorization covers a one-time, single-dose intravenous infusion of Casgevy and is valid for twelve (12) months.

Step Therapy

Confirm HSCT eligibility and absence of 10/10 matched related donor

Before initiating Casgevy, the provider must confirm the patient is eligible for HSCT as determined by a hematologist and that there is no available 10/10 HLA-matched related donor.

Documentation Required

Required documentation to submit with prior authorization

Key Definitions

Transfusion-dependent β-thalassemia — definition & clinical context (inv-11)

DefinitionTransfusion-dependent β-thalassemia: patients who require regular transfusions due to severe anemia and/or significant complications of extramedullary hematopoiesis.

Clinical significanceThese patients have reduced beta-globin production causing imbalance of alpha to non-alpha globin resulting in ineffective erythropoiesis and need for chronic RBC transfusions.

Age context for therapyCasgevy is indicated for patients aged 12 years and older with transfusion-dependent β-thalassemia.

Casgevy — product definition & indication summary (inv-12)

Product name and genericCasgevy (exagamglogene autotemcel)

Product descriptionSingle-dose autologous CRISPR/Cas9-modified CD34+ hematopoietic stem cell gene therapy

Clinical Background

Beta-thalassemia is an inherited hemoglobinopathy caused by reduced or absent beta-globin production leading to excess unpaired alpha chains, ineffective erythropoiesis, and chronic anemia. Patients with transfusion-dependent β-thalassemia require regular red blood cell transfusions to manage severe anemia and complications such as extramedullary hematopoiesis. Casgevy is an autologous CRISPR/Cas9-modified CD34+ hematopoietic stem cell gene therapy designed to increase fetal hemoglobin (via BCL11A modulation) and reduce transfusion requirements; it is administered as a single-dose, autologous cell infusion at an authorized treatment center with hematology oversight.

Policy Summary

Payerhusky_health

PolicyCasgevy (exagamglogene autotemcel) — Beta‑Thalassemia coverage criteria

Policy CodePolicy N/A

Change TypeMaterial revision — separated Sickle Cell and Beta‑Thalassemia policies

Effective DateFeb 1, 2025

Last ReviewAug 27, 2025

Next Review DateN/A

SourceLink

On This Page

Submit a fully completed CT DSS HUSKY Health Casgevy Prior Authorization Request form including the physician's order and signature, plus supporting clinical documentation: genetic testing confirming β-thalassemia; laboratory data confirming absence of HIV-1/HIV-2/HBV/HCV and advanced liver disease; and a signed provider attestation addressing transfusion history, HSCT eligibility and donor status, prior HSCT/gene therapy, and absence of malignancy or significant immunodeficiency.

State of Connecticut DSS HUSKY Health Casgevy for Beta-Thalassemia Prior Authorization Request form with physician's order and signature
Genetic testing results confirming β-thalassemia
Laboratory data confirming absence of HIV-1, HIV-2, HBV, HCV and advanced liver disease
Signed provider attestation confirming transfusion history (≥100 mL/kg/year or ≥10 units/year in prior 2 years), HSCT eligibility, no available 10/10 HLA-matched related donor, no prior HSCT, no prior gene therapy, and no prior/current malignancy or significant immunodeficiency

Denial Risk

Denial risk if ALL medical necessity criteria are not met

Requests that do not meet ALL listed medical necessity criteria are at risk of denial.

Age < 12 years
No genetic confirmation of β-thalassemia
Insufficient transfusion history (<100 mL/kg/year and <10 units/year in prior 2 years)
Not prescribed by or in consultation with a hematologist
Not administered at an authorized treatment center
Not eligible for HSCT or has an available 10/10 HLA-matched related donor
Prior HSCT or prior Casgevy/other gene therapy
Presence of exclusions (advanced liver disease, HIV/HBV/HCV or other active infections, prior/current malignancy or significant immunodeficiency)

Indication summaryIndicated for treatment of patients aged ≥12 years with transfusion-dependent β-thalassemia to increase γ-globin and fetal hemoglobin, reducing ineffective erythropoiesis and transfusion dependence.

Mechanism (brief)Targets the erythroid-specific enhancer of the BCL11A gene to reduce BCL11A expression and increase γ-globin (HbF) production.