CurrentCountyCarePolicy RX.PA.071.CCH

Zynteglo (betibeglogene autotemcel)

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This policy governs prior authorization and medical-necessity review for Zynteglo in adult and pediatric members with β-thalassemia who require regular red blood cell transfusions. Approval requires specialist prescribing, age, diagnostic, transfusion-dependence, laboratory, imaging, and safety criteria.

Policy Summary

PayerCountyCare

PolicyZynteglo (betibeglogene autotemcel)

Policy CodePolicy RX.PA.071.CCH

Change TypeNo material change

Effective Date08/2024

Next Review DateN/A

Key ActionSubmit documentation confirming specialist involvement, genetically confirmed β-thalassemia, transfusion dependence, and all required screening, imaging, laboratory, and safety criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥4 and <65Initial authorization age range

100 mL/kg/year or ≥8/yearTransfusion dependence

6 monthsAuthorization duration

N/AReauthorization

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CurrentCountyCarePolicy RX.PA.071.CCH

Zynteglo (betibeglogene autotemcel)

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Policy Summary

PayerCountyCare

PolicyZynteglo (betibeglogene autotemcel)

Policy CodePolicy RX.PA.071.CCH

Change TypeNo material change

Effective Date08/2024

Next Review DateN/A

Key ActionSubmit documentation confirming specialist involvement, genetically confirmed β-thalassemia, transfusion dependence, and all required screening, imaging, laboratory, and safety criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥4 and <65Initial authorization age range

100 mL/kg/year or ≥8/yearTransfusion dependence

6 monthsAuthorization duration

N/AReauthorization

≥70 mL/min/1.73 m²

Minimum creatinine clearance

Coverage Criteria

Initial Authorization

Covered when ALL applicable criteria are met.

Initial authorization criteria

Prescriber and age: Zynteglo is prescribed by or in consultation with a hematologist or transplant specialist, and the member is at least 4 years of age and younger than 65 years of age.≥4 and <65 years
Diagnosis and transfusion dependence
- ONE of: At least 100 mL/kg/year of packed red blood cell transfusions.≥100 mL/kg/year within the preceding 2 years
- ONE of: At least 8 packed red blood cell transfusions per year.≥8 transfusions per year within the preceding 2 years
Recent screening and laboratory testing: Laboratory screening, results, or imaging collected within the preceding 3 months include negative HIV-1 and HIV-2 screening, negative hepatitis B and C screening, negative HTLV-1 or HTLV-2 screening, a CBC meeting the stated WBC and platelet thresholds, and baseline creatinine clearance meeting the stated threshold.WBC >3 × 10^9/L; platelets >100 × 10^9; creatinine clearance ≥70 mL/min/1.73m2
CBC results below the WBC or platelet thresholds may be acceptable when attributable to hypersplenism.
Liver, cardiac, and pulmonary assessment: Liver function tests and associated imaging rule out advanced liver disease, including bridging fibrosis, cirrhosis, or active hepatitis; liver MRI has been performed; cardiac MRI shows a T2* greater than 10 ms; and DLCO is greater than 50% predicted.Cardiac T2* >10 ms; DLCO >50% predicted
For members aged 18 years or older with liver iron content ≥15 mg/g on MRI, liver biopsy results are required to rule out advanced liver disease. For members younger than 18 years with liver iron content ≥15 mg/g on MRI, the request is denied.
Required provider attestations and safety criteria: The provider chart note or attestation confirms that the member does not have hemoglobin S/β-thalassemia or α-thalassemia; applicable antiretrovirals and hydroxyurea will be discontinued at least 1 month before mobilization and until completion of all apheresis cycles; applicable iron chelation therapy will be discontinued at least 7 days before conditioning; pregnancy testing is negative at the specified treatment milestones when applicable; and the member has none of the listed bleeding, malignancy, immunodeficiency, familial cancer syndrome, seizure, infection, prior gene therapy, or prior hematopoietic stem cell transplant exclusions.
Pregnancy testing applies to members of child-bearing age and must be confirmed before mobilization, before conditioning procedures, and before Zynteglo administration.

For members younger than 18 years, coverage is denied when liver MRI demonstrates liver iron content of ≥15 mg/g.

Coverage is not supported for members with hemoglobin S/β-thalassemia or α-thalassemia.

Coverage is not supported when the member has an uncontrolled bleeding disorder, uncontrolled seizure disorder, or a clinically significant, active bacterial, viral, fungal, or parasitic infection.

Coverage is not supported when the member has any prior or current malignancy, a myeloproliferative disorder, or a significant immunodeficiency disorder, or when an immediate family member has a known familial cancer syndrome.

Product Coding and Clinical Thresholds

Brand: ZyntegloHCPCSCovered

J3393

Injection, betibeglogene autotemcel, per treatment

Packed RBC transfusion volume

Minimum volumeAt least 100 mL/kg/year of packed red blood cell transfusions

Look-back periodWithin the preceding 2 years

Transfusion-dependence pathwayThis is one of two alternative criteria for demonstrating transfusion dependence

Packed RBC transfusion frequency

Minimum frequencyAt least 8 packed red blood cell transfusions per year

Look-back periodWithin the preceding 2 years

Transfusion-dependence pathway

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Zynteglo (betibeglogene autotemcel). CountyCare reviews requests using FDA criteria to determine Medical Necessity, with approval by the Medical Policy Committee.

Documentation Required

Diagnosis and Transfusion History

Submit documentation showing specialist involvement, the member’s age and genetically confirmed β-thalassemia diagnosis, and transfusion dependence within the 2 years preceding the request.

Prescriber must be, or consult with, a hematologist or transplant specialist.
Member must be ≥4 years and <65 years of age.
Provide genetic confirmation of β-thalassemia.
Document transfusion dependence with either ≥100 mL/kg/year of pRBCs or ≥8 pRBC transfusions per year within the preceding 2 years.

Therapy Overview

Zynteglo (betibeglogene autotemcel) is a gene therapy for adult and pediatric patients with β-thalassemia who require regular red blood cell transfusions. Eligibility is determined through review of transfusion history, genetic confirmation, organ function and iron overload, infection screening, and specified safety exclusions.

Policy Definitions

Transfusion dependent

DefinitionA patient with a history within the preceding 2 years of receiving packed red blood cell transfusions meeting at least one listed threshold

Volume criterionAt least 100 mL/kg/year of packed red blood cell transfusions

Frequency criterionAt least 8 packed red blood cell transfusions per year

CBC threshold

White blood cell threshold>3 × 10^9/L

Platelet threshold>100 × 10^9

ExceptionLower CBC results can be acceptable if attributable to hypersplenism

Initial Therapy

Initial Therapy Criteria

Initial authorization requires ALL applicable criteria to be met.

Initial therapy criteria

Prescriber and age: Zynteglo is prescribed by or in consultation with a hematologist or transplant specialist, and the member is at least 4 years of age and younger than 65 years of age.≥4 and <65 years
Genetically confirmed β-thalassemia: The member has β-thalassemia confirmed by genetic testing.
ONE transfusion-dependence criterion
- Transfusion volume:

Continuation and Reauthorization

Authorization Duration

Zynteglo (betibeglogene autotemcel)

Initial authorization duration6 months

ReauthorizationNot applicable

Authorization basisZynteglo (betibeglogene autotemcel) is authorized for the initial treatment course

Policy Summary

PayerCountyCare

PolicyZynteglo (betibeglogene autotemcel)

Policy CodePolicy RX.PA.071.CCH

Change TypeNo material change

Effective Date08/2024

Next Review DateN/A

Key ActionSubmit documentation confirming specialist involvement, genetically confirmed β-thalassemia, transfusion dependence, and all required screening, imaging, laboratory, and safety criteria.

SourceLink

On This Page

This is one of two alternative criteria for demonstrating transfusion dependence

White blood cell count

Minimum WBC count>3 × 10^9/L

Testing requirementComplete blood count collected within the preceding 3 months

ExceptionA lower result may be acceptable when attributable to hypersplenism

Platelet count

Minimum platelet count>100 × 10^9

Testing requirementComplete blood count collected within the preceding 3 months

ExceptionA lower result may be acceptable when attributable to hypersplenism

Baseline creatinine clearance

Minimum creatinine clearance≥70 mL/min/1.73m2

Testing requirementBaseline result collected within the preceding 3 months

Clinical useRequired as part of the baseline laboratory screening

Liver iron content

MRI threshold≥15 mg/g liver iron content

Members aged 18 years or olderLiver biopsy results are required to rule out advanced liver disease when the MRI threshold is met

Members younger than 18 yearsA liver MRI result meeting the threshold results in denial

Cardiac MRI T2*

Required cardiac MRI resultCardiac T2* >10 ms

Test typeMRI scan of the heart

TimingImaging documentation must be collected within the preceding 3 months

Diffusing capacity of carbon monoxide

Required DLCO result>50% predicted

TestDiffusing capacity of carbon monoxide (DLCO)

TimingTesting documentation must be collected within the preceding 3 months

Documentation Required

Recent Laboratory and Imaging Results

Submit all required screening, laboratory, and imaging results collected within the 3 months preceding the request. Include documentation addressing infectious screening, blood counts, renal function, liver disease, iron burden, cardiac status, and pulmonary function.

Negative HIV-1/HIV-2, hepatitis B/C, and HTLV-1/2 screening.
CBC with WBC count >3×10⁹/L and platelet count >100×10⁹; lower results may be accepted when attributable to hypersplenism.
Baseline creatinine clearance ≥70 mL/min/1.73m².
Liver function tests and associated imaging ruling out advanced liver disease, including bridging fibrosis, cirrhosis, or active hepatitis.
Liver MRI; for members ≥18 years with liver iron content ≥15 mg/g, submit liver biopsy results ruling out advanced liver disease.
Heart MRI showing cardiac T2* >10 ms and DLCO >50% predicted.

Documentation Required

Provider Attestation and Safety Review

Provide chart-note documentation or a provider attestation confirming that all required exclusions, medication changes, pregnancy testing, and safety conditions have been reviewed and addressed before treatment.

Member does not have hemoglobin S/β-thalassemia or α-thalassemia.
If applicable, antiretrovirals and hydroxyurea will be stopped at least 1 month before mobilization through completion of all apheresis cycles; iron chelation therapy will be stopped at least 7 days before conditioning.
For members of child-bearing potential, document negative serum pregnancy testing before mobilization, again before conditioning, and before ZYNTEGLO administration.
Confirm absence of uncontrolled bleeding or seizure disorders, prior/current malignancy, myeloproliferative or significant immunodeficiency disorders, an immediate family history of known familial cancer syndrome, and clinically significant active infection.
Confirm no prior gene therapy or hematopoietic stem cell transplant.

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History of receiving at least 100 mL/kg/year of packed red blood cell transfusions.

≥100 mL/kg/year within the preceding 2 years

Transfusion frequency: History of receiving at least 8 packed red blood cell transfusions per year.≥8 transfusions per year within the preceding 2 years

Recent screening and laboratory testing: Within the preceding 3 months, documentation includes negative HIV-1 and HIV-2 screening, negative hepatitis B and C screening, negative HTLV-1 or HTLV-2 screening, CBC meeting the stated WBC and platelet thresholds, and baseline creatinine clearance of at least 70 mL/min/1.73m2.WBC >3 × 10^9/L; platelets >100 × 10^9; creatinine clearance ≥70 mL/min/1.73m2

CBC values below threshold may be acceptable when attributable to hypersplenism.

Liver, cardiac, and pulmonary assessment: Liver function tests and associated imaging rule out advanced liver disease, including bridging fibrosis, cirrhosis, or active hepatitis; liver MRI has been performed; cardiac MRI shows a T2* greater than 10 ms; and DLCO is greater than 50% predicted.Cardiac T2* >10 ms; DLCO >50% predicted

For members aged 18 years or older with liver iron content ≥15 mg/g on MRI, liver biopsy results are required to rule out advanced liver disease. For members younger than 18 years with liver iron content ≥15 mg/g on MRI, the request is denied.

Required provider attestations and exclusions: The provider attestation confirms that the member does not have hemoglobin S/β-thalassemia or α-thalassemia; applicable antiretrovirals and hydroxyurea will be discontinued at least 1 month before mobilization and until all apheresis cycles are complete; applicable iron chelation therapy will be discontinued at least 7 days before conditioning; applicable pregnancy testing is negative; and the member has no uncontrolled bleeding disorder, malignancy, myeloproliferative or significant immunodeficiency disorder, immediate family history of a known familial cancer syndrome, uncontrolled seizure disorder, clinically significant active infection, prior gene therapy, or prior hematopoietic stem cell transplant.

Pregnancy testing applies to members of child-bearing age and is required before mobilization, before conditioning procedures, and before Zynteglo administration.