CurrentNew Hampshire Department of Health and Human ServicesPolicy N/A

Zynteglo (betibeglogene autotemcel) Coverage Criteria

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New Hampshire Medicaid Fee-for-Service coverage and prior authorization for Zynteglo in eligible adults and pediatric patients with transfusion-dependent beta thalassemia; coverage requires clinical, safety, treatment-preparation, and monitoring criteria and is limited to one treatment course.

Policy Summary

PayerNew Hampshire Department of Health and Human Services

PolicyZynteglo (betibeglogene autotemcel) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing that all clinical eligibility, diagnostic, transfusion, safety screening, treatment-preparation, reproductive, administration, monitoring, and prior-treatment criteria are met before Zynteglo is administered.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Age 4+Minimum patient age

≥100 mL/kg/year or ≥8/yearTransfusion-dependent disease threshold

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CurrentNew Hampshire Department of Health and Human ServicesPolicy N/A

Zynteglo (betibeglogene autotemcel) Coverage 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

PolicyZynteglo (betibeglogene autotemcel) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage change

Effective DateN/A

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Age 4+Minimum patient age

≥100 mL/kg/year or ≥8/yearTransfusion-dependent disease threshold

Covered treatment course

≥7 daysIron chelation discontinuation

15 mg/gLiver iron exclusion threshold

Zynteglo Coverage Criteria

Initial Zynteglo coverage

Covered when ALL of the following are met:

Zynteglo approval criteria

Age and diagnosis
- ONE of
  - Beta thalassemia is confirmed by HBB sequence gene analysis showing biallelic pathogenic variants.
  - Patient has severe microcytic hypochromic anemia, anisopoikilocytosis with nucleated red blood cells on peripheral blood smear, and hemoglobin analysis showing decreased or absent hemoglobin A with increased hemoglobin F.
Transfusion dependence: Patient has a history of transfusions of at least 100 mL/kg/year of packed red blood cells or 8 or more packed red blood cell transfusions per year in each of the 2 years preceding therapy.≥100 mL/kg/year or ≥8 transfusions/year
Disease-related exclusions: Patient does not have severely elevated cardiac iron, including cardiac T2* less than 10 msec by MRI; advanced liver disease; or liver MRI liver iron content of 15 mg/g or more, unless biopsy confirms absence of advanced disease.Cardiac T2* must not be <10 msec; liver iron must be <15 mg/g unless qualifying biopsy
Infectious disease screening: Patient has been screened for HBV, HCV, HTLV-1/HTLV-2, and HIV in accordance with clinical guidelines before collection of cells by leukapheresis.Screening before leukapheresis
Medication restrictions during mobilization and apheresis: Patient has not used prophylactic HIV antiretroviral medication or hydroxyurea within 30 days of mobilization, or for the expected medication-elimination duration, and until all cycles of apheresis are completed. If antiretrovirals are required for HIV prophylaxis, a negative HIV test must be confirmed before mobilization.No prohibited medication exposure during specified period
Conditioning readiness: Iron chelation therapy has been discontinued for at least 7 days before initiating myeloablative conditioning therapy.≥7 days
Pregnancy testing: Females of reproductive potential have a negative pregnancy test before mobilization, re-confirmed before conditioning procedures, and again before administration of betibeglogene autotemcel.Negative test at three specified time points
Treatment use: Zynteglo is used as single-agent therapy; this requirement does not apply to lymphodepleting or bridging therapy while awaiting manufacture.Single-agent therapy
Monitoring: Patient will receive periodic lifelong monitoring for hematological malignancies.Periodic lifelong monitoring
Transplant and prior therapy eligibility: Patient is eligible to undergo hematopoietic stem cell transplant and has not had a prior HSCT or other gene therapy.HSCT eligible; no prior HSCT or gene therapy
Treatment limit: Coverage is provided for one treatment course consisting of one dose of Zynteglo and may not be renewed.1 dose; no renewal

Alpha-thalassemia and hemoglobin S/beta-thalassemia variants are excluded from the covered beta thalassemia diagnosis.

Coverage excludes patients with severely elevated cardiac iron, including a cardiac T2* less than 10 msec by MRI.

Patients with advanced liver disease are excluded from coverage.

Liver MRI must demonstrate a liver iron content of less than 15 mg/g. Patients with liver iron content of 15 mg/g or more are excluded unless a biopsy confirms the absence of advanced disease.

Patients who have undergone a prior hematopoietic stem cell transplant (HSCT) or received other gene therapy are excluded.

Coverage Parameters

Minimum age

Minimum age4 years or older

Patient requirementPatient must be at least 4 years of age

Coverage stageCriteria for approval

Transfusion-dependent disease

Annual volume thresholdAt least 100 mL/kg/year of packed red blood cells (pRBCs)

Annual transfusion threshold8 or more pRBC transfusions per year

Lookback periodThe threshold must be met in each of the 2 years preceding therapy

Authorization and Documentation Requirements

Prior Authorization

Full Clinical Authorization Review

Before authorization, complete a full clinical review and document that the patient meets every applicable Zynteglo approval criterion, including clinical eligibility, diagnostic confirmation, transfusion dependence, iron and liver assessment, infection screening, treatment preparation, safety restrictions, HSCT eligibility, administration requirements, and long-term monitoring.

Submit supporting medical records for each criterion and resolve any conflicting or incomplete documentation before treatment authorization.

Documentation Required

Diagnosis and Transfusion History

Document that the patient is at least 4 years old and has transfusion-dependent beta thalassemia. Beta thalassemia must be distinguished from alpha-thalassemia and hemoglobin S/β-thalassemia variants, and the diagnosis must be supported by qualifying genetic or clinical and laboratory findings.

Confirmatory pathway 1: HBB sequence gene analysis demonstrates biallelic pathogenic variants.

Therapy Overview

Zynteglo (betibeglogene autotemcel) is a gene therapy for adult and pediatric patients with beta thalassemia who require regular red blood cell transfusions. Coverage applies to transfusion-dependent beta thalassemia and requires eligibility for hematopoietic stem cell transplantation, pre-treatment safety and readiness screening, and lifelong monitoring for hematological malignancies.

Key Definitions

Zynteglo indication

PopulationAdult and pediatric patients

DiagnosisBeta thalassemia

Transfusion requirementPatients who require regular red blood cell transfusion

Transfusion-dependent disease

Volume definitionAt least 100 mL/kg/year of packed red blood cells (pRBCs)

Count definition8 or more pRBC transfusions per year

Required historyThe volume or transfusion count must apply in each of the 2 years preceding therapy

Initial Therapy Authorization Criteria

Initial treatment authorization

Initial therapy is covered when ALL Zynteglo approval criteria are met:

Initial Zynteglo treatment authorization: Patient meets the age, beta thalassemia diagnosis, transfusion-dependence, disease-exclusion, infectious disease screening, medication-restriction, conditioning, reproductive, administration, monitoring, transplant eligibility, prior-treatment, and one-course treatment-limit requirements stated in the policy.Age ≥4 years; transfusion threshold met; 1 dose only; no renewal

Prior authorization documentation must be submitted before Zynteglo is administered.

Treatment Quantity Limit

Quantity limits

ProductZynteglo (betibeglogene autotemcel)

Maximum covered quantity1 dose

Quantity basisPer treatment course

Policy Summary

PayerNew Hampshire Department of Health and Human Services

PolicyZynteglo (betibeglogene autotemcel) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Cardiac iron

MRI measurementCardiac T2* by magnetic resonance imaging (MRI)

Eligibility thresholdCardiac T2* must not be less than 10 msec

Exclusion thresholdCardiac T2* less than 10 msec indicates severely elevated cardiac iron and is excluded

Liver iron content

Imaging methodLiver iron content measured by MRI

Eligibility thresholdLiver iron content must be less than 15 mg/g

Biopsy exceptionAt 15 mg/g or more, coverage may be considered only if biopsy confirms absence of advanced disease

Iron chelation discontinuation

Minimum interval7 days or more

MedicationIron chelation therapy must be discontinued

TimingDiscontinuation must occur before initiating myeloablative conditioning therapy

Treatment quantity

Covered quantityOne treatment course

Dose per course1 dose of Zynteglo

RenewalMay not be renewed

Confirmatory pathway 2: severe microcytic hypochromic anemia; anisopoikilocytosis with nucleated red blood cells on peripheral smear; and hemoglobin analysis showing decreased or absent hemoglobin A with increased hemoglobin F.

Document transfusion dependence as at least 100 mL/kg/year of packed red blood cells (pRBCs) or at least 8 pRBC transfusions per year during each of the 2 years preceding therapy.

Documentation Required

Iron Overload and Liver Assessment

Document cardiac and hepatic assessments showing that the patient does not have severe cardiac iron, advanced liver disease, or liver iron content at or above the applicable threshold without qualifying biopsy confirmation.

Cardiac MRI T2* must not be less than 10 msec.
Liver MRI must not demonstrate liver iron content of 15 mg/g or more unless biopsy confirms absence of advanced liver disease.
Include the relevant MRI reports and, when applicable, liver biopsy findings.

Documentation Required

Treatment Readiness and Safety Documentation

Document treatment readiness and safety requirements before cell collection, mobilization, conditioning, and administration. The patient must be eligible for HSCT and must not have had a prior HSCT or other gene therapy.

Before leukapheresis, screen according to clinical guidelines for HBV, HCV, HTLV-1/HTLV-2, and HIV.
The patient must not have used prophylactic HIV antiretroviral medication or hydroxyurea within 30 days before mobilization, or for the expected medication-elimination period, and through completion of all apheresis cycles. If antiretrovirals are required for HIV prophylaxis, confirm a negative HIV test before mobilization.
Discontinue iron chelation therapy at least 7 days before initiating myeloablative conditioning.
For females of reproductive potential, obtain a negative pregnancy test before mobilization, reconfirm before conditioning, and reconfirm again before betibeglogene autotemcel administration.
Document eligibility to undergo HSCT and absence of prior HSCT or other gene therapy.

Prior Authorization

Administration and Long-Term Monitoring Plan

Document that Zynteglo will be used as single-agent therapy and administered as one treatment course, with a plan for periodic lifelong monitoring for hematological malignancies.

Single-agent use does not preclude lymphodepleting or bridging therapy while awaiting manufacture.
Plan for one dose of Zynteglo and periodic lifelong hematologic malignancy monitoring.

Denial Risk

Failure to Meet Approval Criteria

Coverage will be denied when the patient does not meet all applicable Zynteglo approval criteria or when required supporting documentation is absent or does not substantiate eligibility.

Approval requires satisfaction of the age, diagnosis, transfusion-dependence, iron and liver, infection-screening, medication-restriction, treatment-preparation, HSCT-eligibility, administration, and monitoring requirements.

Denial Risk

Significant Iron Overload or Advanced Liver Disease

Coverage will be denied when the patient has severely elevated cardiac iron, advanced liver disease, or liver MRI findings demonstrating liver iron content of 15 mg/g or more, unless a qualifying biopsy confirms absence of advanced liver disease.

Cardiac T2* less than 10 msec by MRI is an example of severely elevated cardiac iron.
Document qualifying liver MRI and, when applicable, biopsy results.

Billing Rule

Repeat Treatment or Renewal

Coverage is limited to one treatment course consisting of one dose of Zynteglo and may not be renewed or repeated.

Do not submit requests for repeat treatment or renewal under this coverage policy.