CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zynteglo (betibeglogene autotemcel) — Coverage Criteria

Policy governing prior authorization, coverage criteria, dosing, and administration requirements for a single course of Zynteglo for Medicaid, Commercial, and MMP members who meet clinical criteria.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZynteglo (betibeglogene autotemcel) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2022

Next Review DateN/A

Key ActionSubmit prior authorization with required medical records and documentation; coverage is for a single nonrenewable treatment course.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1treatment course authorized (nonrenewable)

≥5.0×10^6minimum dose per single administration

≥12×10^6target CD34+ cells to collect

≥4 yrsminimum patient age for treatment

D56.1covered ICD-10 code

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Coverage Criteria for Zynteglo (betibeglogene autotemcel)

Initial Therapy

Covered when ALL of the following are met

Initial Approval Criteria: Patient is at least 4 years of age; AND patient has been screened for hepatitis B virus (HBV), hepatitis C virus (HCV), human T-lymphotrophic virus 1 & 2 (HTLV-1/HTLV-2), and human immunodeficiency virus (HIV) in accordance with clinical guidelines prior to collection of cells (leukapheresis); AND patient has not used prophylactic HIV antiretroviral medication or hydroxyurea within 30 days prior to mobilization (or for the expected duration for elimination of those medications) and until all cycles of apheresis are completed (if a patient requires anti-retrovirals for HIV prophylaxis, confirm a negative test for HIV before beginning mobilization); AND iron chelation therapy has been discontinued for at least 7 days prior to initiating myeloablative conditioning therapy; AND females of reproductive potential have a negative pregnancy test prior to start of mobilization, reconfirmed prior to conditioning procedures and again before administration of betibeglogene autotemcel; AND used as single agent therapy (not applicable to lymphodepleting or bridging therapy while awaiting manufacture); AND patient will receive periodic life-long monitoring for hematological malignancies; AND patient is eligible to undergo hematopoietic stem cell transplant (HSCT) and has not had prior HSCT or other gene-therapy; AND patient has a documented diagnosis of beta thalassemia (excludes alpha-thalassemia and hemoglobin S/ß-thalassemia variants) confirmed by either HBB sequence gene analysis showing biallelic pathogenic variants OR by clinical/laboratory criteria (severe microcytic hypochromic anemia, anisopoikilocytosis with nucleated red blood cells, and hemoglobin analysis with decreased/absent HbA and increased HbF); AND patient has transfusion-dependent disease defined as history of transfusions of at least 100 mL/kg/year of packed red blood cells (pRBCs) or 8 or more pRBC transfusions per year in the 2 years preceding therapy; AND patient does not have severely elevated cardiac iron (cardiac T2* < 10 msec by MRI), advanced liver disease, or liver iron content ≥ 15 mg/g by MRI (unless biopsy confirms absence of advanced disease).see text

Combines age, infection screening, medication restrictions, reproductive testing, transplant eligibility, diagnostic confirmation, transfusion history, and organ iron burden exclusions.

Renewal

Renewal: Coverage cannot be renewed (single nonrenewable course).N/A

Coverage provided for one treatment course (one dose) and is nonrenewable.

General coverage criteria

Covered when ALL of the following are met:

FDA/Clinical alignment: Use is consistent with FDA-approved labeling and relevant clinical literature.

Plan criteria were adopted following P&T review and are intended to align with FDA labeling and relevant literature.

Medicare coverage considerations: For Medicare/INTEGRITY members, applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), or Local Coverage Articles (LCAs) must be followed where present; where absent, the plan criteria apply.

See CMS coverage database for NCD/LCD/LCA guidance.

Exclusions and clinical contraindications include patients with non–beta-thalassemia genotypes such as alpha-thalassemia and hemoglobin S/β-thalassemia variants. Candidates are ineligible if they have severely elevated cardiac iron, defined as a cardiac T2* 10 msec by MRI, or if they have advanced liver disease. Patients with liver iron content ≥ 15 mg/g by MRI are also excluded unless a liver biopsy confirms absence of advanced disease.

Medicare Part B covered diagnosis codes are N/A in the provided excerpt. Medicare coverage references including NCDs, LCDs, and LCAs apply where present and can be found in the CMS coverage database.

Coverage is limited to a single treatment course of Zynteglo; coverage cannot be renewed. Authorization, when approved, is for one dose (one treatment course) only.

Not medically necessary determinations will be made when requests are not consistent with FDA-approved labeling or the relevant clinical literature. The plan will review prescriber-submitted clinical information and other available data and may deny coverage if individual consideration does not support use per FDA labeling or the adopted clinical criteria.

Coding and Clinical Thresholds

HCPCS CodesHCPCS

J3590	Unclassified biologics
J3393	Injection, betibeglogene autotemcel, per treatment (effective 07/01/2024)

NDCNDC

73554-3111-xx

Zynteglo up to 4 infusion bags, 20 mL/infusion bag, overwrap, and metal cassette

Covered Diagnosis CodesICD-10Covered

D56.1

Beta thalassemia

Medicare Part B Covered Diagnosis CodesICD-10

No codes listed

Medicare Part B Administrative Contractor (MAC) Jurisdictionsmixed

No codes listed

CD34+ cell dose thresholds — inv-13

Minimum dose per single administrationA single dose containing a minimum of 5.0 × 10^6 CD34+ cells/kg of body weight (one or more infusion bags)

Target collection for manufactureTarget number of CD34+ cells to be collected is ≥ 12 × 10^6 CD34+ cells/kg

Back-up collection (apheresis)Back-up collection required ≥ 1.5 × 10^6 CD34+ cells/kg (if collected by apheresis)

Back-up collection (bone marrow)Back-up collection required > 1.0 × 10^8 total nucleated cells (TNC)/kg (if collected by bone marrow harvest)

Additional collections if minimum not metIf minimum dose (5.0 × 10^6 CD34+ cells/kg) is not met, additional cycles of mobilization and apheresis may be performed, separated by at least 14 days; up to two drug product lots may be administered to meet target dose

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for this therapy. Coverage will be provided for one treatment course (1 dose of Zynteglo) and may not be renewed.

Length of authorization: 1 treatment course (1 dose)
Prior authorization required — submit via PA web portal or fax

Note

Requests Evaluated Against Clinical Criteria and FDA Labeling

Requests will be evaluated against the plan's clinical coverage criteria and FDA labeling. Neighborhood will give individual consideration to each request based on information submitted by the prescriber and other information available to the plan.

Step Therapy

Step Therapy Exception for Recent Recipients

MMP members who have received this medication within the past 365 days are exempt from Step Therapy requirements.

Step therapy exception applies only to MMP members with documented receipt within the prior 365 days

Step Therapy

Step Therapy Stance

Neighborhood's step therapy stance: ensure cost-effective options are used first when appropriate. Requests should document prior trials of preferred alternatives when step therapy is applicable, unless an exception (such as the 365‑day recent recipient rule) applies.

Prescribers should document prior therapies and rationale for bypassing step therapy when applicable

Documentation Required

Required Documentation — Medical Records and Testing

Submission of medical records (chart notes) related to the medical necessity criteria is REQUIRED on all authorization requests. Prescribers must provide documentation related to diagnosis, step therapy, and relevant clinical markers (e.g., genetic and mutational testing). Failure to submit required medical records or chart documentation may result in delayed review or denial of the request.

Provide documentation via direct upload through the PA web portal or by fax
Include testing results (HBV, HCV, HTLV-1/2, HIV) and other relevant clinical notes

OpenPayer

Zynteglo (betibeglogene autotemcel) — Coverage Criteria

Coverage Criteria for Zynteglo (betibeglogene autotemcel)

Coding and Clinical Thresholds

Provider Requirements and Prior Authorization

Background on Therapy

Key Definitions