CurrentMass General Brigham Health PlanPolicy N/A

Tzield

Medical-benefit prior authorization policy for Tzield (teplizumab-mzwv) for delaying onset of stage 3 Type 1 diabetes mellitus, applicable to MassHealth members; may also be available under the pharmacy benefit per MassHealth Drug List.

Policy Summary

PayerMass General Brigham Health Plan

PolicyTzield

Policy CodePolicy N/A

Change TypeRevised (formatting/references); initial creation

Effective DateJun 1, 2025

Next Review Date

Key ActionPrior authorization is required for Tzield under the medical benefit for MassHealth; submit documentation meeting all criteria including diagnosis, age, dosing, prescriber specialty, autoantibody results, and glycemic test within 3 months.

SourceLink

POLICY UPDATE CHANGES

Reviewed and updated formatting and references.

Initial policy created requiring prior authorization for Tzield.

1Covered indication (Stage 2 T1DM)

>=8Minimum age (years)

14 daysApproval duration

>=2Required islet autoantibodies

Coverage Summary

This policy is a MassHealth medical-benefit prior authorization policy for Tzield (teplizumab-mzwv) to delay the onset of stage 3 Type 1 diabetes mellitus in members. Coverage stance: covered_with_criteria. The product is indicated for Stage 2 Type 1 diabetes mellitus. Tzield may also be available under the pharmacy benefit per the MassHealth Drug List.

Thresholds

Age>= 8 years

Islet autoantibodies>= 2 islet autoantibodies

Fasting plasma glucose (FPG)100-125 mg/dL (within last 3 months)

2-hour plasma glucose (2-h PG)140-199 mg/dL (within last 3 months)

Approval duration14 days

Authorization Criteria (Initial Therapy)

Authorization Criteria

Authorization may be granted when ALL of the following criteria are met and documentation is provided:

ALL of the following

Diagnosis of Stage 2 type 1 diabetes mellitus
Member is ≥ 8 years of age>= 8 years
Appropriate dosing
Prescribed dose must match the product's approved dosing regimen (per package insert)
Prescriber is an endocrinologist
Lab results documenting ≥ 2 islet autoantibodies>= 2 islet autoantibodies
ONE of the following within the last three months
- Fasting plasma glucose (FPG): 100 to 125 mg/dL100-125 mg/dL
  Result within the last 3 months
- 2-hour plasma glucose (2-h PG): 140 to 199 mg/dL140-199 mg/dL
  Result within the last 3 months
Member has not previously been treated with Tzield (teplizumab-mzwv)

Transition / Continuation Criteria

Transition / Continuation for members new to plan

Case-by-case review

Authorization may be reviewed on a case by case basis for members who are new to the plan currently receiving treatment with requested medication

Excludes when the product is obtained as samples or via manufacturer's patient assistance programs

Limitations

Approvals will be granted for 14 days

Single course duration; no data to support more than one course of treatment

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required (Medical Benefit)

Prior authorization is required for Tzield under the medical benefit for MassHealth. Submit documentation that meets ALL criteria (diagnosis, age, dosing, prescriber specialty, autoantibody results, and glycemic test within 3 months).

Diagnosis: Stage 2 type 1 diabetes mellitus
Age: ≥ 8 years
Dosing: matches product's approved regimen
Prescriber: endocrinologist
Autoantibodies: laboratory results documenting ≥ 2 islet autoantibodies
Glycemic test: FPG 100–125 mg/dL or 2‑h PG 140–199 mg/dL within the last 3 months

Documentation Required

Required documentation

Provide laboratory results showing at least 2 islet autoantibodies and a fasting plasma glucose (100–125 mg/dL) or 2‑hour plasma glucose (140–199 mg/dL) result from within the last 3 months. Also document the prescriber specialty (endocrinologist) and that the member has not previously been treated with Tzield.

Prior Authorization

Short approval duration

Authorizations will be granted for 14 days. There is no data to support more than one course of treatment.

Documentation Required

Transition member review

For members new to the plan who are currently receiving Tzield, authorization may be reviewed on a case‑by‑case basis. This does not apply when the product was obtained as samples or through the manufacturer's patient assistance programs.

Background & Definitions

Tzield (teplizumab-mzwv) is a CD3-directed antibody indicated to delay the onset of stage 3 Type 1 diabetes mellitus. This policy governs medical-benefit prior authorization for MassHealth members. The product may also be covered under the pharmacy benefit; consult the MassHealth Drug List for pharmacy benefit coverage and criteria.

Stage 2 type 1 diabetes mellitus: clinical stage defined by the presence of multiple islet autoantibodies with dysglycemia but not yet clinical (stage 3) diabetes; authorization criteria require documentation consistent with this stage (including ≥ 2 islet autoantibodies and dysglycemia as shown by specified glucose thresholds).

Revision History

05/10/2023added

Initial policy created requiring prior authorization for Tzield (teplizumab-mzwv); effective 06/05/2023.

05/15/2025revisedLatest

Reviewed and updated formatting and references per P&T; effective date updated to 06/01/2025 (no clinical policy statement changes).