CurrentMass General Brigham Health PlanPolicy N/A

Tzield (teplizumab-mzwv) prior authorization and coverage

Defines prior authorization, eligibility, and coverage criteria for Tzield (teplizumab-mzwv) for members of Mass General Brigham Health Plan; applies to pharmacy benefit and specialty medication handling. Affects prescribers and pharmacy prior authorization reviewers.

Policy Summary

PayerMass General Brigham Health Plan

PolicyTzield (teplizumab-mzwv) prior authorization and coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 1, 2023

Next Review DateN/A

Key ActionSubmit prior authorization with OGTT confirming dysglycemia within 2 months, documentation of ≥2 islet autoantibodies, provider attestation of no type 1 or 2 diabetes, and request limited to a one-time 14-day course.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>=8minimum patient age for coverage

14-daytreatment duration limit

1 monthinitial authorization length

>=2autoantibody requirement

Coverage Criteria

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Initial Authorization

Authorization may be granted when ALL of the following are met (or for members new to plan already receiving Tzield):

Entry option: Either member is currently receiving Tzield and is new to the plan (excluding samples or manufacturer patient assistance program supplies) OR all criteria below are met

Supports transfers-in or new starts

Patient age: Member is 8 years of age or older>= 8 years

Dysglycemia (OGTT) documentation: Medical charts documenting an abnormal oral glucose tolerance test (OGTT) confirming dysglycemia within the past 2 months using specified thresholdsOGTT within 2 months

Includes fasting, 2-hour, or intervening postprandial criteria

Autoantibody requirement: Medical charts documenting TWO or more pancreatic islet cell autoantibodies detected in two samples obtained in the last 6 months (GAD65, IA-2, IAA, ZnT8, ICA)>=2 autoantibodies in two samples within 6 months

Lists GAD65, IA-2, IAA, ZnT8, ICA

Diabetes diagnosis exclusions: Provider attestation that member does NOT have a diagnosis of type 2 diabetes

Attestation required

Diabetes diagnosis exclusions: Provider attestation that member does NOT have a diagnosis of type 1 diabetes

Attestation required

Treatment course limit: Member will not exceed a one-time 14-day treatment course with the dosing schedule specified in the policy14 days, one-time

Dosing schedule enumerated in policy

Providers must provide a provider attestation that the member does NOT have a diagnosis of type 1 diabetes and does NOT have a diagnosis of type 2 diabetes. Members with a documented diagnosis of either type 1 or type 2 diabetes are therefore excluded from this indication and are not appropriate candidates for Tzield under this policy.

Tzield is covered only to delay the onset of Stage 3 type 1 diabetes in members with Stage 2 type 1 diabetes. Requests that seek to treat other conditions, to treat Stage 3/type 1 diabetes, or that lack the required diagnostic documentation (recent OGTT-confirmed dysglycemia and ≥2 pancreatic islet autoantibodies in two samples) are considered not medically necessary and may be denied.

Coding & Clinical Thresholds

Header benefit codingmixed

No codes listed

Age

Minimum age for coverageMember is 8 years of age or older

Applies toAdults and pediatric patients 8 years and older with Stage 2 type 1 diabetes

Reference indicationIndicated to delay onset of Stage 3 type 1 diabetes

Fasting blood glucose

Fasting OGTT range110 to 125 mg/dL (6.1 to 6.9 mmol/L)

Use windowOGTT documenting dysglycemia must be within the past 2 months

Role in diagnosisMeets one of the OGTT dysglycemia criteria for Stage 2 type 1 diabetes

2-hour postprandial plasma glucose

2-hour postprandial OGTT criterion2-hour plasma glucose ≥ 140 mg/dL (7.8 mmol/L) and < 200 mg/dL (11.1 mmol/L)

Documentation timeframeOGTT confirming this result must be within the past 2 months

Diagnostic roleOne acceptable OGTT abnormality consistent with dysglycemia for Stage 2 type 1 diabetes

Intervening postprandial glucose

Intervening postprandial thresholdIntervening postprandial glucose > 200 mg/dL (11.1 mmol/L) at 30, 60, or 90 minutes on two occasions

Measurement timingMust be measured at 30, 60, or 90 minutes during OGTT

Role in exclusion/diagnosisCounts as dysglycemia criterion when documented on two occasions within OGTT documentation period

Provider Actions & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. May be granted for members new to the plan who are currently receiving Tzield (excluding samples or manufacturer patient assistance program supplies), and for new treatment starts when all clinical criteria below are met.

Applies to Tzield (teplizumab-mzwv).
Excludes product received as samples or via manufacturer patient assistance programs.

Step Therapy

Step Therapy Note

Program Type: Step Therapy is listed in the header but no specific step sequence is defined in the source policy.

Documentation Required

Required Documentation

Provide medical records supporting the clinical criteria at time of request. Documentation must include recent OGTT/dysglycemia evidence and confirmatory autoantibody testing.

Medical charts documenting an abnormal oral glucose tolerance test (OGTT) confirming dysglycemia within the past 2 months.
Medical charts documenting detection of TWO or more pancreatic islet autoantibodies in two samples obtained in the last 6 months (examples: GAD65, IA-2, IAA, ZnT8, ICA).
Provider attestation that the member does NOT have a diagnosis of type 1 diabetes or type 2 diabetes.
Specify that member is currently receiving Tzield if request is for a member new to the plan.

Denial Risk

Denial Triggers

Requests may be denied if the member is not currently receiving Tzield and does not meet ALL specified clinical criteria for new starts (age, OGTT/dysglycemia, autoantibodies, dosing limits, and provider attestations).

Denial risk if member age is < 8 years.
Denial risk if OGTT/dysglycemia documentation is older than 2 months or not consistent with criteria.
Denial risk if fewer than TWO pancreatic islet autoantibodies are documented in two samples within the last 6 months.
Denial risk if provider attestations regarding absence of type 1 or type 2 diabetes are not provided.
Denial risk if requested treatment would exceed the one-time 14-day dosing course limits.

Background

Tzield (teplizumab-mzwv) is an anti-CD3 monoclonal antibody indicated to delay the onset of Stage 3 type 1 diabetes in adults and pediatric patients 8 years of age and older with Stage 2 type 1 diabetes. Coverage is limited to a one-time 14-day course and requires documentation of OGTT-confirmed dysglycemia and at least two pancreatic islet autoantibodies detected in two samples within the prior 6 months. Prior authorization is required; members already receiving Tzield who transfer into the plan may be authorized per the continuation rules.

Definitions

Stage 2 type 1 diabetes

Stage 2 definitionPresence of dysglycemia on OGTT plus multiple positive pancreatic islet autoantibodies

Autoantibody requirementMedical charts must document TWO or more pancreatic islet cell autoantibodies detected in two samples obtained in the last 6 months

Listed autoantibodiesGAD65, IA-2, IAA, ZnT8, ICA

Dysglycemia (OGTT criteria)

Fasting110 to 125 mg/dL (6.1 to 6.9 mmol/L)

2-hour postprandial≥ 140 mg/dL and < 200 mg/dL (7.8 to <11.1 mmol/L)

Intervening postprandial> 200 mg/dL at 30, 60, or 90 minutes on two occasions

Initial Therapy Criteria

Initial therapy

Initial therapy coverage criteria

Age: Member is 8 years of age or older>=8 years

OGTT/dysglycemia: Medical chart documentation of abnormal OGTT confirming dysglycemia within the past 2 months using one of the following: fasting blood glucose 110 to 125 mg/dL (6.1–6.9 mmol/L); 2-hour postprandial plasma glucose ≥140 mg/dL and <200 mg/dL (7.8–11.1 mmol/L); or intervening postprandial glucose >200 mg/dL at 30, 60, or 90 minutes on two occasionsOGTT within 2 months

Specific glucose ranges enumerated in policy

Autoantibodies: Two or more pancreatic islet cell autoantibodies detected in two samples within the last 6 months (GAD65, IA-2, IAA, ZnT8, ICA)>=2 autoantibodies in two samples within 6 months

No diabetes diagnosis: Provider attestation that member does NOT have type 1 diabetes or type 2 diabetes

Both attestations required

Treatment duration: One-time 14-day treatment course with the dosing schedule specified in the policy14 days

Dose schedule listed in policy

Step	Requirement / Notes
Program lists 'Step Therapy' in the policy header	No specific step-failure sequence, required prior agents, or step definitions are provided in the document; reviewers should follow prior authorization clinical criteria rather than a step-failure pathway