Currentsierra health and lifePolicy 2026D0117H

Tzield (teplizumab-mzwv) — coverage criteria to delay progression to Stage 3 type 1 diabetes

Defines medical necessity and coverage criteria for a one-time 14-day course of Tzield to delay progression from Stage 2 to Stage 3 type 1 diabetes for eligible pediatric and adult members; applies to UnitedHealthcare Commercial and Individual Exchange benefit plans.

Policy Summary

Payersierra health and life

PolicyTzield (teplizumab-mzwv) — coverage criteria to delay progression to Stage 3 type 1 diabetes

Policy CodePolicy 2026D0117H

Change TypeNo material changes

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document Stage 2 T1D with ≥2 islet autoantibodies, dysglycemia per thresholds, endocrinologist involvement, and no prior Tzield; authorization limited to one 14‑day course.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

14 dosesmaximum authorized treatment per lifetime

≥8 yrsminimum eligible patient age

J9381HCPCS code listed

Stage 2 T1Dindication targeted

Coverage Criteria for Tzield (teplizumab-mzwv)

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Initial Therapy — Medical Necessity Criteria

Covered when ALL of the following are met:

Age and indication

Autoantibody confirmation: Presence of at least two positive pancreatic islet autoantibodiesautoantibodies >= 2
Autoantibodies include GAD65, IAA, IA-2A, ZnT8A, ICA
Dysglycemia without overt hyperglycemia: Dysglycemia defined by one of: fasting plasma glucose ≥100 mg/dL and <126 mg/dL; or 2-hour post-prandial plasma glucose ≥140 mg/dL and <200 mg/dL; or A1C ≥5.7% and <6.5% or ≥10% increase in A1CFPG 100-125 mg/dL; 2-hr PG 140-199 mg/dL; A1C 5.7-6.4% or ≥10% increase
Dysglycemia must be present without overt hyperglycemia per OGTT
Clinical exclusion of Stage 3 and type 2 diabetes: No symptoms of Stage 3 type 1 diabetes (e.g., polyuria, polydipsia, weight loss) AND diagnosis of type 2 diabetes has been ruled out
Clinical history should not suggest type 2 diabetes
Prescriber, dosing, and prior treatment: Prescribed by or in consultation with an endocrinologist AND dosing per FDA labeling AND patient has not received prior Tzieldno prior Tzield; dosing per label
Authorization limited to one 14-day course (14 doses) per lifetime

Stage 2 definition reference: Stage 2 requires autoimmunity with dysglycemia without overt hyperglycemia, confirmed as above

See autoantibody and dysglycemia criteria

Authorization for additional courses of Tzield is not permitted for members who have previously received the product. Patients previously treated with Tzield are excluded from authorization for additional treatment courses, and coverage is limited to one treatment course (14 doses) per lifetime. This policy requires that the patient has not received prior Tzield as part of the eligibility determination, and dosing must follow the United States Food and Drug Administration–approved labeling. Prescriber involvement (prescribed by or in consultation with an endocrinologist) and documentation that type 2 diabetes has been ruled out are required as contextual eligibility notes.

Provider Actions and Authorization Rules

Prior Authorization

Prior authorization required

Prior authorization is required and will be granted only when all medical necessity criteria are met, including patient age 8 years or older, confirmed Stage 2 type 1 diabetes with at least two pancreatic islet autoantibodies and dysglycemia without overt hyperglycemia per specified thresholds, prescribed by or in consultation with an endocrinologist, no prior Tzield treatment, and dosing per FDA labeling.

Patient is 8 years of age or older
Stage 2 T1D confirmed: ≥2 pancreatic islet autoantibodies and dysglycemia without overt hyperglycemia
Prescribed by or in consultation with an endocrinologist
Patient has not been previously treated with Tzield
Dosing per FDA approved labeling

Step Therapy

Step therapy

No step therapy requirements are specified in this policy.

Documentation Required

Required clinical documentation

Document confirmation of Stage 2 type 1 diabetes including at least two positive pancreatic islet autoantibodies (e.g., GAD65, IAA, IA‑2A, ZnT8A, ICA), evidence of dysglycemia without overt hyperglycemia using OGTT or laboratory thresholds, absence of Stage 3 symptoms, documentation that type 2 diabetes has been ruled out, and that treatment is prescribed by or in consultation with an endocrinologist with dosing per FDA labeling.

At least two positive pancreatic islet autoantibodies (GAD65, IAA, IA‑2A, ZnT8A, ICA)
Dysglycemia documented by OGTT or: fasting plasma glucose ≥100 and <126 mg/dL; 2‑hour post‑prandial plasma glucose ≥140 and <200 mg/dL; or A1C ≥5.7 and <6.5% (or ≥10% increase)
No symptoms of Stage 3 T1D (e.g., polyuria, polydipsia, weight loss)
Type 2 diabetes ruled out
Prescriber is or consulted with an endocrinologist; dosing per FDA label

Denial Risk

Lifetime course limit

Authorization will be issued for no more than one treatment course per lifetime (a one‑time 14‑day course).

Billing Rule

Dose limit

Authorization will be issued for no more than 14 doses.

Background

Type 1 diabetes is an autoimmune condition characterized by progressive destruction of insulin‑producing beta cells and clinical evolution through presymptomatic stages. Stage 1 is defined by the presence of multiple pancreatic islet autoantibodies with normoglycemia; Stage 2 by autoimmunity plus dysglycemia without overt hyperglycemia (for example, fasting plasma glucose ≥100 and <126 mg/dL, 2‑hour post‑prandial plasma glucose ≥140 and <200 mg/dL, or A1C ≥5.7 and <6.5% or ≥10% increase in A1C); and Stage 3 by overt hyperglycemia with symptomatic diabetes. Teplizumab‑mzwv (Tzield) is intended to delay progression from Stage 2 to Stage 3 in appropriately selected patients.

Definitions of Type 1 Diabetes Stages

Stage 1 T1D — inv-12

DefinitionMultiple islet autoantibodies with normoglycemia (no dysglycemia)

Clinical statusPresymptomatic (no symptoms of clinical diabetes)

Diagnostic noteAutoimmunity detected by presence of multiple pancreatic islet autoantibodies

Stage 2 T1D — inv-13

DefinitionAutoimmunity with dysglycemia (presymptomatic)

Fasting plasma glucose100–125 mg/dL

2-hour post-prandial plasma glucose140–199 mg/dL

A1C criteriaA1C 5.7–6.4% or ≥ 10% increase in A1C

Clinical notesRequires presence of islet autoantibodies (usually multiple) and absence of symptoms of Stage 3; diagnosis of type 2 diabetes must be ruled out

Stage 3 T1D — inv-14

DefinitionAutoimmunity with overt hyperglycemia and symptomatic diabetes meeting standard diagnostic criteria

CharacteristicsOvert hyperglycemia with clinical symptoms (eg, polyuria, polydipsia, weight loss)

Diagnostic noteAutoantibodies may become absent; diagnosis made by standard diabetes diagnostic criteria