CurrentAetnaPolicy N/A

Tzield (teplizumab-mzwv) Medication Precertification Request

Precertification request form for Tzield (teplizumab-mzwv) used to delay onset of stage 3 type 1 diabetes in qualifying patients; intended for prescribers and dispensing providers submitting authorization to Aetna.

Policy Summary

PayerAetna

PolicyTzield (teplizumab-mzwv) Medication Precertification Request

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete the Aetna medication precertification request form with required clinical documentation to request authorization for an initial or continuation one-time 14-day course.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

14-daytreatment course

2+autoantibodies required

2 moOGTT recency

110-125fasting BG range

Coverage Criteria for TZIELD (teplizumab-mzwv)

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Eligibility for Tzield precertification: Patient has stage 2 type 1 diabetes AND the request is to delay onset of stage 3 type 1 diabetes

form requires yes/no for both

Specialist involvement: Tzield will be prescribed by or in consultation with an endocrinologist

form asks provider to confirm endocrinologist involvement

Autoantibody requirement: Patient has 2 or more pancreatic islet cell autoantibodies detected in two samples obtained within the past 6 months (e.g., GAD65, IAA, IA-2A, ZnT8A, ICA)>=2 antibodies

form lists specific antibodies

Dysglycemia confirmation: Abnormal OGTT confirming dysglycemia within past 2 months OR fasting blood glucose 110–125 mg/dL OR 2-hour postprandial plasma glucose >=140 and <200 mg/dLOGTT within 2 months or specified glucose ranges

form requires documentation of these values

Treatment course limit: Treatment will not exceed a one-time 14-day dosing course per the specified schedule<=14 days

form includes Day 1–14 mcg/m2 dosing schedule

If the documented clinical information does not demonstrate the required antibody positivity or dysglycemia measures, the patient will not meet the form's clinical requirements for precertification. Specifically, the form requires 2 or more pancreatic islet autoantibodies detected in two samples within the past 6 months and evidence of dysglycemia via an abnormal OGTT within the past 2 months or specified glucose ranges (fasting blood glucose 110–125 mg/dL or 2‑hour postprandial plasma glucose ≥140 mg/dL and <200 mg/dL). Absence of these documented findings implies the request will not satisfy the eligibility criteria on the precertification form.

Requests for Tzield that lack documentation of stage 2 type 1 diabetes, do not show the required autoantibody positivity (≥2 islet autoantibodies), or do not provide confirmation of dysglycemia as specified on the form (abnormal OGTT within 2 months or the fasting/postprandial glucose ranges detailed) will not meet the clinical information required for precertification. The form explicitly asks providers to indicate these items and to confirm whether the request is intended to delay onset of stage 3 type 1 diabetes.

Initial Therapy Requirements

Initial therapy requirements

Initial therapy requests must document diagnosis, antibody positivity, dysglycemia, prescriber specialty, and intended dosing not to exceed the one-time 14-day schedule.

Documented diagnosis: Confirmation of stage 2 type 1 diabetes and intent to delay stage 3

Form asks yes/no

Autoantibodies: Presence of 2 or more specified pancreatic islet cell autoantibodies detected in two samples within past 6 months>=2 antibodies

Lists GAD65, IAA, IA-2A, ZnT8A, ICA

Glycemic criteria: Abnormal OGTT within 2 months OR fasting BG 110–125 mg/dL OR 2-hour postprandial 140–199 mg/dLOGTT within 2 months or specified glucose ranges

Form requests OGTT, fasting and 2-hour postprandial values

Dosing schedule: Intended dosing follows Day 1–14 schedule with total course not to exceed one 14-day course14 days

Day 1: 65 mcg/m2; Day 2: 125 mcg/m2; Day 3: 250 mcg/m2; Day 4: 500 mcg/m2; Days 5–14: 1,030 mcg/m2

Continuation Therapy Requirements

Continuation therapy

Continuation requests require date of last treatment and completion of clinical fields.

Continuation request details: Indicate continuation of therapy and provide date of last treatment; update clinical documentation as required

Form has checkbox and date field for continuation

Coding, Clinical Thresholds, and Dosing

Administration/CPT codes (provider supplied)CPT

Administration code(s) (CPT)

Form includes a field to provide applicable CPT administration codes

ICD-10 diagnosis codes (provider supplied)ICD-10

Primary ICD Code	Field for primary diagnosis ICD code
Secondary ICD Code	Field for secondary diagnosis ICD code
Other ICD Code	Field for other applicable ICD codes

inv-06: Fasting blood glucose — clinical range

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

PurposeOne of the dysglycemia criteria required for Tzield precertification

Documentation requirementForm asks provider to indicate 'Yes' if fasting BG is within this range

inv-07: 2-hour postprandial plasma glucose — clinical range

2-hour postprandial plasma glucose range>=140 mg/dL and <200 mg/dL (7.8–11.1 mmol/L)

PurposeMeets dysglycemia confirmation for Tzield precertification when documented

Documentation requirementForm asks provider to indicate 'Yes' if 2-hour postprandial glucose is within this range

inv-08: Dosing schedule per day — day-by-day mcg/m2 schedule

Day-by-day dosing scheduleDay 1: 65 mcg/m2; Day 2: 125 mcg/m2; Day 3: 250 mcg/m2; Day 4: 500 mcg/m2; Days 5–14: 1,030 mcg/m2

Course duration limitOne-time treatment course not to exceed 14 days

Form confirmationForm includes checkbox confirming whether patient will exceed a one-time 14-day treatment course

Provider Actions and Documentation Requirements

Prior Authorization

Precertification Required

Precertification is required for TZIELD (teplizumab-mzwv). Providers must complete the Aetna medication precertification request form in full and ensure all fields are legible. Incomplete, illegible, or missing documentation may prompt requests for additional information or delay review.

All fields on the TZIELD precertification form must be completed and legible.
Precertification requests may be for start of treatment (include start date) or continuation of therapy (include date of last treatment).
Aetna may request additional documentation or clarification if information is incomplete.

Documentation Required

Endocrinology Involvement

The prescriber must indicate whether the requested drug will be prescribed by or in consultation with an endocrinologist. If applicable, mark the prescriber specialty as Endocrinologist and include any consultation documentation.

Prescriber specialty must be completed on the form (Endocrinologist or Other).
Include documentation of endocrinology involvement or consultation when applicable.

Documentation Required

Required Documentation for Precertification

Required documentation must accompany the precertification request. Complete patient demographics, insurance details, prescriber and dispensing information, product and dosing information, and all clinical fields on the form. Clinical documentation (labs, antibody results, OGTT, glucose measurements, symptom history) must be provided as indicated.

Patient information: name, DOB, contact, weight, height, allergies.
Insurance information: Aetna Member ID, group number, other coverage details, Medicare/Medicaid IDs if applicable.
Prescriber information: name, credentials (MD/DO/NP/PA), address, phone, fax, state license, NPI, DEA, specialty, office contact.
Product information: confirm request is for TZIELD and provide dose and frequency.
Diagnosis information: primary and secondary ICD codes.
Clinical information: stage 2 type 1 diabetes diagnosis, intent to delay onset of stage 3, presence of ≥2 pancreatic islet autoantibodies (specify which and dates), OGTT and fasting/postprandial glucose results (with dates), symptom presence, and intended treatment course (confirm dosing schedule/duration).
Signature and date from the person completing the request.

Documentation Required

Form Completion and Documentation

The completed form must be signed and dated by the person submitting the request. The plan may request additional information or clarification to evaluate requests; knowingly submitting false information is a fraudulent act and subject to penalties. Use the Aetna precertification contact channels if further assistance is needed.

Signature and date required on the Acknowledgement section.
Aetna may contact the provider for missing or unclear information.
Precertification contact: Phone 1-866-752-7021, Fax 1-888-267-3277. For Medicare Advantage Part B, use the Medicare request form.

Place of Administration

Note

Specify place of administration

Indicate the place of administration on the form; available options include self-administered, physician's office, outpatient infusion center, or home infusion center.

Self-administered
Physician's Office
Outpatient Infusion Center
Home Infusion Center

Key Definitions

inv-14: Stage 2 type 1 diabetes — referenced diagnosis for TZIELD consideration

Referenced diagnosisStage 2 type 1 diabetes (form asks whether patient has this diagnosis and whether request is to delay onset of stage 3)

IndicationDelay onset of stage 3 type 1 diabetes in qualifying patients

Form requirementProvider must indicate 'Yes' that patient has stage 2 type 1 diabetes to meet initial authorization criteria

inv-15: Dysglycemia confirmation — OGTT within 2 months, or fasting BG 110–125 mg/dL, or 2-hour postprandial plasma glucose range

OGTT recencyAbnormal OGTT confirming dysglycemia within the past 2 months

Fasting blood glucose110 to 125 mg/dL (6.1 to 6.9 mmol/L)

2-hour postprandial plasma glucose>=140 mg/dL and <200 mg/dL (7.8–11.1 mmol/L)

Additional noteForm also asks about intervening postprandial values >200 mg/dL on two or more occasions as related information

Specialist involvement
Will the requested drug be prescribed by or in consultation with an endocrinologist?

Background

Tzield (teplizumab-mzwv) is intended for use to delay the onset of stage 3 type 1 diabetes in patients identified as having stage 2 type 1 diabetes who meet antibody and dysglycemia criteria. The precertification form requires documentation of both the diagnostic intent (that the request is to delay progression to stage 3) and the supporting laboratory evidence (required autoantibodies and dysglycemia confirmation) before an authorization can be considered.

Policy Summary

PayerAetna

PolicyTzield (teplizumab-mzwv) Medication Precertification Request

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete the Aetna medication precertification request form with required clinical documentation to request authorization for an initial or continuation one-time 14-day course.

SourceLink

On This Page

OpenPayer

Tzield (teplizumab-mzwv) Medication Precertification Request

Coverage Criteria for TZIELD (teplizumab-mzwv)

Initial Therapy Requirements

Continuation Therapy Requirements

Coding, Clinical Thresholds, and Dosing

Provider Actions and Documentation Requirements

Place of Administration

Key Definitions

Step Therapy Considerations

Quantity Limits

Background