CurrentAetnaPolicy N/A

Tzield (teplizumab-mzwv) Medication Precertification Request

Aetna precertification request form to collect patient, prescriber, dispensing, diagnosis, and required clinical information to support prior authorization for TZIELD (teplizumab-mzwv) for initiation or continuation of therapy.

Policy Summary

PayerAetna

PolicyTzield (teplizumab-mzwv) Medication Precertification Request

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionComplete and submit a legible precertification form with all required sections and supporting clinical documentation (autoantibodies and glycemic testing) via phone or fax to Aetna Precertification Notification.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes

1Form pages

14-dayStandard dosing course length

2Required autoantibodies (minimum)

Policy overview

This is an Aetna precertification request form to collect required clinical and administrative information to evaluate requests for TZIELD (teplizumab-mzwv) for initiation or continuation of therapy intended to delay the onset of stage 3 type 1 diabetes in patients with stage 2 disease and qualifying laboratory markers. The single-page form requires completion of patient, insurance, prescriber, dispensing, product, and diagnosis sections, and includes signature/acknowledgement instructions for submission via Aetna Precertification Notification.

The form requests specific clinical documentation: confirmation of stage 2 type 1 diabetes and intent to delay stage 3, prescribing by or in consultation with an endocrinologist, evidence of at least two pancreatic islet cell autoantibodies detected in two samples within the past 6 months, and abnormal glycemic testing (OGTT, fasting glucose, 2‑hour postprandial, or intervening postprandial values) as applicable. The single-page note indicates the form is Page 1 of 1.

The form also documents the standard 14-day dosing course and asks whether the patient will exceed a one-time 14-day treatment course. The specified dosing schedule is: 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.

Key facts

Form pages1

Standard dosing course length14-day

Required autoantibodies (minimum)2

Coverage stanceinformational

SubjectTzield (teplizumab-mzwv) Medication Precertification Request Form

PayerAetna

PolicyMedication Precertification Request

Required clinical information for precertification

For all requests (clinical documentation required):

ALL of the following

Diagnosis of stage 2 type 1 diabetes
Requestor must indicate Yes/No
Intent: Request is to delay the onset of stage 3 type 1 diabetes
Requestor must indicate Yes/No
Prescriber: Drug prescribed by or in consultation with an endocrinologist
Requestor must indicate Yes/No; prescriber specialty checkbox includes Endocrinologist
Autoantibodies: At least 2 pancreatic islet cell autoantibodies detected in two samples obtained within the past 6 monthsAt least 2 autoantibodies from two samples within past 6 months
Options listed: Glutamic acid decarboxylase 65 (GAD), Insulin autoantibody (IAA), Insulinoma-associated antigen 2 autoantibody (IA-2A), Zinc transporter 8 autoantibody (ZnT8A), Islet cell autoantibody (ICA); requestor must indicate Yes/No
Glycemic thresholds (requestor indicates applicable)
- Fasting glucose: Fasting blood glucose 110 to 125 mg/dL (6.1 to 6.9 mmol/L)110 to 125 mg/dL (6.1 to 6.9 mmol/L)
  Requestor must indicate Yes/No
- 2-hour postprandial plasma glucose >= 140 mg/dL (7.8 mmol/L) and < 200 mg/dL (11.1 mmol/L)>= 140 mg/dL and < 200 mg/dL (7.8 to 11.1 mmol/L)
  Requestor must indicate Yes/No
- Intervening postprandial glucose at 30, 60, or 90 minutes > 200 mg/dL (11.1 mmol/L) on two or more occasions> 200 mg/dL (11.1 mmol/L) on two or more occasions
  Yes/No
Symptoms: Presence of symptoms associated with type 1 diabetes (e.g., increased urination, excessive thirst, weight loss)
Requestor must indicate Yes/No
Treatment course duration: Whether patient will exceed a one-time 14-day treatment course with specified dosing scheduleOne-time 14-day treatment course (Day1:65 mcg/m2; Day2:125 mcg/m2; Day3:250 mcg/m2; Day4:500 mcg/m2; Days5–14:1,030 mcg/m2)
Requestor must indicate Yes/No; dosing schedule specified on form

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Glycemic thresholds and dosing schedule

Thresholds

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 to 11.1 mmol/L)

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

Treatment course durationOne-time 14-day treatment course with detailed per-day dosing (Day1:65 mcg/m2; Day2:125 mcg/m2; Day3:250 mcg/m2; Day4:500 mcg/m2; Days5–14:1,030 mcg/m2)

Coding guidance

ICD-10 primary/secondary/other diagnosis codesICD-10

No codes listed

Administration code(s) (CPT) - to be provided by requestorCPT

No codes listed

Actions required from providers

Prior Authorization

Submit precertification request

Complete the precertification form with all required sections (patient, insurance, prescriber, dispensing, product, diagnosis, and complete clinical information) and signature, then submit via phone or fax to Aetna Precertification Notification.

Patient
Insurance
Prescriber
Dispensing
Product
Diagnosis
Complete clinical information
Signature

Documentation Required

Clinical documentation of autoantibodies and glycemic testing

Provide evidence that at least two pancreatic islet cell autoantibodies were detected in two samples obtained within the past 6 months and include OGTT, fasting plasma glucose, and postprandial glucose results as indicated on the form.

Billing Rule

Provide administration CPT codes

If the drug will be administered by a provider, include the administration CPT code(s) in the Administration section of the precertification form as requested.

Supply administration CPT code(s) on the form in the 'Administration code(s) (CPT)' field.

Definitions

TZIELD = Brand name for teplizumab-mzwv.

Policy Summary

PayerAetna

PolicyTzield (teplizumab-mzwv) Medication Precertification Request

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Tzield (teplizumab-mzwv) Medication Precertification Request

Policy overview

Required clinical information for precertification

Glycemic thresholds and dosing schedule

Coding guidance

Actions required from providers

Definitions

Revision history