CurrentCignaPolicy N/A

Tzield_Prior_Authorization_Form

Form for prescribers to request prior authorization for Tzield (teplizumab-mzwv) including patient, clinical, laboratory, prescribing and dispensing site information and attestations. The form captures required documentation elements to support approval (diagnosis, autoantibody testing, glycemic criteria, baseline labs, infection status, prescriber specialty, and site of administration).

Policy Summary

PayerCigna

PolicyTzield_Prior_Authorization_Form

Policy CodePolicy N/A

Change TypeInformational

Effective DateN/A

Next Review DateN/A

Key ActionFax completed form (including all asterisked items) to (855) 840-1678 or submit online; attach patient-specific supporting documentation (labs, chart notes, claims) or request may be denied.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

1Medication covered via PA form

>=2Autoantibody test occasions required

2 monthsAcceptable recency for glycemic labs

Tzield prior authorization form — purpose & scope

Purpose: This prior authorization form is used by prescribers to request coverage of Tzield (teplizumab-mzwv) and to collect the clinical and laboratory information necessary to evaluate medical necessity and safety for use in patients with Stage 3 (clinical) type 1 diabetes.

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What the form collects: documented diagnosis/indication; confirmation of autoantibody testing (at least two positive type 1 diabetes–related autoantibodies on two separate occasions); glycemic testing within the prior 2 months (2‑hour OGTT, fasting plasma glucose, or HbA1c thresholds); baseline hematologic and hepatic labs using specified thresholds; prescriber attestations about EBV/CMV and other active or chronic infections; prescriber specialty and attestation of prior Tzield exposure; and where the medication will be obtained and administered (acquisition and administration site).

Clinical criteria and required documentation (form fields)

Prior Authorization Clinical Criteria and Required Documentation

Form collects required criteria/documentation; approval contingent on attestation and attached documentation

ALL of the following

Clinical diagnosis of type 1 diabetes (Stage 3; clinical type 1 diabetes).
Stage 1 and 2 are preclinical and do not qualify
Documentation confirming patient tested positive for at least TWO type 1 diabetes-related autoantibodies on two separate occasions (at least two positive autoantibodies per occasion).
Acceptable antibodies: GAD65, IA-2, ICA, IAA, ZnT8; medical documentation must be attached
Glycemic criteria (at least one)
- 2-hour postprandial glucose >= 140 to < 200 mg/dL during an oral glucose tolerance test in the preceding 2 months2-hour OGTT >=140 to <200 mg/dL (within 2 months)
  Documentation must be attached
- Fasting plasma glucose >= 100 to < 126 mg/dL in the preceding 2 monthsFasting plasma glucose >=100 to <126 mg/dL (within 2 months)
  Used if OGTT not provided; documentation must be attached
- HbA1c >= 5.7% to < 6.5% in the preceding 2 monthsHbA1c >=5.7% to <6.5% (within 2 months)
  Used if other tests not provided; documentation must be attached
Baseline hematologic and hepatic parameters (documentation required)
- Lymphocyte count >= 1,000 lymphocytes/mcLLymphocyte count >= 1,000 lymphocytes/mcL
- Hemoglobin >= 10 g/dLHemoglobin >= 10 g/dL
- Platelet count >= 150,000 platelets/mcLPlatelet count >= 150,000 platelets/mcL
- Absolute neutrophil count >= 1,500 neutrophils/mcLAbsolute neutrophil count >= 1,500 neutrophils/mcL
Infection and prescribing constraints
- No laboratory or clinical evidence of acute Epstein-Barr Virus (EBV) or cytomegalovirus (CMV) infection (prescriber must indicate status)
  Prescriber must indicate status
- No active serious infection (prescriber attestation required)
  Prescriber attestation required
- No chronic active infection (other than localized skin infection) (prescriber attestation required)
  Prescriber attestation required
Prescriber attestation that patient has not previously received Tzield (or indicate if not attested).
Form asks prescriber to attest
Prescriber specialty field (form asks if prescriber is an endocrinologist).
Attach required medical documentation (chart notes, lab tests, claims records) including patient-specific identifiers; failure to attach may result in denial.

Stage 3 type 1 diabetes: Clinical type 1 diabetes (also referred to in the form as Stage 3); symptomatic/clinical disease that qualifies for consideration of Tzield. The form explicitly notes that Stage 1 and Stage 2 are preclinical and do not qualify.

Autoantibodies: Type 1 diabetes–related autoantibodies accepted on the form include glutamic acid decarboxylase 65 (GAD65), islet antigen‑2 (IA‑2), islet‑cell autoantibody (ICA), insulin autoantibody (IAA), and zinc transporter 8 (ZnT8). The form requires documentation showing at least two positive autoantibodies on two separate occasions (at least two positive per occasion).

What the provider must do

Prior Authorization

Submit completed prior authorization form

Fax the completed prior authorization form (including all asterisked items) to (855) 840-1678 or submit online via the CoverMyMeds/SureScripts portal. Attach patient-specific supporting documentation (labs, chart notes, claims) with identifiers to avoid denial.

(855) 840-1678
Attach labs/chart notes/claims or risk denial

Documentation Required

Attach autoantibody testing results

Provide documentation confirming the patient tested positive for at least two type 1 diabetes–related autoantibodies on two separate occasions (at least two positive autoantibodies per occasion). Attach the specific laboratory reports or chart notes showing the results.

GAD65
IA-2
ICA
IAA
ZnT8

Documentation Required

Attach glycemic testing within 2 months

Attach glycemic testing performed within the preceding 2 months. Acceptable tests include a 2-hour postprandial level from an oral glucose tolerance test (OGTT), fasting plasma glucose, or HbA1c; include the lab report or chart note.

OGTT 2-hour: >= 140 to < 200 mg/dL
Fasting plasma glucose: >= 100 to < 126 mg/dL
HbA1c: >= 5.7% to < 6.5%

Documentation Required

Attach baseline hematologic and hepatic labs

Provide baseline hematologic and hepatic laboratory results prior to initiation and attach the corresponding lab reports or chart notes showing these values meet the specified thresholds.

Lymphocyte count >= 1,000 lymphocytes/mcL
Hemoglobin >= 10 g/dL
Platelet count >= 150,000 platelets/mcL
Absolute neutrophil count >= 1,500 neutrophils/mcL
ALT <= 2 x ULN
AST <= 2 x ULN
Bilirubin <= 1.5 x ULN

Documentation Required

Infection status attestation

Prescriber must attest to the patient’s infection status: absence of acute EBV or CMV infection, absence of active serious infection, and absence of chronic active infection (other than localized skin infection). Note that active infections may preclude approval.

Billing Rule

Specify acquisition and administration site

Indicate where the medication will be obtained (for example, Accredo Specialty Pharmacy, hospital outpatient, retail, physician office, home infusion) and where it will be administered. Some plans require infusion in the least intensive medically appropriate setting.

Step Therapy

New start vs continuation

Indicate on the form whether the request is for a new start of therapy or continuation of therapy.

Attachments and denial risk

Denial Risk

Risk of denial if documentation missing

Failure to attach required, patient-specific medical documentation (laboratory reports, chart notes, claims records) and identifiers may result in denial of the request.

Autoantibody test reports (>=2 positive on two occasions)
Glycemic tests within 2 months (OGTT, fasting glucose, or HbA1c)
Baseline hematologic and hepatic labs (see thresholds)

Policy Summary

PayerCigna

PolicyTzield_Prior_Authorization_Form

Policy CodePolicy N/A

Change TypeInformational

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

OpenPayer

Tzield_Prior_Authorization_Form

Tzield prior authorization form — purpose & scope

Clinical criteria and required documentation (form fields)

Medication / code groups

What the provider must do

Attachments and denial risk

Document history