CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tzield (teplizumab-mzwv) — Coverage Criteria for Delaying Stage 3 Type 1 Diabetes

Defines medical necessity, dosing, eligibility, and coverage limits for Tzield (teplizumab-mzwv) for members (Medicaid, Commercial, Medicare) to delay progression from Stage 2 to Stage 3 Type 1 Diabetes in patients aged ≥8 years.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTzield (teplizumab-mzwv) — Coverage Criteria for Delaying Stage 3 Type 1 Diabetes

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateAug 1, 2023

Next Review DateMay 28, 2025

Key ActionSubmit prior authorization for a single 14-dose course (maximum 400 HCPCS units/day; use J9381 for billing).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

14maximum authorized dosing course

400max billable units/day

J9381HCPCS code

≥8minimum age

Norenewal allowed

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Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Tzield initial approval criteria: Patient is at least 8 years of age; medication prescribed by or in consultation with an endocrinologist; no prior teplizumab therapy; patient is up to date with all vaccinations per current guidelines prior to initiating therapy; no active infection including clinically important localized infections; evaluated and screened for absence of acute EBV or CMV infection; no laboratory indices as follows: lymphocyte count <1,000/mcL, hemoglobin <10 g/dL, platelet count <150,000/mcL, absolute neutrophil count <1,500/mcL, ALT or AST >2x ULN, or bilirubin >1.5x ULN; patient will not receive live or live-attenuated vaccines within 8 weeks or inactivated/mRNA vaccines within 2 weeks prior to or during treatment; documentation does not suggest use for Type 2 diabetes; used as single-agent therapy; patient will receive treatment to delay onset of Stage 3 Type 1 Diabetes; documentation of current body surface area (BSA); patient will not exceed a one-time 14-day treatment course per the dosing schedule referenced in Dosage/Administration; and member does not have symptoms associated with clinical type 1 diabetes (e.g., increased urination, excessive thirst, weight loss).

Confirmation of Stage 2 Type 1 Diabetes

Two or more pancreatic islet autoantibodies within the past 6 months: GAD65, insulin autoantibody (IAA), IA-2A, ZnT8A, or ICA.
Evidence of dysglycemia without overt hyperglycemia within the past 2 months defined by one of: fasting glucose 100-125 mg/dL; 2-hour postprandial plasma glucose 140-199 mg/dL; or an intervening postprandial glucose ≥200 mg/dL at 30, 60, or 90 minutes on two occasions.

Patients who present with clinical symptoms of type 1 diabetes are not eligible for this presymptomatic treatment pathway. Specifically, members with symptoms such as increased urination (polyuria), excessive thirst (polydipsia), or unexplained weight loss are excluded from consideration for Tzield for delaying progression from Stage 2 to Stage 3 Type 1 Diabetes. Additionally, eligibility requires documentation of body surface area and confirmation of dysglycemia and autoantibody criteria per the policy; absence of symptoms is an explicit requirement of the initial approval criteria.

Coverage is limited to a single course of therapy. Coverage cannot be renewed and requests for continuation or additional courses beyond the one-time 14-day treatment are not medically necessary. The policy therefore authorizes only the single 14-dose regimen described under Dosage/Administration.

Coding, dosing, and billing details

Covered HCPCS CodesHCPCSCovered

J9381

Injection, teplizumab-mzwv, 5 mcg; 1 billable unit = 5 mcg

NDCNDC

73650-0316-xx

Tzield 2 mg/2 mL solution for injection as a single-dose vial

Covered Diagnosis Codes (Appendix 1)ICD-10Covered

E10.8	Type 1 diabetes mellitus with unspecified complications
E10.9	Type 1 diabetes mellitus without complications

HCPCS unit and daily dose — inv-07

Maximum billable units per day400 billable units (equivalent to 2,000 mcg) per day

Authorized treatment course length14 consecutive days (single one-time course)

HCPCS billing unit conversion1 billable unit = 5 mcg (use HCPCS code J9381 for billing)

Dosing schedule (body surface area based) — inv-08

Dosing schedule (mcg/m2 by day)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

Route and frequencyAdminister by intravenous infusion once daily for 14 consecutive days (minimum infusion time 30 minutes)

Dose administration cautionDo not administer two doses on the same day; refer to prescribing information for missed doses

Premedication recommendationPremedicate prior to infusion for the first 5 days with an NSAID or acetaminophen, an antihistamine, and/or an antiemetic; give additional doses as needed

Required provider actions, documentation, and billing rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for a single 14-dose course of teplizumab. Coverage is limited to one 14-day treatment course and may not be renewed.

Single 14-dose course only — do not request renewal
Maximum billing: 400 billable units (2,000 mcg) per day for 14 days
Use HCPCS code J9381 (5 mcg per billable unit)

Step Therapy

Step therapy (Medicare)

Medicare members who previously received teplizumab within the past 365 days are exempt from step therapy requirements. For non‑Medicare members, standard step therapy policies may apply where relevant.

Medicare exception: prior receipt within 365 days → no step therapy requirement

Documentation Required

Required documentation to support medical necessity

Documenting medical necessity is required at the time of prior authorization. Include prescriber information, diagnostic confirmation, relevant labs, vaccination status, infection screening, and dosing plan.

Prescriber: name and specialty (must be prescribed by or in consultation with an endocrinologist)
Age: patient is at least 8 years of age
Diagnosis: confirmed Stage 2 Type 1 Diabetes Mellitus with documentation that therapy is to delay progression to Stage 3
Autoantibodies: documentation of two or more pancreatic islet cell autoantibodies within the past 6 months (GAD65, IAA, IA-2A, ZnT8A, ICA)
Glycemic testing: evidence of dysglycemia without overt hyperglycemia within the past 2 months (OGTT results or acceptable alternative; fasting glucose 100–125 mg/dL; 2‑hour 140–199 mg/dL; intervening postprandial ≥200 mg/dL on two occasions)
Symptom status: documentation that the member does not have symptoms of type 1 diabetes (eg, polyuria, polydipsia, weight loss)
Vaccination status: up to date with vaccinations prior to initiation; will not receive live/live‑attenuated vaccines within 8 weeks or inactivated/mRNA vaccines within 2 weeks before or during treatment
Infection screening: absence of active or clinically important localized infections; evaluated/ screened for acute EBV and CMV infection
Laboratory thresholds: lymphocytes ≥1,000/mcL; hemoglobin ≥10 g/dL; platelets ≥150,000/mcL; ANC ≥1,500/mcL; ALT/AST ≤2× ULN; bilirubin ≤1.5× ULN
Prior exposure: documentation that patient has not received prior teplizumab (unless Medicare exception applies)
Body surface area (BSA): current BSA and confirmation dosing will follow the 14‑day BSA‑based schedule

Denial Risk

Denial triggers for not meeting criteria

Denials may be issued when initial criteria are not met. Common denial triggers include age, prescribing specialty, prior treatment, symptomatic disease, vaccination/infection issues, and abnormal laboratory values.

Patient under 8 years of age
Medication not prescribed by or in consultation with an endocrinologist
History of prior teplizumab therapy (unless Medicare exception applies)
Evidence of symptomatic type 1 diabetes (eg, polyuria, polydipsia, weight loss)
Active infection or clinically important localized infection, or incomplete EBV/CMV screening
Vaccinations not up to date or live/live‑attenuated vaccines given within 8 weeks (or inactivated/mRNA vaccines within 2 weeks) before or during therapy
Laboratory values outside allowed thresholds (lymphocytes <1,000/mcL; hemoglobin <10 g/dL; platelets <150,000/mcL; ANC <1,500/mcL; ALT/AST >2× ULN; bilirubin >1.5× ULN)
Intent to treat Type 2 Diabetes Mellitus rather than delay progression of Stage 2 T1D
Requests for renewal or additional courses beyond the single 14‑day course

OpenPayer

Tzield (teplizumab-mzwv) — Coverage Criteria for Delaying Stage 3 Type 1 Diabetes

Coverage criteria for Tzield (teplizumab-mzwv)

Coding, dosing, and billing details

Required provider actions, documentation, and billing rules

Key definitions used in this policy

Background and clinical indication