Baylor Scott & White Health PlanCommercial Clinical Policy

Teplizumab-mzwv (Tzield™) Form

Chat with GenHealth to automate any policy or prior auth task.


Teplizumab-mzwv (Tzield™)

Indications

(1) The member has a diagnosis of Stage 2 T1D; AND 2) The medication is prescribed by or in consultation with an endocrinologist; AND 3) The member is ≥ 8 years old; AND 4) The member has both of the following: a) Documentation of the presence of at least two of the following pancreatic islet autoantibodies: i) Glutamic acid decarboxylase 65 (GAD65) autoantibody ii) Insulin autoantibody (IAA) iii) Insulinoma-associated antigen 2 autoantibody (IA-2A) iv) Zinc transporter 8 autoantibody (ZnT8A) v) Islet cell autoantibody (ICA) AND b) Documentation of dysglycemia without overt hyperglycemia conducted within 2 months of the request as demonstrated by at least ONE of the following results on an oral glucose tolerance test (OGTT) or alternative method if appropriate and OGTT is not available: i) Fasting blood glucose level of 100 to 125 mg/dL (5.6 to 6.9 mmol/L) ii) 2-hour post-prandial glucose of 140 to 199 mg/dL (7.8 to 11.0 mmol/L) iii) A1c of 5.7 – 6.4% (39 – 47 mmol/mol) AND MEDICAL COVERAGE POLICY SERVICE: Teplizumab-mzwv (Tzield®) Policy Number: 303 Effective Date: 08/01/2025 Last Review: 07/14/2025 Next Review: 07/14/2026 Page 2 of 5 5) The member does NOT have any of the following: a) Clinical diagnosis of T1D (i.e. Stage 3 T1D) b) Type 2 diabetes c) Lymphocyte count less than 1,000 lymphocytes/mcL d) Hemoglobin less than 10 g/dL e) Platelet count less than 150,000 platelets/mcL f) Absolute neutrophil count less than 1,500 neutrophils/mcL g) Elevated ALT or AST greater than 2 times the upper limit of normal (ULN) or bilirubin greater than 1.5 times ULN h) Laboratory or clinical evidence of acute infection with Epstein-Barr virus (EBV) or cytomegalovirus (CMV) i) Active serious infection or chronic active infection other than localized skin infections Approval will be for a one-time 14-day treatment course per lifetime. BSWHP considers only one treatment per lifetime is medically necessary as repeat administration of teplizumab is experimental and investigational because the effectiveness of this strategy has not been established. BSWHP considers teplizumab for the treatment of all other indications to be experimental and investigational because the effectiveness of this strategy has not been established . BACKGROUND: Type 1 Diabetes (T1D) is a chronic, progressive autoimmune condition in which the pancreas does not produce enough insulin due to destruction of beta cells. According to the Centers for Disease Control and Prevention (CDC), about 5%–10% of people with diabetes have type 1, which usually develops in children, teenagers, and young adults, but could happen at any age. An estimated 1.6 million Americans are living with T1D (200,000 youth [˂20 years of age] and 1.4 million adults [≥20 years of age]). Approximately 64,000 people are diagnosed with T1D each year, and 5 million people are expected to have T1D by 2040, including nearly 600,000 youth. Patients who have a genetic susceptibility to developing T1D progress through stages before developing overt hyperglycemia requiring insulin treatment. • Stage 1 is defined by the appearance of autoantibodies indicating the immune system has started attacking beta cells in the pancrease. • Stage 2 involves asymptomatic dysglycemia. • At Stage 3, significant autoimmune destruction of beta cells has occurred, so blood glucose is elevated and patients are symptomatic and require insulin treatment. Eventually, all patients with T1D have to monitor blood sugar levels and are at risk of the same complications as patients with type 2 diabetes (T2D). Acute complications include diabetic ketoacidosis MEDICAL COVERAGE POLICY SERVICE: Teplizumab-mzwv (Tzield®) Policy Number: 303 Effective Date: 08/01/2025 Last Review: 07/14/2025 Next Review: 07/14/2026 Page 3 of 5 which can be potentially life-threatening. Long term damage includes cardiovascular disease, kidney damage, eye disease, and nerve damage. The American Diabetes Association (ADA) recommends screening for autoantibodies in patients with first-degree relatives with T1D. The presence of multiple autoantibodies increases the probability for T1D; 70% of patients with T1D have 3 or 4 autoantibodies, while only 10% have a single autoantibody. The peak age of T1D diagnosis is around 13–14 years, but people can be diagnosed much younger or older. Currently, broad-population screening for T1D does not occur. Interventions at Stage 1 or Stage 2 may delay the progression to Stage 3 T1D. While islet cell transplantation has been used, this treatment requires lifelong immunosuppression. Teplizumab (Tzield) is the first FDA-approved pharmacological therapy for delaying the onset of clinical T1D, and was granted Breakthrough Therapy Designation by the FDA and PRIME designation by the European Medicines Agency (EMA). Teplizumab is an intravenously (IV) administered anti-CD3- directed antibody designed to bind to certain immune system cells and delay progression to Stage 3 T1D. Teplizumab is an Fc receptor nonbinding anti-CD3 monoclonal antibody that modifies CD8+ T lymphocytes, which are thought to be the important effector cells that kill insulin-producing beta cells in the pancreas. In the Phase 2 multicenter TN-10 trial (NCT01030861), teplizumab delayed the onset of Stage 3 T1D by approximately 2 years compared to placebo. It was studied in patients 8 years of age and older who were at high risk of developing clinical diabetes. 76 patients were randomly assigned 1:1 to either teplizumab or placebo. A total of 20 (45%) of the 44 participants who received teplizumab and 23 (72%) of the 32 participants who received placebo had T1D diagnosed over a median follow-up of 51 months. With a median follow-up time of 51 months, therapy with teplizumab resulted in a statistically significant delay in development of Stage 3 T1D, hazard ratio (HR) 0.41 (95% confidence interval [CI]: 0.22 to 0.78; P = 0.0066). The most common adverse reactions (>10%) were lymphopenia, rash, leukopenia and headache Teplizumab is administered once daily for 14 consecutive days, with no additional teplizumab treatment approved. If a planned infusion is missed, dosing is resumed by administering all remaining doses on consecutive days to complete the 14-day treatment course. CODES: Important note: Due to the wide range of applicable diagnosis codes and potential changes to codes, an inclusive list may not be presented, but the following codes may apply. Inclusion of a code in this section does not guarantee that it will be reimbursed, and patient must meet the criteria set forth in the policy language. CPT Codes: 96365 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour 93413 Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug HCPCS Codes: J9381 Injection, teplizumab-mzwv, 5 mcg MEDICAL COVERAGE POLICY SERVICE: Teplizumab-mzwv (Tzield®) Policy Number: 303 Effective Date: 08/01/2025 Last Review: 07/14/2025 Next Review: 07/14/2026 Page 4 of 5 ICD10 codes: E10.10 – E10.9 Type 1 diabetes mellitus ICD10 Not covered: POLICY HISTORY: Status Date Action New 06/28/2023 New policy Updated 07/24/2024 Applied new format and layout Updated 07/14/2024 Updated dysglycemia criteria to align with ADA 2025 Standards of Care in Diabetes. Updated experimental and investigational language for consistency. Updated ending note sections to align with business entity changes. Update 8/11/2025 Removed, Medicare NCD/LCD Interqual statement for clarity. REFERENCES: The following scientific references were utilized in the formulation of this medical policy. BSWHP will continue to review clinical evidence related to this policy and may modify it at a later date based upon the evolution of the published clinical evidence. Should additional scientific studies become available, and they are not included in the list, please forward the reference(s) to BSWHP so the information can be reviewed by the Medical Coverage Policy Committee (MCPC) and the Quality Improvement Committee (QIC) to determine if a modification of the policy is in order. 1. American Diabetes Association Professional Practice Committee. 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes-2025. Diabetes Care. 2025 Jan 1;48(Supplement_1):S27-S49. doi: 10.2337/dc25-S002. PMID: 39651986; PMCID: PMC11635041. 2. Centers for Disease Control and Prevention (CDC). What is type 1 diabetes? Last reviewed March 11, 2022. Accessed? 

Effective Date

NA

Last Reviewed

NA

Original Document

  Reference



MEDICAL COVERAGE POLICY SERVICE: Teplizumab-mzwv (Tzield®) Policy Number: 303 Effective Date: 08/01/2025 Last Review: 07/14/2025 Next Review: 07/14/2026

Page 1 of 5

Important note: Unless otherwise indicated, medical policies will apply to all lines of business. Medical necessity as defined by this policy does not ensure the benefit is covered. This medical policy does not replace existing federal or state rules and regulations for the applicable service or supply. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan documents. See the member plan specific benefit plan document for a complete description of plan benefits, exclusions, limitations, and conditions of coverage. In the event of a discrepancy, the plan document always supersedes the information in this policy.

SERVICE: Teplizumab-mzwv (Tzield®) PRIOR AUTHORIZATION: Required POLICY: Please review the plan’s EOC (Evidence of Coverage) or Summary Plan Description (SPD) for details. For Medicare plans, please refer to appropriate Medicare NCD (National Coverage Determination) or LCD (Local Coverage Determination). If there are no applicable NCD or LCD criteria, use the criteria set forth below. For Medicaid plans, please confirm coverage as outlined in the Texas Medicaid Provider Procedures Manual | TMHP (TMPPM). Texas Mandate HB154 is applicable for Medicaid plans.
Baylor Scott & White Health Plan (BSWHP) may consider teplizumab (Tzield®) medically necessary to delay the onset of Stage 3 type 1 diabetes (T1D) when ALL of the following criteria are met: 1) The member has a diagnosis of Stage 2 T1D; AND 2) The medication is prescribed by or in consultation with an endocrinologist; AND 3) The member is ≥ 8 years old; AND 4) The member has both of the following: a) Documentation of the presence of at least two of the following pancreatic islet autoantibodies: i) Glutamic acid decarboxylase 65 (GAD65) autoantibody ii) Insulin autoantibody (IAA) iii) Insulinoma-associated antigen 2 autoantibody (IA-2A) iv) Zinc transporter 8 autoantibody (ZnT8A) v) Islet cell autoantibody (ICA) AND b) Documentation of dysglycemia without overt hyperglycemia conducted within 2 months of the request as demonstrated by at least ONE of the following results on an oral glucose tolerance test (OGTT) or alternative method if appropriate and OGTT is not available: i) Fasting blood glucose level of 100 to 125 mg/dL (5.6 to 6.9 mmol/L) ii) 2-hour post-prandial glucose of 140 to 199 mg/dL (7.8 to 11.0 mmol/L) iii) A1c of 5.7 – 6.4% (39 – 47 mmol/mol)
AND

MEDICAL COVERAGE POLICY SERVICE: Teplizumab-mzwv (Tzield®) Policy Number: 303 Effective Date: 08/01/2025 Last Review: 07/14/2025 Next Review: 07/14/2026

Page 2 of 5

5) The member does NOT have any of the following: a) Clinical diagnosis of T1D (i.e. Stage 3 T1D) b) Type 2 diabetes c) Lymphocyte count less than 1,000 lymphocytes/mcL d) Hemoglobin less than 10 g/dL e) Platelet count less than 150,000 platelets/mcL f) Absolute neutrophil count less than 1,500 neutrophils/mcL g) Elevated ALT or AST greater than 2 times the upper limit of normal (ULN) or bilirubin greater than 1.5 times ULN h) Laboratory or clinical evidence of acute infection with Epstein-Barr virus (EBV) or cytomegalovirus (CMV) i) Active serious infection or chronic active infection other than localized skin infections

Approval will be for a one-time 14-day treatment course per lifetime.
BSWHP considers only one treatment per lifetime is medically necessary as repeat administration of teplizumab is experimental and investigational because the effectiveness of this strategy has not been established. BSWHP considers teplizumab for the treatment of all other indications to be experimental and investigational because the effectiveness of this strategy has not been established . BACKGROUND: Type 1 Diabetes (T1D) is a chronic, progressive autoimmune condition in which the pancreas does not produce enough insulin due to destruction of beta cells. According to the Centers for Disease Control and Prevention (CDC), about 5%–10% of people with diabetes have type 1, which usually develops in children, teenagers, and young adults, but could happen at any age. An estimated 1.6 million Americans are living with T1D (200,000 youth [˂20 years of age] and 1.4 million adults [≥20 years of age]). Approximately 64,000 people are diagnosed with T1D each year, and 5 million people are expected to have T1D by 2040, including nearly 600,000 youth. Patients who have a genetic susceptibility to developing T1D progress through stages before developing overt hyperglycemia requiring insulin treatment. • Stage 1 is defined by the appearance of autoantibodies indicating the immune system has started attacking beta cells in the pancrease. • Stage 2 involves asymptomatic dysglycemia. • At Stage 3, significant autoimmune destruction of beta cells has occurred, so blood glucose is elevated and patients are symptomatic and require insulin treatment. Eventually, all patients with T1D have to monitor blood sugar levels and are at risk of the same complications as patients with type 2 diabetes (T2D). Acute complications include diabetic ketoacidosis

MEDICAL COVERAGE POLICY SERVICE: Teplizumab-mzwv (Tzield®) Policy Number: 303 Effective Date: 08/01/2025 Last Review: 07/14/2025 Next Review: 07/14/2026

Page 3 of 5

which can be potentially life-threatening. Long term damage includes cardiovascular disease, kidney damage, eye disease, and nerve damage. The American Diabetes Association (ADA) recommends screening for autoantibodies in patients with first-degree relatives with T1D. The presence of multiple autoantibodies increases the probability for T1D; 70% of patients with T1D have 3 or 4 autoantibodies, while only 10% have a single autoantibody. The peak age of T1D diagnosis is around 13–14 years, but people can be diagnosed much younger or older. Currently, broad-population screening for T1D does not occur. Interventions at Stage 1 or Stage 2 may delay the progression to Stage 3 T1D. While islet cell transplantation has been used, this treatment requires lifelong immunosuppression. Teplizumab (Tzield) is the first FDA-approved pharmacological therapy for delaying the onset of clinical T1D, and was granted Breakthrough Therapy Designation by the FDA and PRIME designation by the European Medicines Agency (EMA). Teplizumab is an intravenously (IV) administered anti-CD3- directed antibody designed to bind to certain immune system cells and delay progression to Stage 3 T1D. Teplizumab is an Fc receptor nonbinding anti-CD3 monoclonal antibody that modifies CD8+ T lymphocytes, which are thought to be the important effector cells that kill insulin-producing beta cells in the pancreas.
In the Phase 2 multicenter TN-10 trial (NCT01030861), teplizumab delayed the onset of Stage 3 T1D by approximately 2 years compared to placebo. It was studied in patients 8 years of age and older who were at high risk of developing clinical diabetes. 76 patients were randomly assigned 1:1 to either teplizumab or placebo. A total of 20 (45%) of the 44 participants who received teplizumab and 23 (72%) of the 32 participants who received placebo had T1D diagnosed over a median follow-up of 51 months. With a median follow-up time of 51 months, therapy with teplizumab resulted in a statistically significant delay in development of Stage 3 T1D, hazard ratio (HR) 0.41 (95% confidence interval to 0.78; P = 0.0066). The most common adverse reactions (>10%) were lymphopenia, rash, leukopenia and headache Teplizumab is administered once daily for 14 consecutive days, with no additional teplizumab treatment approved. If a planned infusion is missed, dosing is resumed by administering all remaining doses on consecutive days to complete the 14-day treatment course. CODES: Important note: Due to the wide range of applicable diagnosis codes and potential changes to codes, an inclusive list may not be presented, but the following codes may apply. Inclusion of a code in this section does not guarantee that it will be reimbursed, and patient must meet the criteria set forth in the policy language.

CPT Codes: 96365 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour 93413 Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug HCPCS Codes: J9381 Injection, teplizumab-mzwv, 5 mcg

MEDICAL COVERAGE POLICY SERVICE: Teplizumab-mzwv (Tzield®) Policy Number: 303 Effective Date: 08/01/2025 Last Review: 07/14/2025 Next Review: 07/14/2026

Page 4 of 5

ICD10 codes: E10.10 – E10.9 Type 1 diabetes mellitus ICD10 Not covered:

POLICY HISTORY: Status Date Action New 06/28/2023 New policy Updated 07/24/2024 Applied new format and layout Updated 07/14/2024 Updated dysglycemia criteria to align with ADA 2025 Standards of Care in Diabetes. Updated experimental and investigational language for consistency. Updated ending note sections to align with business entity changes. Update 8/11/2025 Removed, Medicare NCD/LCD Interqual statement for clarity.

REFERENCES:

The following scientific references were utilized in the formulation of this medical policy. BSWHP will continue to review clinical evidence related to this policy and may modify it at a later date based upon the evolution of the published clinical evidence. Should additional scientific studies become available, and they are not included in the list, please forward the reference(s) to BSWHP so the information can be reviewed by the Medical Coverage Policy Committee (MCPC) and the Quality Improvement Committee (QIC) to determine if a modification of the policy is in order.

  1. American Diabetes Association Professional Practice Committee. 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes-2025. Diabetes Care. 2025 Jan 1;48(Supplement_1):S27-S49. doi: 10.2337/dc25-S002. PMID: 39651986; PMCID: PMC11635041.
  2. Centers for Disease Control and Prevention (CDC). What is type 1 diabetes? Last reviewed March 11, 2022. Accessed November 30, 2022. https://www.cdc.gov/diabetes/basics/what-is-type-1-diabetes.html
  3. Crossen S, et al. Changing costs of type 1 diabetes care among US children and adolescents. Pediatr Diabetes. 2020;21(4):644-648. doi:10.1111/pedi.12996
  4. Ghalwash M, et al. Two-age islet-autoantibody screening for childhood type 1 diabetes: a prospective cohort study. Lancet Diabetes Endocrinol. 2022;10(8):589–596. doi:10.1016/S2213-8587(22)00141-3
  5. Hagopian W, Ferry RJ Jr, Sherry N, et al. Teplizumab preserves C-peptide in recent-onset type 1 diabetes: two-year results from the randomized, placebo-controlled Protégé trial. Diabetes. 2013;62(11):3901-3908. doi:10.2337/db13-0236
  6. Herold KC, Gitelman SE, Ehlers MR, et al. Teplizumab (anti-CD3 mAb) treatment preserves C-peptide responses in patients with new-onset type 1 diabetes in a randomized controlled trial: metabolic and immunologic features at baseline identify a subgroup of responders. Diabetes. 2013a;62(11):3766-3774. doi:10.2337/db13-0345
  7. Herold KC, Gitelman SE, Willi SM, et al. Teplizumab treatment may improve C-peptide responses in participants with type 1 diabetes after the new-onset period: a randomised controlled trial. Diabetologia. 2013b;56(2):391-400. doi:10.1007/s00125-012-2753-4
  8. Herold KC, et al. An anti-CD3 antibody, teplizumab, in relatives at risk for type 1 diabetes [published correction appears in N Engl J Med. 2020 Feb 6;382(6):586]. N Engl J Med. 2019;381(7):603–613. doi:10.1056/NEJMoa1902226
  9. Insel RA, Dunne JL, Atkinson MA, et al. Staging presymptomatic type 1 diabetes: a scientific statement of JDRF, the Endocrine Society, and the American Diabetes Association. Diabetes Care. 2015;38(10):1964-1974. doi:10.2337/dc15-

MEDICAL COVERAGE POLICY SERVICE: Teplizumab-mzwv (Tzield®) Policy Number: 303 Effective Date: 08/01/2025 Last Review: 07/14/2025 Next Review: 07/14/2026

Page 5 of 5

1419

  1. Juvenile Diabetes Research Foundation (JDRF). Type 1 diabetes facts. Accessed November 29, 2022. https://www.jdrf.org/t1d-resources/about/facts/
  2. Mital, S, et al. Cost effectiveness of teplizumab for prevention of type 1 diabetes among different target patient groups. PharmacoEconomics. 2020;38(12):1359–1372. doi:10.1007/s40273-020-00962-y
  3. Perdigoto AL, Preston-Hurlburt P, Clark P, et al. Treatment of type 1 diabetes with teplizumab: clinical and immunological follow-up after 7 years from diagnosis. Diabetologia. 2019;62(4):655-664. doi:10.1007/s00125-018-4786-9
  4. Regnell SE, Lernmark Å. Early prediction of autoimmune (type 1) diabetes. Diabetologia. 2017;60(8):1370-1381. doi:10.1007/s00125-017-4308-1
  5. Sherry N, Hagopian W, Ludvigsson J, et al. Teplizumab for treatment of type 1 diabetes (Protégé study): 1-year results from a randomised, placebo- controlled trial. Lancet. 2011;378(9790):487-497. doi:10.1016/S0140-6736(11)60931-8
  6. Sims EK, et al. Teplizumab improves and stabilizes beta cell function in antibody-positive high-risk individuals. Sci Transl Med. 2021;13(583):eabc8980. doi:10.1126/scitranslmed.abc8980

  7. Sims EK, Cuthbertson D, Herold KC, Sosenko JM. The deterrence of rapid metabolic decline within 3 months after teplizumab treatment in individuals at high risk for type 1 diabetes. Diabetes. 2021b;70(12):2922-2931. doi:10.2337/db21- 0519

    Note: Health Maintenance Organization (HMO) products are offered through Scott and White Health Plan dba Baylor Scott & White Health Plan, and Scott & White Care Plans dba Baylor Scott & White Care Plan. Insured PPO and EPO products are offered through Baylor Scott & White Insurance Company. Scott and White Health Plan dba Baylor Scott & White Health Plan serves as a third-party administrator for self-funded employer-sponsored plans. Baylor Scott & White Care Plan and Baylor Scott & White Insurance Company are wholly owned subsidiaries of Scott and White Health Plan. These companies are referred to collectively in this document as Baylor Scott & White Health Plan. RightCare STAR Medicaid is offered through Scott and White Health Plan in the Central Texas Medicaid Rural Service Area (MRSA); FirstCare STAR is offered through SHA LLC dba FirstCare Health Plans (FirstCare) in the Lubbock and West MRSAs; and FirstCare CHIP is offered through FirstCare in the Lubbock Service Area.

Book a walkthrough

Walk through this policy with us

Review how this policy can be converted into cited criteria, prior authorization checks, and operational automation.