Teprotumumab-trbw (Tepezza) (Medicaid Expansion)

Policy ID: ME-I-220-004-05

Section: Injections

Effective Date: January 01, 2022

Revised Date: February 28, 2025

Revision Effective Date: April 01, 2025

Last Reviewed: March 11, 2025

Applies To: Medicaid Expansion Only

Description

Teprotumumab-trbw (Tepezza) binds to IGF-1R and blocks its activation and signaling.

There is a risk of hyperglycemia with teprotumumab-trbw (Tepezza) and, if an individual is diabetic, glycemic control medications may need to be adjusted as appropriate. Compliance with glycemic control should be encouraged.

There is a risk of inflammatory bowel disease (IBD) with teprotumumab-trbw (Tepezza). Individual should be advised to seek medical advice immediately if they experience diarrhea, with or without blood or rectal bleeding, associated with abdominal pain or cramping/colic, urgency, tenesmus or incontinence.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

The use of teprotumumab-trbw (Tepezza) may be considered medically necessary when ALL of the following criteria are met:

The member must meet FDA-approved label for use (e.g., use outside of studied population will be considered investigational); and
The requested medication must be prescribed by, or in consult annually with, endocrinologist, ophthalmologist, or specialist in the treatment of Thyroid Eye Disease (TED); and
If the member is a current tobacco user, the member must have received tobacco cessation counseling in the past year; and
The member has one of the following:
- Inflamed eyes with increasing diplopia; or
- Proptosis ≥ 3 mm above ULN; or
- Lid retraction of > 2 mm; or
- Moderate to severe-soft tissue involvement; and
The provider must submit documentation of each of the following:
- Free thyroxine (FT4) and free triiodothyronine (FT3) levels are within normal limits; and
- Must have a Clinical Activity Score of greater than or equal to 4; and
The member has failed a one-month trial of a maximally tolerated indicated dose of IV systemic glucocorticoids; and
The member has not required prior surgical ophthalmologic intervention.

Authorization: Six (6) months (eight (8) infusions per lifetime)

Teprotumumab-trbw (Tepezza) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J3241

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Code

E05.00

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-23-2021- Effective January 1, 2022

Adopted Medicaid Expansion specific policy

Internal Medical Policy Committee 11-29-2022 - Effective January 1, 2023

Updated initial criteria, and
Updated experimental/investigational statement

Internal Medical Policy Committee 7-26-2023 - Effective August 01, 2023

Updated criteria based on the DHHS PDL Version 2023.3

Internal Medical Policy Committee 7-16-2024 Effective September 01, 2024

Annual review no clinical content change

Internal Medical Policy Committee 03-11-2025 Effective April 01, 2025

Updated criteria required based on the DHHS PDL Version 2025.2

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: ME-I-220-004-04

Section: Injections

Effective Date: January 01, 2022

Revised Date: July 10, 2024

Revision Effective Date: September 01, 2024

Last Reviewed: July 16, 2024

Archived Date: March 31, 2025

Applies To: Medicaid Expansion Only

Description

Teprotumumab-trbw (Tepezza) binds to IGF-1R and blocks its activation and signaling.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

The use of teprotumumab-trbw (Tepezza) may be considered medically necessary when ALL of the following criteria are met:

The member must meet FDA-approved label for use (e.g., use outside of studied population will be considered investigational)
The requested medication must be prescribed by, or in consult annually with, endocrinologist, ophthalmologist, or specialist in the treatment of Thyroid Eye Disease (TED)
The provider must submit documentation of each of the following:
- Thyroxine (FT4) and free triiodothyronine (FT3) levels less than 50% above or below normal limits
- Must have a Clinical Activity Score of greater than or equal to 4
The member has had a one-month trial of a maximally tolerated indicated dose of systemic glucocorticoids.
The member has not required prior surgical ophthalmologic intervention
The member does not have any of the following:
- A decrease in best corrected visual acuity (BVCA) due to optic neuropathy within the previous six months (i.e., decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement)
- Corneal decompensation that is unresponsive to medical management
- Poorly controlled diabetes or diabetes must be maximally treated by, or in consult with, an endocrinologist with good adherence.

Authorization: Six (6) months (eight (8) infusions per lifetime)

Procedure Code

J3241

Diagnosis Code

E05.00

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-23-2021- Effective January 1, 2022

Adopted Medicaid Expansion specific policy

Internal Medical Policy Committee 11-29-2022 - Effective January 1, 2023

Updated initial criteria, and
Updated experimental/investigational statement

Internal Medical Policy Committee 7-26-2023 - Effective August 01, 2023

Updated criteria based on the DHHS PDL Version 2023.3

Internal Medical Policy Committee 7-16-2024 Effective September 01, 2024

Annual review no clinical content change

Medical Policies Quick Search

Teprotumumab-trbw (Tepezza) (Medicaid Expansion)

Description

Policy Application

Criteria

Procedure Code

Diagnosis Code

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Policy Application

Criteria

Procedure Code

Diagnosis Code

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer