Teprotumumab-trbw (Tepezza) (Medicaid Expansion)

Policy ID: ME-I-220-004-03

Section: Injections

Effective Date: January 01, 2022

Revised Date: July 24, 2023

Revision Effective Date: August 01, 2023

Last Reviewed: July 26, 2023

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.

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)

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 U.S. Food and Drug Administration (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

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-220-004-02

Section: Injections

Effective Date: January 01, 2022

Revised Date: November 29, 2022

Revision Effective Date: January 01, 2023

Last Reviewed: November 29, 2022

Archived Date: July 31, 2023

Applies To: Medicaid Expansion Only

Description

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

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 individual must meet FDA-approved label for use (e.g., use outside of studied population will be considered investigational); and
Teprotumumab-trbw (Tepezza) must be prescribed by, or in consult annually with, endocrinologist, ophthalmologist, or specialist in the treatment of Graves’ disease associated with Thyroid Eye Disease (TED); and
The individual must have a diagnosis of moderate to severe Graves’ disease associated with Thyroid Eye Disease; and
The onset of Thyroid Eye Disease (TED) symptoms is within nine (9) months of request for treatment; and
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; and
- Must have a Clinical Activity Score of greater than or equal to four (4); and
The individual has had a one (1)-month trial of a maximally tolerated indicated dose of systemic glucocorticoids; and
The individual has not required prior surgical ophthalmologic intervention; and
The individual does not have any of the following:
- A decrease in best corrected visual acuity (BVCA) due to optic neuropathy within the previous six (6) months (i.e., decrease in vision of two (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 Codes

J3241

Diagnosis Codes

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

Links

References (PDF)

Disclaimer

Our Partners in Health:
Members
Employers
Producers

Fargo (Headquarters)
4510 13th Ave. S.
Fargo, N.D., 58121

Medical Policies Quick Search

Teprotumumab-trbw (Tepezza) (Medicaid Expansion)

Description

Criteria

Procedure Code

Diagnosis Code

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Criteria

Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer