Teprotumumab-trbw (Tepezza)

Policy ID: I-220-007

Section: Injections

Effective Date: April 01, 2020

Revised Date: September 05, 2023

Revision Effective Date: November 01, 2023

Last Reviewed: September 12, 2023

Applies To: Commercial 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.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

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

Individual is 18 years of age or older; and
Individual has a diagnosis of Thyroid associated orbitopathy [thyroid eye disease (TED)]; and
Individual does not require immediate surgical ophthalmological intervention; and
Individual does not have clinically significant optic neuropathy (Individual has not had a decrease in best corrected visual acuity (BVCA) 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); and
Individual does not have corneal decompensation unresponsive to medical management; and
Individual is euthyroid, mild hypothyroid, mild hyperthyroid (defined as free thyroxine (FT4) and free triiodothyronine (FT3) levels less than 50 percent above or below the normal limits) or seeking care for dysthyroid state from an endocrinologist or other provider experienced in the treatment of thyroid diseases; and
If individual is diabetic, individual is being managed by an endocrinologist or other provider experienced in the treatment and stabilization of diabetes; and
Individual is not pregnant; and
Authorization period is for one (1) course of therapy.

Reauthorization Criteria

More than one (1) course of therapy of eight (8) infusions of teprotumumab-trbw (Tepezza) is considered experimental/investigational. Scientific evidence does not support more than one (1) course of therapy of eight (8) infusions.

The use of 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 Codes

E05.00

E05.01

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 3-16-2020

Adopted new policy

Internal Medical Policy Committee 7-22-2020 - Effective July 01, 2020

Added new code, C9061

Internal Medical Policy Committee 9-21-2020

Removed procedure code C9061; and
Added new procedure code J3241

Internal Medical Policy Committee 1-19-2020 Annual review, no clinical content change

Internal Medical Policy Committee 1-19-2021 Annual review, no clinical content change

Internal Medical Policy Committee 1-20-2022

Updated criteria wording; and
Added diagnosis code E05.01

Internal Medical Policy Committee 1-26-2023 Annual review, no clinical content change

Internal Medical Policy Committee 3-23-2023 Effective May 01, 2023

Removed criteria 'Onset of TED symptoms within 9-12 months prior'
Updated experimental/investigational statement

Internal Medical Policy Committee 9-12-2023 - Effective November 01, 2023

Updated criteria per Food and Drug Administration (FDA) labeling
- Removed "moderate to severe"
- Removed "Clinical activity score (see table below) of greater than or equal to four (4)"
Removed Professional Statements and Societal Positions Guidelines

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: I-220-006

Section: Injections

Effective Date: April 01, 2020

Revised Date: March 13, 2023

Revision Effective Date: May 01, 2023

Last Reviewed: March 23, 2023

Archived Date: October 31, 2023

Applies To: Commercial 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.

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

Individual is 18 years of age or older; and
Individual has a diagnosis of moderate to severe Thyroid associated orbitopathy [thyroid eye disease (TED)]; and
Clinical activity score (see table below) of greater than or equal to four (4); and
Individual does not require immediate surgical ophthalmological intervention; and
Individual does not have clinically significant optic neuropathy (Individual has not had a decrease in best corrected visual acuity (BVCA) 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); and
Individual does not have corneal decompensation unresponsive to medical management; and
Individual is euthyroid, mild hypothyroid, mild hyperthyroid (defined as free thyroxine (FT4) and free triiodothyronine (FT3) levels less than 50 percent above or below the normal limits) or seeking care for dysthyroid state from an endocrinologist or other provider experienced in the treatment of thyroid diseases; and
If individual is diabetic, individual is being managed by an endocrinologist or other provider experienced in the treatment and stabilization of diabetes; and
Individual is not pregnant; and
Authorization period is for one (1) course of therapy.

Reauthorization Criteria

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 Codes

E05.00

E05.01

Professional Statements and Societal Positions Guidelines

Adapted from Endocrine Society Publication. Diagnosis of Graves' Orbitopathy (DiaGO). J Clin Endocrinol Metab . 2015;100(3):E458-E462.

Clinical Activity Score for Graves Orbitopathy

For each item present, one (1) point is given. The sum of these points is the clinical activity score

Pain

Painful oppressive feeling on or behind the globe, during the last four (4) weeks

Pain on attempted u, side or down gaze, during the last four (4) weeks

Redness

Redness of the eyelid(s)

Diffuse redness of the conjunctiva, covering at least one (1) quadrant

Swelling

Swelling of the eyelid(s)

Chemosis

Swollen caruncle

Increase of proptosis of greater than or equal to 2mm during a period of 1-3 months

Impaired function

Decrease of eye movements in any direction greater than or equal to 5o during a period of 1-3 months

Decrease of visual activity of greater than or equal to one (1) line(s) on the Snellen chart (using a pinhole) during a period of 1-3 months