IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-Approved Indication
Tepezza is indicated for the treatment of thyroid eye disease regardless of thyroid eye disease activity or duration.
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review: Supporting chart notes or medical record indicating moderate-to-severe disease as applicable to Section V.
III. EXCLUSIONS
Coverage will not be provided for repeat series of Tepezza infusions.
IV. PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with an ophthalmologist.
V. CRITERIA FOR INITIAL APPROVAL
Thyroid eye disease (TED)
Authorization of 6 months may be granted for treatment of TED when all of the following criteria are met:
A. Member is 18 years of age or older
B. Member has moderate-to-severe (active and inactive) disease (see Appendix A)
C. Member will not exceed a one-time treatment course consisting of 8 infusions given once every 3 weeks (10mg/kg on first infusion, followed by 20mg/kg every 3 weeks for 7 additional infusions).
VI. APPENDIX
Appendix A: Disease Severity Assessment
1. Mild disease, at least one of the following:
a. Minor lid retraction (<2 mm)
b. Mild soft-tissue involvement
c. Exophthalmos <3 mm above normal for race and gender
d. No or intermittent diplopia
e. Corneal exposure responsive to lubricants
2. Moderate-to-severe disease, at least one of the following:
a. Lid retraction ≥2 mm
b. Moderate or severe soft-tissue involvement
c. Exophthalmos ≥3 mm above normal for race and gender
d. Inconstant or constant diplopia
3. Sight-threatening disease, at least one of the following:
a. Dysthyroid optic neuropathy (DON)
b. Corneal breakdown
MEDICATION QUANTITY LIMITS
Drug Name |
Diagnosis |
Maximum Dosing Regimen |
Tepezza (Teprotumumab-trbw) |
Thyroid Eye Disease |
Route of Administration: Intravenous ≥18 Years Initial:10mg/kg once Maintenance: 20mg/kg every 3 weeks for 7 doses |
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
1. Tepezza [package insert]. Deerfield, IL: Horizon Therapeutics USA Inc; April 2023.
2. Bartalena L, Kahaly L, Baldeschi L, et al. The 2021 European Thyroid Association/European Group on Graves' Orbitopathy guidelines for the management of Graves' orbitopathy. Eur J Endocrinol. 2021. ;185(4):G43-G67.
3. Ross DS, Burch HB, Cooper DS, et al. 2016 American Thyroid Association guidelines for diagnosis and management of hyperthyroidism and other causes of thyrotoxicosis. Thyroid. 2016;26(10):1343-1421.
4. Burch HB, Perros P, Bednarczuk T, Cooper DS, et al. Management of Thyroid Eye Disease: A Consensus Statement by the American Thyroid Association and the European Thyroid Association. Thyroid. 2022 Dec;32(12):1439-1470.
5. ClinicalTrials.gov [Internet]. Bethesda, MD: National Library of Medicine. 2023 March 16 NCT04583735, A Study Evaluating TEPEZZA® Treatment in Patients with Chronic (Inactive) Thyroid Eye Disease; Accessed 2023 April 23.
ORIGINAL EFFECTIVE DATE: 4/1/2020
MOST RECENT REVIEW DATE: 4/1/2024
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.