This policy version was replaced on March 28, 2022. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-policy-and-utilization-management, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).
Teprotumumab is a human monoclonal antibody that targets insulin-like growth factor-1 receptor (IGF-1R), a protein that plays a role in immune function. Pathogenic autoantibodies activating a signaling complex result in inflammation and tissue expansion behind the eyes. Teprotumumab blocks the stimulatory effects of these autoantibodies and is administered via intravenous infusion.
The U.S. Food and Drug Administration (FDA) has approved teprotumumab (Tepezza™) for treatment of thyroid eye disease. Thyroid eye disease, also known as Graves’ ophthalmopathy, occurs in a subset of individuals with Graves’ disease, and is often characterized by a forward protrusion of the eyes. Adverse reactions have occurred in patients treated with teprotumumab, including muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dry skin, dysgeusia, and headache.
Clinical Activity Score: A score used to assess patients with thyroid eye disease based on seven components: spontaneous retrobulbar pain, pain on attempted eye movements, conjunctival redness, redness of the eyelids, chemosis, swelling of the caruncle or plica, and swelling of the eyelids. Each component is scored as present or absent (score of 1 or 0, respectively). Score is summed, with higher scores indicating greater level of inflammation.
Diplopia: Double vision.
Proptosis: Abnormal protrusion of the eye.
I. Review for Teprotumumab (Tepezza™)
Teprotumumab may be considered MEDICALLY NECESSARY AND APPROPRIATE when ALL of the following criteria are met:
II. Experimental/Investigative Uses
All other uses of teprotumumab, including but not limited to restarting an incomplete course of therapy, are considered EXPERIMENTAL/ INVESTIGATIVE due to the lack of clinical evidence demonstrating an impact on improved health outcomes.
Table 1. FDA Labeled Contraindications
FDA Labeled Contraindications
Table 2. Dosing
NOTE: See documentation submission requirements below if the requested dose is higher or more frequent than the dosing criteria provided in this table.
FDA Labeled Indications
Thyroid Eye Disease
10 mg/kg followed by 20 mg/kg every 3 weeks for 7 additional infusions.
Documentation supporting the medical necessity criteria described in the policy must be included in the prior authorization, when prior authorization is required. In addition, the following documentation must also be submitted:
Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. When determining coverage, reference the member’s specific benefit plan, including exclusions and limitations.
Medicaid products may provide different coverage for certain services, which may be addressed in different policies. For Minnesota Health Care Program (MHCP) policies, please consult the MHCP Provider Manual website.
Medicare products may provide different coverage for certain services, which may be addressed in different policies. For Medicare National Coverage Determinations (NCD), Local Coverage Determinations (LCD), and/or Local Coverage Articles, please consult CMS, National Government Services, or CGS websites.
Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.
Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and/or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement.
These guidelines are the proprietary information of Blue Cross and Blue Shield of Minnesota. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.
CPT® codes copyright American Medical Association® 2022. All rights reserved.
CDT codes copyright American Dental Association® 2022. All rights reserved.