Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Tepezza (teprotumumab) requires prior authorization.

2)    Tepezza is indicated to treat thyroid eye disease (TED).

3)    Tepezza is covered under the medical benefit.

I. Initial Approval Criteria A. Thyroid Eye Disease (must meet all):

A. Diagnosis of Graves’ disease with associated TED (i.e., Graves’ ophthalmopathy, Graves’ orbitopathy);

B. Member has active TED with a clinical activity score (CAS) of ≥ 4 (see Appendix D);

C. Prescribed by or in consultation with an ophthalmologist;

D. Age ≥ 18 years;

E. One of the following (a or b):

a. Member is euthyroid with documentation of a recent (within the last 30 days) free thyroxine (FT4) and total triiodothyronine (T3) or free T3 (FT3) levels within the laboratory defined reference range;

b. Member has a recent (within the last 30 days) free thyroxine (FT4) and total triiodothyronine (T3) or free T3 (FT3) levels less than 50% above or below the laboratory defined reference range and is undergoing treatment to correct the mild hypo- or hyperthyroidism to maintain a euthyroid state;

F. Member has not had previous surgical intervention for TED;

G. Member does not require surgical ophthalmological intervention;

H. Failure of a 4-week trial of a systemic corticosteroid (at up to maximally indicated doses), unless clinically significant adverse effects are experienced or all are contraindicated;

I. Member has not received ≥ 8 Tepezza infusions (including the initial 10 mg/kg first infusion);

J. Dose does not exceed both of the following (a and b):

a. A single 10 mg/kg dose followed by seven 20 mg/kg infusions given every 3 weeks;

b. Vial quantity as identified by the online dose calculator using the member’s weight or as recommended in for vial rounding.

Approval duration: 6 months (up to 8 total lifetime infusions)

II. Continued Therapy

A. Thyroid Eye Disease (must meet all):

1. Member is currently receiving medication via QualChoice benefit or member has previously met initial approval criteria;

2. Member is responding positively to therapy as evidenced by both of the following (a and b):

a. Reduction in proptosis ≥ 2 mm;

b. Reduction in CAS from baseline of ≥ 2 points;

3. Member has not had previous surgical intervention for TED;

4. Member does not require surgical ophthalmological intervention;

5. Member has not received ≥ 8 Tepezza infusions (including the initial 10 mg/kg first infusion);

6. If request is for a dose increase, new dose does not exceed both of the following (a and b):

a. A total of seven 20 mg/kg infusions given every 3 weeks;

b. Vial quantity as identified by the online dose calculator using the member’s weight or as recommended for vial rounding.

Approval duration: 6 months (up to 8 total lifetime infusions)

Codes Used In This BI:

1)    J3241 – Injection, teprotumumab-trbw, 10mg

Tepezza Prescribing Information. Deerfield, IL: Horizon Therapeutics USA, Inc.; October 2021. Available at: https://www.hzndocs.com/TEPEZZA-Prescribing-Information.pdf. Accessed September 19, 2022.

2. NCT03298867 in ClinicalTrials.gov. NIH U.S. National Library of Medicine. Available at: https://clinicaltrials.gov/ct2/show/NCT03298867?term=NCT03298867&draw=2&rank=1. Accessed October 7, 2021.

3. Douglas RS, Kahaly GJ, Patel A, et al. Teprotumumab for the Treatment of Active Thyroid Eye Disease. N Engl J Med. 2020 Jan 23;382(4):341-352.

4. Smith TJ, Kahaly GJ, Ezra DG, et al. Teprotumumab for Thyroid-Associated Ophthalmopathy. N Engl J Med. 2017 May 4;376(18):1748-1761.

5. 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; 26:1343.

6. Mourits MP, Prummel MF, Wiersinga WM, Koornneef L. Clinical activity score as a guide in the management of patients with Graves` ophthalmopathy. Clin Endocrinol (Oxf) 1997; 47:9.

7. Smith TJ, Kahaly GJ, Ezra DG, et al. Teprotumumab for Thyroid-Associated Ophthalmopathy. NEJM 2017; 376 (18): 1748-1761.

8. Patel KN, Yip L, Lubitz CC, et al. The American Association of Endocrine Surgeons Guidelines for the Definitive Surgical Management of Thyroid Disease in Adults. Annals of Surgery: March 2020; 271 (3): e21-e93.

9. Bartalena L, Kahaly GJ, Baldeschi L, et al. The 2021 European Group on Graves’ orbitopathy (EUGOGO) clinical practice guidelines for the medical management of Graves’ orbitopathy. European Journal of Endocrinology: 27 August 2021; 185 (4): G43-G67.