CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Teprotumumab (Tepezza) — Coverage Criteria for Thyroid Eye Disease (TED)

Policy governs coverage and pharmacy benefit use of teprotumumab (Tepezza) for treatment of thyroid eye disease (TED) for Medicaid members; defines authorization length, dosing limits, eligibility and renewal rules, and required prescriber specialties.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTeprotumumab (Tepezza) — Coverage Criteria for Thyroid Eye Disease (TED)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization limited to 6 months (maximum 8 infusions) and document specialist consultation, age, thyroid status, prior IV glucocorticoid trial or contraindication, and dosing (HCPCS J3241 units or NDC).

SourceLink

6 monthsLength of authorization

18+Minimum age

J3241HCPCS unit

115 → 230 unitsDose pattern

Coverage Criteria for Teprotumumab (Tepezza)

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Age: Patient is at least 18 years old

Prescriber: Prescribed by, or in consultation with, a specialist in ophthalmology, endocrinology, oculoplastic surgery, or neuro-ophthalmology

Thyroid function: Patient is euthyroid; mild hyper- or hypothyroidism permitted (defined as FT4 and FT3 levels <50% above or below normal) and should be corrected promptly

Ocular and metabolic status: No corneal decompensation unresponsive to medical management and no poorly controlled diabetes

Treatment intent: Teprotumumab (Tepezza) is used as single-agent therapy and is not for retreatment

Disease-specific

Disease activity/prior therapy
- Active disease pathway: Patient has active TED
- Prior glucocorticoid pathway: Patient had inadequate response to, or has a contraindication or intolerance to, high-dose intravenous glucocorticoids
- Inactive disease pathway: Patient has inactive TED

Coding, Units, and NDCs

Covered HCPCS CodesHCPCSCovered

J3241

Injection, teprotumumab-trbw, 10 mg (1 billable unit = 10 mg)

NDCNDCCovered

75987-0130-xx

Tepezza 500 mg single-dose vial for injection

Covered Diagnosis Codes (Appendix 1)ICD-10Covered

E05.00

Thyrotoxicosis with diffuse goiter without thyrotoxic crisis or storm (hyperthyroidism)

Dose units per infusion

Initial billable units115 billable units (initial dose)

Subsequent billable units230 billable units every 3 weeks for subsequent doses

HCPCS unit definitionJ3241: 1 billable unit = 10 mg (see coding for code mapping)

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required — initial authorization limited to 6 months (maximum of 8 infusions). Coverage will be provided for 6 months and may not be renewed.

Initial authorization: 6 months (maximum 8 total infusions).
Quantity/dosing limits apply (see dosing limits).

Step Therapy

Prior Therapy Requirement

Prior therapy requirement — patient must have had inadequate response to, or a contraindication/intolerance of, high‑dose IV glucocorticoids for active Thyroid Eye Disease (TED) before teprotumumab is approved.

Applies when treating active TED related to Graves' disease.
Documentation of prior IV glucocorticoid trial or clear contraindication/intolerance required.

Documentation Required

Required Documentation

Required documentation — include prescriber specialty, patient age, disease activity, prior therapy details, and other clinical information to support the request.

Prescriber: ophthalmologist, endocrinologist, oculoplastic surgeon, or neuro‑ophthalmologist (or consult with these specialists).
Patient age: must be ≥ 18 years.
Disease activity: documentation that TED is active and related to Graves' disease.
Prior therapy: evidence of inadequate response to high‑dose IV glucocorticoids or documentation of contraindication/intolerance.
Clinical exclusions: absence of corneal decompensation unresponsive to medical management and absence of poorly controlled diabetes.

Denial Risk

Triggers for Denial

Triggers for denial — renewal requests will be denied; patients under 18 years of age will be denied; and requests from prescribers outside the required specialties or without appropriate consultation will be denied.

Renewal requests are not approved — initial authorization is non‑renewable.
Patients younger than 18 years are not eligible.
Prescriptions must be from (or in consultation with) an ophthalmologist, endocrinologist, oculoplastic surgeon, or neuro‑ophthalmologist — requests from other specialties without required consultation will be denied.

Definitions and Background

Euthyroid / mild thyroid dysfunction

Required thyroid statusPatient must be euthyroid; mild hyper- or hypothyroidism is permitted

Definition of mild dysfunctionFT4 and FT3 levels less than 50% above or below normal limits

Management expectationEvery effort should be made to correct mild hyper- or hypothyroidism promptly

Active disease

Clinical diagnosis requirementClinical diagnosis of thyroid eye disease (TED) related to Graves' disease is required

Activity requirementPatient must have active inflammatory disease (policy specifies active disease as an eligibility criterion)

Prior therapy alternativeOR patient had inadequate response, contraindication, or intolerance to high‑dose IV glucocorticoids

Thyroid eye disease (TED) is an inflammatory orbital condition associated with Graves’ disease that can cause proptosis, diplopia, and vision‑threatening complications. Teprotumumab (Tepezza) is an anti‑IGF‑1R monoclonal antibody administered intravenously for TED and is indicated for patients with an active clinical diagnosis of TED related to Graves’ disease. Per policy, treatment is restricted to adults (minimum age 18 years), requires specialist prescribing or consultation (ophthalmology, endocrinology, oculoplastic surgery, or neuro‑ophthalmology), and is intended as a single course of therapy rather than for retreatment. Patients should be euthyroid (mild thyroid dysfunction is permitted if promptly addressed) and must not have corneal decompensation unresponsive to medical management or poorly controlled diabetes.