CurrentBlue Cross Blue Shield - IowaPolicy 05.03.93

Tepezza (teprotumumab-trbw) for thyroid eye disease — Prior Authorization and Medical Necessity Criteria

This policy governs prior authorization and medical necessity criteria for Tepezza (teprotumumab-trbw) treatment of thyroid eye disease for Wellmark/Blue Cross Blue Shield members in Iowa.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyTepezza (teprotumumab-trbw) for thyroid eye disease — Prior Authorization and Medical Necessity Criteria

Policy CodePolicy 05.03.93

Change TypeNo material change

Effective DateDec 23, 2024

Next Review DateOct 1, 2025

Key ActionObtain prior authorization by submitting chart notes documenting CAS, disease severity, thyroid testing, prior glucocorticoid response or exception, and specialist involvement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18minimum age

CAS ≥4CAS required

up to 8infusions per course

6 monthsapproval duration

J3241current HCPCS

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Coverage Criteria for Tepezza (teprotumumab-trbw)

Initial Approval Criteria

Covered when ALL of the following are met

Initial therapy criteria: Member is 18 years of age or olderage >=18

Medication is prescribed by or in consultation with a specialist in the treatment of Graves' disease associated with TED (e.g., endocrinologist, ophthalmologist)

Member has active disease with a Clinical Activity Score (CAS) greater than or equal to 4CAS >=4

Member has moderate-to-severe disease (see Appendix B)

Member has experienced an inadequate response to glucocorticoids at a maximally tolerated dose unless there is documented intolerance, FDA-labeled contraindication, or hypersensitivity; OR member is currently receiving treatment with the requested product through insurance (excluding samples or manufacturer assistance) and is experiencing a positive therapeutic outcome

Member is euthyroid prior to initiating therapy

Member is not currently pregnant and does not plan to become pregnant during treatment or within 6 months of the last treatment

Approval limits: Approval will be for 6 months and limited to one course of treatment (up to 8 infusions) per lifetime

Approval duration 6 months; one course (up to 8 infusions) per lifetime

Members with contract exclusions or members who do not have benefit coverage for Tepezza are excluded from consideration; benefit determinations are based on the member’s contract language and applicable plan terms. The intent of this policy is to ensure appropriate selection of patients for therapy based on product labeling, clinical guidelines, and clinical studies, and the policy applies only when the member’s benefit permits coverage for the prescribed therapy.

Use of Tepezza beyond a single course of therapy is not supported. Approval is limited to one course of treatment (up to 8 infusions) per lifetime; requests for additional courses or more than 8 infusions will be considered not medically necessary under this policy.

Procedural and Clinical Coding

Procedural/Drug codesHCPCS

C9061	Injection, teprotumumab-trbw, 10 mg (deleted 09-30-2020)
J3241	Injection, teprotumumab-trbw, 10 mg (effective 10-01-2020)

Clinical Activity Score (CAS) — required threshold

Required CAS thresholdClinical Activity Score (CAS) ≥ 4 is required for coverage consideration

CAS scoring timeframeSymptoms assessed over the last 4 weeks for each CAS element (each element = 1 point)

Use in prior authorizationDocument CAS in submitted chart notes or medical records for review

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit supporting chart notes or medical records indicating Clinical Activity Score (CAS), thyroid testing results, and documentation of moderate-to-severe disease. Include specialist prescribing or consultation notes (e.g., endocrinologist, ophthalmologist) and any records of current treatment with the requested product if applicable.

Include CAS documentation and assessment showing active disease (CAS ≥ 4)
Provide thyroid function testing results demonstrating member is euthyroid prior to initiating therapy
Attach specialist consultation or prescribing notes (endocrinologist or ophthalmologist)
If member is currently receiving the requested product through insurance, provide documentation of positive therapeutic outcome
If prior glucocorticoid therapy was not used, provide documentation of intolerance, FDA-labeled contraindication, or hypersensitivity

Step Therapy

Glucocorticoid Trial Requirement

Background

Teprotumumab‑trbw (Tepezza) is FDA‑approved for the treatment of thyroid eye disease (TED). This policy follows the FDA‑approved indication and requires that therapy be prescribed by or in consultation with a specialist experienced in TED management. TED activity is assessed using the Clinical Activity Score (CAS), and disease severity is categorized as mild, moderate‑to‑severe, or sight‑threatening based on findings such as lid retraction, soft‑tissue involvement, exophthalmos, diplopia, dysthyroid optic neuropathy, or corneal breakdown. For initial approval the policy requires the member be ≥18 years old, have active disease with CAS ≥4, meet criteria for moderate‑to‑severe disease, be euthyroid, not pregnant (and agree not to become pregnant during treatment or for 6 months after the last dose), and have had an inadequate response to glucocorticoids at a maximally tolerated dose unless a documented exception applies. Approvals are for 6 months and limited to one course (up to 8 infusions) per lifetime.

Key Definitions and Scoring

Clinical Activity Score (CAS) elements

CAS elements (each = 1 point)Painful feeling behind the globe; Pain with eye movement; Redness of the eyelids; Redness of the conjunctiva; Swelling of the eyelids; Chemosis (conjunctival edema); Swollen caruncle

Scoring noteEach element is scored as 1 if present (assessed over last 4 weeks)

Active disease definitionActive disease requires CAS ≥ 4 per policy

Disease severity categories

Mild disease — criteria (at least one)Minor lid retraction (<2 mm); Mild soft-tissue involvement; Exophthalmos <3 mm above normal for race and gender; No or intermittent diplopia; Corneal exposure responsive to lubricants

Moderate-to-severe disease — criteria (at least one)Lid retraction ≥2 mm; Moderate or severe soft-tissue involvement; Exophthalmos ≥3 mm above normal for race and gender; Inconstant or constant diplopia