CurrentCommunity-CarePolicy N/A

Teprotumumab for thyroid eye disease — Coverage Criteria

Criteria and coverage rules for outpatient medical benefit use of teprotumumab to treat active moderate-to-severe thyroid eye disease for members of Community-Care; applies to providers prescribing and requesting authorization.

Policy Summary

PayerCommunity-Care

PolicyTeprotumumab for thyroid eye disease — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateDec 1, 2024

Key ActionObtain prior authorization demonstrating all coverage criteria are met; approvals allow coverage for 24 weeks.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J3241HCPCS code for teprotumumab

CAS ≥ 4minimum CAS required

24 weeksauthorization period

Nonequantity limit

Coverage Criteria for Teprotumumab (Initial Therapy)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Initial Coverage Criteria

Prescribed by, and in consultation with, both an endocrinologist and an ophthalmologist.
Diagnosis of active moderate-to-severe thyroid eye disease.
Clinical Activity Score of at least 4.CAS >= 4
A trial of intravenous methylprednisolone at a recommended dose and duration was ineffective, contraindicated, or not tolerated.

Policy Summary

PayerCommunity-Care

PolicyTeprotumumab for thyroid eye disease — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateDec 1, 2024

Key ActionObtain prior authorization demonstrating all coverage criteria are met; approvals allow coverage for 24 weeks.

SourceLink

On This Page

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Prior Authorization, Documentation, and Required Trials

Prior Authorization

Prior Authorization Required

Prior authorization is required for teprotumumab (HCPCS J3241). If prior authorization is approved, coverage is allowed for a single course of therapy of up to 24 weeks and is not eligible for renewal. Providers must request prior authorization before administration to avoid denial of payment.

HCPCS: J3241 – Injection, teprotumumab-trbw, 10 mg
Approval period: up to 24 weeks; not eligible for renewal

Denial Risk

Triggers for Denial

Denial may be triggered when required documentation is missing or incomplete, when clinical criteria are not met, or when prior authorization was not obtained. Common denial triggers include: missing documentation of required endocrinology and ophthalmology consultations, absence of a documented Clinical Activity Score (CAS) ≥ 4, lack of documentation of a steroid trial (or a documented reason why it was ineffective, contraindicated, or not tolerated), prior receipt of teprotumumab, or when the patient requires surgical ophthalmologic intervention or is a candidate for radiation therapy.

Missing consultations with both an endocrinologist and an ophthalmologist
No documented Clinical Activity Score ≥ 4
No documentation of IV methylprednisolone trial or justification for exemption
Previous treatment with teprotumumab
Patient requires surgical ophthalmologic intervention or is a candidate for radiation therapy
Prior authorization not obtained

Documentation Required

Required Documentation for Prior Authorization

Prescribing clinicians must provide clinical documentation supporting the coverage criteria at the time of prior authorization submission. Required documentation includes evidence of: consultation with an endocrinologist and an ophthalmologist, diagnosis of active moderate-to-severe thyroid eye disease, a documented Clinical Activity Score (CAS) of at least 4, rationale and documentation for an IV methylprednisolone trial (or documentation that it was ineffective, contraindicated, or not tolerated), thyroid function evidence supporting euthyroid status or mild thyroid dysfunction, and confirmation that the patient has not previously received teprotumumab.

Documentation of consultations: endocrinologist and ophthalmologist
Documented diagnosis: active moderate-to-severe thyroid eye disease
Clinical Activity Score (CAS) ≥ 4
Record of IV methylprednisolone trial or documentation of why it was ineffective/contraindicated/not tolerated
Thyroid function labs supporting euthyroid or mild dysfunction (FT4/FT3 within ≤50% of normal limits)
Statement that patient is not a candidate for radiation therapy and does not yet require surgical ophthalmologic intervention
Statement that patient has not previously received teprotumumab

Documentation Required

Weight Requirement

Patient weight must be provided with the prior authorization request. Weight is required to determine dosing and is a condition for approval.

Include current patient weight (kg or lb) on the authorization request

Background on Thyroid Eye Disease and Treatment Context

Thyroid eye disease (TED) is an inflammatory condition of the orbit that is assessed by both activity and severity features to guide treatment. The policy uses the Clinical Activity Score (CAS) to quantify inflammatory activity and requires CAS ≥ 4 to define active moderate-to-severe disease eligible for teprotumumab. Severity elements include lid retraction, soft tissue involvement, proptosis, diplopia, corneal exposure, and optic nerve status; numeric thresholds for some features (for example, proptosis) are detailed in the referenced American Thyroid Association TED severity guidelines in the appendix.

Clinical Activity Score (CAS) and Severity Descriptors

Clinical Activity Score (CAS) — Severity Descriptors

Lid retractionMild: < 2 mm; Moderate/Severe: ≥ 2 mm; Sight‑threatening: not specified in measurement table

Soft tissue involvementMild: mild involvement; Moderate: moderate involvement; Severe: severe involvement; Sight‑threatening: not specified

ProptosisMild: < 3 mm; Moderate/Severe: ≥ 3 mm; Sight‑threatening: not specified

DiplopiaMild: transient or absent; Moderate: inconstant; Severe: constant; Sight‑threatening: not specified

Corneal exposureMild: absent; Moderate: mild; Severe: mild; Sight‑threatening: severe

Optic nerve statusMild/Moderate/Severe: normal; Sight‑threatening: compression

OpenPayer

Teprotumumab for thyroid eye disease — Coverage Criteria

Coverage Criteria for Teprotumumab (Initial Therapy)

Billing and Clinical Codes

Prior Authorization, Documentation, and Required Trials

Background on Thyroid Eye Disease and Treatment Context

Clinical Activity Score (CAS) and Severity Descriptors