ModifiedCentenePolicy CP.PHAR.465

Teprotumumab (Tepezza)

Defines Centene's medical-benefit coverage criteria for teprotumumab (Tepezza) for treatment of thyroid eye disease (TED) for applicable commercial and Medicaid lines, and HIM when processed as a medical benefit. Affects prescribers and payers reviewing prior authorization requests.

Policy Summary

PayerCentene

PolicyTeprotumumab (Tepezza) - Clinical Policy

Policy CodePolicy CP.PHAR.465

Change TypeMaterial updates to indication, lab options, dosing/vial documentation, and step therapy (including IL HIM bypass)

Effective DateJan 21, 2020

Next Review Date

Key ActionSubmit prior authorization with office notes, thyroid labs (FT4 and T3/FT3 or total T3), dosing calculation or vial quantity per online calculator or Appendix E.

SourceLink

POLICY UPDATE CHANGES

Indication updated to treatment of thyroid eye disease regardless of TED activity or duration.

Removed initial therapy requirement of a clinical activity score (CAS) and removed positive response criteria (proptosis/CAS reduction) from continued therapy.

Added option for thyroid lab assessment allowing total T3 or free T3 (FT3) and allowance for values within 50% above/below reference if being corrected toward euthyroid.

Added dosing requirements for vial quantity via online dose calculator or Appendix E vial rounding recommendations.

Step therapy bypass added for Illinois HIM per IL HB 5395.

8max infusions (lifetime)

6 monthsinitial approval

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Teprotumumab (Tepezza)

Initial Therapy

Covered when ALL of the following are met

Initial Approval - TED: 1. Diagnosis of Graves' disease with associated thyroid eye disease (TED); 2. Prescribed by or in consultation with an ophthalmologist; 3. Age ≥ 18 years; 4. One of the following (a or b): (a) Member is euthyroid with documentation of a recent (within 30 days) free thyroxine (FT4) and total triiodothyronine (T3) or free T3 (FT3) within the laboratory reference range; (b) Member has recent (within 30 days) FT4 and total T3 or FT3 levels less than 50% above or below the laboratory reference range and is undergoing treatment to correct the mild hypo- or hyperthyroidism to maintain a euthyroid state; 5. Member has not had previous surgical intervention for TED; 6. Member does not require surgical ophthalmologic intervention; 7. Failure of a 4-week trial of systemic corticosteroid at up to maximally indicated doses unless one of the following applies: (a) clinically significant adverse effects or contraindication to corticosteroids, (b) significant proptosis (examples include proptosis ≥ 3 mm above the upper limit for race and sex or proptosis that impacts activities of daily living), or (c) diplopia; 8. Member has not received ≥ 8 Tepezza infusions (including the initial 10 mg/kg infusion); 9. Dose does not exceed both: (a) an initial 10 mg/kg dose followed by seven 20 mg/kg infusions every 3 weeks, and (b) vial quantity as identified by the online dose calculator using the member's weight or per Appendix E vial rounding recommendations.8 infusions; dosing per prescribing information

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

Continuation Therapy

Covered when ALL of the following are met

Continued Therapy - TED: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria, or (b) member is currently receiving medication and continuity of care regulations apply; 2. Member has not had previous surgical intervention for TED; 3. Member does not require surgical ophthalmologic intervention; 4. Member has not received ≥ 8 Tepezza infusions (including the initial 10 mg/kg infusion); 5. If request is for a dose increase, the new dose must not exceed both: (a) a total of seven 20 mg/kg infusions given every 3 weeks, and (b) vial quantity as identified by the online dose calculator using the member's weight or as recommended in Appendix E for vial rounding.8 infusions

Approval duration: 1 month (up to 8 total lifetime infusions)

Other Indications / Off-label Guidance

Non-standard uses

Other/Off-label: 1. If the drug label has recently (within the last 6 months) changed and the change is not yet reflected in this policy, follow applicable formulary/no-coverage or non-formulary policy for the relevant line of business (see CP.CPA.190, HIM.PA.33, CP.PMN.255, CP.PMN.16 as applicable); 2. If the requested use (diagnosis, age, dosing regimen) is not specifically listed under 'Diagnoses/Indications for which coverage is NOT authorized' and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for HIM-Medical Benefit, CP.PMN.53 for Medicaid).

Policy update coverage elements

Policy updates and coverage intent elements extracted from document excerpts:

Thyroid status and labs: Member must have acceptable euthyroid assessment; policy allows total T3 or free T3 (FT3) as options and permits recent FT4 plus total T3 or FT3 values less than 50% above or below laboratory reference range while undergoing treatment to correct to euthyroid.FT4 and T3/FT3 within 50% of reference

Added in 1Q 2023 annual review; supports initiation of teprotumumab.

Dosing documentation: Dosing must follow vial quantity requirements using the online dose calculator or dose rounding recommendations (Appendix E).use online dose calculator or Appendix E

Added in 1Q 2023 annual review.

Treatment endpoints and duration: Indication updated to allow TED treatment regardless of TED activity or duration; proptosis and Clinical Activity Score (CAS) reduction are endpoints assessed at 24 weeks after full duration of therapy; initial therapy CAS criterion and positive response criteria were removed from continued therapy decisions.

Non-FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety per the applicable off‑label use policy: CP.CPA.09 (Commercial), HIM.PA.154 (HIM‑Medical Benefit), or CP.PMN.53 (Medicaid).

Teprotumumab (Tepezza) is excluded from the HIM pharmacy benefit and for the HIM line of business is therefore managed under the HIM medical benefit. Prior authorization and benefit determination for HIM members should follow the medical‑benefit process.

Requests that exceed the approved dosing regimen, recommended vial quantity, or the program lifetime infusion limit of ≥ 8 total Tepezza infusions will not be authorized as medically necessary. Dose must adhere to the prescribing regimen (initial 10 mg/kg dose followed by seven 20 mg/kg infusions every 3 weeks) and vial quantity should be calculated using the online dose calculator or Appendix E vial‑rounding recommendations; continuation requests must also stay within these limits.

The policy revisions removed the prior requirement that continued therapy demonstrate specific positive response criteria (for example, proptosis or Clinical Activity Score reductions). Clinical endpoints such as proptosis and CAS reduction remain assessed at 24 weeks after the full course of therapy, but these positive‑response thresholds were omitted from the continued‑therapy approval criteria.

Coding and Dosing References

HCPCS CodesHCPCSCovered

J3241

Injection, teprotumumab-trbw, 10 mg

Proptosis threshold (example)

Significant proptosis threshold≥ 3 mm above the upper limit for race and sex (example used as a bypass for corticosteroid step therapy)

Proptosis impactProptosis that impacts activities of daily life (e.g., reading, driving, computer work, watching television)

Step-therapy bypass examplesSignificant proptosis or diplopia may qualify for bypass of the 4-week systemic corticosteroid trial

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required — Documentation

Prior authorization required. Provider must submit documentation (such as office chart notes, laboratory results, or other clinical information) supporting that the member meets all approval criteria. Lack of submitted documentation supporting criteria (including thyroid testing, dose/vial calculations, or clinical assessments) may trigger denial or delay of the request.

Provider must include chart notes, labs, or other clinical information that support diagnosis, prior treatments, and clinical status.
Documentation should include thyroid function testing per allowed options: a recent (within 30 days) free thyroxine (FT4) and either total T3 or free T3 (FT3) within the laboratory reference range, or FT4 with total T3/FT3 less than 50% above or below the reference range while undergoing treatment to restore euthyroid status.

Documentation Required

Dose and Vial Documentation

Dose and vial quantity must be documented. Requests must show the dose calculation or vial quantity determined by the online dose calculator (Appendix D) or conform to the Appendix E vial rounding recommendations. Refer to Appendix E for rounding guidance.

Background and Clinical Context

Teprotumumab is a monoclonal antibody that targets the insulin‑like growth factor‑1 receptor (IGF‑1R) and is indicated for treatment of thyroid eye disease (TED). Systemic corticosteroids (for example, intravenous methylprednisolone), while commonly recommended as initial medical therapy in guideline guidance, remain part of the policy's step‑therapy framework: initiation of teprotumumab generally requires failure of a 4‑week trial of systemic corticosteroids at up to maximally indicated doses unless a bypass applies (for example, significant proptosis or diplopia). Teprotumumab is administered as an initial 10 mg/kg IV dose followed by seven 20 mg/kg infusions every 3 weeks, with treatment endpoints (proptosis and CAS reduction) evaluated at 24 weeks after the full treatment course.

Definitions and Abbreviations

Clinical Activity Score (CAS)

DefinitionCAS: clinical activity score

ContextListed in Appendix A: Abbreviation/Acronym Key for use in assessing disease activity

Use in policyHistorically used as an initial therapy criterion prior to 1Q 2023/2024 updates; endpoints referencing CAS are assessed at 24 weeks for full duration evaluations

Thyroid eye disease (TED / GO)

DefinitionTED/GO: thyroid eye disease (also referred to as Graves' ophthalmopathy/orbitopathy)

Acronym sourceDefined in Appendix A: Abbreviation/Acronym Key

Indication

Policy Summary

PayerCentene

PolicyTeprotumumab (Tepezza) - Clinical Policy

Policy CodePolicy CP.PHAR.465

Change TypeMaterial updates to indication, lab options, dosing/vial documentation, and step therapy (including IL HIM bypass)

Effective DateJan 21, 2020

Next Review Date

Key ActionSubmit prior authorization with office notes, thyroid labs (FT4 and T3/FT3 or total T3), dosing calculation or vial quantity per online calculator or Appendix E.

SourceLink

On This Page

Step Therapy

Corticosteroid Step Therapy / Illinois HIM Bypass

Step therapy requirement: A 4‑week trial of systemic corticosteroid is required prior to approval unless criteria for bypass are met. For Illinois HIM requests, a step therapy bypass was added per IL HB 5395; the corticosteroid step therapy requirements do not apply for Illinois HIM as of 1/1/2026.

If bypassing step therapy for documented contraindication or adverse effects, include clinical rationale and supporting records.
For non-Illinois HIM lines of business, include documentation of a 4-week systemic corticosteroid trial (at up to maximally indicated doses) or documentation of contraindication/adverse effects or clinical findings (significant proptosis or diplopia) that meet bypass criteria.

Denial Risk

Excess Doses/Infusions and Endpoint Assessment

Excess doses/infusions and assessment of endpoints: Requests exceeding 8 total infusions (including the initial 10 mg/kg first infusion) or doses exceeding the approved regimen/vial limits may be denied. Additionally, failure to document that endpoints for proptosis and Clinical Activity Score (CAS) are assessed at 24 weeks (after the full duration of therapy) may affect authorization decisions.

Maximum allowed = up to 8 total lifetime infusions; include prior infusion history to confirm count.
If requesting beyond regimen or vial limits, provide justification and supporting clinical documentation.
Document assessment of proptosis and CAS at 24 weeks when applicable; absence of this documentation may delay or result in denial.

Euthyroid assessment — acceptable thyroid lab evidence

Accepted thyroid lab optionsTotal T3 or free T3 (FT3) are acceptable options to determine euthyroid status (added in 1Q 2022)

FT4 + T3/FT3 allowanceRecent (within 30 days) free thyroxine (FT4) plus total T3 or FT3 levels less than 50% above or below the laboratory reference range while undergoing treatment to correct mild hypo- or hyperthyroidism are acceptable

Documentation timingThyroid lab assessment should be recent (within the last 30 days) when used for initiation criteria

Policy originChanges reflecting these options were added in 1Q 2022 and expanded in 1Q 2023 per prescribing information and ATA guidance