ModifiedCentenePolicy CP PHAR.465

Teprotumumab (Tepezza) — Clinical Policy

Clinical policy governing medical-benefit coverage criteria, authorization, dosing, and continued use of teprotumumab (Tepezza) for thyroid eye disease for Centene lines of business (Commercial, HIM-Medical Benefit, Medicaid).

Policy Summary

PayerCentene

PolicyTeprotumumab (Tepezza) — Clinical Policy

Policy CodePolicy CP PHAR.465

Change TypeMaterial revisions to indications, dosing, and continuation criteria

Effective Date01.21.20

Next Review Date

Key ActionSubmit prior authorization with documentation of recent FT4 and total T3 or free T3 (within 30 days) and dosing calculations using the online dose calculator or Appendix E.

SourceLink

POLICY UPDATE CHANGES

Updated indication to treatment of thyroid eye disease (TED) regardless of TED activity or duration; removed initial therapy CAS criterion and removed proptosis/CAS reduction as continued therapy response criteria.

Added dosing requirements for vial quantity using online dose calculator or dose rounding recommendations (Appendix E).

HIM line of business revised to HIM medical benefit and Tepezza excluded from HIM pharmacy benefit.

Added dosing requirements for vial quantity using the online dose calculator or dose rounding recommendations (Appendix E) and added thyroid lab assessment requirement for FT4 and total T3 or FT3 within 30 days to demonstrate near-euthyroid status.

Updated indication extension for TED treatment regardless of TED activity or duration; removed initial therapy CAS criterion; removed proptosis and CAS reduction as continued therapy positive response criteria.

For corticosteroid redirection added bypass for significant proptosis and diplopia consistent with 2022 ATA recommendations; continuation approval duration reduced to 1 month.

Updated lab guidance to include total T3 or free T3 (FT3) to determine member is euthyroid per 2016 ATA guidelines.

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Coverage Criteria

inv-01: Initial Therapy

Covered when ALL of the following are met:

Initial Approval Criteria: 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. Thyroid laboratory status: either (a) recent (within 30 days) FT4 and total T3 or free T3 within the laboratory reference range, OR (b) recent (within 30 days) FT4 and total T3 or free T3 less than 50% above or below the laboratory reference range and member is undergoing treatment to correct 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 ophthalmological intervention. 7. Failure of a 4-week trial of systemic corticosteroid at up to maximally indicated doses, unless an exception applies (significant proptosis, contraindication to corticosteroids, or diplopia). 8. Member has not received >= 8 Tepezza infusions (including the initial 10 mg/kg first infusion). 9. Dosing does not exceed a single 10 mg/kg initial infusion followed by seven 20 mg/kg infusions every 3 weeks, with vial quantity determined by the online dose calculator or Appendix E vial rounding recommendations.

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

inv-02: Continuation Therapy

Covered when ANY of the following are met (continuation conditions):

Continued Therapy Criteria: a) Member is currently receiving teprotumumab via the Centene benefit, OR b) Member previously met initial approval criteria (continuity of care provisions may apply where state/product-specific rules exist). Additional continued-therapy requirements: member has not had previous surgical intervention for TED; member does not require surgical ophthalmological intervention; member has not received >= 8 Tepezza infusions (including initial 10 mg/kg infusion). If a dose increase is requested, the new dose must not exceed the approved regimen (seven 20 mg/kg maintenance infusions) and vial quantity must follow the online dose calculator or Appendix E vial rounding recommendations.

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

inv-03: Policy criteria summary

Policy criteria highlights and modifications from annual reviews

Thyroid lab requirement: Member must have recent (within 30 days) FT4 and total T3 or free T3 levels less than 50% above or below the laboratory reference range and be undergoing treatment as needed to maintain near-euthyroid status.FT4 and T3 within +/-50% of reference

Added per 1Q2022 and 1Q2023 reviews

Indication and activity: Indication updated to allow treatment of TED regardless of TED activity or duration; the prior initial Clinical Activity Score (CAS) requirement for initiation was removed.

RT4 04.28.23

Authorization duration: Full lifetime course of therapy is authorized within a 6-month authorization period; clinical endpoints such as proptosis and CAS reduction are assessed at 24 weeks after completion of therapy, and therefore were removed as continued-therapy positive response criteria.6 months

Non-FDA approved uses of teprotumumab (Tepezza) that are not specifically addressed in this policy are not authorized unless the provider submits sufficient supporting documentation per the applicable off-label use policies: CP.CPA.09 (Commercial), HIMPA.154 (HIM – Medical Benefit), or CP PMN.53 (Medicaid).

For Health Insurance Marketplace (HIM) members, teprotumumab (Tepezza) is excluded from the HIM pharmacy benefit and must be processed under the HIM medical benefit. Ensure prior authorization and billing are submitted to the medical benefit to avoid incorrect benefit processing or denial.

Requests for teprotumumab for indications that are not FDA‑approved and are not covered by this policy are considered not authorized unless the provider documents efficacy and safety in accordance with the appropriate off‑label policies or the member's evidence of coverage.

The policy no longer requires demonstration of proptosis reduction or Clinical Activity Score (CAS) improvement as conditions for continued therapy. This change reflects that the full authorized course (up to 8 total infusions) is accommodated within a 6‑month authorization and that proptosis and CAS are assessed as endpoints at approximately 24 weeks after completion of therapy.

Coding and Dosing

HCPCS CodesHCPCS

J3241

Injection, teprotumumab-trbw 10 mg

Body weight ranges for vial rounding — Appendix E

Body weight range 40.0–52.5 kgInitial dose vial quantity recommendation per Appendix E (see table) and maintenance vial quantity: 2 vials per dose

Body weight range 52.6–55.0 kgInitial dose vial quantity recommendation per Appendix E and maintenance vial quantity: 3 vials per dose

Body weight range 55.1–77.5 kgInitial dose vial quantity recommendation per Appendix E and maintenance vial quantity: 3 vials per dose

Body weight range 77.6–102.5 kgInitial dose vial quantity recommendation per Appendix E and maintenance vial quantity: 4 vials per dose

Body weight range 102.6–127.5 kgInitial dose vial quantity recommendation per Appendix E and maintenance vial quantity: 5 vials per dose

Body weight range 127.6–152.5 kg

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for teprotumumab (Tepezza). Requests that do not meet the policy approval criteria or are for unsupported/off‑label indications may be denied.

Prior authorization required for teprotumumab per policy CP PHAR.465.
Requests failing to meet approval criteria or for non‑FDA/unsupported off‑label uses may be denied.

Billing Rule

Medical Benefit Placement / Billing

Teprotumumab for members in the HIM line of business must be billed and processed under the HIM medical benefit. Teprotumumab is excluded from the HIM pharmacy benefit; placing it on the pharmacy benefit may lead to incorrect processing and denial.

Background

Thyroid eye disease (TED) is an orbital inflammatory condition typically associated with Graves disease. Teprotumumab (an insulin‑like growth factor‑1 receptor [IGF‑1R] inhibitor) is FDA‑approved for the treatment of TED and, per recent policy updates, is authorized for TED regardless of disease activity or duration. The agent is positioned after inadequate response to first‑line medical therapy (for example, systemic corticosteroids) and is administered as a course of up to 8 infusions (one initial 10 mg/kg dose followed by seven 20 mg/kg maintenance doses). Policy revisions remove the prior initial CAS requirement and clarify that clinical endpoints (proptosis and CAS) are evaluated after completion of the full therapy course.

Definitions

Clinical Activity Score (CAS) definition

TermClinical Activity Score (CAS)

DefinitionAbbreviated disease activity index used to quantify inflammatory signs and symptoms in thyroid eye disease

Source appendixListed in Appendix A: CAS = clinical activity score

Graves' ophthalmopathy (GO) definition

TermGraves' ophthalmopathy (GO)

DefinitionAlternate term for thyroid eye disease associated with Graves disease (also called Graves' orbitopathy)

Context

Initial Therapy Criteria

inv-27: Initial

Initial authorization criteria and limits

Initial Therapy: Diagnosis of Graves disease with TED; prescribed by or in consultation with an ophthalmologist; age >=18; thyroid lab requirements as specified (recent FT4 and total T3 or free T3 within reference range OR within 50% above/below and being treated to euthyroid); no prior surgical intervention for TED; not requiring surgical ophthalmological intervention; failure of a 4-week systemic corticosteroid trial unless exceptions apply; not previously received >=8 infusions; dosing limited to initial 10 mg/kg then seven 20 mg/kg infusions every 3 weeks; vial quantity determined by online dose calculator or Appendix E for vial rounding.

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

inv-28: Initial therapy

Initial therapy: Initial activity (Clinical Activity Score, CAS) requirement removed — therapy may be authorized regardless of TED activity or duration when other initial criteria are met (including laboratory and dosing documentation).

RT4 04.28.23

Continuation Therapy Criteria

inv-29: Continuation

Continuation authorization requirements and limits

Continued Therapy: Member currently receiving medication via Centene benefit or previously met initial approval criteria; continuity of care provisions where applicable; member has not had prior surgical intervention for TED; member does not require surgical ophthalmological intervention; member has not received >=8 total infusions; dose limits per regimen and vial rounding per Appendix E or online dose calculator.

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

inv-30: Continuation therapy

Continuation therapy: Requirement for documented improvement in proptosis or CAS was removed because the full lifetime course is authorized within a 6-month authorization and endpoints are assessed at 24 weeks post-therapy. In corticosteroid-redirection situations (significant proptosis or diplopia), a bypass to the corticosteroid trial requirement is permitted and continuation approvals in that context may be issued for a reduced duration (1 month).

RT4 updates and 1Q2024 review

Step Therapy and Exceptions

Step	Requirement / Exceptions
1	Requires failure of a 4‑week trial of systemic corticosteroid at up to maximally indicated doses unless one of the following exceptions applies: a) significant proptosis (examples include proptosis ≥3 mm above the upper limit for race and sex or proptosis that impacts activities of daily life), b) contraindication to systemic corticosteroids (clinically significant adverse effects or all corticosteroids are contraindicated), or c) diplopia.

Step

Requirement / Exceptions

Requires failure of a 4‑week trial of systemic corticosteroid at up to maximally indicated doses unless one of the following exceptions applies: a) significant proptosis (examples include proptosis ≥3 mm above the upper limit for race and sex or proptosis that impacts activities of daily life), b) contraindication to systemic corticosteroids (clinically significant adverse effects or all corticosteroids are contraindicated), or c) diplopia.

Step	Policy change
1	Initial Clinical Activity Score (CAS) requirement removed — no CAS prerequisite for initiation; indication extended to treatment of TED regardless of TED activity or duration.

Quantity Limits

Teprotumumab (Tepezza) — dosing and total infusions

Total infusionsUp to 8 total infusions per course

Initial infusion doseSingle initial 10 mg/kg IV infusion (one-time)

Maintenance infusionsSeven maintenance infusions of 20 mg/kg IV every 3 weeks

Full course authorization duration (quantity/authorization limit)

Authorization duration (repeat)Full lifetime course authorized within a 6-month authorization period (covers up to 8 infusions)

Continuation approval contextContinuation approvals after initial course are handled per policy with shorter (1-month) approvals in certain corticosteroid redirection contexts

Site of Care

Note

Infusion center: teprotumumab covered via HIM medical benefit only

Teprotumumab administration for HIM members should be handled as a medical‑benefit infusion (infusion center/site of care) — Tepezza is excluded from the HIM pharmacy benefit and must be authorized and billed through the medical benefit.

Use medical‑benefit authorization and billing processes for infusion center services.
Do not route Tepezza through HIM pharmacy billing.

Note

Infusion center management — HIM medical benefit (not pharmacy)

Reinforcement: for HIM line of business teprotumumab is managed under the medical benefit (not pharmacy); authorization, site‑of‑care, and billing follow medical‑benefit criteria.

Medical‑benefit management applies for infusion center and related services.
Ensure billing/coding aligns with medical benefit HCPCS usage (e.g., J3241).

Policy Summary

PayerCentene

PolicyTeprotumumab (Tepezza) — Clinical Policy

Policy CodePolicy CP PHAR.465

Change TypeMaterial revisions to indications, dosing, and continuation criteria

Effective Date01.21.20

Next Review Date

Key ActionSubmit prior authorization with documentation of recent FT4 and total T3 or free T3 (within 30 days) and dosing calculations using the online dose calculator or Appendix E.

SourceLink

On This Page

Step Therapy

Corticosteroid Trial Requirement

A trial of systemic corticosteroids is required prior to teprotumumab unless an exception applies. The trial should be up to 4 weeks at maximally indicated doses. Exceptions include significant proptosis, diplopia, or contraindication to corticosteroids.

Document a 4‑week systemic corticosteroid trial at up to maximally indicated doses, or
Document that the member meets an exception: significant proptosis (e.g., ≥3 mm above upper limit for race/sex or impacting activities of daily living), diplopia, or documented contraindication/intolerable adverse effects to corticosteroids.