Prior authorization required — demonstrate all initial approval criteria

Submit a prior authorization request demonstrating the member meets all initial approval criteria for thyroid eye disease (Graves' disease with TED), including ophthalmologist involvement, age ≥ 18, thyroid laboratory results, prior steroid trial or documented exception, dosing and vial quantity within limits, and that the member has not previously received Lumvoa or ≥ 8 Tepezza infusions.

• Include diagnosis of Graves' disease with associated TED and documentation that treatment was prescribed by or in consultation with an ophthalmologist.
• Provide evidence of age ≥ 18 and thyroid laboratory results as specified (recent FT4 and total T3 or FT3).
• Document prior 4-week systemic corticosteroid trial at up to maximally indicated doses or a listed exception.
• Confirm the member has not previously received Lumvoa and has not received ≥ 8 Tepezza infusions.
• Provide dosing plan consistent with single 10 mg/kg initial dose then seven 20 mg/kg infusions and vial quantity per the online dose calculator or Appendix E.

Prior auth and billing — Tepezza is a medical benefit (use J3241)

Prior authorization is required under the medical benefit and billing should use HCPCS code J3241 for teprotumumab when Tepezza is administered as a medical/infusion service (Tepezza is excluded from the HIM pharmacy benefit).

• Do not submit under the HIM pharmacy benefit; route requests for HIM members to the HIM medical benefit criteria.
• Use HCPCS code J3241 (Injection, teprotumumab-trbw, 10 mg) for claims/billing as referenced by the policy.

Step therapy — document 4-week systemic corticosteroid trial or exception

Before approval, document failure of a 4-week trial of systemic corticosteroid at up to maximally indicated doses unless the member meets an exception (clinically significant adverse effects/contraindication, significant proptosis, or diplopia).

• If claiming an exception, provide documentation of adverse effects or contraindication to corticosteroids, or objective evidence of significant proptosis or diplopia as defined in policy.
• For Illinois HIM requests on/after 1/1/2026, step therapy requirements do not apply per IL HB 5395 (see bypass guidance).

Step therapy bypass for Illinois HIM per IL HB 5395

For Illinois HIM members, the step therapy requirement is bypassed per IL HB 5395; document HIM line-of-business and that the request pertains to an Illinois HIM member to apply the bypass.

• Include evidence the member is covered under an Illinois HIM plan so the step therapy requirement will not be applied.
• Note policy revision history referencing addition of the IL HIM bypass per IL HB 5395.

Required supporting documentation — office notes, labs, ophthalmology consults

Include supporting clinical documentation with the prior authorization: office chart notes, relevant lab results, and ophthalmology consultation/notes demonstrating the member meets policy criteria.

• Office notes documenting diagnosis, symptom history, and functional impact.
• Ophthalmology consult notes confirming diagnosis, exam findings, and whether surgical intervention is required.
• Lab results showing recent FT4 and total T3 or FT3 within required timeframes.

Document labs and dosing calculations — thyroid labs and vial/dose calculator

Provide thyroid laboratory results and dosing calculations: recent FT4 with total T3 or FT3 per policy, and include dose/vial calculations from the online dose calculator or Appendix E vial rounding recommendations.

• Attach recent (within 30 days) FT4 and total T3 or FT3 results, or documentation of treatment to maintain euthyroid state if values are within 50% above/below reference range.
• Include the dosing plan showing initial 10 mg/kg then seven 20 mg/kg infusions and the vial quantity determined by the online dose calculator or Appendix E.

Missing documentation may lead to denial

Requests missing required documentation (diagnosis, labs, ophthalmology consults, steroid trial or exception, dosing/vial calculations) may be denied for failure to demonstrate that approval criteria are met.

• If the prior authorization does not include the required clinical and laboratory documentation or dosing/vial calculation, expect potential denial.
• Denials may occur for failure to document prior steroid trial or applicable exception, or for exceeding infusion/dose limits.

Coding listed does not guarantee coverage — verify current coding guidance

Inclusion of HCPCS code J3241 in the policy is informational only and does not guarantee coverage; providers must verify current coding guidance before claim submission.

• Codes referenced are for informational purposes only; reference the most up-to-date professional coding guidance prior to claim submission.
• Coding inclusion or exclusion in the policy does not by itself assure payment or coverage.

Tepezza excluded from HIM pharmacy benefit — use medical benefit review

For HIM/ICHRA lines of business, Tepezza is excluded from the pharmacy benefit and should not be approved under pharmacy criteria; these coverage criteria may be used only for medical benefit review.

• Do not submit pharmacy benefit prior authorization requests for Tepezza for HIM/ICHRA members.
• Use medical benefit prior authorization pathways for review.

Site-of-care and billing alignment: Tepezza billed as medical benefit

Tepezza is designated as a medical benefit (HIM medical benefit); billing, site-of-care, and authorization should align with medical benefit administration (infusion center/medical setting) rather than pharmacy.

• Align site-of-care and claims submission with medical benefit (infusion center or other medical administration setting).
• Billing should use the appropriate HCPCS code (J3241) under the medical benefit.