Precertification required for Tepezza

Precertification of teprotumumab-trbw (Tepezza) is required of all Aetna participating providers and members in applicable plan designs prior to administration; contact the specialty pharmacy precertification number or use the Statement of Medical Necessity (SMN) precertification forms as directed by the plan.

• Call (866) 752-7021 or fax (888) 267-3277 for precertification per policy.
• Site-of-care utilization management policy applies for Tepezza infusions.

Prior authorization for decompression and orbital radiotherapy (RT 20 Gy)

Prior authorization should verify that orbital decompression is being reserved for severe, medication‑refractory ophthalmopathy (e.g., marked proptosis or optic neuropathy) and that orbital radiotherapy (commonly RT 20 Gy) is being considered for moderate‑to‑severe active disease, often when intravenous glucocorticoids have been inadequate or in combination with glucocorticoids.

• Document that conservative measures and medication trials have failed before decompression.
• If RT 20 Gy is requested, indicate whether it will be used with or after glucocorticoids and the clinical rationale.

Teprotumumab prior authorization (headline)

Teprotumumab (Tepezza) is FDA‑approved for treatment of thyroid eye disease regardless of activity or duration; prior authorization requests should verify the indication, pregnancy status, and baseline diabetes control given the risk of hyperglycemia.

• Confirm FDA‑approved indication (TED regardless of activity/duration).
• Verify pregnancy status and contraception counseling for women of child‑bearing potential.
• Document diabetes status and plans for glucose monitoring/management.

Prior authorization for specialty biologics

Specialty biologic therapies such as teprotumumab typically require documentation of the clinical indication and reference to the drug’s prescribing information; prior authorization processes and specialty pharmacy precertification apply for high‑cost biologics.

• Include prescriber specialty (ophthalmologist or consultation with one) as required by the policy.
• Reference Tepezza prescribing information and site‑of‑care policy in the authorization request.

Prior authorization requirement

Coverage determinations are governed by the member’s plan benefit provisions and Aetna clinical policy processes; prior authorization may be required per the plan and clinical policy procedures and absence of required documentation may lead to denial.

• Ensure authorization requests include all required plan‑specific documentation to avoid administrative denials.

Conservative/medical trial before surgery

Surgical interventions (orbital decompression, eye muscle surgery, eyelid surgery) are considered medically necessary only after trials of conservative measures and medications have been unsuccessful.

• Document prior conservative measures (e.g., head elevation, cool compresses, lubricating eyedrops, prisms) and medication trials (e.g., diuretics, methimazole, prednisone, propylthiouracil).
• Confirm stability of thyroid‑related orbitopathy before elective surgery.

Therapy sequencing (steroids before/with radiotherapy)

Evidence and policy guidance support systemic corticosteroids—particularly intravenous methylprednisolone pulses—as first‑line medical therapy for active inflammation; orbital radiotherapy is typically considered adjunctive or second‑line and may be combined with glucocorticoids for greater effect.

• Document prior IV corticosteroid trial and response when radiotherapy is proposed.
• Note that combination therapy (RT plus glucocorticoids) may improve outcomes for some endpoints.

Conservative and steroid-first approaches

Standard conservative and steroid‑first approaches are described as current practice measures prior to considering novel biologic therapies and include smoking cessation, supportive measures, systemic glucocorticoids, and IV methylprednisolone pulses.

• Document lifestyle measures (e.g., smoking cessation, euthyroid status), supportive ocular care, and details of systemic glucocorticoid therapy and response.

No explicit step therapy ordering in this section

The document summarizes multiple treatment modalities (medical, surgical, radiation) but does not mandate a single required step‑therapy sequence in this extract; clinical judgment and plan provisions guide sequencing decisions.

• Authorization reviews should consider the individualized treatment history and documented rationale rather than a prescriptive step order.

Tepezumab precertification documentation

Precertification of teprotumumab‑trbw (Tepezza) requires submission of Statement of Medical Necessity (SMN) forms and use of the specialty pharmacy precertification process as specified by Aetna.

• Follow specialty pharmacy precertification instructions and submit SMN forms per policy.
• Site‑of‑care utilization management policy applies to infusion location selection.

Indication and treatment specifics

Authorization requests should document the indication and treatment specifics—for example, severe ophthalmopathy refractory to medications and/or radiotherapy, presence of marked proptosis or optic neuropathy for decompression, or rationale for RT 20 Gy and whether glucocorticoids are being used concomitantly.

• Describe prior therapies tried and clinical findings (e.g., marked proptosis, optic neuropathy) supporting the requested intervention.
• For RT requests, specify dose regimen (RT 20 Gy) and planned combination with glucocorticoids if applicable.

Suggested clinical documentation elements

Suggested clinical documentation elements mirrored from clinical trials include documentation of active disease using Clinical Activity Score (CAS) thresholds, euthyroid status, limited prior glucocorticoid exposure, and exclusion of optic neuropathy or severe ocular surface damage when relevant to the requested therapy.

• Include CAS value (trial inclusion often used CAS ≥4; some trials used ≥3) and disease duration when applicable.
• Document thyroid status, prior steroid dosing, and baseline ophthalmic exam findings.

Reference FDA label and trial data

When documenting indications for teprotumumab, reference the FDA prescribing information and recent label updates (including the April 14, 2023 update expanding indication to TED regardless of activity or duration).

• Cite the Tepezza prescribing information and note the April 14, 2023 FDA label revision in the authorization documentation.

Provider responsibility and documentation

Treating providers are responsible for medical advice and treatment decisions; plan participation and member‑specific benefit provisions govern coverage and require appropriate provider documentation for authorization and claims.

• Ensure documentation aligns with member plan benefits and policy requirements to support coverage determinations.

Tepezuma precertification and repeat-course exclusion

Aetna considers repeat series (more than one course) of Tepezza infusions excluded from coverage; precertification is required and repeat treatment courses are not covered.

• One course is defined as a total of 8 infusions; requests for additional courses are excluded.

Orbital radiation evidence limitations

Randomized controlled trials of orbital radiation often excluded patients with optic neuropathy and some sham‑controlled trials did not show benefit over sham for proptosis, lid fissure, or soft tissue changes; requests seeking RT specifically for those endpoints without supporting evidence may be at risk for denial.

• Highlight objective indications (e.g., motility impairment) and prior therapy failure when requesting orbital radiation to mitigate denial risk.

Pregnancy verification and contraception

Teprotumumab is contraindicated in pregnancy; women of child‑bearing potential must have pregnancy status verified prior to initiating treatment and be counseled on contraception during treatment and for 6 months following the last dose.

• Provide documented negative pregnancy test and contraception counseling in the authorization record.
• Counsel and document plans for contraception for 6 months after final dose.

Clinical Policy Bulletin change risk

Clinical Policy Bulletins are subject to change and do not guarantee coverage; lacking required plan benefit documentation or noncompliance with plan provisions may result in denial of services.

• Verify current policy version and member benefit design when preparing prior authorization requests.

Administrative disclaimer

This Clinical Policy Bulletin provides a partial description of plan benefits and does not constitute a contract; failure to provide required documentation or adhere to plan provisions may lead to denial.

• Treating providers remain responsible for medical advice and must ensure authorization materials meet plan requirements.