CurrentAetnaPolicy N/A

Tegsedi (inotersen) Precertification Request Form and Required Clinical Information

This document is Aetna's precertification notification form and required clinical information checklist for requests to initiate or continue Tegsedi (inotersen) therapy for hereditary transthyretin-mediated amyloidosis with polyneuropathy (ATTR-FAP). It affects prescribing clinicians, dispensing providers, and Aetna members seeking coverage approval.

Policy Summary

PayerAetna

PolicyTegsedi (inotersen) Precertification Request Form

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete and submit the Aetna Tegsedi precertification form with required clinical documentation including TTR genetic confirmation and evidence of clinical manifestations or documented benefit for continuation requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 pageform length

RequiredTTR confirmation

Response documentedcontinuation assessment

Phone & Faxcontact

Coverage Criteria for Tegsedi (inotersen)

Initial Therapy

Covered when ALL of the following are documented on the precertification form

Diagnosis and confirmation: Diagnosis of polyneuropathy of hereditary transthyretin-mediated amyloidosis (ATTR-FAP) and confirmation by detection of a mutation in the TTR gene (checkbox).TTR mutation detected

form requires checkbox indicating genetic confirmation

Clinical manifestations: Documentation of clinical manifestations of ATTR-FAP such as amyloid deposition in biopsy specimens, TTR protein variants in serum, or progressive peripheral sensory-motor polyneuropathy.clinical evidence present

form includes checkbox for presence of clinical manifestations

Prescriber specialty:

Policy Summary

PayerAetna

PolicyTegsedi (inotersen) Precertification Request Form

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Although the form does not present an explicit list of non‑covered scenarios, coverage evaluation depends on required documentation fields. Failure to document a TTR gene mutation (the form asks if diagnosis was confirmed by detection of a TTR mutation) or failure to document clinical manifestations of ATTR‑FAP (e.g., amyloid deposition, TTR variants in serum, progressive peripheral sensory‑motor polyneuropathy) are grounds for not approving the request. Additionally, for continuation requests, lack of documented benefit may result in denial. Incomplete or illegible submissions or omission of requested information may prompt requests for clarification and could delay or jeopardize authorization.

Provider Actions and Submission Requirements

Prior Authorization

Precertification Required

Precertification is required for initiation or continuation of Tegsedi (inotersen). Complete and submit the Aetna Tegsedi precertification form per the instructions on the form. All fields must be completed and legible for precertification review; incomplete or illegible submissions may delay review or result in denial. The plan may request additional information or clarification as needed.

Aetna Precertification Notification phone: 1-866-752-7021 (TTY: 711); Fax: 1-888-267-3277
For Medicare Advantage Part B: use Medicare Request Form
Indicate whether request is Start of treatment (include start date) or Continuation of therapy (include date of last treatment)

Documentation Required

Concomitant Therapy Documentation

The precertification form requires documentation of whether Tegsedi will be used concomitantly with any other medication approved for ATTR-FAP. Providers must indicate if Tegsedi will be used in combination with therapies such as Amvuttra, Onpattro, Vyndamax, Vyndaqel, or Wainua and provide rationale and supporting clinical documentation when combination therapy is planned.

Form item: "Will the requested medication be used in combination with any other medication approved for the treatment of hereditary transthyretin-mediated amyloidosis (e.g., Amvuttra, Onpattro, Vyndamax, Vyndaqel, Wainua)?" — mark Yes or No
If Yes, include details of concomitant agents, prescribing clinician, and clinical justification

Documentation Required

Required Documentation for Prior Authorization

Submit the completed, legible Tegsedi precertification form with all required clinical documentation. Required documentation for prior authorization includes confirmation of diagnosis and evidence of disease and treatment response as applicable.

Diagnosis confirmation: documentation of a pathogenic TTR gene mutation (check box on form and attach supporting genetic test results)
Evidence of ATTR-FAP clinical manifestations (e.g., amyloid on biopsy, TTR protein variants in serum, progressive peripheral sensory-motor polyneuropathy)
For continuation requests: documentation of beneficial response compared to baseline (examples: mNIS+7, Norfolk QoL-DN total score, PND score, FAP disease stage, manual grip strength)
Documentation that the medication is prescribed by or in consultation with a neurologist, geneticist, or physician specializing in amyloidosis (form asks to confirm)
Signature and date on the acknowledgement section of the form

Denial Risk

Incomplete Submission May Delay or Risk Denial

Incomplete or illegible fields may impede precertification review and could result in delayed processing or denial of the request. Ensure all requested items are provided at initial submission to avoid requests for additional information.

All fields on the Tegsedi precertification form must be completed and legible
The plan may request additional information or clarification if needed to evaluate the request

Definitions

ATTR-FAP — definition: Polyneuropathy of hereditary transthyretin-mediated amyloidosis, diagnosis confirmed by TTR mutation

TermPolyneuropathy of hereditary transthyretin-mediated amyloidosis (ATTR-FAP)

Diagnostic confirmation requiredDiagnosis confirmed by detection of a mutation in the TTR gene (checkbox on precertification form)

Clinical manifestationsDocumentation of clinical manifestations such as amyloid deposition in biopsy specimens, TTR protein variants in serum, or progressive peripheral sensory-motor polyneuropathy (checkbox on form)

Prescriber specialtyMedication prescribed by or in consultation with a neurologist, geneticist, or physician specializing in amyloidosis (checkbox on form)

Concomitant therapyForm queries whether requested medication will be used in combination with other approved hereditary transthyretin-mediated amyloidosis therapies (e.g., Amvuttra, Onpattro, Vyndamax, Vyndaqel, Wainua)

Primary ICD Code:	placeholder for primary diagnosis ICD-10 code
Other ICD Code:	placeholder for additional diagnosis ICD-10 codes

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Tegsedi (inotersen) Precertification Request Form and Required Clinical Information

Coverage Criteria for Tegsedi (inotersen)

Coding and Billing

Provider Actions and Submission Requirements

Background

Definitions