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Tegsedi (inotersen) Precertification Request Form and Required Clinical Information
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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.
No material clinical or coverage changes in this revision.
Coverage Criteria for Tegsedi (inotersen)
Initial Therapy
Covered when ALL of the following are documented on the precertification form
form requires checkbox indicating genetic confirmation
form includes checkbox for presence of clinical manifestations
form asks prescriber specialty/consultation
Continuation Therapy
For continuation requests, covered when ALL of the following are documented
form requires checkbox indicating beneficial response and examples of assessment measures
The precertification form explicitly asks whether the requested medication will be used in combination with any other medication approved for hereditary transthyretin-mediated amyloidosis (examples listed include Amvuttra, Onpattro, Vyndamax, Vyndaqel, Wainua). Providers must indicate combination use on the form so the plan can consider concomitant therapies during the review; the form does not state that combination therapy is prohibited, only that concomitant use should be documented.
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.
Coding and Billing
| Administration code(s) (CPT): | placeholder on form for administration CPT codes |
| Primary ICD Code: | placeholder for primary diagnosis ICD-10 code |
| Other ICD Code: | placeholder for additional diagnosis ICD-10 codes |
Provider Actions and Submission Requirements
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)
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
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
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
Background
Hereditary transthyretin‑mediated amyloidosis with polyneuropathy (ATTR‑FAP) is described on the form as polyneuropathy of hereditary transthyretin‑mediated amyloidosis (transthyretin‑type familial amyloid polyneuropathy). Diagnosis for requests must be confirmed by detection of a mutation in the TTR gene, and clinical manifestations of ATTR‑FAP (for example, amyloid deposition on biopsy, TTR protein variants in serum, or progressive peripheral sensory‑motor polyneuropathy) are required to be indicated on the precertification form.
Definitions
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