CurrentAetnaPolicy N/A

Wainua (eplontersen) Medication Precertification Request

Aetna precertification/notification form to request authorization for Wainua (eplontersen), capturing patient, insurance, prescriber, dispensing, product, diagnosis and clinical information required for review. It applies to start or continuation of therapy and lists required clinical confirmation and continuation response items.

Policy Summary

PayerAetna

PolicyWainua (eplontersen) Medication Precertification Request

Policy CodePolicy N/A

Change TypeAdministrative form (no material change)

Effective Date

Next Review Date

Key ActionProviders must complete and legibly submit this Aetna precertification notification form with all required fields and clinical documentation for start or continuation of Wainua (eplontersen) to Aetna via phone or fax for precertification review.

SourceLink

POLICY UPDATE CHANGES

No material changes — form remains an administrative precertification/notification template without clinical coverage policy changes.

1Precertification form pages

ATTR-FAPIntended indication

Policy overview and purpose

This one-page Aetna precertification/notification form is used to request authorization for Wainua (eplontersen) for patients with hereditary transthyretin-mediated amyloidosis with polyneuropathy (ATTR‑FAP). It captures administrative and clinical information across patient, insurance, prescriber, dispensing, product, and diagnosis sections to support review.

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Required clinical confirmation items for both start and continuation of therapy include: confirmation of ATTR‑FAP diagnosis, detection of a TTR gene mutation, documentation of clinical manifestations of ATTR‑FAP, liver transplant status, concomitant use of other approved hereditary transthyretin‑mediated amyloidosis therapies, and that the medication is prescribed by or in consultation with an appropriate specialist (neurologist, geneticist, or amyloidosis specialist).

Required clinical information for precertification and continuation

Required clinical information for precertification

For All Requests (clinical documentation required):

ALL of the following

Diagnosis of polyneuropathy of hereditary transthyretin-mediated amyloidosis (transthyretin-type familial amyloid polyneuropathy [ATTR-FAP])
checkbox yes/no on form
Genetic confirmation: Diagnosis confirmed by detection of a mutation in the TTR gene
checkbox yes/no on form
Clinical manifestations: Patient exhibits clinical manifestations of ATTR-FAP (e.g., amyloid deposition in biopsy specimens, TTR protein variants in serum, progressive peripheral sensory-motor polyneuropathy)
checkbox yes/no on form
Transplant status: Is the patient a liver transplant recipient?
checkbox yes/no on form
Concomitant therapies: Will the requested medication be used in combination with any other medication approved for treatment of hereditary transthyretin-mediated amyloidosis (e.g., Amvuttra, Onpattro, Tegsedi, Vyndamax, Vyndaqel)?
checkbox yes/no on form
Treating specialist involvement: Will the requested medication be prescribed by or in consultation with: a) Neurologist, b) Geneticist, or c) Physician specializing in the treatment of amyloidosis?
checkbox yes/no on form

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Continuation requests required information

For Continuation Requests (clinical documentation required):

ALL of the following

Demonstration of beneficial response: Patient has demonstrated a beneficial response to treatment with the requested medication compared to baseline
Examples of measures: improvement of neuropathy severity and rate of disease progression as demonstrated by modified Neuropathy Impairment Scale+7 (mNIS+7), Norfolk QoL-DN total score, polyneuropathy disability (PND) score, FAP disease stage, manual grip strength; checkbox yes/no on form

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What the provider must do

Prior Authorization

Complete precertification form

Complete and legibly submit the Aetna precertification notification form with all required fields and clinical documentation for initiation or continuation of Wainua (eplontersen). Submission may be made via phone or fax for precertification review.

Documentation Required

Clinical confirmation and mutation documentation

Include documentation confirming a diagnosis of ATTR‑FAP, detection of a mutation in the TTR gene, evidence of clinical manifestations of ATTR‑FAP, liver transplant status, any concomitant amyloidosis therapies, and the treating specialist or consultation details (e.g., neurologist, geneticist, or physician specializing in amyloidosis).

Documentation Required

Continuation response documentation

For continuation requests, submit objective evidence that the patient has demonstrated a beneficial response compared to baseline using measures such as mNIS+7, Norfolk QoL‑DN total score, PND score, FAP disease stage, manual grip strength, or similar validated measures.

Billing Rule

Contact information for precertification submission

Submit precertification requests via phone or fax: Phone 1-866-752-7021 (TTY 711); Fax 1-888-267-3277. For Medicare Advantage Part B requests, use the Medicare request form.

Denial Risk

Incomplete form risk

Claims or precertification requests may be denied or delayed if the form is not fully completed, is illegible, or is missing required clinical documentation.

Definitions

ATTR‑FAP: Polyneuropathy of hereditary transthyretin‑mediated amyloidosis (transthyretin‑type familial amyloid polyneuropathy).

mNIS+7: Modified Neuropathy Impairment Score plus 7, a composite measure of neuropathy severity.

Norfolk QoL‑DN: Norfolk Quality of Life‑Diabetic Neuropathy total score, a patient‑reported outcome measure.

This form’s purpose is to collect the clinical and administrative elements Aetna requires to evaluate and authorize coverage for Wainua (eplontersen). It obtains confirmation of ATTR‑FAP diagnosis and detection of a TTR gene mutation, documents clinical manifestations and transplant status, captures concomitant amyloidosis therapies, and confirms involvement of a treating specialist or consultation (neurologist, geneticist, or amyloidosis specialist).

Policy Summary

PayerAetna

PolicyWainua (eplontersen) Medication Precertification Request

Policy CodePolicy N/A

Change TypeAdministrative form (no material change)

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Wainua (eplontersen) Medication Precertification Request

Policy overview and purpose

Required clinical information for precertification and continuation

What the provider must do

Codes referenced on the form

Definitions

Document changes