CurrentAetnaPolicy N/A

Onpattro (patisiran) Injectable Medication Precertification Request

Precertification/authorization request form used by Aetna for Onpattro (patisiran) to collect patient, prescriber, clinical, dispensing, diagnosis, and justification information for start or continuation of therapy; includes required clinical questions to support review and contact/fax information for submission.

Policy Summary

PayerAetna

PolicyOnpattro (patisiran) Injectable Medication Precertification Request

Policy CodePolicy N/A

Change TypeAdministrative form (no material change)

Effective Date

Next Review Date

Key ActionProviders must complete and submit the precertification request form with all required fields and clinical documentation to Aetna Precertification Notification via phone 1-866-752-7021 (TTY: 711) or fax 1-888-267-3277; Medicare Advantage Part B requests must use the Medicare Request Form.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes — this document is an administrative precertification request form and has no material change noted.

1Form pages

OnpattroMedication covered by form

Policy summary and purpose

This form is the Aetna precertification/authorization request for Onpattro (patisiran) used to support review of start or continuation of infusion therapy. It must be completed and submitted to Aetna Precertification Notification (phone 1-866-752-7021, TTY 711 or fax 1-888-267-3277); Medicare Advantage Part B requests must use the Medicare Request Form.

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The form collects patient demographics (name, DOB, contact, weight/height, allergies), insurance details (Aetna member ID, group, other coverage, Medicare/Medicaid IDs), and prescriber information (name, credentials, specialty, NPI, licensure, contact). It also captures dispensing and administration details including place of administration, dispensing provider type, administration CPT code(s), product requested (Onpattro dose and frequency), and dispensing provider contact information.

Diagnosis and clinical justification fields are required: primary/secondary/other ICD-10 codes, confirmation of ATTR‑FAP diagnosis (including TTR mutation), documentation of clinical manifestations, and detailed required clinical questions for all requests (setting, adverse events, venous access, behavioral or medical instability, concurrent amyloidosis treatments, prescriber specialty/consult). Continuation requests must document beneficial response using specified measures (e.g., mNIS+7, Norfolk QoL‑DN, PND, FAP stage, or manual grip strength).

Required clinical information for precertification and continuation

Required clinical information for precertification

For all requests, the following information must be provided:

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Continuation requests

Clinical documentation required for continuation requests:

Continuation - clinical benefit: Has the patient demonstrated a beneficial response to treatment with the requested medication compared to baseline (e.g., improvement of neuropathy severity and rate of disease progression as demonstrated by the modified Neuropathy Impairment Scale+7 (mNIS+7) composite score, the Norfolk Quality of Life-Diabetic Neuropathy (QoL-DN) total score, polyneuropathy disability (PND) score, FAP disease stage, manual grip strength)?

Yes/No checkbox

What providers must do

Prior Authorization

Precertification submission required

Complete and submit the precertification request form with all required fields and clinical documentation to Aetna Precertification Notification. Submission channels: phone or fax. For Medicare Advantage Part B requests, use the Medicare Request Form.

Phone: 1-866-752-7021 (TTY: 711)
Fax: 1-888-267-3277

Documentation Required

Required clinical documentation elements

Provide documentation confirming diagnosis and genetics (TTR mutation), evidence of clinical manifestations of ATTR-FAP, information on infusion setting and safety considerations (outpatient hospital setting, medical instability, behavioral or caregiver issues), history of adverse events to the product, severe venous access issues, prescriber specialty or consultation, and for continuation requests evidence of clinical benefit using mNIS+7, Norfolk QoL-DN, PND score, FAP disease stage, or manual grip strength.

Denial Risk

Incomplete form risk

Incomplete or illegible fields on the form may not be reviewed; the plan may request additional information or clarification and may deny or delay authorization if required information is not provided.

Billing Rule

Place of administration designation

Indicate the place of administration (self-administered, physician's office, outpatient infusion center, home infusion center) and the dispensing provider type on the form. Administration CPT code(s) should also be provided on the form.