Amvuttra (vutrisiran) prior authorization for transthyretin amyloidosis
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This AvMed medical prior authorization/step-edit form governs coverage and authorization requirements for Amvuttra (vutrisiran) for members with transthyretin-mediated polyneuropathy or cardiomyopathy; it applies to providers seeking medical (non-pharmacy) benefit approval.
No material clinical or coverage changes in this revision.
Coverage Criteria for Amvuttra (vutrisiran)
Initial Therapy (hATTR polyneuropathy)
Covered when ALL of the following are met for hATTR polyneuropathy:
Reauthorization (hATTR polyneuropathy)
Reauthorization covered when ALL of the following that apply are met:
Initial Therapy (ATTR cardiomyopathy)
Covered when ALL of the following are met for ATTR-CM without polyneuropathy:
Pharmacy paid claims MUST show adherence when claiming progression despite stabilizer.
Reauthorization (ATTR cardiomyopathy)
Reauthorization covered when ALL of the following are met for ATTR-CM:
The following conditions are not medically necessary and will result in denial of Amvuttra (vutrisiran) under the medical benefit: history of liver transplant; severe renal impairment or end-stage renal disease; moderate or severe hepatic impairment; New York Heart Association (NYHA) class IV heart failure; sensorimotor or autonomic neuropathy not related to hereditary transthyretin amyloidosis (for example, neuropathy due to monoclonal gammopathy or autoimmune disease); cardiomyopathy not related to transthyretin amyloidosis; or concurrent use of other specified transthyretin-targeting therapies or diflunisal.
Coding, Dosing, and Quantity Limits
| J0225 | Injection, vutrisiran, 1 mg (Amvuttra) - medical benefit |
Provider Requirements, Prior Authorization, and Documentation
Prior authorization required; prescriber signature and complete PA form
Prior authorization is required for Amvuttra (vutrisiran) billed as J0225. The prescribing physician must sign and clearly print their name on the medical prior authorization/step-edit request (preprinted stamps are not valid) and submit the completed PA form with required clinical documentation; incomplete, incorrect, or illegible information may delay authorization.
- Drug Requested: Amvuttra (vutrisiran) SQ (J0225)
- Prescribing physician must sign and clearly print name on the request (preprinted stamps not valid)
- Submit required clinical documentation per checklist for the chosen indication
Step requirement — progression despite ≥90 days of a TTR stabilizer or intolerance
For ATTR cardiomyopathy, approval requires documentation of disease progression despite at least 90 consecutive days of a transthyretin stabilizer, or documentation of intolerance/contraindication to both tafamidis and acoramidis; pharmacy paid claims must verify adherence when progression is claimed.
- Progression must be shown by worsening signs/symptoms, increased NYHA class, heart-failure hospitalizations, or decline in quality of life (verified by chart notes)
- If claiming progression despite stabilizer, pharmacy paid claims MUST show adherence to therapy
- Alternatively, documentation of intolerance/contraindication to both tafamidis (Vyndamax/Vyndaqel) and acoramidis (Attruby) is acceptable
Required supporting documentation: genetics, biopsy/imaging, neurophysiology, and baseline assessments
Providers must submit supporting documentation to verify diagnosis and baseline disease status, including genetic testing, biopsy or diagnostic cardiac imaging, nerve conduction or neurologic exam results, baseline functional scores, and pharmacy paid claims where prior stabilizer use is relevant.
- Genetic testing showing a pathogenic TTR mutation (for hATTR or as an ATTR-CM confirmation option)
- Tissue biopsy demonstrating amyloid deposits or cardiac tissue biopsy confirming TTR amyloid; or nuclear scintigraphy (Tc‑PYP) grade 2–3 uptake for ATTR-CM
- Nerve conduction study or neurologic exam results for polyneuropathy indications
- Baseline assessments: PND score or FAP stage (polyneuropathy); KCCQ, 6-minute walk, CV hospitalization frequency, or NT‑proBNP (cardiomyopathy)
- Pharmacy paid claims to verify adherence to prior transthyretin stabilizer when progression is asserted
Triggers that may delay or deny authorization: incomplete form, missing diagnostics, or absent clinician signature
Authorization may be delayed or denied if the PA form or supporting records are incomplete, incorrect, or illegible, if required labs/diagnostics or chart documentation supporting each checked criterion are not provided, or if an exclusion applies (e.g., history of liver transplant, severe renal/hepatic impairment, NYHA class IV, or concurrent prohibited TTR therapies).
- Illegible or unsigned (by prescribing physician) PA requests can delay authorization
- Missing required labs, diagnostics, chart notes, or baseline assessments for the indication may result in denial
- Concurrent use of other specified TTR-targeting therapies or presence of listed exclusions (see exclusions) will prevent approval
Background and Clinical Context
Transthyretin-mediated amyloidosis produces two principal clinical syndromes: hereditary transthyretin-mediated polyneuropathy (hATTR / FAP) and transthyretin amyloid cardiomyopathy (ATTR-CM). Assessment for polyneuropathy relies on neurologic evaluation and electrophysiology plus standardized disability staging (e.g., PND score or FAP stage). For cardiac disease, diagnosis and baseline assessment use imaging (echocardiography or cardiac MRI demonstrating increased left ventricular wall thickness), nuclear scintigraphy or biopsy for confirmation, and functional measures such as NYHA class, 6-minute walk distance, Kansas City Cardiomyopathy Questionnaire (KCCQ), and cardiac biomarkers (e.g., NT-proBNP).
Verification of transthyretin etiology and exclusion of light-chain (AL) amyloidosis are required for cardiac indications. Initial authorization durations differ by phenotype: hATTR polyneuropathy initial authorizations are typically for 6 months, while ATTR-CM initial authorizations are typically for 12 months. Recommended dosing for Amvuttra is 25 mg administered subcutaneously once every 3 months.
Definitions
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