CurrentBlue Cross Blue Shield - IowaPolicy 05.05.93

Amvuttra (vutrisiran) coverage for transthyretin-mediated amyloidosis

Defines prior authorization, medical necessity criteria, dosing limits, and required documentation for coverage of Amvuttra (vutrisiran) for hereditary transthyretin-mediated polyneuropathy and transthyretin-mediated cardiomyopathy in adults.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyAmvuttra (vutrisiran) coverage for transthyretin-mediated amyloidosis

Policy CodePolicy 05.05.93

Change TypeNo material changes

Effective DateMar 6, 2026

Next Review DateJan 1, 2026

Key ActionSubmit prior authorization with required documentation including genetic testing or biopsy/scintigraphy results, baseline scores/staging, and evidence of response for continuation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA-approved indications covered

25 mg q3 moRecommended dosing

J0225HCPCS code

1/3moQuantity limit

Coverage Criteria for Amvuttra (vutrisiran)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Familial Amyloid Polyneuropathy

Covered when ALL of the following are met:

ALL of the following

Member is 18 years of age or older
Member has a diagnosis of hereditary ATTR amyloidosis with polyneuropathy confirmed by the presence of a TTR gene mutation (e.g., V30M)
Member has a polyneuropathy disability (PND) score ≤ IIIb or familial amyloid polyneuropathy (FAP) disease stage ≤ 2
Member has clinical signs and symptoms of polyneuropathy (e.g., weakness, sensory loss, decreased motor strength, decreased gait speed)
Other causes of peripheral neuropathy have been assessed and ruled out
Member is receiving Vitamin A supplementation at the recommended daily allowance prior to initiating therapy and will continue to receive supplementation for duration of treatment
Member will not receive the requested medication in combination with tafamidis (Vyndamax, Vyndaqel), acoramidis (Attruby), patisiran (Onpattro), eplontersen (Wainua), or inotersen (Tegsedi)

Cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis

Covered when ALL of the following are met:

ALL of the following

Member does not have NYHA Class IV heart failure or Class III that is considered high risk (defined as NT-proBNP >3000 ng/L and eGFR <45 mL/min/1.73 m2)
For hereditary ATTR-CM, presence of a TTR gene mutation was confirmed
ANY of the following
- Biopsy-proven pathway
  - Presence of transthyretin amyloid deposits on analysis of biopsy from cardiac or noncardiac sites (e.g., fat aspirate, gastrointestinal sites, salivary glands, bone marrow)
  - Presence of transthyretin precursor proteins confirmed by immunohistochemical analysis, mass spectrometry, tissue staining, or polarized light microscopy

Continuation Therapy - FAP

Continuation therapy is covered when ALL of the following are met:

ALL of the following

Member meets all initial approval criteria for familial amyloid polyneuropathy
Member has achieved a therapeutic response as evidenced by stabilization or improvement from baseline in polyneuropathy disability (PND), FAP disease stage, or other assessments of neuropathy severity (e.g., mNIS+7, Norfolk QoL-DN total score, NIS)
Medical record documentation confirming the member demonstrates signs and symptoms of polyneuropathy and an improvement or stabilization since starting therapy

Continuation Therapy - ATTR-CM

Continuation therapy is covered when ALL of the following are met:

ALL of the following

Member meets all initial approval criteria for ATTR-CM
Member has achieved a therapeutic response to treatment as evidenced by improvement in rate of disease progression (e.g., 6-minute walk test distance, KCCQ-OS score, reduced cardiovascular-related hospitalizations, improved NYHA classification, increased left ventricular stroke volume, or improved NT-proBNP level)
Medical record documentation confirming the member demonstrates a beneficial response to treatment

The requested medication will not be used in combination with tafamidis (Vyndamax, Vyndaqel), acoramidis (Attruby), patisiran (Onpattro), eplontersen (Wainua), or inotersen (Tegsedi).

Amvuttra (vutrisiran) is considered not medically necessary for members who do not meet the criteria set forth above.

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Amvuttra (vutrisiran). Submission of complete documentation listed below is necessary to initiate the prior authorization review and for both initial and continuation requests.

Prior authorization required before therapy is initiated
Submit complete clinical documentation to support indication (see Required Documentation callout and Criteria sections)

Denial Risk

Denial Risk — Not Medically Necessary When Criteria Not Met

Amvuttra (vutrisiran) is considered not medically necessary when the member does not meet the medical necessity criteria in this policy (see "Criteria for Initial Approval" for familial amyloid polyneuropathy and ATTR cardiomyopathy). Requests that lack required diagnostic confirmation or necessary baseline/continuation evidence may be denied.

Denial risk if documentation does not confirm TTR gene mutation for hereditary disease when required
Denial risk if diagnostic evidence of cardiac involvement or biopsy/scintigraphy criteria for ATTR-CM is absent
Denial risk if baseline disease severity/PND score or FAP staging is not documented for FAP indication
Denial risk for continuation requests without documentation of clinical benefit

Documentation Required

Required Documentation for Prior Authorization

Required documentation to accompany prior authorization requests. Provide the applicable items below based on the requested indication (Familial Amyloid Polyneuropathy or ATTR‑CM). Incomplete submissions may delay review or result in denial.

For Familial Amyloid Polyneuropathy (FAP): testing or analysis confirming a mutation of the TTR gene
For FAP: medical records documenting baseline polyneuropathy disability (PND) score or baseline FAP disease stage
For FAP continuation: medical record documentation that the member demonstrates signs/symptoms of polyneuropathy and clinical improvement or benefit since starting therapy
For ATTR Cardiomyopathy (wild-type or hereditary): biopsy-proven disease documentation including tissue biopsy showing transthyretin amyloid deposition and confirmatory testing (immunohistochemistry, mass spectrometry, tissue staining, or polarized light microscopy)
For ATTR-CM: technetium-labeled bone scintigraphy results confirming amyloid deposits and documentation that light chain amyloidosis has been ruled out (serum kappa/lambda free light chain ratio, serum and/or urine protein immunofixation)
For ATTR-CM: echocardiography or cardiac MRI results confirming cardiac involvement (e.g., increased interventricular septal wall thickness)
For hereditary ATTR-CM: documentation of TTR gene mutation test results
For ATTR-CM: medical records documenting NYHA classification of heart failure
For ATTR-CM continuation: documentation of beneficial response to treatment (examples: change in 6-minute walk distance, KCCQ-OS score, reduction in cardiovascular hospitalizations, improvement in NYHA class, changes in NT-proBNP or left ventricular stroke volume)

Definitions and Scoring Systems

Polyneuropathy Disability (PND) score

Stage 0No impairment

Stage ISensory disturbances but preserved walking capability

Stage IIImpaired walking capability but able to walk without a stick or crutches

Stage IIIaWalking only with the help of one stick or crutch

Stage IIIbWalking with the help of two sticks or crutches

Stage IVConfined to a wheelchair or bedridden

Policy requirement for initial approvalPND score must be ≤ IIIb for initial approval

NYHA functional classification and policy exclusions

Class INo limitation of physical activity; ordinary activity does not cause undue fatigue, palpitation, or dyspnea

Class IISlight limitation of physical activity; comfortable at rest; ordinary activity results in symptoms

Class IIIMarked limitation of physical activity; comfortable at rest; less than ordinary activity causes symptoms

Class IVUnable to carry on any physical activity without discomfort; symptoms of heart failure at rest; NYHA Class IV is excluded from coverage

High-risk Class III exclusionNYHA Class III patients considered high risk (NT-proBNP >3000 ng/L AND eGFR <45 mL/min/1.73 m2) are excluded from initial approval

OpenPayer

Amvuttra (vutrisiran) coverage for transthyretin-mediated amyloidosis

Coverage Criteria for Amvuttra (vutrisiran)

Coding and Billing

Provider Actions and Prior Authorization Requirements

Background

Definitions and Scoring Systems