CurrentCommunity-CarePolicy N/A

Amvuttra (vutrisiran) medical benefit coverage

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Defines medical necessity criteria, quantity limits, and authorization requirements for Amvuttra (vutrisiran) for treatment of hATTR polyneuropathy and ATTR cardiomyopathy for affected members and prescribers.

Policy Summary

PayerCommunity-Care

PolicyAmvuttra (vutrisiran) medical benefit coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewMay 1, 2025

Next Review DateMay 1, 2025

Key ActionObtain prior authorization; if approved, limit is 1 prefilled syringe (25 mg) every 3 months and authorization is for 1 year.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 per 3 momaximum authorized quantity

1 yearauthorization period

J0225HCPCS code

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CurrentCommunity-CarePolicy N/A

Amvuttra (vutrisiran) medical benefit coverage

Customize your policy alerts

Sign up for all Community-Care policy alerts

Know when Community-Care releases new policies or updates existing guidance.

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Policy Summary

PayerCommunity-Care

PolicyAmvuttra (vutrisiran) medical benefit coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewMay 1, 2025

Next Review DateMay 1, 2025

Key ActionObtain prior authorization; if approved, limit is 1 prefilled syringe (25 mg) every 3 months and authorization is for 1 year.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 per 3 momaximum authorized quantity

1 yearauthorization period

J0225HCPCS code

Coverage Criteria for Amvuttra (vutrisiran)

Initial Therapy - hATTR polyneuropathy

Covered when ALL of the following are met:

hATTR polyneuropathy initial criteria

amyloidosis confirmation: Amyloidosis confirmed by positive tissue biopsy OR non-invasive testing demonstrating ALL of: (a) bone scintigraphy myocardial uptake > 1.5 heart-to-contralateral ratio or grade > 2 visual evidence; (b) serum kappa/lambda free light chain ratio 0.26 - 1.65; (c) absence of monoclonal protein via serum protein immunofixation; (d) absence of monoclonal protein via urine protein immunofixation.
polyneuropathy confirmation: Polyneuropathy confirmed by baseline Polyneuropathy Disability (PND) score ≥ 1 OR baseline Familial Amyloidosis Polyneuropathy (FAP) Stage ≥ 1 with at least one of: (a) autonomic dysfunction; (b) symmetrical length-dependent peripheral neuropathy beginning in lower limbs progressing proximally; (c) bilateral carpal tunnel syndrome; (d) cardiac symptoms.

Initial Therapy - ATTR-CM

Covered when ALL of the following are met:

ATTR-CM initial criteria

cardiac confirmation: Cardiac ATTR-CM confirmed by cardiac biopsy with positive Congo Red staining and ATTR confirmation by mass spectrometry or immunofluorescence OR by non-invasive methods where ALL of the following are present: (a) serum kappa/lambda free light chain ratio 0.26 - 1.65; (b) absence of monoclonal protein via serum protein immunofixation; (c) absence of monoclonal protein via urine protein immunofixation; (d) myocardial 99mTc-PYP uptake > 1.5 heart-to-contralateral ratio or grade ≥ 2 visual evidence.

Continuation Therapy

Covered when ALL of the following are met:

Continuation criteria: Diagnosis of the respective condition (polyneuropathy of hATTR amyloidosis or ATTR-CM) AND attestation of a positive clinical response to vutrisiran (Amvuttra) AND no concurrent use with other TTR silencing or stabilizing agents.

Use of vutrisiran in combination with other transthyretin (TTR) silencing or stabilizing agents is excluded. Examples of prohibited concurrent therapies include, but are not limited to, tafamidis (Vyndaqel, Vyndamax), eplontersen (Wainua), and patisiran (Onpattro).

For initial and continuation requests, coverage is limited to patients meeting the specified diagnostic and specialist-prescriber requirements for the relevant indication (hATTR polyneuropathy or ATTR-CM) and to members aged ≥ 18 years. Continuation approvals require documentation of a positive clinical response to vutrisiran and confirmation that the member is not receiving concurrent TTR silencing or stabilizing therapy.

Prior authorization is required for vutrisiran and, if approved, is subject to the policy’s quantity limit and authorization period provisions. Providers should submit specialty documentation (prescription or consultation by an appropriate specialist), diagnostic confirmation per the indication-specific criteria, and attestations required for continuation requests to support medical necessity.

Coding and Diagnostic Thresholds

Applicable HCPCS CodesHCPCSCovered

J0225

Injection, vutrisiran, 1 mg

inv-06: Serum kappa/lambda free light chain ratio — numeric diagnostic threshold

Numeric rangeSerum kappa/lambda free light chain ratio 0.26 - 1.65

ContextRequired as part of non-invasive diagnostic criteria for amyloidosis (hATTR polyneuropathy and ATTR-CM)

UsageMeasured on serum testing; absence of monoclonal protein by serum and urine immunofixation also required for non-invasive confirmation

inv-07: Myocardial 99mTc-PYP uptake threshold — > 1.5 heart-to-contralateral ratio or grade ≥ 2 visual evidence

Threshold> 1.5 heart-to-contralateral ratio or grade ≥ 2 visual evidence

ModalityBone scintigraphy / 99mTc-PYP myocardial uptake

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization and Quantity Limits

Prior authorization is required for vutrisiran (Amvuttra) for all indications. Requests should specify the requested regimen and duration. Approval, when granted, will be limited to a single prefilled syringe (25 mg) every 3 months and an authorization period up to 12 months.

Quantity limit: up to one (1) prefilled syringe (0.5 mL) (25 mg) per 3 months.
Authorization period: up to 1 year (subject to benefit changes).

Step Therapy

Step therapy is not required beyond the coverage criteria outlined in the policy. No additional trial of alternate TTR agents is permitted or required prior to approval of vutrisiran — however, concurrent use with other TTR silencing or stabilizing agents is not allowed (see combination therapy exclusion).

Background

Hereditary transthyretin-mediated (hATTR) amyloidosis is a systemic disorder that can present primarily as polyneuropathy or as cardiomyopathy (ATTR‑CM). Diagnostic confirmation for hATTR-related polyneuropathy requires specialist evaluation, genetic sequencing confirming ATTR, and either a positive tissue biopsy or non-invasive testing meeting all specified criteria (including myocardial 99mTc‑PYP uptake and serum/urine testing where applicable).

Vutrisiran is a TTR‑silencing agent indicated for adults with genetically confirmed hATTR polyneuropathy or for ATTR‑CM when diagnostic criteria are met. Treatment with vutrisiran must not be combined with other TTR‑targeted therapies; clinical decisions should be made by or in consultation with an appropriate specialist (neurologist, cardiologist, hematologist, or other provider experienced in ATTR).

Definitions and Diagnostic Confirmation

inv-15: hATTR polyneuropathy confirmation — tissue biopsy or non-invasive testing plus genetic sequencing criteria

Definitive confirmationPositive tissue biopsy demonstrating amyloidosis

Non-invasive confirmation plus geneticsNon-invasive testing meeting all required elements (99mTc-PYP myocardial uptake >1.5 H/CL or grade >2, serum kappa/lambda ratio 0.26–1.65, absence of monoclonal protein on serum and urine immunofixation) AND hATTR confirmed by genetic sequencing

Required specialty involvementDiagnosis and prescription by a neurologist, cardiologist, hematologist, or other specialist experienced in hATTR

inv-16: ATTR-CM confirmation — cardiac biopsy or non-invasive criteria including serum/urine testing thresholds

Definitive confirmationCardiac biopsy with positive Congo Red staining and ATTR confirmation by mass spectrometry or immunofluorescence staining

Policy Summary

PayerCommunity-Care

PolicyAmvuttra (vutrisiran) medical benefit coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewMay 1, 2025

Next Review DateMay 1, 2025

Key ActionObtain prior authorization; if approved, limit is 1 prefilled syringe (25 mg) every 3 months and authorization is for 1 year.

SourceLink

On This Page

RoleOne required element of non-invasive amyloidosis confirmation for hATTR polyneuropathy and ATTR-CM

inv-08: Baseline Polyneuropathy Disability (PND) score — ≥ 1

Minimum scoreBaseline Polyneuropathy Disability (PND) score ≥ 1

PurposeUsed to confirm presence of polyneuropathy for hATTR initial approval

AlternativeFAP Stage ≥ 1 with at least one qualifying feature may be used instead

inv-09: Baseline Familial Amyloidosis Polyneuropathy (FAP) Stage — ≥ 1

Minimum stageBaseline Familial Amyloidosis Polyneuropathy (FAP) Stage ≥ 1

Required accompanying featuresAt least one of: autonomic dysfunction; symmetrical length-dependent peripheral neuropathy beginning in lower limbs progressing proximally; bilateral carpal tunnel syndrome; or cardiac symptoms

UseAcceptable alternative to baseline PND ≥ 1 to confirm polyneuropathy for hATTR initial approval

Documentation Required

Required Documentation for Initial and Continuation Requests

Provide documentation supporting both initial and continuation requests. For initial requests include specialist involvement and diagnostic confirmation; for continuation include evidence of clinical benefit.

Initial request must include: prescriber specialty (neurologist, cardiologist, hematologist, or other specialist experienced in hATTR/ATTR diagnosis and treatment); patient age (≥ 18 years); diagnostic confirmation of amyloidosis (positive tissue biopsy OR non-invasive testing with required elements) and confirmation of hATTR by genetic sequencing for polyneuropathy (or cardiac confirmation methods for ATTR-CM); baseline neuropathy staging (PND ≥1 or FAP Stage ≥1 with supporting signs) when applicable.
Continuation requests must include: documentation of ongoing diagnosis; attestation of a positive clinical response to vutrisiran (Amvuttra); confirmation that the patient is not receiving concurrent TTR silencing or stabilizing therapy (eg, tafamidis, eplontersen, patisiran).
Operational note: Include relevant test reports (biopsy, 99mTc-PYP imaging, serum/urine immunofixation, kappa/lambda free light chain ratio), genetic sequencing results when indicated, and baseline/follow-up clinical status or functional scores to demonstrate response.

Denial Risk

Combination Therapy Exclusion

Concurrent use of vutrisiran with other transthyretin (TTR) silencing or stabilizing agents is not allowed. Requests that indicate combined therapy (including but not limited to tafamidis [Vyndaqel, Vyndamax], eplontersen [Wainua], or patisiran [Onpattro]) will be denied or considered non-covered.

Non-invasive criteria (all required)

Serum kappa/lambda free light chain ratio 0.26 - 1.65; absence of monoclonal protein via serum protein immunofixation; absence of monoclonal protein via urine protein immunofixation; myocardial 99mTc-PYP uptake > 1.5 heart-to-contralateral ratio or grade ≥ 2 visual evidence

Provider requirementPrescribed by or in consultation with a cardiologist or provider experienced in ATTR-CM