CurrentViva Health PlanPolicy IC-0670

Amvuttra (vutrisiran) Coverage Criteria

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This policy governs prior authorization, medical necessity, dosing, renewal, and billing requirements for subcutaneous Amvuttra (vutrisiran) for adult members with hereditary transthyretin-mediated amyloidosis polyneuropathy or wild-type/hereditary transthyretin amyloidosis cardiomyopathy.

Policy Summary

PayerViva Health Plan

PolicyAmvuttra (vutrisiran) Coverage Criteria

Policy CodePolicy IC-0670

Change TypeNo material clinical or coverage changes

Effective DateN/A

Last ReviewAug 4, 2026

Next Review DateN/A

Key ActionObtain prior authorization; initial authorization is valid for 6 months and renewal may be authorized every 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization

12 monthsRenewal authorization

25 mg/3 monthsMaximum dose

18 yearsMinimum age

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CurrentViva Health PlanPolicy IC-0670

Amvuttra (vutrisiran) Coverage Criteria

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Policy Summary

PayerViva Health Plan

PolicyAmvuttra (vutrisiran) Coverage Criteria

Policy CodePolicy IC-0670

Change TypeNo material clinical or coverage changes

Effective DateN/A

Last ReviewAug 4, 2026

Next Review DateN/A

Key ActionObtain prior authorization; initial authorization is valid for 6 months and renewal may be authorized every 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization

12 monthsRenewal authorization

25 mg/3 monthsMaximum dose

18 yearsMinimum age

Coverage Criteria

Universal Initial Criteria

Initial approval requires ALL of the following universal criteria:

Universal initial criteria

Member is at least 18 years of age.Age ≥18 years
Member is receiving vitamin A supplementation at the recommended daily allowance.Recommended daily allowance
Amvuttra is not used in combination with another transthyretin-reducing or transthyretin-stabilizing agent.
Examples include tafamidis, patisiran, acoramidis, inotersen, and eplontersen.

Initial Therapy: hATTR Polyneuropathy

For hATTR polyneuropathy, ALL of the following criteria must be met:

hATTR polyneuropathy

Member has a definitive diagnosis of hATTR amyloidosis documented in a proband with suggestive findings, including imaging or histopathology findings of amyloidosis, and a heterozygous pathogenic or likely pathogenic TTR variant identified by molecular genetic testing.
At least TWO qualifying neuropathy findings
- Subjective member symptoms are suggestive of neuropathy.
- Abnormal nerve conduction studies are consistent with polyneuropathy.
- Abnormal neurological examination is suggestive of neuropathy.
Peripheral neuropathy is attributed to hATTR, and other causes of neuropathy have been excluded.

Initial Therapy: ATTR Cardiomyopathy

For wild-type or hereditary ATTR cardiomyopathy, ALL of the following criteria must be met:

ATTR cardiomyopathy

Member has evidence of cardiac involvement by echocardiography with an end-diastolic interventricular septal wall thickness greater than 12 mm.> 12 mm
Member has a definitive diagnosis of wild-type or hereditary ATTR-CM confirmed by laboratory testing, such as PYP scanning, monoclonal antibody studies, biopsy, scintigraphy, or TTR genotyping.
Heart failure history or clinical evidence
- Member has a medical history of heart failure requiring at least one prior hospitalization.≥1 prior hospitalization

Continuation Therapy

Renewal requires ALL of the following:

Continuation therapy

Member continues to meet the universal and other relevant indication-specific initial criteria.
Member has no unacceptable toxicity from Amvuttra.
Examples of unacceptable toxicity include ocular symptoms related to vitamin A deficiency, such as night blindness.
Member demonstrates disease response compared with pretreatment baseline.
For hATTR polyneuropathy, response is stabilization or improvement in signs and symptoms of neuropathy or MRC muscle strength. For ATTR-CM, response is stabilization or improvement in the frequency of cardiovascular-related hospitalizations or urgent heart failure visits, or total distance walked during the 6-minute walk test.

Concurrent transthyretin therapy is excluded. Amvuttra must not be used in combination with another transthyretin (TTR)-reducing or TTR-stabilizing agent, including tafamidis, patisiran, acoramidis, inotersen, or eplontersen.

For the hATTR polyneuropathy indication, coverage is excluded when the member has received an orthotopic liver transplant (OLT).

For ATTR cardiomyopathy (ATTR-CM), coverage is excluded for members with high-risk NYHA Class III heart failure or NYHA Class IV heart failure.

Billing and Coding

HCPCS CodeHCPCSCovered

J0225

Injection, vutrisiran, 1 mg; 1 billable unit = 1 mg

NDCNDCCovered

71336-1003-xx

Amvuttra 25 mg/0.5 mL single-dose prefilled syringe

Covered Diagnosis CodesICD-10Covered

E85.1	Neuropathic heredofamilial amyloidosis
E85.4	Organ-limited amyloidosis
E85.82	Wild-type transthyretin-related (ATTR) amyloidosis

Covered Diagnosis CodesICD-10Covered

E85.1	Neuropathic heredofamilial amyloidosis
E85.4	Organ-limited amyloidosis
E85.82	Wild-type transthyretin-related (ATTR) amyloidosis

Vutrisiran Dose

Maximum dose25 mg per dose

Dosing intervalOnce every 3 months

AdministrationSubcutaneous injection by a healthcare professional

ATTR-CM Echocardiographic Threshold

Diagnostic thresholdEnd-diastolic interventricular septal wall thickness greater than 12 mm

Assessment methodEchocardiography

Provider Requirements and Action Items

Prior Authorization

Authorization Duration

Prior authorization is required for Amvuttra. Initial authorization is valid for 6 months (180 days), and renewal authorization may be granted every 12 months (365 days).

Prior Authorization

Prior Authorization Applies

Viva Health Plan applies utilization management and prior authorization to this drug/drug group. Providers must obtain authorization before treatment and subsequent renewals.

Prior authorization is a utilization-management requirement for this medical benefit prescription drug.

Documentation Required

Background

Amvuttra (vutrisiran) is a subcutaneous transthyretin-directed therapy for adults with hereditary transthyretin-mediated amyloidosis presenting as polyneuropathy or with wild-type or hereditary transthyretin amyloidosis presenting as cardiomyopathy. Coverage requires objective confirmation of the applicable amyloidosis manifestation, baseline functional assessment, and ongoing evidence of treatment response and tolerability.

Definitions

ATTR-CM

Disease typeWild-type or hereditary transthyretin-mediated amyloidosis with cardiac involvement

Diagnostic confirmationDefinitive ATTR-CM diagnosis confirmed by laboratory testing, such as PYP scanning, monoclonal antibody studies, biopsy, scintigraphy, or TTR genotyping

Required clinical featuresQualifying heart failure history or clinical evidence, permitted baseline NYHA status, and echocardiographic cardiac involvement

hATTR Polyneuropathy

Disease typeHereditary transthyretin-mediated amyloidosis with peripheral polyneuropathy

Genetic confirmationA heterozygous pathogenic or likely pathogenic TTR variant identified by molecular genetic testing

Initial Authorization

Renewal Authorization

Amvuttra Renewal

Renewal requires ALL of the following:

Amvuttra renewal

Member continues to meet the universal and relevant indication-specific initial criteria.
Member has no unacceptable toxicity from Amvuttra.
Examples of unacceptable toxicity include ocular symptoms related to vitamin A deficiency, such as night blindness.
Member demonstrates disease response compared with pretreatment baseline.
For hATTR polyneuropathy, response is stabilization or improvement in signs and symptoms of neuropathy or MRC muscle strength. For ATTR-CM, response is stabilization or improvement in the frequency of cardiovascular-related hospitalizations or urgent heart failure visits, or total distance walked during the 6-minute walk test.

Quantity and Dosing Limits

Quantity Limits

DrugAmvuttra (vutrisiran)

Quantity limit25 billable units per dose

Equivalent amount25 mg

FrequencyEvery 3 months

Administration Site and Method

Billing Rule

Use the required administration setting

Amvuttra must be administered by a healthcare professional by subcutaneous injection in the office setting.

Policy Summary

PayerViva Health Plan

PolicyAmvuttra (vutrisiran) Coverage Criteria

Policy CodePolicy IC-0670

Change TypeNo material clinical or coverage changes

Effective DateN/A

Last ReviewAug 4, 2026

Next Review DateN/A

Key ActionObtain prior authorization; initial authorization is valid for 6 months and renewal may be authorized every 12 months when criteria are met.

SourceLink

On This Page

Baseline strength or weakness has been documented using an objective clinical measuring tool, such as the Medical Research Council muscle strength scale.

Member has not received an orthotopic liver transplant.

Member has clinical evidence of heart failure, with or without hospitalization, manifested by signs or symptoms of volume overload or elevated intracardiac pressure and requiring or having required treatment with a diuretic.

Examples include elevated jugular venous pressure, shortness of breath, pulmonary congestion on x-ray or auscultation, or peripheral edema.

Permitted baseline NYHA class

Baseline NYHA Class I or II heart failure.NYHA Class I or II
Baseline NYHA Class III heart failure that is not considered high risk.Non-high-risk NYHA Class III
High-risk NYHA Class III and NYHA Class IV disease are excluded.

Member has a baseline 6-minute walk-test distance of at least 150 meters.≥150 meters

Evidence of cardiac involvement for ATTR-CM

6-Minute Walk Test

Minimum distanceAt least 150 meters

AssessmentBaseline 6-minute walk test

ApplicationRequired functional assessment for ATTR-CM

hATTR Diagnostic Documentation

For hATTR polyneuropathy, document a definitive diagnosis in a proband with suggestive amyloidosis findings and molecular genetic confirmation of a heterozygous pathogenic or likely pathogenic TTR variant.

Include suggestive imaging or histopathology findings of amyloidosis.
Include molecular genetic testing identifying a heterozygous pathogenic or likely pathogenic TTR variant.

Documentation Required

Polyneuropathy Findings

Document polyneuropathy using at least TWO qualifying findings.

Subjective symptoms suggestive of neuropathy.
Abnormal nerve conduction studies consistent with polyneuropathy.
Abnormal neurologic examination suggestive of neuropathy.

Documentation Required

Neuropathy Attribution and Baseline

Document that the peripheral neuropathy is attributable to hATTR and that other causes of neuropathy have been excluded. Establish baseline strength or weakness with an objective clinical measure before treatment.

Use an objective tool such as Medical Research Council (MRC) muscle-strength testing to document baseline status.

Documentation Required

ATTR-CM Diagnostic Documentation

For ATTR-CM, document cardiac involvement and a definitive wild-type or hereditary ATTR-CM diagnosis.

Echocardiography must show end-diastolic interventricular septal wall thickness > 12 mm.
Confirm diagnosis with appropriate laboratory or diagnostic testing, such as PYP scanning, monoclonal antibody studies, biopsy, scintigraphy, or TTR genotyping.

Documentation Required

ATTR-CM Severity and Functional Status

Document the member's heart-failure history and baseline functional status for ATTR-CM authorization.

Document either at least 1 prior heart-failure hospitalization or clinical heart-failure evidence requiring or previously requiring diuretic treatment.
Baseline NYHA class must be I or II, or non-high-risk class III.
Record a baseline 6-minute walk-test distance of ≥150 meters.

Documentation Required

Renewal Documentation

For renewal, document continued satisfaction of the universal and indication-specific criteria, tolerability, and disease response compared with the pretreatment baseline.

For hATTR polyneuropathy, document stabilization or improvement in neuropathy signs and symptoms or MRC muscle strength.
For ATTR-CM, document stabilization or improvement in cardiovascular-related hospitalizations or urgent heart-failure visits, or total 6-minute walk-test distance.

Unsupported block type: denial_risk

Denial Risk

Polyneuropathy Exclusions

Authorization may be denied for hATTR polyneuropathy when exclusionary conditions are present.

Member must not have received an orthotopic liver transplant (OLT).
Other causes of peripheral neuropathy must be excluded.

Unsupported block type: denial_risk

Clinical confirmationAt least two of subjective neuropathy symptoms, abnormal nerve conduction studies consistent with polyneuropathy, or an abnormal neurological examination suggestive of neuropathy

Additional requirementsPeripheral neuropathy must be attributed to hATTR, other causes excluded, and baseline strength or weakness documented with an objective clinical measuring tool

Non-Quantitative Treatment Limitation

DefinitionMethods, guidelines, standards of evidence, or other conditions that can restrict how long or to what extent benefits are provided under a health plan

ExamplesUtilization review or prior authorization

Application in this policyThe utilization management limitation applies to this drug or drug group through prior authorization