CurrentViva HealthPolicy IC-0670

Amvuttra (vutrisiran) — Coverage Criteria

Defines medical necessity, dosing, and authorization criteria for Amvuttra (vutrisiran) for adult members with hereditary transthyretin-mediated (hATTR) polyneuropathy or transthyretin-mediated cardiomyopathy, and specifies renewal and documentation expectations for Viva Health.

Policy Summary

PayerViva Health

PolicyAmvuttra (vutrisiran) — Coverage Criteria

Policy CodePolicy IC-0670

Change TypeNo material changes

Effective Date

Next Review DateMay 5, 2025

Key ActionObtain prior authorization: initial approval for 6 months with annual renewals; dose 25 mg subcutaneously every 3 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

25 mgsingle dose strength

q3 monthsdosing interval

6 monthsinitial authorization length

≥18minimum patient age

≥150 mATTR-CM baseline 6MWT

Coverage Criteria for Amvuttra (vutrisiran)

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Initial: hATTR polyneuropathy

Initial approval — hATTR polyneuropathy covered when ALL of the following are met:

hATTR polyneuropathy initial: Patient is at least 18 years of age; AND Patient is receiving supplementation with vitamin A at the recommended daily allowance; AND Must not be used in combination with other transthyretin (TTR) reducing or stabilizing agents (e.g., tafamidis, patisiran, acoramidis); AND Patient has a definitive diagnosis of hATTR amyloidosis documented by suggestive findings (including imaging or histopathology) and a heterozygous pathogenic or likely pathogenic TTR variant on molecular genetic testing; AND Used for treatment of polyneuropathy as demonstrated by at least TWO of: (1) subjective patient symptoms suggestive of neuropathy; (2) abnormal nerve conduction studies consistent with polyneuropathy; (3) abnormal neurological examination suggestive of neuropathy; AND Peripheral neuropathy is attributed to hATTR with other causes excluded; AND Baseline strength/weakness documented using an objective clinical measuring tool (e.g., MRC muscle strength); AND Patient has not been the recipient of an orthotopic liver transplant (OLT).

From Initial Approval Criteria and Universal Criteria

Initial: ATTR cardiomyopathy

Initial approval — ATTR cardiomyopathy covered when ALL of the following are met:

ATTR-CM initial: Patient is at least 18 years of age; AND Patient is receiving supplementation with vitamin A at the recommended daily allowance; AND Must not be used in combination with other transthyretin (TTR) reducing or stabilizing agents (e.g., tafamidis, patisiran, acoramidis); AND Evidence of cardiac involvement by echocardiography with an end-diastolic interventricular septal wall thickness > 12 mm; AND Definitive diagnosis of Wild Type or Hereditary ATTR-CM confirmed by appropriate testing (e.g., PYP scan, monoclonal studies, biopsy, scintigraphy, TTR genotyping); AND Either: patient has history of heart failure requiring at least 1 prior hospitalization OR patient has clinical evidence of heart failure requiring/required diuretic therapy for volume overload or elevated intracardiac pressure (e.g., elevated JVP, dyspnea, pulmonary congestion, peripheral edema); AND Patient has NYHA Class I or II or Class III disease that is not high-risk (excludes NYHA high-risk Class III and Class IV); AND Baseline 6-minute walk test (6MWT) distance ≥ 150 meters.6MWT >=150 m

From Initial Approval Criteria: Cardiomyopathy

Renewal / Continuation criteria

Renewal criteria — coverage may be renewed when ALL of the following are met:

Renewal general: Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND Absence of unacceptable toxicity from the drug (examples include ocular symptoms related to vitamin A deficiency such as night blindness).

From Renewal Criteria

Renewal hATTR response: For hATTR polyneuropathy: disease response compared to pre-treatment baseline as evidenced by stabilization or improvement in one or more of: signs and symptoms of neuropathy, MRC muscle strength.

From Renewal Criteria: hATTR

Renewal ATTR-CM response: For ATTR-CM: disease response compared to pre-treatment baseline as evidenced by stabilization or improvement in one or more of: frequency of cardiovascular-related hospitalizations or urgent heart failure visits, total distance walked during 6-minute walk test (6MWT).

From Renewal Criteria: ATTR-CM

Use of vutrisiran (Amvuttra) in combination with other transthyretin (TTR)–reducing or TTR–stabilizing agents is prohibited. Specifically, the therapy must not be used concurrently with agents such as tafamidis, patisiran, acoramidis, or other TTR-directed therapies.

Treatment with vutrisiran is not medically necessary when required diagnostic confirmation is not documented. For hATTR polyneuropathy this includes a definitive diagnosis demonstrated by amyloid‑suggestive findings (imaging or histopathology) plus a heterozygous pathogenic or likely pathogenic TTR variant on molecular genetic testing. For ATTR‑CM this includes appropriate cardiac confirmation such as stannous pyrophosphate (PYP) scanning, monoclonal studies, biopsy, scintigraphy, or TTR genotyping. Absent these diagnostic confirmations, coverage is not indicated.

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorization: 6 months. Renewals: may be approved annually thereafter.

Prior authorization required for Amvuttra (vutrisiran).
Initial authorization duration = 6 months.
Renewal authorization = up to 12 months (annual renewal).

Billing Rule

Dosage, Administration & Billing

Dosage and billing guidance: The recommended dosage is 25 mg subcutaneously once every 3 months; product should be administered by a healthcare professional. Billing uses HCPCS J0225 (Injection, vutrisiran, 1 mg). One billable unit = 1 mg. Max billing units: 25 billable units (25 mg) every 3 months. NDC: Amvuttra 25 mg/0.5 mL single‑dose prefilled syringe: 71336-1003-xx.

Recommended dose: 25 mg SC once every 3 months; administer in clinic by a healthcare professional.
HCPCS: J0225 — 1 unit = 1 mg. Bill 25 units per 25 mg dose every 3 months.
Max units: 25 billable units every 3 months.
NDC: 71336-1003-xx.

Denial Risk

Triggers for Denial

Authorization may be denied when required clinical or safety conditions are not met.

Patient is not receiving recommended vitamin A supplementation.
Request documents concomitant use with other transthyretin (TTR) reducing or stabilizing agents (e.g., tafamidis, patisiran, acoramidis) — concomitant use is not permitted.
Age or disease-specific criteria not met per indication-specific criteria (e.g., ATTR-CM NYHA Class III high‑risk or Class IV excluded, or 6MWT <150 meters for ATTR-CM).
Insufficient documentation of definitive diagnosis (genetic testing for hATTR or appropriate diagnostic testing for ATTR-CM).
Lack of baseline objective strength/neuropathy assessment for hATTR polyneuropathy (e.g., MRC or nerve conduction studies) or failure to exclude other causes of neuropathy.
Prior orthotopic liver transplant (OLT) — patient has received OLT (exclusion).

Documentation Required

Required Clinical Documentation

Required clinical documentation to support approval and renewals includes evidence of diagnosis and baseline assessments.

For hATTR polyneuropathy: documentation of definitive hATTR diagnosis with heterozygous pathogenic/likely pathogenic TTR variant and supportive imaging or histopathology; documentation of polyneuropathy with at least two supporting findings (patient symptoms, abnormal nerve conduction studies, or abnormal neurologic exam); baseline objective strength/weakness measurement (e.g., MRC); documentation that neuropathy is attributable to hATTR and other causes excluded; documentation patient has not had OLT.
For ATTR-CM: documentation of cardiac involvement (echocardiography with interventricular septal wall thickness >12 mm) and confirmatory testing (PYP, biopsy, scintigraphy, or TTR genotyping); heart failure history or signs requiring diuretics; NYHA class I–II or non–high‑risk class III; baseline 6MWT ≥150 meters.
Evidence of vitamin A supplementation at recommended daily allowance.
Administration record showing subcutaneous injection by a healthcare professional and billing documentation (J0225 units matching 25 mg = 25 units every 3 months).

Definitions and Diagnostic Criteria

inv-15: Definitive diagnosis of hATTR amyloidosis — required diagnostic elements (genetic confirmation + supportive findings)

Genetic confirmationHeterozygous pathogenic or likely pathogenic TTR variant identified by molecular genetic testing

Supportive findingsProband with suggestive findings of amyloidosis (including imaging or histopathology) documented

Neuropathy demonstrationPolyneuropathy demonstrated by at least two of: subjective symptoms, abnormal nerve conduction studies, or abnormal neurologic exam

ExclusionsPeripheral neuropathy attributed to hATTR with other causes excluded; patient must not have had orthotopic liver transplant

inv-16: ATTR-CM cardiac involvement — echocardiographic and supportive test thresholds for cardiac involvement

Echocardiographic criterionEnd-diastolic interventricular septal wall thickness > 12 mm on echocardiography

Confirmatory testing optionsDefinitive diagnosis confirmed by laboratory testing such as stannous pyrophosphate (PYP) scan, monoclonal antibody studies, biopsy, scintigraphy, or TTR genotyping

Clinical heart failure evidenceHistory of ≥1 heart failure hospitalization OR clinical evidence of heart failure requiring/required diuretic therapy (signs of volume overload or elevated intracardiac pressure)

NYHA class requirementNYHA Class I or II, or selected Class III not considered high risk (excludes NYHA high-risk Class III and Class IV)

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

OpenPayer

Amvuttra (vutrisiran) — Coverage Criteria

Coverage Criteria for Amvuttra (vutrisiran)

Coding and Diagnostic Codes

Provider Actions, Authorization & Documentation

Definitions and Diagnostic Criteria

Background