CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Medicaid_Attruby.20250514

Defines coverage criteria for Attruby (acoramidis) for treatment of cardiomyopathy of wild-type or variant/hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults, initial and continuation authorization (each 6 months), quantity limit, and excluded indications.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMedicaid_Attruby.20250514

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionAuthorization of 6 months may be granted when all initial criteria are met; provider must document diagnosis confirmation, cardiac imaging, symptoms/NYHA class, cardiology involvement, genetic testing for hATTR where applicable, and exclusion of liver transplant and prohibited combination therapies.

SourceLink

POLICY UPDATE CHANGES

No material changes

1Covered Indication (ATTR-CM)

6Authorization Duration (months)

4Daily Tablet Limit (356 mg pak)

Coverage Summary & Indications

Coverage stance: covered_with_criteria for the FDA-approved indication of Attruby (acoramidis) for treatment of cardiomyopathy of wild-type or variant/hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults. Other indications are considered experimental/investigational and not medically necessary.

FDA-Approved Indication

Attruby is indicated for treatment of cardiomyopathy of wild-type or variant/hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults; coverage provided when all approval criteria are met and member has no exclusions.

ALL of the following

Prescribed for cardiomyopathy of wild-type or variant/hereditary transthyretin-mediated amyloidosis (ATTR-CM) in an adult to reduce cardiovascular death and cardiovascular-related hospitalization
Criterion A: Attruby is prescribed by, or in consultation with, a cardiologist
Member is 18 years of age or older>= 18 years
Criterion B
Documentation that the member exhibits clinical symptoms of cardiomyopathy and heart failure (e.g., dyspnea, fatigue, orthostatic hypotension, syncope, peripheral edema) classified as NYHA class I, II, or III diseaseNYHA class I-III
Criterion C
Documentation that cardiac involvement was confirmed by echocardiography or cardiac MRI (e.g., end-diastolic interventricular septal wall thickness exceeding 12 mm)end-diastolic interventricular septal wall thickness > 12 mm
Criterion D
Diagnosis confirmation (one of the following two pathways)
- Pathway 1
  - Presence of transthyretin amyloid deposits on analysis of biopsy from cardiac or noncardiac sites
  - Presence of transthyretin precursor proteins confirmed by immunohistochemical analysis, mass spectrometry, tissue staining, or polarized light microscopy
- Pathway 2
  - Positive technetium-labeled bone scintigraphy tracing
  - Systemic light chain amyloidosis is ruled out by a test showing absence of monoclonal proteins (serum kappa/lambda free light chain ratio, serum protein immunofixation, or urine protein immunofixation)
For variant/hereditary ATTR (hATTR): documentation of genetic testing confirming a mutation of the TTR gene
Criterion F
Member is not a liver transplant recipient
Criterion G
Requested medication will not be used in combination with patisiran (Onpattro), vutisiran (Amvuttra), eplontersen (Wainua), or tafamidis (Vyndaqel/Vyndamax)
Criterion H

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Combination use exception for overlapping ATTR-CM and ATTR-PN

Use in combination with a TTR-silencer/reducer to treat overlapping ATTR-CM and ATTR-PN may be considered when all specified criteria are met.

ALL of the following

Request is for Attruby to be used in combination with a TTR-silencer/reducer (e.g., patisiran, eplontersen) to treat overlapping ATTR-CM and ATTR-PN
Member has documented inadequate response, intolerance, or contraindication to monotherapy vutisiran (Amvuttra)
Criterion I

Continuation Therapy Criteria

Continuation of Therapy

Authorization of 6 months may be granted for continued treatment when ALL of the following are met:

ALL of the following

Member continues to meet all initial authorization criteria
Continuation criterion A
Documentation that the member has demonstrated a beneficial response to acoramidis therapy (e.g., improvement in rate of disease progression as demonstrated by distance walked on the 6-minute walk test, KCCQ-OS score, cardiovascular-related hospitalizations, left ventricular stroke volume, NT-proBNP level)
Continuation criterion B
Documentation that the member has not progressed to NYHA class IV diseaseNYHA class not IV
Continuation criterion C

Authorization, Documentation & Billing Requirements

Prior Authorization

Initial authorization required

Authorization of 6 months may be granted when all initial criteria are met. Provider must document diagnosis confirmation, cardiac imaging showing involvement (e.g., echo or cardiac MRI with interventricular septal wall thickness >12 mm), clinical symptoms/NYHA class (I–III), that the request is prescribed by or in consultation with a cardiologist, and member is ≥18 years. For variant/hereditary ATTR (hATTR) include genetic testing confirming a TTR gene mutation when applicable. Exclude liver transplant recipients and do not authorize use in combination with patisiran, vutisiran, eplontersen, or tafamidis unless combination exception criteria are met.

Diagnosis confirmation required (biopsy or bone scintigraphy pathway)
Cardiac imaging confirming involvement (e.g., septal wall thickness >12 mm)
Document symptoms and NYHA class I–III
Prescribed by or in consultation with a cardiologist; patient ≥18 years
Genetic testing for hATTR when applicable
Member is not a liver transplant recipient
Not to be used with patisiran, vutisiran, eplontersen, or tafamidis

Prior Authorization

Continuation authorization documentation

For renewal (authorization of 6 months) the provider must document that the member continues to meet all initial authorization criteria, provide evidence of clinical benefit such as improved or slowed disease progression measured by distance on the 6-minute walk test, KCCQ-OS score, NT-proBNP level, cardiovascular-related hospitalizations, or left ventricular stroke volume, and confirm the member has not progressed to NYHA class IV.

Continues to meet all initial authorization criteria
Evidence of clinical benefit (6MWT, KCCQ-OS, NT-proBNP, hospitalizations, LV stroke volume)
No progression to NYHA class IV

Billing Rule

Quantity limit enforcement

Attruby 356 mg pak is limited to 4 tablets per day. Claims exceeding this quantity may be denied or require additional justification/documentation.

Quantity limit: 4 tablets per day for Attruby 356 mg pak
Excess claims may be subject to denial or require justification

Documentation Required

Diagnosis confirmation testing required

Provide documentation of diagnosis confirmation by one of two pathways: (1) biopsy showing transthyretin amyloid deposits with confirmation of transthyretin precursor proteins by immunohistochemistry, mass spectrometry, tissue staining, or polarized light microscopy; OR (2) positive technetium-labeled bone scintigraphy tracing plus demonstration that systemic light chain amyloidosis is ruled out by absence of monoclonal proteins on testing (serum kappa/lambda free light chain ratio, serum protein immunofixation, or urine protein immunofixation).

Pathway 1: Biopsy with transthyretin deposits and transthyretin precursor protein confirmation
Pathway 2: Positive technetium bone scintigraphy AND negative testing for monoclonal proteins (serum kappa/lambda FLC ratio, serum and/or urine protein immunofixation)

Documentation Required

Genetic testing for variant ATTR

For variant/hereditary ATTR (hATTR), include documentation of genetic testing that confirms the presence of a mutation in the TTR gene.

Genetic test confirming a TTR gene mutation required for hATTR

Evidence & References

Evidence:

1) Attruby [package insert], BridgeBio Pharma, Inc.; November 2024.

2) Efficacy and Safety of Acoramidis in Transthyretin Amyloid Cardiomyopathy. N Engl J Med. 2024;390(2):132-142.

Policy basis: The policy follows FDA approval of Attruby for ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalizations; other uses beyond this approved indication are considered experimental/investigational.

Background & Definitions

Background: Attruby (acoramidis) is FDA-approved to treat cardiomyopathy of wild-type or variant/hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalizations. Other indications are considered experimental/investigational and not medically necessary. Quantity limits apply (Attruby 356 mg pak: 4 tablets per day).

Term	Definition
ATTR-CM	Transthyretin-mediated amyloid cardiomyopathy (cardiac involvement due to transthyretin amyloid deposition)
NYHA class	New York Heart Association functional classification for heart failure (I-IV); initial therapy limited to classes I–III and continuation requires that the member has not progressed to class IV
KCCQ-OS	Kansas City Cardiomyopathy Questionnaire - Overall Summary score (used to document clinical benefit/response to therapy)

Eligibility thresholds

Age>= 18 years

NYHA class for initiationI, II, or III (must not be class IV for initiation)

Cardiac imaging wall thicknessEnd-diastolic interventricular septal wall thickness exceeding 12 mm on echocardiography or cardiac MRI

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMedicaid_Attruby.20250514

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Medicaid_Attruby.20250514

Coverage Summary & Indications

Continuation Therapy Criteria

Applicable Codes & Quantity Limits

Authorization, Documentation & Billing Requirements

Evidence & References

Background & Definitions

Policy Revisions