CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Attruby (acoramidis) for transthyretin cardiac amyloidosis — Coverage Criteria

Covers use of Attruby (acoramidis) for treatment of cardiomyopathy due to wild-type or variant (hereditary) transthyretin-mediated amyloidosis (ATTR-CM) in adults, when approval criteria are met; applicable to Neighborhood Health Plan of Rhode Island Medicaid population.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAttruby (acoramidis) for transthyretin cardiac amyloidosis — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document age ≥18, cardiac involvement by imaging, diagnostic confirmation, NYHA class I–III, and prescriber/cardiology consultation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsauth length

18+min age

4/dayqty limit

I–IIINYHA class

Coverage Criteria for Attruby (acoramidis)

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Initial Authorization Criteria

Covered when ALL of the following are met:

Eligibility and prescriber: Prescribed by or in consultation with a cardiologist; member is 18 years of age or older.

Cardiac involvement and symptoms: Cardiac involvement confirmed by echocardiography or cardiac MRI (e.g., end-diastolic interventricular wall thickness exceeding 12 mm); clinical symptoms of cardiomyopathy/heart failure consistent with NYHA class I, II, or III.

Diagnostic confirmation: Diagnosis confirmed by EITHER (a) presence of transthyretin amyloid deposits on biopsy with confirmatory protein analysis (immunohistochemistry, mass spectrometry, tissue staining, or polarized light microscopy) OR (b) positive technetium-labeled bone scintigraphy plus documentation that systemic light-chain amyloidosis has been ruled out by appropriate serum/urine testing (serum free light chain ratio, serum and/or urine protein immunofixation).

Genetic testing for variant disease: For variant/hereditary ATTR, documentation of genetic testing confirming a TTR gene mutation.

Exclusions and concomitant therapy: Member is not a liver transplant recipient; requested medication will not be used in combination with patisiran, vutisiran, eplontersen, or tafamidis unless combination criteria are specifically met.

Continuation Criteria

For continuation of therapy, ALL of the following must be met:

Maintain initial criteria: Member continues to meet all initial authorization criteria and has not progressed to NYHA class IV disease.

Clinical benefit: Documentation of beneficial response to acoramidis demonstrated by measures such as 6-minute walk test distance, KCCQ-OS score, reduced cardiovascular-related hospitalizations, left ventricular stroke volume, or NT-proBNP.

Coverage for Attruby (acoramidis) is limited to the FDA-approved indication: treatment of cardiomyopathy due to wild-type or variant (hereditary) transthyretin-mediated amyloidosis (ATTR-CM) in adults when all approval criteria are met. Requests for use of Attruby for indications other than ATTR-CM are excluded and considered not medically necessary. Members who are liver transplant recipients are excluded from coverage for this therapy. Additionally, Attruby must not be used in combination with patisiran, vutisiran, eplontersen, or tafamidis unless specific combination-therapy criteria are met and documented.

All indications other than the FDA-approved indication for ATTR-CM (wild-type or variant/hereditary transthyretin-mediated amyloidosis) are considered experimental/investigational and not medically necessary and therefore are not eligible for coverage.

Product and Diagnostic Coding

Covered product/StrengthmixedCovered

Attruby 356 mg

Preferred product and tablet strength as listed with quantity limit

Echocardiographic wall thickness — diagnostic threshold

Echocardiographic wall thickness> 12 mm end-diastolic interventricular (septal) wall thickness

Imaging modalitiesConfirmed by transthoracic echocardiography or cardiac magnetic resonance imaging (cardiac MRI)

Example wording in recordDocumentation must state end-diastolic interventricular wall thickness exceeding 12 mm

Minimum age

Minimum age for coverage>= 18 years

Documentation requiredMember age documented in medical record or prescription

Applies toAll requests for initiation and continuation of therapy

Provider Requirements and Operational Rules

Prior Authorization

Prior Authorization and Quantity Limit

Prior authorization is required for Attruby. Initial and continuation approvals are for up to 6 months. Attruby 356 mg is limited to 4 tablets per day.

Prior authorization required for initial and continuation therapy (up to 6 months)
Quantity limit: Attruby 356 mg — 4 tablets per day

Documentation Required

Combination Therapy Requirement

If Attruby is requested in combination with a TTR-silencer/reducer (e.g., patisiran [Onpattro], vutisiran [Amvuttra], eplontersen [Wainua]) to treat overlapping ATTR-CM and ATTR-PN, documentation must show an inadequate response, intolerance, or contraindication to monotherapy with the TTR-silencer being considered.

Combination use with TTR-silencers allowed only when criteria for combination therapy are met (documented inadequate response, intolerance, or contraindication to monotherapy)
Specify which TTR-silencer was tried and the clinical reason for combination therapy

Denial Risk

Combination Exclusions

Attruby must not be used in combination with patisiran (Onpattro), vutisiran (Amvuttra), eplontersen (Wainua), or tafamidis (Vyndaqel/Vyndamax) unless the combination therapy requirement is met and documented.

Combination with listed agents is excluded unless documented criteria for combination therapy are satisfied

Documentation Required

Required Baseline Documentation

Baseline documentation required prior to authorization: age ≥18 years; documentation that cardiac involvement was confirmed by echocardiography or cardiac MRI (e.g., end-diastolic interventricular wall/septal thickness >12 mm); documentation of clinical signs/symptoms of cardiomyopathy and heart failure (NYHA class I–III); and confirmation of diagnosis by one of the following: biopsy showing transthyretin amyloid deposits with appropriate protein confirmation (immunohistochemistry, mass spectrometry, tissue staining, or polarized light microscopy) OR positive technetium-labeled bone scintigraphy with exclusion of systemic light-chain amyloidosis (absence of monoclonal proteins by serum free light chains and serum/urine immunofixation). Members who are liver transplant recipients are excluded from coverage for this indication.

Member age documented (≥ 18 years)
Cardiac involvement confirmed by echocardiography or cardiac MRI (e.g., interventricular/septal thickness > 12 mm)
Documented clinical symptoms consistent with cardiomyopathy/heart failure and NYHA class I–III
Confirm diagnosis by biopsy with transthyretin deposition and protein confirmation OR positive technetium-labeled bone scintigraphy plus tests excluding light-chain amyloidosis (serum kappa/lambda free light chain ratio, serum and/or urine protein immunofixation)
Member is not a liver transplant recipient

Documentation Required

Genetic Testing Requirement

For variant/hereditary ATTR (hATTR), documentation of a pathogenic TTR gene mutation by genetic testing is required.

Genetic testing report documenting TTR mutation for variant/hereditary ATTR cases

Documentation Required

Prescriber Requirement

Prescriptions must be written by a cardiologist or by another prescriber in consultation with a cardiologist; include documentation of the consulting cardiologist in the medical record.

Prescriber is a cardiologist OR documentation of consultation with a cardiologist must be provided

Documentation Required

Continuation Documentation

For continuation of therapy, documentation must show the member continues to meet all initial authorization criteria, has not progressed to NYHA class IV, and has demonstrated clinical benefit from treatment (examples: improved or stable 6-minute walk test distance, improved KCCQ-OS score, reduction in cardiovascular-related hospitalizations, improvement or stability in left ventricular stroke volume, or favorable NT-proBNP trend). Provide medical records or chart notes supporting clinical benefit.

Member continues to meet initial authorization criteria
Member has not progressed to NYHA class IV disease
Documentation of clinical benefit (e.g., 6-minute walk test, KCCQ-OS score, hospitalization data, LV stroke volume, NT-proBNP trends)

Background

Transthyretin cardiac amyloidosis (ATTR-CM) results from deposition of misfolded transthyretin protein in the myocardium, producing a restrictive cardiomyopathy with symptoms of heart failure such as dyspnea, fatigue, syncope, orthostatic hypotension, and peripheral edema. Diagnosis requires demonstration of cardiac involvement by imaging—echocardiography or cardiac magnetic resonance imaging (for example, end-diastolic interventricular wall thickness >12 mm)—and confirmation of transthyretin amyloid either by tissue biopsy with proteomic or immunohistochemical confirmation or by positive technetium-labeled bone scintigraphy with exclusion of light-chain amyloidosis. Genetic testing is required to document a pathogenic TTR gene mutation when hereditary (variant) disease is suspected. Clinical severity is staged by NYHA functional class; treatment with Attruby is intended for adults with NYHA class I–III disease.

Definitions and Diagnostic Criteria

ATTR-CM (definition and clinical context)

DefinitionCardiomyopathy of wild-type or variant (hereditary) transthyretin-mediated amyloidosis (ATTR-CM)

Clinical featuresSymptoms may include dyspnea, fatigue, orthostatic hypotension, syncope, peripheral edema

Functional class requirementMember should have NYHA class I–III symptoms (not class IV)

Diagnostic confirmation

Biopsy confirmation optionPresence of transthyretin amyloid deposits on analysis of cardiac or noncardiac biopsy with confirmation by immunohistochemistry, mass spectrometry, tissue staining, or polarized light microscopy

Radionuclide imaging optionPositive technetium-labeled bone scintigraphy tracing plus documentation that systemic light-chain amyloidosis has been ruled out

Exclusion of light-chain amyloidosisAbsence of monoclonal proteins demonstrated by serum free light chain ratio and serum and/or urine protein immunofixation

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAttruby (acoramidis) for transthyretin cardiac amyloidosis — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document age ≥18, cardiac involvement by imaging, diagnostic confirmation, NYHA class I–III, and prescriber/cardiology consultation.

SourceLink

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