CurrentCignaPolicy N/A

Attruby (acoramidis) prior authorization for ATTR-CM

Defines Cigna's prior authorization requirements and medical necessity criteria for coverage of Attruby (acoramidis) for treatment of transthyretin-mediated cardiomyopathy in adults.

Policy Summary

PayerCigna

PolicyAttruby (acoramidis) prior authorization for ATTR-CM

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateDec 4, 2024

Key ActionObtain prior authorization with documentation confirming diagnosis and ensure the prescriber is a cardiologist or amyloidosis specialist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yrinitial approval duration

≥18minimum patient age

I–IIINYHA class allowed

Polyneuropathy/combinationnon-covered uses

Coverage Criteria for Attruby (acoramidis)

FDA-Approved Indication - Initial Therapy for ATTR-CM

Covered when ALL of the following are met:

Initial approval criteria: A) Patient is ≥ 18 years of age; AND B) Diagnosis confirmed by ONE of: (i) technetium pyrophosphate scan (nuclear scintigraphy), OR (ii) tissue biopsy with confirmatory transthyretin (TTR) amyloid typing by mass spectrometry, immunoelectron microscopy, or immunohistochemistry, OR (iii) genetic testing identifying a pathogenic transthyretin (TTR) variant as reported by the prescriber; AND C) Diagnostic cardiac imaging has demonstrated cardiac involvement (e.g., increased ventricular wall or interventricular septal thickness on echocardiogram or cardiac magnetic resonance imaging); AND D) Patient has heart failure and does NOT have New York Heart Association (NYHA) class IV disease; AND E) Medication is prescribed by or in consultation with a cardiologist or a physician who specializes in the treatment of amyloidosis.all conditions required

Approve for 1 year if all criteria are met

Attruby (acoramidis) is considered experimental, investigational, or unproven for any use not listed in the FDA‑approved indication. The policy explicitly lists concurrent use with other transthyretin (TTR)–targeted therapies and use for polyneuropathy of hereditary transthyretin‑mediated amyloidosis (hATTR) as examples of noncovered, unproven uses.

Policy Summary

PayerCigna

PolicyAttruby (acoramidis) prior authorization for ATTR-CM

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateDec 4, 2024

Key ActionObtain prior authorization with documentation confirming diagnosis and ensure the prescriber is a cardiologist or amyloidosis specialist.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Prescriber, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required. Initial approvals are for 1 year. Because of the specialized skills required for evaluation and diagnosis and monitoring, the medication must be prescribed by or in consultation with a cardiologist or a physician who specializes in the treatment of amyloidosis.

Prior authorization required
Initial approval duration: 1 year
Prescriber must be a cardiologist or amyloidosis specialist, or prescribed in consultation with one.

Step Therapy

There are no step therapy requirements specified for approval of this medication.

Documentation Required

Required Documentation for Medical Necessity

Documentation confirming the diagnosis is required for medical necessity. Approvals require confirmation of transthyretin-mediated cardiomyopathy by ONE of the following diagnostic methods and supporting criteria.

Diagnostic confirmation by ONE of: technetium pyrophosphate (PYP) nuclear scintigraphy; OR tissue biopsy with confirmatory TTR amyloid typing by mass spectrometry, immunoelectron microscopy, or immunohistochemistry; OR genetic testing with a documented pathogenic TTR variant per the prescriber.
Evidence of cardiac involvement on diagnostic cardiac imaging (e.g., echocardiogram or cardiac MRI) such as increased ventricular wall or interventricular septal thickness.
Patient is ≥ 18 years of age.
Patient has heart failure but is not New York Heart Association (NYHA) class IV.
Prescriber is a cardiologist or amyloidosis specialist, or treatment is in consultation with one.

Denial Risk

Excluded Uses — Denial Risk

Requests for uses excluded by the policy will be denied.

Excluded uses include treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR).
Concurrent use with other TTR-directed therapies or agents indicated for polyneuropathy of hATTR or ATTR-CM (e.g., vutrisiran, patisiran, inotersen, eplontersen, or tafamidis products) is not allowed and will be denied.

Key Definitions

ATTR-CM — definition and clinical description

DefinitionTransthyretin-mediated amyloid cardiomyopathy (ATTR-CM): amyloid deposition in the heart due to misfolding of transthyretin (TTR) causing restrictive cardiomyopathy and heart failure.

PathophysiologyInstability of the TTR tetramer leads to misfolding and amyloid accumulation, most commonly in the myocardium and peripheral nerves, resulting in stiff, rigid cardiac muscle and heart failure symptoms (often HFpEF).

Clinical presentationPatients commonly present with heart failure (often preserved ejection fraction), but may also have neuropathy, mixed phenotypes, atrial fibrillation, aortic stenosis, conduction disease, angina, or cardiogenic shock.

Adult indicationAttruby (acoramidis) is indicated to reduce cardiovascular death and cardiovascular-related hospitalization in adults with ATTR-CM.

EtiologyATTR may be wild-type (acquired) or hereditary due to pathogenic TTR variants; genetic testing differentiates variant from wild-type disease.

NYHA class IV exclusion — trials and policy

Trials exclusionPivotal clinical studies of Attruby excluded patients with New York Heart Association (NYHA) class IV heart failure.

Policy exclusionPolicy criteria require that the patient has heart failure but does NOT have NYHA class IV disease (NYHA I–III eligible).

Approval implicationRequests for patients with NYHA class IV disease do not meet the coverage criteria and should not be approved under the FDA‑approved indication criteria in this policy.

OpenPayer

Attruby (acoramidis) prior authorization for ATTR-CM

Coverage Criteria for Attruby (acoramidis)

Prescriber, Prior Authorization, and Documentation Requirements

Clinical Background

Key Definitions