CurrentCignaPolicy N/A

Amyloidosis - Acoramidis Prior Authorization Policy

This prior authorization policy governs coverage criteria and prior authorization requirements for Attruby (acoramidis tablets) for treatment of transthyretin-mediated cardiomyopathy (ATTR-CM) for Cigna-administered health benefit plans and specifies conditions, documentation, and exclusions for approval.

Policy Summary

PayerCigna

PolicyAmyloidosis - Acoramidis Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and provide documentation confirming age ≥18, diagnostic confirmation (nuclear scintigraphy OR tissue biopsy with TTR typing OR genetic testing), cardiac imaging showing involvement, NYHA class not IV, and prescriber specialty.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearapproval duration for initial authorization

≥18minimum patient age for coverage

NYHA IVdisease severity not covered

Concurrent prohibitedcombination use considered experimental

Coverage Criteria for Attruby (acoramidis)

FDA-Approved Indication - Initial Approval

Covered when ALL of the following are met for the FDA-approved indication of cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM):

Initial approval criteria: A) Patient is ≥ 18 years of age;

Diagnosis confirmation (one required)

i: A technetium pyrophosphate scan (nuclear scintigraphy).
ii: Tissue biopsy with confirmatory transthyretin (TTR) amyloid typing by mass spectrometry, immunoelectron microscopy, or immunohistochemistry.

Policy Summary

PayerCigna

PolicyAmyloidosis - Acoramidis Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Attruby (acoramidis). Initial approvals are provided for 1 year. Because of the specialized evaluation and monitoring required, the medication must be prescribed by or in consultation with a physician who specializes in the condition being treated.

Initial approval duration: 1 year
Prescriber requirement: prescribed by or in consultation with a cardiologist or physician who specializes in amyloidosis

Step Therapy

There are no step therapy requirements for initiation of Attruby; patients meeting the clinical criteria may be considered for coverage without prior failure of alternate agents.

Documentation Required

Required Documentation for Prior Authorization

The following documentation must be submitted with the prior authorization request to establish medical necessity for Attruby:

Patient age (must be ≥ 18 years)
Diagnostic confirmation by ONE of the following: technetium pyrophosphate scan (nuclear scintigraphy), OR tissue biopsy with confirmatory TTR amyloid typing (mass spectrometry, immunoelectron microscopy, or immunohistochemistry), OR genetic testing documenting a pathogenic TTR variant as reported by 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
Documentation of heart failure status confirming the patient does not have NYHA class IV disease
Clinical indication matching ATTR-CM (wild-type or hereditary transthyretin-mediated cardiomyopathy)
Prescriber attestation that the medication is prescribed by or in consultation with a cardiologist or physician who specializes in amyloidosis

Denial Risk

Combination Therapy Triggers Denial Risk

Concurrent use of Attruby with certain other TTR-targeting therapies is considered experimental and may result in denial of the request.

Concurrent use with agents indicated for polyneuropathy of hereditary transthyretin-mediated amyloidosis or transthyretin-mediated amyloidosis-cardiomyopathy is not recommended
Examples of agents raising denial risk: Amvuttra (vutrisiran), Onpattro (patisiran), Tegsedi (inotersen), Wainua (eplontersen), or any tafamidis product
Rationale: lack of controlled clinical trial data supporting additive efficacy for combination therapy

Background

Transthyretin-mediated cardiomyopathy (ATTR-CM) results from misfolded transthyretin depositing as amyloid fibrils in the myocardium, producing a stiff, restrictive cardiomyopathy that commonly presents as heart failure, often with preserved ejection fraction. ATTR-CM may be caused by wild-type TTR or pathogenic variants in the TTR gene (hereditary). The disease is progressive and underrecognized; effective diagnosis requires cardiac imaging or tissue confirmation and, when hereditary disease is suspected, genetic testing. Clinical trials of Attruby excluded patients with New York Heart Association class IV heart failure, and the policy reflects those study populations in its eligibility considerations.

Definitions

ATTR-CM (transthyretin-mediated cardiomyopathy)

DefinitionTransthyretin-mediated cardiomyopathy (ATTR-CM): amyloid deposition in the myocardium from misfolded transthyretin leading to restrictive cardiomyopathy and heart failure symptoms; may be due to wild-type (acquired) or hereditary (TTR gene variant) transthyretin.

Wild-type ATTR-CMCaused by acquired (non‑pathogenic‑variant) transthyretin leading to cardiac amyloid deposition; genetic testing will not identify a pathogenic TTR variant.

Hereditary (variant) ATTR-CMCaused by a pathogenic TTR gene variant (examples: Val122Ile, Thr60Ala) identified by genetic testing as reported by the prescriber.

Clinical consequenceAccumulation of TTR amyloid in the heart produces stiff, rigid ventricular walls often presenting as heart failure with preserved ejection fraction and other cardiac manifestations.

NYHA class IV

DefinitionNew York Heart Association (NYHA) class IV: patients with severe functional limitation due to heart failure (symptoms at rest).

Clinical trial/policy exclusionClinical trials of Attruby and this coverage policy excluded patients with NYHA class IV disease; patients with NYHA class IV are not eligible under the stated approval criteria.

Coverage implicationApproval requires the patient have heart failure but not NYHA class IV; documentation of NYHA class should be provided as part of prior authorization.