Attruby (acoramidis) prior authorization for transthyretin-mediated amyloid cardiomyopathy
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Prior authorization criteria for initiation and reauthorization of Attruby (acoramidis) for adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). Applies to providers requesting coverage through CareOregon.
No material clinical or coverage changes in this revision.
Coverage Criteria for Attruby (acoramidis)
Initial Authorization
Covered when ALL of the following are met:
Reauthorization
Covered when ALL of the following are met:
Use of the requested drug in combination with a TTR silencer (for example, Amvuttra) or a TTR stabilizer (for example, Diflunisal) is not permitted and will exclude coverage.
Coverage is not offered when the patient is outside New York Heart Association Functional Class I–III, or when diagnostic confirmation is lacking. Acceptable diagnostic evidence requires either a documented TTR mutation by an FDA-approved or CLIA-approved test, a cardiac or noncardiac tissue biopsy demonstrating TTR amyloid, or cardiac imaging (MRI or scintigraphy) suggestive of amyloidosis together with exclusion of light-chain amyloidosis; absence of these findings means the request does not meet criteria.
Provider Requirements and Actions
Prior authorization required; approvals valid 12 months
Prior authorization is required for both initial therapy and reauthorization. Approvals (initial and reauthorization) are issued for 12 months.
No step therapy required
No step therapy sequence is specified for this drug in the guideline.
Required documentation to support request
Include documentation that confirms the diagnosis and clinical eligibility for ATTR-CM and specialty involvement.
- Evidence of transthyretin-mediated amyloidosis with cardiomyopathy: one of — (a) presence of a TTR mutation by FDA-approved or CLIA-approved test; (b) cardiac or noncardiac tissue biopsy showing TTR amyloid deposits; or (c) cardiac MRI or scintigraphy suggestive of amyloidosis plus exclusion of light-chain amyloidosis.
- NYHA functional class documentation showing Class I, II, or III heart failure.
- Documentation that the drug is not being used in combination with a TTR silencer (e.g., Amvuttra) or a TTR stabilizer (e.g., Diflunisal).
- Evidence that the prescription is by or in consultation with a cardiologist.
Denial triggers — common reasons for denial
Requests will be denied when coverage criteria are not met or when disallowed combinations are used.
- Diagnosis is not transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM).
- Required diagnostic evidence is missing: no TTR mutation, no biopsy confirmation, and cardiac imaging not suggestive with unresolved light-chain amyloidosis.
- Patient is outside NYHA Functional Class I–III (e.g., Class IV).
- Drug is prescribed in combination with a TTR silencer (e.g., Amvuttra) or a TTR stabilizer (e.g., Diflunisal).
- Prescription is not by or in consultation with a cardiologist.
Background
Transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) is cardiomyopathy caused by deposition of transthyretin amyloid (wild-type or variant) in the heart, leading to progressive heart failure and increased cardiovascular morbidity and hospitalization. Diagnosis is established by detection of a TTR mutation, tissue biopsy confirming TTR amyloid, or cardiac imaging consistent with amyloidosis combined with exclusion of light-chain amyloidosis. Attruby (acoramidis) is indicated to reduce cardiovascular death and cardiovascular-related hospitalization in adults with ATTR-CM.
Definitions and Key Terms
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