Pharmacy Prior Authorization Criteria

Attruby (acoramidis)- PA, NF

Indications for Prior Authorization

Attruby (acoramidis)

• For diagnosis of Transthyretin-Mediated Amyloidosis (ATTR-CM)
  cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.

Criteria

Attruby

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM)
AND
• One of the following:
• Presence of a transthyretin (TTR) mutation (e.g., V122I) as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
OR
• Cardiac or noncardiac tissue biopsy demonstrating histologic confirmation of TTR amyloid deposits
OR
• Both of the following:
• Cardiac magnetic resonance imaging or scintigraphy scan suggestive of amyloidosis
• Absence of light-chain amyloidosis
AND
• Patient has New York Heart Association (NYHA) Functional Class I, II, or III heart failure
AND
• Requested drug is not used in combination with a TTR silencer (e.g., Amvuttra) or a TTR stabilizer (e.g., Diflunisal)
AND
• One of the following:
• Trial and failure, contraindication or intolerance to one of the following:
• Vyndaqel
• Vyndamax
OR
• For continuation of prior therapy
AND
• Prescribed by or in consultation with a cardiologist

Attruby

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient continues to have New York Heart Association (NYHA) Functional Class I, II, or III heart failure
AND
• Requested drug is not used in combination with a TTR silencer (e.g., Amvuttra) or a TTR stabilizer (e.g., Diflunisal)
AND
• Prescribed by or in consultation with a cardiologist

Attruby

Non Formulary

Length of Approval: 12 Month(s)

• Submission of medical records (e.g., chart notes) confirming diagnosis of transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM)
AND
• Submission of medical records (e.g., chart notes) confirming one of the following:
• Presence of a transthyretin (TTR) mutation (e.g., V122I) as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
OR
• Cardiac or noncardiac tissue biopsy demonstrating histologic confirmation of TTR amyloid deposits
OR
• Both of the following:
• Cardiac magnetic resonance imaging or scintigraphy scan suggestive of amyloidosis
• Absence of light-chain amyloidosis
AND
• Submission of medical records (e.g., chart notes) confirming patient has New York Heart Association (NYHA) Functional Class I, II, or III heart failure
AND
• Requested drug is not used in combination with a TTR silencer (e.g., Amvuttra) or a TTR stabilizer (e.g., Diflunisal)
AND
• One of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication or intolerance to one of the following:
• Vyndaqel
• Vyndamax
OR
• Submission of medical records (e.g., chart notes) or paid claims confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy for continuation of therapy
AND
• Prescribed by or in consultation with a cardiologist

P & T Revisions

2025-07-07, 2025-02-20

References

1. Attruby Prescribing Information. BridgeBio Pharma, Inc. Palo Alto, CA. November 2024.

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Revision History

• 2025-07-07: Added trial and failure criteria and added drug specific non formulary criteria.
• 2025-02-20: New Program.

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