Pharmacy Prior Authorization Criteria

Vyndaqel (tafamidis meglumine), Vyndamax (tafamidis)

Indications for Prior Authorization

Vyndaqel (tafamidis meglumine), Vyndamax (tafamidis)

• For diagnosis of Transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM)
  Indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.

Criteria

Vyndaqel, Vyndamax

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM)
AND
• One of the following: [3, 4]
• Patient has a transthyretin (TTR) mutation (e.g., V122I)
OR
• Cardiac or noncardiac tissue biopsy demonstrating histologic confirmation of TTR amyloid deposits
OR
• All of the following:
• Echocardiogram or cardiac magnetic resonance imaging suggestive of amyloidosis
• Scintigraphy scan suggestive of cardiac TTR amyloidosis
• Absence of light-chain amyloidosis
AND
• One of the following: [2]
• History of heart failure, with at least one prior hospitalization for heart failure
• Presence of clinical signs and symptoms of heart failure (e.g., dyspnea, edema)
AND
• Patient has New York Heart Association (NYHA) Functional Class I, II, or III heart failure [2]
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

Vyndaqel, Vyndamax

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy
AND
• 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

P & T Revisions

2024-08-14, 2024-06-20, 2023-12-20, 2023-10-17, 2023-05-08, 2022-05-22, 2021-06-22, 2021-05-26, 2021-05-25, 2020-06-22

References

1. Vyndaqel and Vyndamax prescribing information. Pfizer, Inc. New York, NY. April 2023.
2. Mauer MS, Schwartz JH, Gundapeneni B, et al. Tafamadis treatment for patients with transthyretin amyloid cardiomyopathy. N Engl J Med. 2018; 379:1007-16.
3. Gillmore JD, Maurer MS, Falk RH, et al. Nonbiopsy diagnosis of cardiac transthyretin amyloidosis. Circulation. 2016; 133:2404-12.
4. Nativi-Nicolau J and Maurer MS. Amyloidosis cardiomyopathy: update in the diagnosis and treatment of the most common types. Curr Opin Cardiol. 2018; 33(5):571-579.

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Revision History

• 2024-08-14: Addition of criterion to confirm the requested drug is not used in combination with a TTR silencer or a TTR stabilizer.
• 2024-06-20: 2024 annual review: no criteria changes.
• 2023-12-20: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-10-17: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-05-08: 2023 UM Annual Review. No criteria changes. Update references
• 2022-05-22: 2022 Annual Review
• 2021-06-22: Updated references section.
• 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2020-06-22: Updated references.

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