Pharmacy Prior Authorization Criteria

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.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

AND

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)

Cardiac or noncardiac tissue biopsy demonstrating histologic confirmation of TTR amyloid deposits

Cardiac magnetic resonance imaging suggestive of amyloidosis 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 [2]

AND

Requested drug is not used in combination with a TTR silencer (e.g., Amvuttra) or a TTR stabilizer (e.g., Diflunisal)

AND

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

2025-02-20, 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

Vyndaqel and Vyndamax prescribing information. Pfizer, Inc. New York, NY. April 2023.
Mauer MS, Schwartz JH, Gundapeneni B, et al. Tafamadis treatment for patients with transthyretin amyloid cardiomyopathy. N Engl J Med. 2018; 379:1007-16.
Gillmore JD, Maurer MS, Falk RH, et al. Nonbiopsy diagnosis of cardiac transthyretin amyloidosis. Circulation. 2016; 133:2404-12.
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.

2025-02-20: Updated criterion 2.3 in line with Attruby along with standard ORx language throughout GL. Removal of requirement of evidence of HF criterion from initial auth and 'patient demonstrates positive clinical response to therapy' form reauth as per P&T recommendations.
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.