VYNDAQEL, VYNDAMAX (tafamidis)

VYNDAQEL, VYNDAMAX (tafamidis)

Self-Administration - Oral 

Indications for Prior Authorization:

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

Coverage Criteria:

1.    For diagnosis of Transthyretin Amyloid Cardiomyopathy: 

• Dose does not exceed either of the following:

  • Vyndaqel: 80 mg (4 capsules) per day

  • Vyndamax: 61 mg (1 capsule) per day; AND

• Patient is 18 years of age or older; AND

• Prescribed by or in consultation with a cardiologist; AND

• Diagnosis of transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM) confirmed by ONE of the following:

  • Patient has a transthyretin (TTR) mutation (e.g., V122I, V30M, T60A, TTRwt)

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

  • All of the following:

    • Echocardiogram or cardiac magnetic resonance imagining suggestive of amyloidosis

    • Scintigraphy scan suggestive of cardiac TTR amyloidosis

    • Absence of light-chain amyloidosis; AND

• One of the following:

  • 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; AND

• Not approvable for:

  • Concomitant use with Onpattro or Tegsedi

  • Concurrent use of Vyndaqel and Vyndamax

Reauthorization Criteria:

1.    For diagnosis of Transthyretin Amyloid Cardiomyopathy: 

• Dose does not exceed either of the following:

  • Vyndaqel: 80 mg (4 capsules) per day

  • Vyndamax: 61 mg (1 capsule) per day; AND

• Patient continues to have NYHA Functional Class I, II, or III heart failure

Coverage Duration:

• Initial: 1 year

• Reauthorization: 1 year 

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Dose and administration

  • Recommended dosage:

    • Vyndaqel 80 mg orally once daily

    • Vyndamax 61 mg orally once daily 

  • Vyndamax and Vyndaqel are not substitutable on a per mg basis

  • Capsules should not be swallowed whole and not crushed or cut

Policy Updates:

• 07/16/2019 – Initial review

• 06/01/2023 – Updating policy to include Vyndamax and updating formatting

References:

• Vyndaqel and Vyndamax prescribing information. Pfizer, Inc. New York, NY. May 2021. 

• 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.