Subject: Specialty Quantity Limit Vyndaqel-Vyndamax 3078-H P2023

Drug

VYNDAQEL  (tafamidis meglumine)

VYNDAMAX  (tafamidis)

Policy:

      I.  PROGRAM DESCRIPTION

          The standard limit is designed to allow a quantity sufficient for
          the most common uses of the medication. The recommended
          dosing parameters for the FDA-approved indication fall within
          the standard limits. Coverage of an additional quantity may be
          reviewed on a case-by-case basis upon request.


II.  COVERED QUANTITIES

Medication	Standard Limit	FDA-recommended dosing
Vyndaqel   (tafamidis meglumine)   20 mg capsules	120 per 30 days	80 mg orally once daily
Vyndamax   (tafamidis)   61 mg capsules	30 per 30 days	61 mg orally once daily

Place of Service:

Outpatient

The above policy is based on the following references:

1. Vyndaqel and Vyndamax [package insert]. New York, NY: Pfizer Labs; April 2023.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

October 15, 2023