Medicare AdvantagePrior AuthHigh impact
Vyndaqel®/Vyndamax™ (tafamidis) (Revised)
Humana·Cardiology, Internal Medicine·Medicare Advantage
Effective date
Jan 1, 2021
We identified it
Jun 25, 2026
Summary
Humana Medicare Advantage has revised its prior authorization policy for Vyndaqel/Vyndamax (tafamidis) effective January 1, 2021, with a revision dated December 17, 2025. The policy requires prior authorization for both formulations when used to treat ATTR-CM (transthyretin-mediated amyloid cardiomyopathy) and specifies four mandatory clinical criteria that must be met: specialist care requirement, NYHA Class I-III heart failure history, confirmed ATTR-CM diagnosis with specific cardiac imaging and protein confirmation, and exclusions for transplant/LVAD patients and pregnant members.
Action Required
By December 17, 2025: Billing and clinical teams must immediately update all prior authorization processes for Vyndaqel (tafamidis meglumine 20mg capsules) and Vyndamax (tafamidis 61mg capsules). Prior to submission of any claim: (1) Verify member meets ALL four criteria (cardiologist/specialist involvement, NYHA Class I-III heart failure, confirmed ATTR-CM with echocardiography/cardiac MRI AND immunohistochemical/scintigraphy/mass spectrometry confirmation, and no history of liver transplant, heart transplant without further amyloid, LVAD, or pregnancy); (2) Obtain and document prior authorization approval from Humana before dispensing; (3) Update pharmacy and clinical documentation templates to include the specific diagnostic confirmation requirements (PYP scintigraphy or biopsy analysis); (4) Train billing staff and providers on the revised criteria. Note: Vyndamax and Vyndaqel are NOT substitutable on a per-milligram basis—verify correct formulation is prescribed. Claims submitted without prior authorization or without documentation of met criteria will be denied. Ensure all communications reference the revision date of 12/17/2025 to confirm you are using the current policy.