Vyndamax and Vyndaqel Prior Authorization Criteria (with Quantity Limit) - Medicare Part D

The following products are included in this PA program (formulary specific):

HC Enhanced and MAPD Stars formularies: Vyndamax and Vyndaqel

Basic formulary: Vyndaqel

Prior authorization criteria for approval

Initial Evaluation

Vyndamax or Vyndaqel will be approved when ALL of the following are met:

1. The patient has a diagnosis of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) 
   AND
2. The diagnosis has been confirmed by testing [e.g., stannous pyrophosphate (PYP) scanning, monoclonal antibody studies, biopsy, scintigraphy, genetic testing]
   AND
3. The requested medication will be used to reduce cardiovascular mortality and cardiovascularrelated hospitalization
   AND
4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., cardiologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
   AND
5. The patient will NOT be using the requested medication in combination with another tafamidis medication for the requested indication
   AND
6. ONE of the following:
   1. The requested quantity (dose) does NOT exceed the program quantity limit 
      OR
   2. BOTH of the following:
      1. The requested quantity (dose) is greater than the program quantity limit
         AND 
      2. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months

Renewal Evaluation

Vyndamax or Vyndaqel will be approved when ALL of the following are met:

1. The patient has been previously approved for the requested medication through the plan’s Prior Authorization criteria 
   AND
2. The patient has a diagnosis of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) 
   AND 
3. The requested medication will be used to reduce cardiovascular mortality and cardiovascularrelated hospitalization
   AND
4. The patient has had clinical benefit with the requested medication
   AND
5. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., cardiologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis 
   AND
6. The patient will NOT be using the requested medication in combination with another tafamidis medication for the requested indication
   AND
7. ONE of the following:
   1. The requested quantity (dose) does NOT exceed the program quantity limit 
      OR
   2. BOTH of the following:
      1. The requested quantity (dose) is greater than the program quantity limit
         AND 
      2. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months