Roflumilast Prior Authorization (with Quantity Limit) Criteria - Medicare Part D

Prior Authorization Criteria for Approval

Roflumilast will be approved when ALL of the following are met:

1. The patient has an FDA labeled indication for the requested medication
   AND
2. ONE of the following:
   1. The patient has tried and had an inadequate response to a medication from two of the following categories:
      1. long-acting beta-2 agonist (LABA) [e.g., salmeterol]
      2. long-acting muscarinic antagonist (LAMA) [e.g., umeclidinium]
      3. inhaled corticosteroid (ICS) [e.g., fluticasone]
         OR
   2. The patient has an intolerance or hypersensitivity to a medication from two of the following categories:
      1. long-acting beta-2 agonist (LABA) [e.g., salmeterol]
      2. long-acting muscarinic antagonist (LAMA) [e.g., umeclidinium]
      3. inhaled corticosteroid (ICS) [e.g., fluticasone]
         OR
   3. The patient has an FDA labeled contraindication to a medication from two of the following categories:
      1. long-acting beta-2 agonist (LABA) [e.g., salmeterol]
      2. long-acting muscarinic antagonist (LAMA) [e.g., umeclidinium]
      3. inhaled corticosteroid (ICS) [e.g., fluticasone]
         AND
3. The patient does NOT have any FDA labeled contraindications to the requested medication
   AND
4. ONE of the following:
   1. The requested quantity (dose) does NOT exceed the program quantity limit
      OR
   2. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit
         AND
      2. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit
         AND
      3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months