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

Prior Authorization and Limit Criteria for Approval

Initial Evaluation

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

1. The patient has an FDA labeled indication or an indication that is supported in CMS approved compendia for the requested medication
   AND

2. ONE of the following:

   1. There is evidence of a claim that the patient is currently being treated with the requested medication within the past 180 days
      OR

   2. The prescriber states the patient is currently being treated with the requested medication
      OR

   3. BOTH of the following:

      1. ONE of the following:

         1. BOTH of the following:

            1. The patient has a diagnosis of Stage IA or IB mycosis fungoides-type cutaneous T-cell lymphoma
               AND
            2. The patient’s medication history indicates use of at least ONE prior skin-directed therapy (e.g., topical corticosteroid)
               OR

         2. The patient has an indication that is supported in CMS approved compendia for the requested medication
            AND

      2. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist, oncologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
         AND

3. 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 Approval: 12 months

Renewal Evaluation

Valchlor 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 an FDA labeled indication or an indication that is supported in CMS approved compendia for the requested medication
   AND

3. ONE of the following:

   1. There is evidence of a claim that the patient is currently being treated with the requested agent within the past 180 days
      OR

   2. The prescriber states the patient is currently being treated with the requested medication
      OR

   3. BOTH of the following:

      1. The patient has had clinical benefit with the requested medication
         AND
      2. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist, oncologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
         AND

4. 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 Approval: 12 months