Multiple Sclerosis (MS) Prior Authorization (with Quantity Limit) Criteria - Medicare Part D

Prior Authorization and Quantity Limit Criteria for Approval

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

Enhanced and MAPD Stars formularies:

Avonex, Betaseron, Copaxone, dimethyl fumarate, fingolimod, glatiramer, Glatopa, Kesimpta, Plegridy, Vumerity 

Basic formulary:

Betaseron, Copaxone, dimethyl fumarate, Kesimpta

Initial Evaluation

The requested medication will be approved when ALL of the following are met:

1. The patient has an FDA labeled indication for the requested medication
   AND
2. The patient will NOT be using the requested medication in combination with another diseasemodifying medication (DMA) or a biologic immunomodulator for the requested indication
   AND
3. ONE of the following:
   1. The requested medication is NOT fingolimod
      OR
   2. The requested medication is fingolimod AND the prescriber has performed an electrocardiogram within 6 months prior to initiating treatment
      AND
4. The patient does NOT have any FDA labeled contraindications to the requested medication
   AND
5. 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 ahigher strength that does not exceed the program quantity limit
         AND
      3. The prescriber has provided information in support of therapy with a higher dosefor the requested indication

Length of Approval: 12 months

Renewal Evaluation

The requested medication 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 PriorAuthorization criteria
   AND
2. The patient has an FDA labeled indication for the requested medication
   AND
3. The patient has had clinical benefit with the requested medication
   AND
4. The patient will NOT be using the requested medication in combination with another diseasemodifying medication (DMA) or a biologic immunomodulator for the requested indication
   AND
5. The patient does NOT have any FDA labeled contraindications to the requested medication
   AND
6. 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