Biologic Immunomodulators – Entyvio Prior Authorization Criteria - Medicare Part D

Prior Authorization Criteria for Approval

Initial Evaluation

Entyvio 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. There is evidence of a claim that the patient is currently being treated with the requested medication within the past 90 days
      OR
   2. The prescriber states the patient is currently being treated with the requested medication AND provided clinical justification to support that the patient is at risk if therapy is changed
      OR
   3. The patient’s medication history indicates use of another biologic immunomodulator medication for the same FDA labeled indication
      OR
   4. The patient’s diagnosis does NOT require a conventional prerequisite medication*
      OR
   5. The patient’s medication history indicates use of ONE formulary conventional prerequisite medication for the requested indication*
      OR
   6. The patient has an intolerance or hypersensitivity to at least ONE formulary conventional prerequisite medication for the requested indication*
      OR
   7. The patient has an FDA labeled contraindication to at least ONE formulary conventional prerequisite medication for the requested indication*
3. The patient does NOT have any FDA labeled contraindications to the requested medication
   AND
4. The patient will NOT be using the requested medication in combination with another biologic immunomodulator
   AND
5. The requested dose is within FDA labeled dosing for the requested indication

*NOTE:

• Use of ONE conventional prerequisite medication is required for diagnoses of moderate ulcerative colitis or Crohn’s disease
• NO prerequisites are required for diagnosis of severe ulcerative colitis
• Formulary conventional medications for Crohn’s disease may include mercaptopurine, azathioprine, corticosteroids, methotrexate, or sulfasalazine.
• Formulary conventional medications for moderate ulcerative colitis may include 5-aminosalicylates (including balsalazide, mesalamine, sulfasalazine), mercaptopurine, azathioprine, and corticosteroids

Length of approval: 14 weeks

Renewal Evaluation

Entyvio 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 for the requested medication
   AND
3. The patient has had clinical improvement (slowing of disease progression or decrease in symptom severity and/or frequency)
   AND
4. The patient does NOT have any FDA labeled contraindications to the requested medication
   AND
5. The patient will NOT be using the requested medication in combination with another biologic immunomodulator
   AND
6. The requested dose is within FDA labeled dosing for the requested indication

Length of approval: 12 months