GLP-1 Agonists – Ozempic Prior Authorization Criteria (with Quantity Limit) – Medicare Part D

Prior Authorization with Quantity Limit Criteria for Approval

PA applies to new starts only

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

1. The requested medication will NOT be used for weight loss alone
   AND
2. ONE of the following:
   1. The patient has a diagnosis of type 2 diabetes mellitus
      OR
   2. BOTH of the following:
      1. The patient has a diagnosis of established cardiovascular disease [e.g., myocardial infarction, stroke, any revascularization procedure, transient ischemic attack, unstable angina, amputation, symptomatic or asymptomatic coronary artery disease] with type 2 diabetes mellitus
         AND
      2. The requested agent will be used to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke)
         OR
   3. BOTH of the following:
      1. The patient has a diagnosis of chronic kidney disease with type 2 diabetes mellitus
         AND
      2. The requested agent will be used to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death
         AND
3. 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 within the past 180 days
      OR
   3. ALL of the following:
      1. The patient does NOT have any FDA labeled contraindications to the requested medication
         AND
      2. The patient will NOT be using the requested medication in combination with another GLP-1 agonist medication, or a medication containing a GLP-1 agonist
         AND
      3. The patient will NOT be using the requested medication in combination with a medication containing a dipeptidyl peptidase-4 (DPP-4) inhibitor
         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