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

Medicare Policy
Version Date: 01/01/2025

Prior Authorization with Quantity Limit Criteria for Approval

PA applies to new starts only

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

  1. The requested medication will NOT be used for weight loss alone
    AND
  2. The patient has a diagnosis of type 2 diabetes mellitus
    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. ONE of the following:
        1. The patient’s medication history includes use of a non glucagon-like peptide-1 (GLP-1) oral diabetes medication (e.g., metformin, glipizide, etc.)* within the past 90 days
          OR
        2. The patient had an ineffective treatment response to a non GLP-1 oral diabetes medication (e.g., metformin, glipizide, etc.)*
          OR
        3. The patient has an intolerance or hypersensitivity to a non GLP-1 oral diabetes medication (e.g., metformin, glipizide, etc.)*
          OR
        4. The patient has an FDA labeled contraindication to a non GLP-1 oral diabetes medication (e.g., metformin, glipizide, etc.)*
          OR
        5. The requested medication is Ozempic or Trulicity and 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]
            AND
          2. The requested medication will be used to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke)
            AND
      2. The patient does NOT have any FDA labeled contraindications to the requested medication
        AND
      3. The patient will NOT be using the requested agent in combination with another GLP-1 agonist agent, or an agent containing a GLP-1 agonist
        AND
      4. The patient will NOT be using the requested agent in combination with an agent 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

*Oral diabetes medications include: Sulfonylureas, biguanides, meglitinide analogues, alpha-glucosidase inhibitors, DPP-4 inhibitors, bromocriptine, TZDs, SGLT2 inhibitors, DPP4/biguanide combinations, DPP4/TZD combinations, SGLT-2/biguanide combinations, SGLT2/DPP4 combinations, SGLT2/DPP4/biguanide combinations, sulfonylurea/biguanide combinations, sulfonylurea/TZD combinations, TZD/biguanide combinations