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Cobenfy Prior Authorization Criteria (with Quantity Limit Criteria) - Medicare Part D
Medicare Drug Policy
Version Date: 11/01/2024
Prior Authorization Criteria for Approval:

Initial Evaluation

Cobenfy 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 180 days OR
    2. The prescriber states the patient is currently being treated with the requested medication OR
    3. ALL of the following:
      1. The prescriber has assessed the patient’s liver enzymes and bilirubin prior to starting therapy with the requested medication AND
      2. The prescriber has assessed the patient’s heart rate prior to starting therapy with the requested medication AND
      3. ONE of the following:
        1. The patient has tried and had an inadequate response to TWO antipsychotic medications (e.g., aripiprazole, olanzapine, quetiapine, risperidone) for the requested indication OR
        2. The patient has an intolerance or hypersensitivity to TWO antipsychotic medications (e.g., aripiprazole, olanzapine, quetiapine, risperidone) OR
        3. The patient has an FDA labeled contraindication to TWO antipsychotic medications (e.g., aripiprazole, olanzapine, quetiapine, risperidone) AND
      4. The patient does NOT have any FDA labeled contraindications to the requested medication AND
  3. 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

Renewal Evaluation

Cobenfy 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. 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. ALL of the following:
      1. The prescriber has assessed the patient’s liver enzymes and bilirubin as clinically indicated during treatment with the requested medication AND
      2. The prescriber has assessed the patient’s heart rate as clinically indicated during treatment with the requested medication AND
      3. The patient does NOT have any FDA labeled contraindications to the requested medication AND 
      4. The patient has had clinical benefit with the requested medication 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
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