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Emsam Prior Authorization (with Quantity Limit) Criteria - Medicare Part D
Utilization Management Policy
Version Date: 01/01/2025
Prior Authorization Criteria for Approval

PA applies to new starts only

Initial Evaluation

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

  1. ONE of the following: 
    1. The patient has a diagnosis of major depressive disorder (MDD) OR 
    2. The patient has an indication that is supported in CMS approved compendia 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. BOTH of the following: 
      1. ONE of the following: 
        1. BOTH of the following: 
          1. The patient has a diagnosis of major depressive disorder (MDD) AND 
          2. ONE of the following: 
            1. The patient has tried and had an inadequate response to at least two different oral antidepressants (e.g., SSRIs, SNRIs, mirtazapine, bupropion) OR 
            2. The patient has an intolerance or hypersensitivity to at least two different oral antidepressants (e.g., SSRIs, SNRIs, mirtazapine, bupropion) OR 
            3. The patient has an FDA labeled contraindication to at least two different oral antidepressants (e.g., SSRIs, SNRIs, mirtazapine, bupropion) OR 
        2. The patient has an indication that is supported in CMS approved compendia for the requested agent AND 
      2. 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

Emsam 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. ONE of the following: 
    1. The patient has a diagnosis of major depressive disorder (MDD) OR 
    2. The patient has an indication that is supported in CMS approved compendia for the requested medication AND 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. BOTH of the following: 
      1. The patient has had clinical benefit with the requested medication AND 
      2. The patient does NOT have any FDA labeled contraindications to 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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