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Auvelity - NC Standard

Commercial Policy
Version Date: October 2022

Restricted Product(s):

  • Auvelity® (dextromethorphan / bupropion hcl ER tab)

FDA Approved Use:

  • For the treatment of adults with major depressive disorder (MDD).

Criteria for Approval of Restricted Product(s):

  1. The patient is 18 years of age or older; AND
  2. ONE of the following:
    1. The patient is currently stable on Auvelity for at least 2 weeks (medical record documentation required); OR 
    2. The patient has a diagnosis of major depressive disorder; AND
      1. The patient has experienced a therapeutic failure or inadequate response to TWO generic antidepressants from different drug classes (SSRI, SNRI, bupropion, mirtazapine, etc.) (medical record documentation required); OR
      2. The patient has a clinical contraindication or intolerance to ALL generic antidepressants (medical record documentation required); AND
  3. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year) 

Quantity Limitations:

Quantity limitations apply to brand and associated generic products.

MedicationQuantity per Day (unless specified)
Auvelity (dextromethorphan hbr / bupropion hcl tab ER 24 hr) 45 mg/105 mg tablet2 tablets

Quantity Limit Exception Criteria:

  1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
  2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
  3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
  4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval: 365 days (1 year) 

References:

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation / Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q4 annually.

October 2022: Original utilization management criteria issued.