Pharmacy Prior Authorization Criteria

Oral Antidepressants

Indications for Prior Authorization

Aplenzin (bupropion extended-release)

• For diagnosis of Major Depressive Disorder
  Indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).

• For diagnosis of Seasonal Affective Disorder
  Indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD).

Citalopram capsules

• For diagnosis of Major Depressive Disorders
  Indicated for the treatment of major depressive disorder (MDD) in adults.

Desvenlafaxine ER

• For diagnosis of Major Depressive Disorder
  Indicated for the treatment of major depressive disorder (MDD) in adults.

Fetzima (levomilnacipran extended-release)

• For diagnosis of Major Depressive Disorder
  Indicated for the treatment of major depressive disorder (MDD).

Forfivo XL (bupropion extended-release)

• For diagnosis of Major Depressive Disorder
  Indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).

Paxil (paroxetine) oral suspension

• For diagnosis of Major Depressive Disorder
  Indicated for the treatment of major depressive disorder (MDD).

• For diagnosis of Obsessive Compulsive Disorder
  Indicated for the treatment of obsessive compulsive disorder (OCD)

• For diagnosis of Panic Disorder
  Indicated for the treatment of panic disorder (PD).

• For diagnosis of Social Anxiety Disorder
  Indicated for the treatment of social anxiety disorder (SAD).

• For diagnosis of Generalized Anxiety Disorder
  Indicated for the treatment of generalized anxiety disorder (GAD).

• For diagnosis of Posttraumatic Stress Disorder
  Indicated for the treatment of posttraumatic stress disorder (PTSD).

Trintellix (vortioxetine)

• For diagnosis of Major Depressive Disorder
  Indicated for the treatment of major depressive disorder (MDD) in adults.

Sertraline capsules

• For diagnosis of Major Depressive Disorder
  Indicated for the treatment of major depressive disorder (MDD) in adults.

• For diagnosis of Obsessive Compulsive Disorder
  Indicated for the treatment of obsessive compulsive disorder (OCD) in adults and pediatric patients 6 years and older.

Venlafaxine ER

• For diagnosis of Major Depressive Disorder
  Indicated for the treatment of major depressive disorder (MDD) in adults.

• For diagnosis of Generalized Anxiety Disorder
  Indicated for the treatment of generalized anxiety disorder (GAD) in adults.

Auvelity (dextromethorphan hydrobromide and bupropion extended-release)

• For diagnosis of Major Depressive Disorder
  Indicated for the treatment of major depressive disorder (MDD) in adults.

Drizalma sprinkle (duloxetine delayed-relased capsules)

• For diagnosis of Multiple Indications
  Indicated for the treatment of: 1) Major Depressive Disorder in adults. 2) Generalized Anxiety Disorder in adults and pediatric patients 7 years of age and older. 3) Diabetic Peripheral Neuropathy in adults. 4) Fibromyalgia in adults. 5) Chronic Musculoskeletal Pain in adults.

Criteria

Aplenzin, Forfivo XL, or Bupropion HCL 450mg ER (XL)

Step Therapy

Length of Approval: 12 Month(s)

• Both of the following:
• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure (of a minimum 30-day supply) or intolerance to a generic bupropion XL product
OR
• For continuation of prior therapy

Brand Desvenlafaxine ER, Brand Citalopram capsules, Drizalma sprinkle, Paxil suspension, Brand Sertraline capsules, Trintellix, or Brand Venlafaxine ER

Step Therapy

Length of Approval: 12 Month(s)

• Both of the following:
• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure (of a minimum 30-day supply), contraindication, or intolerance to any two of the following generics:
• bupropion
• citalopram tablets or oral solution
• desvenlafaxine succinate extended-release (ER)
• duloxetine
• escitalopram
• fluoxetine
• mirtazepine
• paroxetine
• paroxetine ER
• sertraline tablets or oral solution
• venlafaxine
• venlafaxine ER
OR
• For continuation of prior therapy

Auvelity

Step Therapy

Length of Approval: 12 Month(s)

• Both of the following:
• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• One of the following
• Trial and failure (of a minimum 30-day supply), contraindication, or intolerance to any three of the following generics:
• bupropion
• citalopram tablets or oral solution
• desvenlafaxine succinate extended-release (ER)
• duloxetine
• escitalopram
• fluoxetine
• mirtazepine
• paroxetine
• paroxetine ER
• sertraline tablets or oral solution
• venlafaxine
• venlafaxine ER
OR
• Patient has treatment-resistant depression as defined by a failure to respond to a trial of at least 2 antidepressants after at least 4 to 6 weeks of treatment at the maximally tolerated dose [A]
OR
• For continuation of prior therapy

Fetzima or Fetzima Pack

Step Therapy

Length of Approval: 12 Month(s)

• Both of the following:
• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure (of a minimum 30-day supply), contraindication, or intolerance to any two of the following generics:
• desvenlafaxine succinate extended-release (ER)
• duloxetine
• venlafaxine
• venlafaxine ER
OR
• For continuation of prior therapy

P & T Revisions

2024-07-02, 2024-03-06, 2023-12-04, 2023-05-11, 2023-04-17, 2023-03-02, 2022-11-30, 2022-08-05, 2022-08-02, 2022-04-04, 2022-03-03, 2021-11-29, 2021-10-06, 2021-08-31, 2021-05-21, 2021-03-04, 2020-06-30, 2020-03-05

References

1. Aplenzin Prescribing Information. Bausch Health US, LLC. Bridgewater, NJ. March 2022.
2. American Psychiatric Association. Practice guideline for the treatment of patients with major depressive disorder, third edition. Oct. 2010. http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/mdd.pdf. Accessed January 29, 2024.
3. American Geriatrics Society. American Geriatrics Society 2015 updated Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2015;63:2227-46.
4. Soleimani L, Lapidus KA, Losifescu DV. Diagnosis and treatment of major depressive disorder. Neurol Clin. 2011;29(1):177-93.
5. Trintellix Prescribing Information. Takeda Pharmaceuticals America, Inc. Lexington, MA. August 2023.
6. Fetzima Prescribing Information. AbbVie, Inc. North Chicago, IL. October 2023.
7. Paxil Prescribing Information. Apotex Corp. Weston, FL. September 2021.
8. Forfivo XL Prescribing Information. Almatica Pharma, Inc. Morristown, NJ. December 2019.
9. Sertraline capsules Prescribing Information. Almatica Pharma LLC. Morristown, NJ. October 2021.
10. Citalopram capsules Prescribing Information. Almatica Pharma LLC. Morristown, NJ. August 2023.
11. Venlafaxine besylate Prescribing Information. Almatica Pharma LLC. Morristown, NJ. August 2023.
12. Auvelity Prescribing Information. Axsome Therapeutics, Inc. New York, NY. December 2022.
13. Desvenlafaxine ER Prescribing Information. Alembic Pharmaceuticals Limited. Gujarat, India. January 2023.
14. Sforzini L, Worrell C, Kose M, et al. A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials. Molecular Psychiatry. 2021;27(3):1286-1299.
15. Drizalma Prescribing Information. Sun Pharmaceutical Industries Limited. Mohali, India. May 2024.

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Revision History

• 2024-07-02: Added Drizalma sprinkle as a target to guideline
• 2024-03-06: Annual review: Background updates.
• 2023-12-04: Update to Auvelity criteria
• 2023-05-11: Addition of Bupropion HCL ER (XL) (MSC M) product as a target
• 2023-04-17: Annual review: Background updates.
• 2023-03-02: Annual review: Background updates.
• 2022-11-30: Addition of new product, Auvelity
• 2022-08-05: Addition of Brand Venlafaxine ER as a target
• 2022-08-02: Removed EHB formulary from guideline
• 2022-04-04: Added Brand Citalopram capsules as a target
• 2022-03-03: Annual review: GPI clean-up and updated criteria, formatting, and background.
• 2021-11-29: Added Brand Sertraline capsules as a target
• 2021-10-06: Update to add approval length
• 2021-08-31: Remove references to Khedezla from guideline
• 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
• 2021-03-04: Annual review: Background updates.
• 2020-06-30: Added Forfivo XL as step target to guideline, mirroring Aplenzin.
• 2020-03-05: Annual review: background updates.

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