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Oscar Fetzima (levomilnacipran) (PG063) Form


Fetzima (levomilnacipran) Initial Authorization

Notes: If all indications are met, Fetzima (levomilnacipran) will be approved for 12 months.

Indications

(549734) Is the patient 18 years of age or older? 
(549735) Does the patient have a diagnosis of major depressive disorder (MDD)? 
(549736) Has the patient been unable to use, or adequately tried and failed, a minimum one-month trial of at least three therapies from at least three different classes as listed in the document? 
(549737) Is there clinical chart documentation provided for review to substantiate the requirements? 

Fetzima (levomilnacipran) Reauthorization

Notes: Reauthorization for 12 months will be granted if the criteria are met.

Indications

(549738) Has recent chart documentation within the last 12 months shown that the patient experienced therapeutic response to Fetzima? 

YesNoN/A
YesNoN/A

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Effective Date

NA

Last Reviewed

07/25/2022

Original Document

  Reference



American Psychiatric Association: Practice Guideline for the Treatment of Patients with Major Depressive Disorder, 3rd edition

2010. Available at: https://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/mdd.pdf. Published October 2010. Accessed July 25, 2022.

Balt S and Puzantian T. Four Newer Antidepressants: Should You Use Them?

The Carlat Psychiatry Report, April 2016. Volume 14, Issue 4.

WFSBP Task Force on Treatment Guidelines for Unipolar Depressive Disorders
  1. Bauer M, Severus E, Köhler S, Whybrow PC, Angst J, Möller HJ; World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for biological treatment of unipolar depressive disorders. Part 2: maintenance treatment of major depressive disorder-update 2015. World J Biol Psychiatry. 2015;16(2):76-95. doi: 10.3109/15622975.2014.1001786.

  2. Bauer M, Whybrow PC, Anst J, et al. World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for Biological Treatment of Unipolar Depressive Disorders, Part 2: Maintenance treatment of major depressive disorder and treatment of chronic depressive disorders and subthreshold depressions. World J Biol Psychiatry. 2002;3(2):69-86.

Fava M. Prospective studies of adverse events related to antidepressant discontinuation

J Clin Psychiatry. 2006;67(Suppl 4):14-21.

Fetzima (levomilnacipran) [prescribing information]

Madison, NJ: Allergan USA Inc; February 2022.

Gelenberg, A. J., Freeman, M. P., Markowitz, J. C., Rosenbaum, J. F., Thase, M. E., Trivedi, M. H., & Van Rhoads, R. S. (2010)

American Psychiatric Association practice guidelines for the treatment of patients with major depressive disorder. Am J Psychiatry, 167(Suppl 10), 9-118.

Gitlin M. When First-Line Depression Treatments Don’t Cut It: Newer Antidepressants and Sometimes, Antipsychotics

The Carlat Psychiatry Report, July 2017. Volume 15, Issue 7&8.

Hirsch M, Birnbaum RJ. Discontinuing antidepressant medications in adults

Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed June 26, 2022.

National Collaborating Centre for Mental Health (NCCMH). Depression: The Treatment and Management of Depression in Adults (Updated Edition)

National Institute for Health & Clinical Excellence (NICE). 2010.

Puzantian T and Carlat DJ. General Prescribing Tips: Treatment Algorithm for Depression

Medication Fact Book for Psychiatric Practice, 5th edition, 2020. Newburyport, MA; Carlat Publishing, p27-32.

Sambunaris, A et al. Efficacy of levomilnacipran extended-release in improving functional impairment associated with major depressive disorder

International Clinical Psychopharmacology. 2014; 29(4): p197-205. doi: 10.1097/YIC.0000000000000033

Clinical Guideline Revision / History Information
  • Original Date: 11/05/2020
  • Reviewed/Revised: 10/14/2021, 12/01/2021, 9/15/2022, 9/21/2023