Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Recurrent and moderately severe major depressive disorder
Treatment: Fetzima (levomilnacipran)
The health plan denied the Fetzima (levomilnacipran).
The health plan's determination is overturned, in whole.

Clinical Summary: This case involves an adult female with recurrent and moderately severe major depressive disorder who has been in treatment with Fetzima (Levomilnacipran) at 40 milligrams (mg) daily for the past eleven years. The patient has failed to sustain a response or remission or tolerate Fluoxetine, Citalopram, Sertraline, Duloxetine and Bupropion XR (extended release).
Denial Reason: The health plan has denied coverage of Fetzima indicating that the patient must try and fail one other formulary alternatives in keeping with plan guidelines and prior authorization criteria.
Appeal: The patient's physician has requested an exception to the denial of coverage on the basis of the clinical history and treatment failure with multiple formulary alternatives-as noted in the clinical summary. The appeal indicates that the patient is stable on Fetzima with treatment for eleven years, and to stop this medication would lead to decompensation and/or withdrawal symptoms.
Issue under review: Fetzima (Levomilnacipran) 40 mg capsule with 30 capsules/30 days.

In this case, the formulary drug will be or has been ineffective, and would not be as effective as the non-formulary drug, or would have adverse effects in view of the history of a positive clinical response to the non-formulary drug for at least eleven years.
The requested non-formulary drug would be more effective than all other covered formulary drugs on any tier, as the patient has been stable on the non-formulary drug for over 5 years. Clinical guidelines for the management of major depressive disorder would recommend continued use of the non-formulary drug with a unique pharmacologic profile and mechanism of action and side effect profile that is in the best interest of the patient, in view of the positive therapeutic response.

The exception request for Fetzima does appear to meet the plan's criteria for coverage of a non-formulary drug, as multiple formulary agents within the class of antidepressants has been tried and failed. Moreover, in this case, Fetzima is a reasonable next step. According to Durgam et. al. referenced below, Fetzima-Levomilnacipran is used to treat depression. Accordingly, Fetzima works by helping to restore the balance of certain natural substances (serotonin and norepinephrine) in the brain. Levomilnacipran belongs to a class of drugs known as serotonin-norepinephrine reuptake inhibitors (SNRIs). It may improve mood, sleep, and appetite and may help restore your interest in daily living, and this assertion is noted in the multicenter, randomized double-blind study referenced below. The proposed treatment with Fetzima is reasonable and reflects sound medical judgment with regard to medical necessity and prevailing standards of medical practice. The use of Fetzima in this case is in keeping with Food and Drug Administration (FDA) indications and is considered medically necessary with regard to the prescription drug plan requiring step therapy, as well as the reference by Wagner et al comparing Fetzima to other second-generation antidepressants noting the efficacy and safety of this antidepressant medication.