Appeal type: Step Therapy
Decision: Overturned

Diagnosis: Major Depressive Disorder.
Treatment: Prozac Brand Capsules 40 mg (milligrams).

The insurer denied Prozac Brand Capsules 40 mg.  The determination is overturned.

The patient is diagnosed with major depressive disorder with moderate severity, and comorbid generalized anxiety disorder and obsessive-compulsive disorder (OCD). The patient's clinician has prescribed Prozac Brand Capsules 40 mg daily, and the patient has been taking this medication; the patient has shown a satisfactory clinical response with tolerability and is reported to be stable in the submitted progress note. There are no reported symptoms of mania, formal thought disorder, psychosis, or severe cognitive impairment. The patient has no significant general medical comorbidity, and no diagnosed substance use disorder. Formulary alternatives include fluoxetine, sertraline, citalopram, escitalopram and paroxetine.

The prescribing clinician is requesting coverage for the Brand Prozac Capsule at the effective dose of 40 mg daily in view of the positive clinical response to this medication, and treatment failure with generic fluoxetine (anxiety and ineffective), sertraline (ineffective) and escitalopram (ineffective). The prescribing clinician, a mental health specialist, notes that continued use of this medication is medically necessary and indicates in the appeal that this patient must continue on Brand Prozac, as the treatment has resulted in stability of the moderately severe mood disorder and comorbid psychiatric conditions. The prescribing clinician indicates that to switch to another antidepressant medication would be detrimental to this patient and would cause decompensation, an exacerbation of the patient's conditions, or could result in hospitalization.

Prozac Brand Capsule 40 milligrams (mg) is under review.

The requested health service/treatment of Brand Prozac capsule at a daily dose of 40 mg is medically necessary for this patient because:  1) The required prescription drug(s) (those on formulary) are contraindicated or likely to cause an adverse reaction by or physical or mental harm to the insured in view of the clinical history of adverse effect or lack of effectiveness of at least three suggested formulary alternatives, 2) The required prescription drugs(s) (those on formulary) are expected to be ineffective based on the known clinical history and conditions of the patient and the patient's prescription drug regimen, 3) The patient has tried the required prescription drug(s) (those on formulary) while under their current or previous plan or another prescription drug(s) in the same pharmacologic class or with the same mechanism of action and such prescription drug(s) were discontinued due to lack of efficacy or effectiveness, diminished effect or an adverse event, 4) The patient is stable on the current prescription drug, Brand Prozac, selected by their health care provider for the medical conditions under consideration, and
5) The required prescription drug(s) (those on formulary) are not in the best interest of the patient because it will likely cause a significant barrier to the patient's adherence to or compliance with the patient's plan of care, or will likely worsen a condition of the patient, or will likely decrease the patient's ability to achieve or maintain reasonable functional ability in performing daily activities, as clearly noted in the appeal provided by the prescribing clinician.

The patient has been taking the requested medication for many years; the patient has shown a satisfactory clinical response with tolerability, and is reported to be stable. The prescribing clinician notes that continued use of this medication is medically necessary and appropriately indicates that this patient must continue on Brand Prozac Capsule at 40 mg daily, as the treatment with this formulation of fluoxetine has resulted in stability of the mood disorder and comorbid conditions.

This answer is consistent with the scientific literature and published guidelines referenced below.