Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Major depressive disorder.
Treatment:  Duloxetine Hydrochloride 40MG (Irenka).

The insurer denied the Duloxetine Hydrochloride 40MG (Irenka).  The denial is upheld. 

The patient is a adult female, who is in treatment for management of major depressive disorder (MDD) and binge eating in the context of obesity.  Moreover, the patient recently stopped treatment with Saxenda, which led to a recrudescence of her overeating behavior.  In an attempt to address the risk for potential weight gain from Prozac as a contributing factor, the prescribing physician has recommended a switch from Prozac to Irenka (duloxetine capsule) at a dose of 40 mg daily.

The health plan's pharmacy benefit manager has denied coverage for the brand duloxetine (Irenka) on the basis of coverage exclusion.  The denial for coverage of the duloxetine indicated that the patient had not tried and failed to respond to the generic formulation of duloxetine, as required under the plan's prior authorization criteria and prescription drug coverage guidelines.

The prescribing clinician is requesting coverage of the brand formulation of duloxetine (Irenka) at the currently prescribed dose for maintenance therapy of major depressive disorder and to address concerns in the management of the co-morbid eating disorder and obesity.

No, the requested treatment with brand duloxetine (Irenka) is not medically necessary in this case scenario. 

Indeed, the patient has not demonstrated a treatment failure with a health plan approved generic formulation of the requested antidepressant medication, including tolerability problems or lack of efficacy with the generic formulation of Cymbalta or Irenka, generic duloxetine, which is just as likely to be as beneficial as the brand formulation. 

Moreover, the health plan determination of medical necessity of treatment with a specific/brand medication and dosage that is available in generic formulation is consistent with prevailing medical standards and with the plan's clinical guidelines pertaining to prescription drug coverage, as well as consistent with evidence-based studies of treatments known to benefit patients with depressive disorders, as in this case.  Generic formulations must meet the same regulatory and pharmacologic criteria as brand formulations of the same medication, noted in the denial provided by the health plan medical director.  Thus, the health plan preferred alternative in this case is clinically appropriate, and the request for brand formulation is not warranted or medically necessary in keeping with instructions for this mandated review.

Moreover, the request for brand formulation is not warranted or medically necessary in this case scenario, as the generic formulation of Cymbalta/Irenka (duloxetine) must meet the same regulatory and pharmacologic criteria as brand formulations of the same medication, noted in the denial provided by the health plan medical director.  Thus, the plan's decision to deny coverage is reasonable, especially since there is no evidence that the patient has tried and failed to respond to or tolerate the preferred generic formulation of the requested medication.

This answer is consistent with the scientific literature referenced below, as well as prevailing standards of medical practice and NY State instruction for this medical necessity review.