Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Vraylar. The Plan did not grant this request. We received this case to conductan independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Vraylar 1.5 mg cap. The drug is requested to treat F33.9 Major depressive disorder, recurrent,unspecified, which is an off-label (non-FDA approved) use. In a statement dated June 17, 2020, youprovided the diagnosis of major depressive disorder, recurrent, unspecified. Medical records from June 10,2020 were provided which substantiated this diagnosis. These medical records indicate that VraylarCapsule is being prescribed for the treatment of recurrent major depressive disorder.In a letter dated June 25, 2020, you changed the diagnosis to F31.60 Bipolar disorder, current episodemixed, unspecified. You were asked to clarify the enrollee's diagnosis, because it was unclear from the casefile if the underlying etiology of the enrollee's condition is Bipolar I disorder or major depressive disorder.You were also asked to provide medical record documentation from past patient encounters to support thenew stated diagnosis of bipolar I disorder as well as to support the specific manifestations of the enrollee'scondition. You sent a letter dated July 2, 2020 stating the diagnosis of Bipolar I disorder but did not provideany medical records to support this new diagnosis.Medical records from date of service June 10, 2020 document that the requested medication is beingprescribed for the treatment of major depressive disorder. The Medicare-approved compendia do notcontain any citations to support the use of the requested drug, as prescribed, for treatment of the notedcondition. Therefore, the requested drug is not being prescribed for a medically accepted indication asdefined by Medicare law. As such, an exceptions request based on medical necessity cannot be consideredbecause the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug.Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Vraylar for the diagnosed condition. As a result, the drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit for this condition. An exceptions request based on medicalnecessity cannot be considered because this drug, as prescribed, does not meet the definition of a MedicarePart D drug. Therefore, our decision is that the Plan is not required to provide coverage for Vraylar.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.