Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lorazepam. The Plan did not grant this request. We received this case toconduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Lorazepam 0.5 mg, 90 tablets per 30 days. The drug is requested to treat chronic anxiety, which is anoff-label (non-FDA approved) use. You initially stated that the enrollee was using the requested drug forthe treatment of insomnia. You changed the diagnosis to anxiety in the request for reconsideration. Youwere asked to clarify the enrollee's diagnosis, because it was unclear from the case file if the underlyingetiology of the enrollee's condition is insomnia or anxiety. You were also asked to provide supportingmedical records. You sent a statement dated July 8, 2020 clarifying the medical history. You stated that therequested drug is being prescribed for the treatment of anxiety. You also stated Pt has been on thismedication for many years with great results. You stated that the requested drug was started June 6, 2017and has been prescribed by you since August 2018. Medical records were provided which document thatthe enrollee has been receiving Lorazepam since 2018 for anxiety. Medical records from date of serviceJune 11, 2020 also document that the enrollee is taking Diazepam 5 mg twice a day as needed for musclespasms.The following citation in DrugDex, a Medicare approved compendium, does not support the use of therequested drug for the enrollee's condition:Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of thesymptoms of anxiety or anxiety associated with depressive symptoms [3][4].Effectiveness for more than 4 months has not been assessed by systematic clinical studies [4][3].[4] Product Information: lorazepam concentrated oral solution, lorazepam concentrated oral solution.Paddock Laboratories, Inc., Minneapolis, MN, 2008.[3] Product Information: lorazepam oral tablets, lorazepam oral tablets. Watson Laboratories, Inc., Corona,CA, 2008.The Medicare-approved compendia do not contain any citations to support the use of the requested drug, asprescribed, for treatment of the noted condition. Therefore, the requested drug is not being prescribed for amedically accepted indication as defined by Medicare law. As such, an exceptions request based onmedical necessity cannot be considered because the requested drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage underMedicare 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 Lorazepam for the diagnosed condition. As a result, the drug isnot being 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 Lorazepam.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.