Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Pregabalin 50 mg capsule. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Pregabalin 50 mg.Pregabalin 50 mg is requested for treatment of lumbosacral radiculopathy. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of this drug for this condition. DRUGDEX cites results from the following reference in the FDA USE section Neuropathic pain - spinal cord injury: Finnerup NB, Attal N, Haroutounian S, et al: Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol 2015; 14(2):162-173 which concluded that the requested drug is one of several drugs proposed as first line treatment of neuropathic pain. It is noted that the enrollee's condition is included in the patient population of studies cited. Therefore, this drug is being prescribed for a medically accepted indication. Therefore, the requested drug is being prescribed for a medically accepted indication. The enrollee does not satisfy the Plan's coverage criteria. You state that the enrollee is unable to take Gabapentin, and that the requested drug is required in an attempt to keep opioids at a low dose. You have indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that prior authorization exception criteria are met.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are citations in the Medicare approved compendia that support the use of Pregabalin 50 mg capsule for the diagnosed condition. As a result, Pregabalin 50 mg capsule is being prescribed for a medically accepted indication as defined by Medicare law.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Pregabalin 50 mg capsule.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.