Appeal type: Prescription Drug
Decision: Unfavorable

We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Lyrica 50 mg capsule. Lyrica 50 mg capsule is requested for ongoing treatment of unspecified polyneuropathy, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. Upon the reopening of this case, the prescriber statement was returned. Additional medical information was requested by the Part D QIC. The prescribing physician was asked to clarify the diagnosis and address the request for tiering exception. The prescriber documented a diagnosis of unspecified polyneuropathy (ICD-10 G62.9). The prescriber documented that you has significant pain due to diabetic neuropathy and lumbar spinal stenosis. However, there is no documentation provided in the medical records that you have a diagnosis of diabetes mellitus/diabetic neuropathy. In addition, diagnosis code G62.9 does not include diabetic neuropathy. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because 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.We previously requested additional information from the prescriber to determine whether the Plan's tiering exception criteria for Lyrica were satisfied. We did not receive the information from the prescriber. As a result, we issued an unfavorable reconsideration decision. We subsequently received the additional information previously requested from the prescriber. We reopened this appeal to conduct a second review with the additional information.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 no citations in the Medicare approved compendia that support the use of Lyrica for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Lyrica.This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.This decision affirms our previous unfavorable decision.Please note: the request for a tiering exception (lower copayment) for Lyrica was not reviewed. We cannot consider a tiering exception for a drug for which the Part D Plan is unable to provide coverage.