Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Lidocaine 5% patches. 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 Lidocaine 5% patches. Lidocaine 5% patches are requested for treatment of back pain related to spondylolisthesis in the lumbar region associated with radiculopathy, and trigeminal neuralgia. The prescriber has indicated that the enrollee has failed multiple non-steroidal anti-inflammatory drugs (NSAIDs) and has documented gastroesophageal reflux disease being treated with Dexilant; therefore, the prescriber feels topical therapy is more appropriate.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 the requested drug for treatment of the noted condition. Drugdex cites the following medical reference in the Comparative Efficacy section of their Lidocaine monograph in the discussion of chronic back pain, and chronic osteoarthritis of the hip and knee, for multiple drugs: Krebs EE, Gravely A, Nugent S, et al: Effect of opioid vs nonopioid medications on pain-related function in patients with chronic back pain or hip or knee osteoarthritis pain: the SPACE randomized clinical trial. JAMA 2018; 319(9):872-882. The study demonstrated that among patients with chronic back pain, or hip or knee osteoarthritis pain, treatment with opioids compared with nonopioid medications did not result in significantly better pain-related function over 12 months, and that opioids caused significantly more medication-related adverse symptoms than nonopioid medications. The noted reference states that topical Lidocaine was included in the nonopioid prescribing strategy. Therefore, the use of Lidocaine patches for the treatment of chronic back pain in this enrollee who has failed oral NSAIDs is a medically accepted indication. The enrollee satisfies the Plan's coverage criteria which only requires that the requested drug is being prescribed for a medically accepted indication. Our Physician Reviewer's opinion is that prior authorization 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 Lidocaine 5% patches for the diagnosed condition. As a result, Lidocaine 5% patches are 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 Lidocaine 5% patches.