Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Lidocaine 5% patch. 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% Patch. Lidocaine 5% Patch is requested to treat osteoarthritis of the knee. 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. The following citation in the comparative section of DrugDex, a Medicare approved compendium, supports the use of the requested drug for the enrollee's condition: Opioids did not significantly improve pain-related function compared with nonopioids (3.4 vs 3.3 points on the 11-point Brief Pain Inventory (BPI) interference scale), nonopioids significantly improved pain intensity (mean BPI, 4 vs 3.5), and opioids were associated with significantly more adverse effects (mean symptoms, 1.8 vs 0.9) over 12 months in a randomized trial in patients with either chronic back (65%) or hip or knee osteoarthritis (35%) pain despite analgesic use (N=240). In addition, the reference cited in DrugDex states: 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. Nonopioid treatment was associated with significantly better pain intensity. Therefore, the requested drug is being prescribed for a medically accepted indication. You state the enrollee is unable to take nonsteroidal anti-inflammatory agents due to comorbid conditions of diabetes, hypertension, and chronic kidney disease. Upon reconsideration, you submitted supporting chart notes. The enrollee does not satisfy the Plan's coverage criteria. 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 Lidocaine 5% patch for the diagnosed condition. As a result, Lidocaine 5% patch 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 Lidocaine 5% patch.