Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lyrica 100mg, 90 per 30 days and Lyrica 50mg, 30 per 30 days. 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 Lyrica 100mg, 90 per 30 days and Lyrica 50mg, 30 per 30 days. Lyrica 100mg, 90 per 30 days and Lyrica 50mg, 30 per 30 days is requested for ongoing treatment of severe neuropathic pain involving the legs and feet related to the diagnoses of peripheral neuropathy, polyneuropathy (possibly related to critical illness), history of craniotomy, chronic back pain, neurogenic bladder, and traumatic brain injury. The prescriber has provided documentation that Pregabalin was not sufficient to control the enrollee's symptoms, brand Lyrica has been much more effective, and that Gabapentin resulted in adverse effects. The prescriber states that the requested dosing of brand Lyrica has allowed the enrollee to manage most of his activities of daily living. 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 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 prescriber has 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 formulary exception criteria are metA Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are met. Therefore, the Plan is required to cover Lyrica 100mg, 90 per 30 days and Lyrica 50mg, 30 per 30 days.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.