Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Horizant ER. The Plan did not grant this request. We received this case toconduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Horizant.Horizant ER is requested for treatment of the enrollee's condition. There has been discrepant informationprovided from your office regarding the diagnosis being treated with Horizant. The diagnosis initially notedwas lumbar disc disease with lumbar radiculopathy, which is an off-label (non-FDA approved) use. TheMedicare-approved compendia do not contain any citations to support the use of the requested drug, asprescribed, for treatment of the noted condition.You later indicated in a letter dated April 28, 2020 that the enrollee was diagnosed with restless legsyndrome on April 9, 2020, and that Horizant is effective for the enrollee's restless leg syndrome. It is notedin a telemedicine encounter for follow up of low back pain secondary to lumbar spinal stenosis onApril 9, 2020 that in addition to her low back pain, the enrollee reports sharp throbbing calf pain, rightgreater than left at night with minimal knee pain, and that she has severe restless leg pain at night. In theAssessment and Plan from that visit in the discussion of treatment of lumbar disc disease, you have statedto continue Horizant for neuropathic pain, If too expensive, will start Neurontin 300 mg PO BID. Theaccompanying form regarding the trial of formulary alternatives dated April 6, 2020, but submitted onApril 28 with the noted prescriber letter has the diagnosis of Restless leg syndrome crossed out- only thediagnosis of lumbar degenerative disc disease is noted.There is insufficient documentation that the enrollee has restless leg syndrome, and as noted, lumbarradiculopathy is not a medically accepted indication for the use of the requested drug. Additionallyregarding formulary exception, you indicated that the enrollee has failed multiple medications includingGabapentin; however it is documented in the patient encounter of April 9, 2020 to trial Neurontin ifHorizant is too expensive. Additionally, if the enrollee does indeed have a new diagnosis of restless legsyndrome as of April 9, 2020, there is insufficient documentation that the enrollee has tried and failed thePlan's alternatives specifically for treatment of her restless leg syndrome.In summary, there is insufficient documentation that the requested drug is being prescribed for treatment ofa medically accepted indication as defined by Medicare law, and there is insufficient documentation thatthe enrollee has failed the plan's formulary alternatives for treatment of a medically accepted indication.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Horizant ER for the diagnosed condition. As a result, the drugis not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannotbe covered under the Medicare Part D benefit for this condition. An exceptions request based on medicalnecessity cannot be considered because this drug, as prescribed, does not meet the definition of a MedicarePart D drug. Therefore, our decision is that the Plan is not required to provide coverage for Horizant ER.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.