Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Verzenio. 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 Verzenio. The drug is requested to treat non-small cell cancer consistent with breast cancer with unknown hormone receptor status, which is an off-label (non-FDA approved) use. The enrollee is a 65 year old woman with metastatic non-small cell cancer in bone and scalp that is stated to be consistent with breast cancer. No hormone receptor or HER2 testing results are submitted for review. A letter dated January 13, 2020 states it sounds like ER (estrogen receptors) and PR (progesterone receptors) and HER2 were non-diagnostic but may have been from bone. She has been treated with Carboplatin, Nab-Paclitaxel, Pembrolizumab, Gemcitabine, Capecitabine, and Doxil. She has had Zometa. She has radiation. She has had surgical decompression of the spinal cord though it is not stated if that related to her cancer. Foundation One testing identified CCND1 amplification suggesting possible response to Abemaciclib (Verzenio.) The prescriber requests Verzenio to treat her.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. There was no peer-reviewed, clinically relevant, medical literature from an approved journal submitted to support this appeal. 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.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. For Part D drugs used in an anticancer chemotherapeutic regimen, 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 or peer-reviewed medical literature in CMS-approved journals or publications.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia and there was no peer-reviewed literature from an approved journal submitted to support the use of Verzenio 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 Verzenio. 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.