Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Erleada. 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 Erleada. The drug is requested to treat the enrollee's condition, which is an off-label (non-FDA approved) use.The enrollee is a 74-year-old man with metastatic prostate cancer involving bone and nodes. He has been treated with Lupron and Casodex. His PSA decreased from 78.45 at diagnosis in 2018 to 6.1. He has also been treated with Zytiga/Prednisone with continued Lupron. His PSA rose to 15.7. His medication list at the office visit lists Xtandi which is another drug used to treat prostate cancer. He had worsening pain and received radiation to the left iliac and sacral bones. The prescriber states the enrollee has castration sensitive metastatic prostate cancer and requests Erleada in combination with Lupron to treat him.The NCCN Guidelines Version 3.2020 Prostate Cancer page MS-48 notes most men with advanced disease eventually stop responding to traditional androgen deprivation therapy (ADT) and are categorized as castration-resistant. The enrollee has had rising PSA while on Lupron and Zytiga and Xtandi. These are types of ADT. Therefore, the enrollee has castration resistant prostate cancer, not castration sensitive prostate cancer in the opinion of this reviewer. Erleada is not approved or compendium supported for metastatic castration resistant prostate cancer.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 Erleada 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 Erleada. 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.