Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Nubeqa. 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 Nubeqa. The drug is requested to treat metastatic prostate cancer, which is an off-label (non-FDA approved) use.The enrollee is a 90-year-old man with prostate cancer involving pelvic lymph nodes. He has been treated with androgen deprivation therapy and Enzalutamide. He did not tolerate full doses of Enzalutamide and it was ineffective. His PSA rose: 8/26/19 it was 9.6 and on 11/7/19 it was 12.6. He was started on Nubeqa supplied by the manufacturer on 11/28/19. His PSA was 16.2 on 1/14/20. The prescriber requests Nubeqa to treat him in combination with Zoladex. In response to inquiry the prescriber did not adequately address whether there are other treatment options as he only addressed Enzalutamide. The only imaging results of the abdomen/pelvis date from 2016.The drug is indicated for treatment of non-metastatic, M0, prostate cancer. Pelvic lymph nodes are considered M1 (metastatic) disease per the AJCC staging system (NCCN Guidelines Version 4.2019 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 Nubeqa 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 Nubeqa. 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.