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 300 mg; 120 per 30 days. The drug is requested to treat metastatic prostate cancer, which is an off-label (non-FDA approved) use. The enrollee is a 60 year old man with comorbidities and a diagnosis of castration resistant prostate cancer involving lymph nodes. At the time of attempted surgery in 2014 there was pathologic involvement of left and right pelvic nodes. He has been treated with Lupron, Casodex, Degaralix and Xtandi. CT imaging on February 12, 2020 showed right retroperitoneal adenopathy has improved compared to the previous outside examination of May 14, 2019. The report indicates that formerly the aortocaval nodes measured 3.6 x 2.4 cm shrank to 2.2 x2.2 cm and retrocaval nodes were 2.3 x 2.2 reduced to 1.0 x1.7. The prescriber requests Nubeqa to treat him. Nubeqa is indicated for non-metastatic castration resistant prostate cancer. The office notes and prior authorization question letter dated March 12, 2020 state he has metastatic prostate cancer and no to does he have non-metastatic castration-resistant prostate cancer? The prescriber stated in the appeal dated March 19, 2020 that the latest CT does not show metastatic prostate cancer spread. This information is inconsistent with the office notes and the CT reports. The enrollee has had metastatic disease since the time of diagnosis. 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.