Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Nubeqa, 300 mg tablet. 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 tablet.The drug is requested to treat the enrollee's condition, which is an off-label (non-FDA approved) use. The enrollee is a 68 year old man with prostate cancer treated with surgery in 2017. He had an abnormal PSMA scan in May 2018 with increased uptake in the T8 vertebral body possibly representing metastatic disease versus sequela of adjacent degenerative change. Consider MRI for confirmation. The submitted notes indicate the MRI was negative. He was started on Leuprolide in October 2018. MRI thoracic spine dated December 20, 2018 showed decreased conspicuity of peripherally enhancing T8 vertebral body lesion. Bone scan and CT scans in September 2020 showed no metastases. His PSA has risen from 0.09 in 4/9/20 to 0.69 on July 15, 2020 to 1.95 on September 9, 2020. The prescriber requests Nubeqa for castration resistant non-metastatic prostate cancer. He will continue to receive Lupron.The submitted documents indicate that there was a bone metastasis in the past which may have resolved on the most recent bone scan. Therefore the enrollee does not have non-metastatic prostate cancer. For the clinical trial noted in the FDA label and published in the New England Journal of Medicine (N Engl J Med 2019; 380:1235-1246) eligibility required no current or history of metastatic disease. Therefore the trial does not reflect the enrollee's clinical situation.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, 300 mg tablet 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, 300 mg tablet.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.