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 metastatic breast cancer as monotherapy and no chemotherapy in the metastatic setting, which is an off-label (non-FDA approved) use.The enrollee is a 66-year-old woman with metastatic breast cancer involving bones and liver. Her cancer is hormone receptor positive and HER2 negative. She was treated neoadjuvantly with Adriamycin, Cytoxan and Taxol then had surgery, radiation and adjuvant Arimidex. She relapsed in 2015 and was treated with Faslodex and Ibrance (a CDK inhibitor). When she progressed on those drugs, she received Tamoxifen and then Aromasin and Afinitor. Imaging in 1/2020 showed progressive cancer. The prescriber requests Verzenio to be given as monotherapy. The prescriber states there has been a long interval since use of the CDK inhibitor Ibrance. The prescriber also states the enrollee has had disease progression following endocrine therapy and chemotherapy in the metastatic setting. However, the office notes do not indicate any chemotherapy used in the metastatic setting. Her chemotherapy was given at the time of diagnosis before surgery, as neoadjuvant treatment.The use of Verzenio as monotherapy is supported in the setting of hormone receptor positive, HER2 negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.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.