Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Verzenio, 200 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 Verzenio 200 mg; 56/28.The drug is requested to treat breast cancer previously treated with Ibrance and no history of chemotherapy, which is an off-label (non-FDA approved) use. The enrollee is a 64 year old woman with metastatic estrogen receptor positive, HER2 negative breast cancer involving bones and liver. She has been treated with surgery, radiation, Tamoxifen, Arimidex, Ibrance (a CDK4/6 inhibitor), Faslodex, Afinitor, and Aromasin. Her CT scan on 12/27/19 showed 1. worsening of osseous metastases, 2. Interval development of two 0.9 cm hypodense lesions in the liver concerning for metastases. and 3. 7 mm cystic lesion in the tail the pancreas, could again reflect a sidebranch I PMN. The submitted documents do not indicate the enrollee has received any chemotherapy. The prescriber requests Verzenio to be given as monotherapy to treat her. The prescriber submitted a journal article, two abstracts (one a retrospective chart review) and press releases in support of the request. The article from JAMA Oncology does not reflect the enrollee's clinical situation. Abstracts cannot be used to determine medically accepted use by Medicare rules.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, 200 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 Verzenio, 200 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.