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 without prior chemotherapy for metastatic disease which is an off-label (non-FDA approved) use.The enrollee is a 76 year old woman with metastatic breast cancer involving bones, lungs, and lymph nodes. Her recurrent cancer was biopsied in 2017 and was hormone receptor positive and HER2 negative. She had chemotherapy in the adjuvant setting in 1987 and 1992. Her treatment for recurrent/metastatic cancer has included Anastrozole, Ibrance (Palbociclib, a CK4/6 inhibitor) since 2017. She has had neutropenia on that combination. Her CA 15-3 has been rising form 80 in September 2019 to 138 on February 7, 2020. Her PET scan on December 23, 2019 showed: Interval development of multiple new hypermetabolic osseous lesions as described above are highly suspicious for progression of osseous metastatic disease. There has been interval decrease in the preexisting remainder of the hypermetabolic osseous lesions compared to the previous PE/CT scan dated June 16, 2017. Interval decrease in bilateral hypermetabolic pulmonary nodules along with interval resolution of hypermetabolic thoracic lymphadenopathy. Interval development of moderate-sized left pleural effusion. Therefore she has progression of her cancer while being treated with Ibrance. You request Verzenio to treat her as monotherapy. Per the FDA website, the drug is indicated for use as monotherapy of hormone receptor positive, HER2 negative metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy for metastatic disease. The enrollee has not had chemotherapy for metastatic disease. Her chemotherapy was given in the adjuvant setting when there is no evidence of 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 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.