Appeal type: Prescription Drug
Decision: Favorable

At issue is coverage for Verzenio 150 milligram tablet, 56 tablets per 28 days, to treat with HR positive, HER2 negative breast cancer. The Part D plan denied the request for coverage because the following prior authorization requirement was not met: there was not confirmation that the enrollee had tried Ibrance or Kisqali. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level.The submitted medical records indicate that the enrollee has HR positive, HER2 negative breast cancer after surgery with the pathology showing T2N1a disease (3 nodes positive, grade 3 disease). The records show that the enrollee has received chemotherapy and radiation and now the prescriber is requesting is for Verzenio to be given in combination with an aromatase inhibitor in the adjuvant setting.While the plan denied the drug because the enrollee had not first tried Ibrance or Kisqali, Ibrance or Kisqali are not indicated in adjuvant treatment of breast cancer. In addition, the plans prior authorization criteria for adjuvant use are consistent with the Food and Drug Administration (FDA) guidelines that indicate, Abemaciclib [Verzenio] is indicated in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of 20 percent or higher as determined by an FDA approved test.' It is noted that the enrollees Ki-67 score is not greater than 20 percent.However, as outlined in the National Comprehensive Cancer Network (NCCN) guidelines, it is a 2A recommendation for Verzenio to be given as adjuvant therapy in combination with endocrine therapy in patients with HR positive, HER2, high-risk (i.e., more than 4 positive lymph nodes, or 1 to 3 positive lymph nodes with one or more of the following: grade 3 disease, tumor size greater than or equal to 5 centimeters, or a Ki-67 score of greater than or equal to 20 percent) disease. Therefore, the enrollee fits the NCCN criteria for high-risk disease as the enrollee has 3 positive lymph nodes and grade 3 disease. As such, it is not necessary, per the NCCN guidelines, for the enrollee to also have a Ki-67 score of greater than or equal to 20 percent.Therefore, the submitted documentation supports that the requested drug is being used for a medically accepted indication outlined in the NCCN guidelines. Furthermore, the NCCN guidelines support an exception to the plans prior authorization requirement that the enrollee must first try tried Ibrance or Kisqali. Furthermore, the NCCN guidelines support that since the enrollee meets the criteria for high-risk disease, a Ki-67 score of greater than or equal to 20 percent is not required in this situation. Therefore, coverage for the drug is supported.A physician reviewed the appeal and determined that the requested drug is eligible for Part D coverage.