Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cerebellar glioblastoma 

Treatment: Verzenio 150 milligrams (mg) oral tablets

The insurer denied coverage for Verzenio 150 milligrams (mg) oral tablets. The denial is upheld. 

This patient is a male with a history of cerebellar glioblastoma status post resection with adjuvant temozolomide and Optune treatments. The patient presented to the Emergency Department (ED) with complaints of progressive dull headaches, nausea, and vomiting. Based on an Oncomine panel, the patient's oncologist started the patient on Verzenio (abemaciclib) chemotherapy treatment for this patient's glioblastoma.

As per literature review, abemaciclib was shown to be able to enter the brain, stop CDK4 and CDK 6 from making cells and slow the growth of glioblastoma in mice. However, these studies are at the stage of clinical studies, and there is no supporting guidelines or randomized controlled studies to support that this medication is effective and safe for humans. Currently it is in a clinical study: A Study of Abemaciclib in Recurrent Glioblastoma, ClinicalTrials.gov Identifier: NCT02981940. The results of this study are not available to provide evidence to support the abemaciclib use for the treatment of glioblastoma in humans. Currently, the use of abemaciclib (Verzenio) is not supported by the National Comprehensive Cancer Network (NCCN) for its use for glioblastoma. 
As to date, the FDA prescribing information for Verzenio is clinically indicated for the treatment of certain advanced or metastatic breast cancer with disease progression following endocrine therapy. However, currently multiple studies are being conducted worldwide to test whether or not CDK4/6 inhibitor, Verzenio, can be used to effectively and safely treat other solid tumors in humans. According to Naz et al. (2019) article, "worldwide, Abemaciclib is undergoing phase IIII trials for the treatment of breast cancer and non-small cell lung cancer (NSCLC), phase II development for the treatment of brain tumors, liposarcoma, mantle-cell lymphoma, colon cancer, pancreatic ductal adenocarcinoma, and preclinical development for several other solid tumors [1, 2]." However, Naz et al. (2019) indicates that "despite its success in phase I and II clinical trials, recent reports of Abemaciclib failure as monotherapy in a phase III trial for KRAS-mutant NSCLC has been discouraging (http://www.ascopost.com/News/58135), and Abemaciclib did not meet its primary endpoint of overall survival in patients with KRAS-mutated, advanced NSCLC [3]." Dowless et al. (2018) article also supports that abemaciclib is widely being studied for its use in pediatric cancers, such as Ewing's sarcoma, and that these studies are gaining better understanding of this medication's anti-cancer activity.  Thus, while articles such as Naz et al. (2019) and Dowless et al (2018) indicate that this medication, Verzenio may become more widely used for other anti-cancer treatment, such as this patient's glioblastoma, the current evidence is lacking to ensure that Verzenio is a safe and effective treatment method to treat this patient's glioblastoma. Thus, Verzenio is not considered medically necessary to treat this patient's medical condition. 

The health care plan acted reasonably with sound medical judgment and in the best interest of the patient.

The carrier's denial of coverage for the Verzenio 150 milligrams (mg) oral tablets is upheld.  The medical necessity is not substantiated.