Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Breast Cancer

Treatment Verzenio

The insurer denied coverage for Verzenio

The denial is overturned

The patient has a past medical history (PMH) with the diagnosis of left breast cancer, early stage, HR (hormone receptor) positive, HER2 (human epidermal growth factor receptor 2)  negative. The treating provider is requesting plan approval for treatment with Verzenio (abemaciclib). 

According to the clinical documentation provided for review, the treating provider is requesting plan approval for treatment with Verzenio (abemaciclib). The patient has a past medical history (PMH) with the diagnosis of left breast cancer, early stage, HR positive, HER2 negative. The patient underwent biopsy (Bx), the diagnosis of breast cancer is biopsy proven. The patient is being seen and treated for left breast cancer. The patient's breast cancer is early stage. The patient's breast cancer is HR positive and HER2 negative. The patient has the diagnosis of T1cN1a (tumor stage) breast cancer with Ko67 (biomarker) 20% [percent]. The treating provider has requested Verzenio (abemaciclib), which is the topic of this review. The treating provider prescribed therapy with Verzenio (abemaciclib).

The patient has a past medical history (PMH) with the diagnosis of left breast cancer, early stage, HR positive, HER2 negative. The patient underwent biopsy (Bx), the diagnosis of breast cancer is biopsy proven. The patient is being seen and treated for left breast cancer. The patient's breast cancer is early stage. The patient's breast cancer is HR positive and HER2 negative. The patient has the diagnosis of T1cN1a breast cancer with Ko67 20%. The treating provider has requested Verzenio (abemaciclib), which is the topic of this review. The treating provider prescribed therapy with Verzenio (abemaciclib). This individual with breast cancer with a ki67 (biomarker)% of 20% with grade 3 disease and 1 positive lymph node would be eligible for Verzenio (abemaciclib) per the National Comprehensive Cancer Network (NCCN) and monarch E. Verzenio (abemaciclib) when combined with ET (endocrine therapy) is the first CDK4/6 (inhibitor for metastatic breast cancer) to demonstrate a significant improvement in IDFS (invasive disease-free survival) in patients with HR+, HER2 node-positive EBC at high risk of early recurrence. Therefore, the request for Verzenio (abemaciclib) is approved and medically necessary for this patient. 

"Many patients with HR+, HER2- early breast cancer (EBC) will not experience recurrence or have distant recurrence with currently available standard therapies. However, up to 30% of patients with high-risk clinical and/or pathologic features may experience distant recurrence, many in the first few years. Superior treatment options are needed to prevent early recurrence and development of metastases for this group of patients. Abemaciclib is an oral, continuously dosed, CDK4/6 inhibitor approved for HR+, HER2- advanced breast cancer (ABC). Efficacy and safety of abemaciclib in ABC supported evaluation in the adjuvant setting." (Johnston, et al., 2020).

The formulary drug(s) are likely to cause the patient an adverse reaction. The requested drug would be more effective than the formulary drug.    
                                    
The insurer's denial of Formulary Exception for Verzenio is overturned.