Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Verzenio, 150 mg tablet as prescribed. 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, 150 mg tablet; 60/30.   The drug is requested to treat breast cancer. The enrollee is a 65 year old woman with metastatic breast cancer involving bone, chest wall, spleen and liver. Her cancer is hormone receptor positive and HER2 negative. At diagnosis in 2005 she was treated with surgery, radiation, adjuvant chemotherapy and 5 years of Arimidex. For relapse, she has been treated with Ibrance/Femara, Ibrance/Faslodex.  Her Ca 27.29 has increased from 48 on August 19, 2020, to 64 on September 16, 2020.  PET scan on October 12, 2020, showed no evidence of malignancy in the head/neck, Mildly FDG avid left chest wall lesion essentially unchanged, consistent with stable disease. Foci of increased FDG uptake within segment 3 and right hepatic lobe with CT correlated, which may be secondary to nonspecific mis-registration of large bowel activity; however, these foci are indeterminate for metastases. Recommend correlation with MRI. Splenic lesion, essentially unchanged consistent with stable disease, and no evidence of malignancy in the pelvis or musculoskeletal systems. The prescriber requests Verzenio to be given with Fuvlestrant (Faslodex) to treat her.  Per the FDA website, Verzenio is indicated in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. Her cancer is hormone receptor positive and HER2 negative. She has progressed on previous endocrine therapy with Femara and Fulvestrant. The CA 27.29 is rising and therefore she can be considered to have progressive metastatic breast cancer.  For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a  medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. Therefore, the requested drug is being prescribed for a medically accepted indication.   The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.  For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. 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. Our Physician Reviewer reviewed this file and determined that there are citations in the Medicare approved compendia that support the use of Verzenio, 150 mg tablet as prescribed for the diagnosed condition. As a result, Verzenio, 150 mg tablet as prescribed is being prescribed for a medically accepted indication as defined by Medicare law.  Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Verzenio, 150 mg tablet as prescribed.