A. While helpful for some clinical situations, real-world evidence (RWE) is not acceptable to support regulatory or guideline decision-making. B. Attempts to use RWE for several years with claims and prescription data have been found to be lacking reliability and validity and should not be used to make clinical or regulatory decisions. C. Use of RWE is a mandate by congress via the 21st Century Cures Act to speed development advances in therapy, optimize efficiency and improve access to life-changing treatments. D. Similar statistical methods are utilized for RWE and are used to confirm reliability and validity of observational data. E. Unsure

A. Palbociclib and fulvestrant have only been studied in women. There is no real-world safety or efficacy data in males. Contact the oncologist to discuss other treatment options as the palbociclib will likely not be covered by insurance. B. Palbociclib has RWE to support its use in male breast cancer; however, fulvestrant does not and would not be likely to work in men. Contact the oncologist to discuss other treatment options as the palbociclib will likely not be covered by insurance. C. Fulvestrant has RWE to support its use in male breast cancer; however, palbociclib does not and would not be likely to work in men. Contact the oncologist to discuss other treatment options as the palbociclib will likely not be covered by insurance. D. Palbociclib and fulvestrant have RWE to support use in male breast cancer and have FDA-labeling to support this indication. Proceed with prescription adjudication and insurance clearance. E. Unsure

A. There is RWE to support the use of this combination. Proceed with processing orders and dispensing as appropriate. B. There is no RWE to support eribulin in combination with trastuzumab. Contact the oncologist to discuss other treatment options as the combination will likely not be covered by insurance. C. There is no RWE to support trastuzumab with combinations outside of the randomized clinical trials and safety concerns exist with this combination that are concerning. Contact the oncologist to discuss the potential risks of this therapy. D. There is no RWE to support continuation of trastuzumab beyond progression of cancer. Contact the oncologist to discuss other treatment options as the treatment will likely not be covered by insurance. E. Unsure