Amanda Brahim, PharmD, BCOP, BCPS, BCACP, discusses the members of her institution’s Pharmacy and Therapeutics (P&T) Committee who review acute myeloid leukemia treatments for formulary consideration.
Katie Culos, PharmD, BCOP: Amanda, can you talk a little bit about the structure of your P&T committee?
Amanda Brahim, PharmD, BCOP, BCPS, BCACP: Yes. For our health system, there is a subcommittee for P&T specifically for hematology-oncology. That’s a system-wide committee, so it is chaired by [me] and a physician, and there’s representation from nursing, advanced practice providers, physicians, and pharmacists on here. Generally, when we go through the formulary process, a request is made, and a physician and pharmacist dyad…review the literature regarding the agent that’s proposed to be added to formulary. We then review it at the system-wide hematology-oncology P&T committee, and from there it moves on to the system overall formulary committee for final approval.
Katie Culos, PharmD, BCOP: How often does your subcommittee meet?
Amanda Brahim, PharmD, BCOP, BCPS, BCACP: It meets once a month.
Katie Culos, PharmD, BCOP: We have a new AML [acute myeloid leukemia] drug that comes on the market, and you’re bringing this to your P&T committee for formulary consideration. What are some important outcomes or efficacy endpoints that are critical for you to present to help support your decision making?
Amanda Brahim, PharmD, BCOP, BCPS, BCACP: This is an interesting question. We always like to see a randomized, controlled clinical trial that has 100s, if not 1000s, of patients. Unfortunately, in AML, that’s not always feasible. So, we have approved agents based on phase 2 trials, based on open-label studies, based on smaller trials, where we did feel like there was enough evidence to say that the benefit outweighed the risk. I think more than anything, just because the need is so great in AML, some of these agents have been able to come to market and have been added to formulary. Overall, the best thing that we like to see, obviously, is a difference in overall survival. Other efficacy end points that we look at are maybe a proportion of patients who are able to go to transplant, relapse-free survival….
Yehuda Deutsch, MD: And rates of remission. Even the FDA has taken that into account. They have approved medications for AML, even before there is necessarily overall survival data or phase 3 data. Some of the newer medications that have been approved recently were approved based on phase 2 data by the FDA, including venetoclax combinations.