Experts discuss who and what is involved in adding subcutaneous formulations to the formulary.
Adam M. Brufsky, MD, PhD: Let's go a little further and talk more generally in terms of formulary. So let's start here. At Memorial Sloan Kettering Cancer Center, who recommends products for the formulary? How does it work?
Tim Peterson, PharmD, BCOP: When we have a new FDA-approved agent, or one that is soon to be FDA approved, it would be our specialist medical oncologist. Dr Matasar working in his area in lymphoma, he or 1 of his colleagues would request addition of this agent to the formulary. They then work with clinical pharmacists to develop a form that goes through all the clinical efficacy and safety data and anticipates the number of patients we would treat and the context in which we would use these agents. And this has been presented to the P&T [pharmacy and therapeutics] committee to give them an opportunity to ask questions—the other medical oncologists, the administrative staff—regarding logistical issues with pharmacy prep work and that sort of thing. But it's generally a collaboration of a medical oncologist, the clinical pharmacy team, our chemotherapy guidelines committee, and P&T.
Adam M. Brufsky, MD, PhD: What criteria do you use at Memorial Sloan Kettering then to put something on the formulary? Does it have to be better than what already exists? How do you usually work it?
Tim Peterson, PharmD, BCOP: It doesn't necessarily have to be better per se, but the context in which it's used needs to add something to the patient's options. For instance, for multiple myeloma, we know is an incurable disease, right? We're having relapse after relapse, right? We need to have agents.
Adam M. Brufsky, MD, PhD: They have ninth-line therapy for myeloma.
Tim Peterson, PharmD, BCOP: Exactly, exactly, and that's what we're seeing with those agents. Actually, daratumumab is another subcutaneous formulation that's soon to be coming, right? I see no issue incorporating it within these relapsed-refractory settings, so it doesn't necessarily need to replace anything per se but should add some benefit.
Adam M. Brufsky, MD, PhD: Do you take into account the route of administration and the chair time? Is that all put in the P&T deal or not?
Matthew J. Matasar, MD: I'd say that the P&T at Memorial Sloan Kettering is effective because it has the co-leadership of physicians, pharmacists, and administrators, so they can look at an agent holistically and say, "Is this adding value to our patients?" Pricing, quality of life, outcomes, toxicity, alternative options—what's it going to replace? And they can look at it in context of the disease state for which it's intended to decide whether this belongs on our formulary.
Adam M. Brufsky, MD, PhD: The next question is, do payers have anything to say about this? Do you ever get a payer saying, "I want you to give subcutaneous and not IV [intravenous]"? Has that happened yet?
Matthew J. Matasar, MD: Yes. The IV formulation has its FDA label, and it has its NCCN [National Comprehensive Cancer Network] compendium listings. And there are some clinical situations that fall technically outside those defined parameters, but clinicians may still want to use it in those settings. When one attempts to prescribe subcutaneous rituximab outside those parameters, it usually creates a conversation with a payer, and you will have to explain the clinical rationale and why you want this to be done. And sometimes that conversation will lead to approval, and soemtimes it will not.