Revumenib’s Safety Profile and Path to Formulary: Ivo Abraham, PhD, RN

With revumenib now recommended by the National Comprehensive Cancer Network (NCCN) guidelines as the sole targeted therapy for patients with KMT2At-rearranged acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL), payers will likely follow suit and add it to formularies, but they may put some utilization management strategies in place, explained Ivo Abraham, PhD, RN, professor, Department of Pharmacy Practice and Science, R. Ken Coit College of Pharmacy, The University of Arizona. He was a lead author on an analysis comparing revumenib against all other treatments in the NCCN guidelines for AML or ALL.

The budget impact analysis found revumenib for relapsed/refractory acute leukemias with KMT2A translocation would be cost-neutral for a health plan. There would be slight savings, mainly due to lower administration costs.

Transcript edited for clarity; captions were auto-generated.

Transcript

The model assumed that grade 3 or greater AEs would incur significant health care resource utilization and associated costs. What are some of the most impactful AEs associated with current treatments available for these patients, and how does revumenib's safety profile compare?

If you go to the table [in the study], a lot of the drugs that you see in there—whether it's for the AML part of the study or the ALL part of the study—are or have a chemotherapy component. And we know chemotherapy: it has its benefits. We do a lot now of combinations seen that elsewhere in cancer, [such as] PD-1 inhibitors with chemotherapy. That is one area where you would see a significant increase in the cost.

The other thing also is, if you really focus on this population, at some point in time, these patients may also be a candidate for CAR [chimeric antigen receptor] T-cell [and] that increases the costs very much. To the credit of CAR T-cell therapies and related therapies, their benefit horizon goes much beyond—and I'm talking in general terms—goes much beyond 3 years. That's probably the only treatment type of treatment, class of treatments that payers would say, “Let's project this out over a longer period of time,” because we also see with those types of therapies that there might be a curative outcome, or at least a very long delay [in progression]. That then also increases the cost inputs in the whole equation.

The challenge, really—and having listened to hematologists about this population—is we keep on trying, we keep on doing trials, and it builds slowly, certain efficacy and relative safety signals. That's also why, in our market share assumptions, we were saying we need to be fair to those treatments, because they also work. It's just that it doesn't address the specific targets, the translocation target that we're trying to deal with.

Revumenib is now recommended in the most recent NCCN Guidelines as the sole targeted therapy for patients with KMT2At-rearranged AML and ALL. How do you anticipate this guideline update will specifically influence formulary decisions and patient access?

The payers, to their credit, follow the guidelines. They follow the evidence, and there's a lot of payer bashing going on and issues of prior authorization. We need to make a distinction. There is that confidence in the product in revumenib will probably increase. Payers are going to follow the evidence. Now, they will not say, “Okay, newly diagnosed [patients] immediately go on to revumenib.” That probably will not happen because there's also good rationale to start with cheaper in total, or lower-cost treatments, and then to put in place—and I know that's a word nobody likes—step therapy, to say, “Okay, this is what the guidelines show. Let's start with 1 treatment. If that doesn't work, if you relapse or you're refractory, then we may go to the next one.”