Louis S. Christos, RPh: From a payer perspective, the right patient is really determined by the provider. But when you look at the ADA [American Diabetes Association] guidelines, for patients who are on basal insulins who were not at goal, one of the recommendations is to add on a GLP-1 [glucagon-like peptide-1] receptor agonist. From our perspective, the appropriate [patients] for the fixed-dose combinations are the ones determined by the physicians where a GLP-1/insulin combination would benefit that patient.
DUAL VII is another comparative trial, this time with basal insulin plus rapid-acting insulin versus the basal insulin/GLP-1 combination. And what we saw, there, was what would be expected from an efficacy perspective: comparable A1C reduction. But there was a benefit shown in the reduction of severe hypoglycemic events; and there was a benefit shown in slight weight reduction versus an actual weight gain that you saw in the insulin arm. This is important because, again, if you look at the ADA guidelines for patients who were initiated on a basal insulin, who are not at goal, one of the recommendations is to add rapid-acting insulin. And one other recommendation is to add a GLP-1 receptor product. The benefit, here, is now physicians have data showing them that by switching to, or adding on, a GLP-1 versus adding on a rapid-acting insulin, you are going to potentially have lower hypoglycemic events. And obviously, you’re not going to have the issues regarding the weight gain associated with the insulin products.
Clinical trial data are obviously very important because that’s really what’s used in the initial P & T [Pharmacy and Therapeutics] committee review process. We don’t have any real world evidence for newly approved products. As real world evidence becomes available, as manufacturers continue these additional studies after product launch, they become more valuable. These real world studies actually force us to go back and review some of these products based on the benefit that I’ve seen and some of the real world evidence. The cardiovascular benefits, hypoglycemic benefits, safety benefits, these types of studies, even though they’re done post launch, are important because they help us to manage the category in the future based on actual real world evidence. And, hopefully, that real world evidence either complements or provides better benefit for a product based on what we saw in the clinical trials.