Finding Value in Today's New Insulin - Episode 10
Louis S. Christos, RPh: The basic review process for any therapeutic area in diabetes is always going to be efficacy, then safety, then cost. Within efficacy, obviously, we’ll look at an A1C reduction, but we are now starting to bring in cardiovascular benefit because there have been some products that have actually shown cardiovascular benefit, from that perspective. So, that’s something new that we’ll bring in. From the safety perspective, the biggest one is, obviously, hypoglycemia. Specifically, severe hypoglycemia that leads to hospitalizations or some sort of medical intervention is always going to be top-of-mind from a safety perspective. Within the different products, themselves, they do have certain side effects that are more consistent with one MOA [mechanism of action] versus the other, so we will look at that as well. With GLP-1s [glucagon-like peptide-1s], we will look at the rates of nausea and vomiting, but we will look at the entire adverse event profile. And, more importantly, the discontinuation rates are the most important. So, whether it’s hypoglycemia or whether it’s the gastrointestinal complications, we’re still looking at whether or not patients can actually tolerate those adverse events or whether they have to discontinue therapy. So, we are bringing that into consideration. There are secondary events that we sort of look at. You can talk about the weight gain or the weight loss. Is that brought up? It is, but it is not as significant of an issue as hypoglycemia, and it’s not as significant an issue as looking at the cardiovascular benefit or the A1C reduction.
We think it’s very important for individualization of diabetes treatment. We provide access to all therapies based on the ADA [American Diabetes Association] recommendations. When you look at the ADA recommendations, obviously, metformin is the preferred initiation therapy. But after that point, it’s really up to the provider’s discretion. The way we manage our formulary is based on those recommendations, and that is through allowing access to the different products within the different MOAs. We leave it up to the provider to make that determination for their particular patient.
Diabetes is a category that we’ve never traditionally tightly managed. We’ve never had steps in place. We did allow open access to the different MOAs and therapeutic categories. We do have preferred agents within those categories, but we don’t manage them from a clinical perspective. But going forward, what you’re seeing in this space (as you are in a lot of other spaces), is implementation of more restrictions. Again, just based on how healthcare is evolving and based on how the payer market is evolving, you will start seeing use of step edits and prior authorizations in diabetes, just given the fact that we have so many different products available. And we do have multiple therapeutic options available within those specific categories.
Even with the potential use of additional restrictions in this category, we still feel that it’s important for individualization of treatment for these patients. We still feel that, at the end of the day, it is the provider who’s making the right choice for their patient based on symptoms, based on A1C levels, based on prior medication use, and based on comorbid conditions. So, that is always going to be an important factor in formulary access—allowing for individualization of treatment.