Off-Label Communications to Inform Formulary Management

Joseph Alvarnas, MD: Let’s add another layer to this. We talked about knowledge gaps—label gaps. We’ve talked about patient access and how this can help us navigate that. Let’s add the value dimension to it, which we’ll delve into further in a bunch of the other questions that we’ll come to. How do you expect these off-label communications to have an impact upon healthcare costs and formulary management?

Robert Carlson, MD: I could see that going either way, and it depends on the specific circumstance. The off-label communications that would come from, potentially, industry or others are likely to be focused primarily on drugs that are still on patent for which there is still protection. There’s very little benefit for a generic drug producer to communicate information about the drugs that they’re supplying, even if it is on-label. There are a whole lot of reasons a drug company that has a drug on-patent would want to promote both on-label and off-label indications. So, there are biases here that enter into, again, the motivation for why a company or an organization might or might not want to communicate information about a drug.

John Fox, MD: I think the larger issue is that these individual off-label communications by one manufacturer to a physician or a group of physicians are taken out of context of all the available therapies that exist. I think it was the PointBreak trial that showed that the combination of 2 expensive therapies didn’t produce a beneficial effect, and the folks at Dana-Farber Cancer Institute said, “Well, we should stop using this.”

Even though that may have been promoted, I think the greater body of evidence suggests that there’s no beneficial effect. So, I’m not sure that the communication of off-label indications is going to substantially impact the practice of medicine. But I’m worried that if physicians take this out of context—what other regimens are available—it could have a deleterious effect on patients when we have better evidence to support alternative therapies.