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Dr Stephen Hanauer Weighs In on Pharmacovigilence, Nonmedical Switching in Crohn Disease


Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, discusses why providers need to be wary when deciding whether patients with Crohn disease should switch from Humira (reference adalimumab) to an adalimumab biosimilar.

There are many steps that health systems can take to prevent the nocebo effect when transitioning patients from Humira (reference adalimumab) to an adalimumab biosimilar, according to Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University.


Can you discuss the importance of pharmacovigilance in populations with Crohn disease and ulcerative colitis since there haven’t been many studies evaluating adalimumab biosimilars in these patients?

Pharmacovigilance studies for any specific biosimilar are going to be quite a challenge, because it's likely that, [for example,] third party A will pick biosimilar 1 for a year and then, because of changing costs may pick biosimilar 2 or 3. So I believe in this environment. There's going to be a lot of switching between the different agents, which means that pharmacovigilance of a single agent is going to be much more challenging.

How do you think the Crohn disease patient community is responding to adalimumab biosimilar options and the potential for more nonmedical switching from the reference agent to a biosimilar? Are you fearful of the nocebo effect for these patients?

That's the most challenging question, because patients see the medicine as their medicine; for instance, "my Humira." One of the worst things that you can do in social psychology is take something away from an individual. And if you're taking away "their Humira" and substituting something else, they perceive that as not necessarily being good—often as being bad.

So, we need to be able to circumvent that concept that feeds into the nocebo effect, which is going to be accomplished by having the biosimilar company not just having a biosimilar product but having it perform and be administered in the same or easier ways [as the reference product.] For instance, there may be better injectors available for individuals that might be easier [to use]. It will be important for patients who are using citrate-free products to have a citrate-free formulation available to obviate worsening symptoms with injections or injection site reactions.

And then all the other services that have come with the originator, with Humira from AbbVie, need to be replicated for each and every biosimilar for it to be acceptable to the patient. So, the presence of having nurse navigators or ambassadors present, for having assistance programs available, and all the other services to patients are really going to be needed in order to prevent this nocebo effect.

Another important concept is cognitive dissonance. In other words, the more effort somebody puts into something, the more perceived benefit, and that includes costs. So that's why if someone sees 2 identical sweaters and 1 cost more than the other, they tend to like it better. And so substituting a less costly [option] may be perceived as less beneficial or less effective.

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