Professor Robert Moots - The Biologic Consultation
Professor Robert Moots discusses the importance of physician/patient interaction in clinical treatment decision-making.
About the speaker
Robert Moots is a Professor of Rheumatology at University of Liverpool and also the Director for Research and Development at the University Hospital, Aintree.
What factors need to be considered when making switching decisions?
I think of all the roles that we have in medicine the crucial thing is our relationship with the patient. And we really have to be an advocate for our patients. I think whatever the situation, wherever we are, we have to do things that we believe are the best for our patient. Sometimes that’s really easy, sometimes that might need a bit of a fight. And that could be a fight with a number of different bodies such as the ones that are making us potentially give the wrong drug to a patient. So fundamentally, for us as physicians, be an advocate for the patient and do whatever we can to make sure we can stay that way. And from the patient’s angle, that’s what they want from us as well. There’s a huge amount of data coming through for biologic drugs. On the one hand, the trials that we are very familiar with and these are for the bio-originator drugs. And these trials are designed to identify does the drug work and is it safe. But now with biosimilars, we’ve got a different type of trial coming through. It’s not designed to really show if a drug works or not, it’s designed to show whether one drug is not really significantly different to another. And that’s against what we’ve really normally been brought up for. On the one hand, we can say “Who cares, the regulators make the decision.” And that’s not an unreasonable attitude to take. But if we want to try and look at the data ourselves we’ve got to look at it in a slightly different way. Because we’re looking at data for fewer patients, less disease indications and trials designed to show that there isn’t really a difference rather than what we’re used to seeing before.
Real world data is very important whatever we do. If we rely on clinical trials we’re first of all looking at things that can only pick up a fairly common side effect. Also, patients put into clinical trials have a very defined, tight set of disease characteristics. And when we see people in real life they don’t really fit into that mould. So when we look, for example at biosimilar data we’ve got very limited clinical trial data. We’ve got lots of different biosimilars coming along and the only way we’re going to really get a handle on whether there are any signals for adverse events or problems or less efficacy, it’ll be actually having registries and looking at real world data for your and my patients in normal clinics.
With the onset of biosimilars we now have the issue about whether we switch a patient between one bio-originator and another biosimilar. All of the trials for biosimilars include an element of switching to see whether or not this is effective. Whether for example it creates immunogenicity or whether there are any other problems as you switch between the bio-originator and the biosimilar. In real life, however, it’s not quite so straightforward because patients may switch once and then feel they definitely want to switch back again, for whatever reason. That’s often not been studied before and then when patients have the opportunity to experience one biosimilar and then another biosimilar comes in and the regulators or the payers want to swap between one biosimilar and another, we have no clinical data to tell us what to do, so there are lots of unanswered questions but I think the bottom line is, if we’re thinking about switching a patient we’ve got to think, why are we switching? Is it for a good clinical reason? Or is it just for a cost reason? If it’s for a clinical reason there’s probably no clinical reason why we would want to swap between a bio-originator and a biosimilar reason. For a cost reason, that is something that we may not get an option on.
PP-ENB-GBR-0603 Date of preparation August 2017