Hope S. Rugo, MD: It’s an interesting one. We first sort of dealt with the challenge of talking to patients about filgrastim. “You’ve been getting this brand of filgrastim, but now our institution is switching to this other one, which is a biosimilar. It’s been tested in the laboratory and in the clinic, and it looks to be the same.” Patients did not care. They didn’t even blink an eye. And meanwhile, they don’t like generic ibuprofen. They say that the pink one isn’t as good as the white one, right? Or, “That gave me a headache” or “a rash” or whatever else. So I think that there is more attention paid to that than there is to the switch.
Growth factors may be different when we start looking at the therapeutic drugs, particularly in the curable setting, like trastuzumab. Will patients feel differently and feel anxious about switching? We don’t really know. So the question is, in an area where the insurance is paying for the drug, will we transition patients who are already on the reference biologic? Probably not because what’s the push? If you’re going for your 6-month approval and the insurer says, “I’m only going to pay for this,” then we’re going to transition them.
For naïve patients, when we’re starting a drug, if we have that drug and it’s less expensive and we look at the data and the FDA has looked at the data and feels that they meet the criteria for a biosimilar, I think it would be fine to use the biosimilar instead.
For patient education, it’s interesting. I show Google images to patients all the time to show them the transdermal delivery system for pegfilgrastim, for example. I show them what a port looks like. I show them some unusual finding that was mentioned in their radiology report. I can often show it on Google better than I can show them their own X-ray images. In terms of patient education, I think that helps a lot.
I do think that educational tools for patients will be very helpful in understanding what biosimilars are. You can show the small molecule and the big antibody and the difference between the generic and the biosimilar. You can also show them those triangles and how you really assess them. You can show them the kind of robust evaluation that has gone on, as well as the regulatory guidance that has been given, that people have agreed on internationally. I think that those points are all very comforting for patients, as well as the fact that they don’t cause antibodies, and, if anything, are very, very well studied, in terms of safety.
Cornelius F. Waller, MD: Manufacturers provide patients with information in a variety of ways, such as through printed materials, webcasts, and other learning devices. In addition to that, they put in a lot of effort, for example, at clinical conferences such as the [American Society of Clinical Oncology, ASCO] and the European Society of Medical Oncology annual meetings, to educate physicians and patients on the use of biosimilars.
Hope S. Rugo, MD: I think that the biosimilar companies are going to be doing work in patient and physician education—provider education. Both of these areas are really important. In terms of patients, it’s about understanding the basics behind biosimilars. I’ve seen some of these companies sort of start to look at how we’re going to tell patients what these are or how much of a role patients have in making that decision about treatment. Do we let them know, or do they get to decide yes or no? If the insurer says, “I’m only paying for 80% of the reference biologic but will pay for all of the biosimilar,” how will we sort of make that decision? That remains to be seen. I’m not even sure the insurers know yet. I know that the insurers want to support the biosimilar filgrastim versus the branded product, in many cases.