Delivery Systems and the Acceptance of Biosimilars

Bruce A. Feinberg, DO: Hope, this brings up a couple different points that we hear from Marcus and hear from Brandon. One is the distinction that might be made by both patients and providers between a supportive care drug—a drug for a chronic disease that doesn’t have a short-term or immediately life-threatening component—and a life-threatening disease. Will those differences be the kinds of differences that will create higher bars in order to gain that acceptance? Institutionally, and within your practice and within your peers, what has been the adoption of the biosimilar for Neupogen?

Hope S. Rugo, MD: This is a fascinating world, because therapeutic drugs obviously are a different consideration and require different considerations. But, for the growth factor used—and we use a lot of growth factors in breast cancer oncology, as well as in other areas of oncology—the decisions about what agent we use are very much determined by negotiations, as you pointed out, with practices, but the insurers also. So, they’re going to tell us what we’re going to do. And what happens at the university level, and I think in many of the managed practices, is that there are contracts that are developed. If you’re going to use a certain amount of product, you’re going to get it for “this” price. The actual biosimilar has been adopted, and there was an email that went out about discussing it if we had any comments or concerns. We’ve all looked at the data, and we didn’t have comments or concerns. And so, now we have actually adopted the use of the biosimilar for what we’re giving in patients in the outpatient pharmacy and in the inpatient setting.

For patients who received their growth factor at home, then it very much depends on this injectable pharmacy plan that many people have—where you actually make a contract and get approval through this identified group that delivers the medication to the home, as opposed to going to the pharmacy itself. And so, that just depends on the individual pharmacy and what they want to cover. I think that for us, what’s been interesting is to see how that’s changed over time.

We give a short-acting growth factor. That’s where the biosimilar is. But, we give a lot of the long-acting growth factor, pegfilgrastim. Pegfilgrastim, now, has come out with a new delivery system where you put this little white package on your skin and it flashes this little green light for 24 hours until it delivers itself, automatically, into the skin. So, for anything where we’re dosing, for example, dose-dense chemotherapy, we give doxorubicin and cyclophosphamide, dose-dense, every 2 weeks. We’ve been using this product—the sort of delayed delivery of pegfilgrastim, which is known as Nuelasta Onpro—in almost everybody. We’ve taken away that whole question. Where we’re using the biosimilar is mainly in metastatic disease where, obviously, there are different considerations.

Bruce A. Feinberg, DO: It’s interesting, because it brings up this issue that it’s more complicated than just drug-to-drug comparison. It’s a dynamic, moving marketplace. I don’t know if you know the statistics from your institution. I know there are national statistics. But, in terms of the use of the long-acting pegfilgrastim versus the short-acting daily option, do you know what the difference is in your institution?

Brandon Shank, PharmD, MPH, BCOP: In our practice, it depends on the chemotherapy regimen. But, we are almost always using the long-acting option. In specific situations—for stem cell transplant as well as when a chemotherapy regimen is given more frequently than every 14 days—we would use Neupogen instead. So, our use is kind of variable, but the long-acting option is typically the largest use for us. The number of doses would be the Neupogen, since we give it daily.

Bruce A. Feinberg, DO: I’ve seen that, outside of mobilization for stem cell transplant, the use is almost all with the long-acting option. The long-acting product has somewhere in the range nationally of 85%, 90% market share. Now, on top of that, Hope, you introduced this idea that you’ve already got this distinction and there will be a biosimilar to the long-acting option. But, now the long-acting option has upped its game because they have a different delivery system. That difference in delivery system is going to be looked at, now, as we look at other biosimilars coming into the market.

One would be a drug like rituximab, which is also on this short list of drugs to come off patent for which there are biosimilars in development. But, in that case, you’ve now got subcutaneous administration as opposed to a long intravenous infusion. I kind of see this as a pattern.

Marcus, within the world of rheumatologic drugs, now you’re going to have 5 biosimilars. They’re likely to be in use. Are we seeing any differences in terms of this manufactured obsolescence, where there’s going to be a better anti-CD20 antibody that’s likely to take the place of the old and, so, the biosimilar will become a dated product, or are we seeing changes in terms of the administration delivery system that’s going to facilitate a difficulty in adopting these products because it will have a quality of life concern or less consumerism around it?

Marcus H. Snow, MD: Yes. Those are being developed and they’re starting to hit the market. Tofacitinib hit the market and then a longer acting product came out soon thereafter. So, we see that, and that’s a small molecule, not a biosimilar. But, you know we see this in every different type of medication in oncology and rheumatology. I do not think that’s going to be a big issue at this point, mainly because the medications we use are life-long and the delivery devices are things that certainly play a role. But, when you’re dealing with a medication for rheumatoid arthritis, it’s more the medication than it is the delivery device.

Hope S. Rugo, MD: It is interesting. Just to point out the growth factors and delivery systems—for example, a lot of people use the pegfilgrastim with docetaxel/cyclophosphamide for breast cancer, but you probably only need filgrastim for 5 doses for most situations. And in some places, the HMOs (health maintenance organizations) might choose not to give any growth factor for the first cycle because the rate of febrile neutropenia may not reach their criteria for giving growth factors up front. And then, if you have a biosimilar product that’s a fraction of the cost, and if that’s what it turns out to be for the institution, you’re giving 5 doses of that versus the Onpro. That decision may be taken out of our hands in some situations.