In order to maintain sustainability and make sure that the switch goes well, what I like to do is organize regular catch-ups and touch base just to see how the homecare providers are doing in terms of switching.

What we do is, I usually switch patients in batches, so patients who have come to the clinic and have been told that they’ll be changing. I communicate this information to the homecare providers so that they know which patients they will be delivering the biosimilar to.

It’s important that homecare providers are aware, and also that they have enough medicines, because the last thing that I want is to switch a patient and there to be a problem with procuring the biosimilar for them. So it’s just really about organization and communication.

Videos

Kalveer Flora, MPharm, London North West University Healthcare National Health Service (NHS) Trust, discusses how she coordinates with providers on biosimilar switching programs.

Kalveer Flora, MPharm: Coordinating With Providers on Biosimilar Switching

Well it's just a safety analysis, and it’s the first interim safety analysis of about 80 patients. Another study recruited in March, so we will get the information of 182 patients, and they are now recorded but they [have not] finished their therapy. So we expect the first efficacy results this year. We're looking for efficacy, complete remission, and after the end of the therapy, and the second endpoint with [progression-free survival, PFS) rate at 12 months. So we have to wait at least 1 more year to look at this point.

Manfred Welslau, MD, Onkologie Aschaffenburg, Germany, discusses ongoing research on biosimilar rituximab, Rixathon.

Manfred Welslau, MD: Ongoing Research on Biosimilar Rituximab

Biosimilars are really a very good solution to the ever-rising Part B drug price, and they have directed the reference biologic manufacturers to come and become competitive. That’s how we’re seeing the subcutaneous molecule for rituximab, which actually is going to be standing up firm against the biosimilar in the market.

Any competition in the market helps improve the cost, helps improve the patient’s convenience, and helps the physicians as well. So at the end of the day, it’s all about treating patients right, saving dollar volume for the Part B drug space, and doing good for all.  

Kashyap Patel, MD, discusses how biosimilars impact cost in the Medicare Part B context.

Kashyap Patel, MD: Biosimilars and Cost in Part B

What we have done in Denmark is, actually, we have taken the patients onboard. In the decision-making process, we have developed information for patients, which has been done by the authorities, not by companies, but by the authorities in cooperation with the patients. They have not been able to dictate the contents, but their concerns and their questions have been taken into consideration and have been answered.

If you look, for instance, at the website of the Danish Medicines Agency, you will see some very convincing “yes” answers or “no” answers to some of the most normal questions that patients might have about biosimilars.

But I think the main thing is to explain to people that, no, you’re not getting a new treatment. You’re not getting a new product. You’re simply getting another producer at a much lower price. It’s not a new treatment. It’s not really switching in the sense where we normally use that word. 

Language is of course important. It’s very, if you will, uphill to try to change people’s perception of language and what you interpret when you use special words. That is also true in this area.

Peter Jørgensen, director of the Industrial Association for Generic and Biosimilar Medicines, Denmark, explains how Denmark has engaged with patients on biosimilars.

Peter Jørgensen: Patient Engagement on Biosimilars

So, the [Biologics Price Competition and Innovation Act, BPCIA] was enacted as part of the Affordable Care Act, and there was a recent successful challenge on constitutional grounds to the Affordable Care Act before a District Court in Texas. That decision is up on appeal now before the Fifth Circuit, and the Department of Justice has submitted a brief saying not only should the Fifth Circuit affirm that decision, but it should further find that provisions of the Affordable Care Act other than the individual mandate provision, which is the subject of the constitutional challenge, should be found to be not severable from the rest of the statute, meaning that if one provision of the statute goes down, so too the rest of the statute.

So, the question of whether the constitutional challenge to the Affordable Care Act has any effect on the BPCIA will hinge on that question of severability and whatever court makes the ultimate decision on this question, whether that be the Fifth Circuit or the Supreme Court in this case, finds that the individual mandate is severable from the rest of the statute. Of course, this doesn’t matter if the courts ultimately decide that the individual mandate provision is constitutional.

Interestingly, in the original challenge to the Affordable Care Act back in 2012, that was [

National Federation of Independent Business v Sebelius

], before the Supreme Court, President Obama’s Department of Justice submitted a brief that argued that the rest of the statute should not be found to be severable from the individual mandate because Congress would not have enacted the entire statute without the Individual Mandate Provision. So, it’s interesting to see the Obama administration and the Trump administration taking essentially the same position on the same issue.  

Alexandra Valenti, JD, associate at Goodwin, discusses the future of the Biologics Price Competition and Innovation Act (BPCIA) in light of challenges to the Affordable Care Act.

Alexandra Valenti, JD: The ACA and the Future of the BPCIA

Patients face a lot of challenges when it comes to getting on therapy, particularly some of the biologics. What we're finding is that, physicians, particularly the sophisticated physicians, a lot of the academic institutions, are able to subjectively figure out which patients will respond to which biologic, but if they go to prescribe that biologic, oftentimes, the insurers will not allow the patient to get on it until they fail another therapy.

So it’s this fail-first therapy before they get access to it. That's frustrating for the patient, and frustrating for the physician. If the physician is pretty good at determining that this patient likely will not do well, in his mind, why does that patient have to fail first?

Also, it’s tough for the patient. They go through a regimen that doesn't work, their disease progresses, gets more entrenched, and then it’s a more difficult disease to face. So that’s one of the big challenges currently. 

Rolf Benirschke, chief executive officer of Legacy Health Strategies, discusses the challenges patients face in getting access to biologics to treat inflammatory bowel disease. 

Rolf Benirschke: Access to Biologics for IBD

In the developed countries, it’s very hard to say that it has improved; globally, it has improved. In the United States and in Germany, access to trastuzumab was not actually really a problem. In the developing countries, it definitely has improved. I know that from a hospital in China that I’m cooperating with.

Hans-Christian Kolberg, MD, head of the department of obstetrics and gynecology, breast cancer center, and gynecologic cancer center at Marienhospital Bottrop, Germany, discusses the impact that biosimilars have made on patient access to therapy.

Hans-Christian Kolberg, MD: Biosimilars and Patient Access

Basically, we need to educate our colleagues about the science of biosimilars: how they’re developed, how they’re equal, and how the FDA has put in very rigorous standards for evaluating the safety, efficacy, and similarity of the biosimilar molecule to the originator molecule.

Kashyap Patel, MD, discusses the need for provider education on biosimilars.

Kashyap Patel, MD: Provider Education on Biosimilars

Perhaps, for the developing countries, biosimilars are a way to get more people on therapy. I’m thinking of China, thinking of India, thinking of Mexico and the Middle East countries. In these health systems, I think a lot of people are pending getting these medications, so this is a way to help people in these countries to be on therapy.

Manfred Welslau, MD, Onkologie Aschaffenburg, Germany, discusses the benefits that biosimilars have in terms of patient access.

Manfred Welslau, MD: Biosimilars and Patient Access

There is absolutely a need for more educational activities, and we’ll continue to pursue that, both in the medical literature, in reviews, at the major medical meetings, including here at [National Comprehensive Cancer Network, NCCN]. It’s imperative. 

However, I've been doing these educational programs probably for the last 3, 3-and-a-half years, and at each one, I do see a more educated audience. When I get the questions about the use of biosimilars that are being asked, they’re clearly more familiar with the concepts, and they're asking more subtle and deeper questions. So I think we are seeing an impact. 

Again, we've got NCCN, [the American Society of Clinical Oncology, ASCO], the American Society of Hematology, all doing large educational programs on these, and it's like anything that's new: It takes time. As I said at the beginning, oncologists and hematologists tend to be skeptical of new things. They need to be shown. They need to get some personal experience with it. But I think that's coming, and I think over the next 3 to 5 years, I'm anticipating there will be a large-scale impact of biosimilars.

Gary Lyman, MD, MPH, of the Fred Hutchinson Cancer Research Center and Seattle Cancer Care Alliance, discusses the need for ongoing provider education about biosimilars. 

Interviews