What role can biosimilars play in bringing down costs for patients and for the healthcare system?

LT: I think biosimilars are a natural outgrowth of, of course, the biologic—the innovator biologics&mdash;and they are the solution to the near-term cost issue and the near-term access issue. It doesn’t mean that biologics may not come down in price to meet biosimilar pricing, and good for that, we would love that. We’ve seen that when drugs have gone from branded to generic, we see the brand name drugs become lower.

The most important part of biosimilars today is the fact that they’re going to be able to bring greater access to patients. How do we think this is going to happen and who do we think is going to benefit from it?

We think that, in the first place, the biologically naïve patients should have the first access to biosimilars based on cost. If biologics are as cheap, good for them. But we really need to look at how soon we’re getting folks onto these medicines.

We’re also looking at, if you’re already on a monotherapy like a methotrexate, how long are you going to stay on methotrexate? Oftentimes, the insurance companies, whether it’s the medical benefits folks with infusion drugs or [pharmacy benefit managers, PBMs] with injectables, will have an arbitrary date that says “you’ll be on methotrexate for 6 months and then we’ll see how you’re doing.”

Well, it seems to us that there’s a simpler answer to this than just an arbitrary date, and that’s just radiography. You can have X-rays and you can see, in this case, ‘Is my rheumatoid arthritis progressing?’ If it’s progressing under methotrexate, it’s time to get onto a biologic. If biosimilars are cheaper, if biosimilars are more available, then it’s time to get them on a biosimilar.

We think that this is going to compress the time between diagnosis and what most professionals would consider appropriate therapy.

SM: Yeah, I would add just the point that education is really going to be key here in order for biosimilar uptake to be a positive one. In order for the promise of biosimilars to be achieved, and those prices start to go down, and patients start to realize those benefits, we really need to have confidence. Patients need to have confidence, physicians need to have confidence, and the only way we’re going to get to confidence is through education.

Education is a little bit more difficult than it may sound because it’s very difficult to get all of these stakeholders to agree on similar educational approaches. I think we look to [the] FDA to take the lead here, and we’re really pleased that they have. They’ve released some very valuable tools on their website, and [I] would encourage folks to check those out, but there really isn’t a ‘1-stop-shop’ for education right now. Just like everything else, it’s important that you go to trusted sources. Go to patient advocacy organizations like ours or others in the arthritis area, [or] in the oncology area. Many of us have educational materials and many of them are robust.

I will mention that there are efforts underway through collections of organizations like the Biosimilars Forum where some of these very diverse stakeholders are getting together, having difficult conversations, and coming out with educational principles that we’ll all be promoting collectively.

I think that will be a massive step forward, but in order for us to achieve that critical cost savings, we’re going to have to educate together. So, the [Global Healthy Living Foundation, GHLF] and others are committed. The great news is that we’re all committed to working together to make sure that educational effort is uniform.

Videos

Louis Tharp, cofounder and executive director of the Global Healthy Living Foundation, and Stephen Marmaras, director of policy and advocacy for the Global Healthy Living Foundation, discuss the value of biosimilars to the healthcare system.
 

Louis Tharp and Stephen Marmaras: Biosimilars and the Healthcare System

What is your organization’s position on step therapy?

So, step therapy is a topic that causes a lot of emotion from our community members—from people living with chronic disease. Most of our membership have experienced step-therapy at one point or another. We understand in concept why insurers use step therapy, [but] we think it’s like using a hatchet to attempt a surgery. It really is kind of a 1-size-fits-all practice that really isn’t applicable.

We think medicine is so nuanced, and especially the patients in our community live with very complex chronic diseases, [so] you cannot make a policy as encompassing as a step therapy, or like folks in our community like to call it, “fail first,” that is going to work for everyone.

We understand generally why it’s in place. We think it’s appropriate in some cases, but for the vast majority of the instances we think it’s very inappropriate, and we would argue even unethical.

I think that we’re encouraged to see many states across the country starting to implement legislation that has been introduced—a newer version of step-therapy legislation&mdash;that was introduced starting around 2015 that is much stronger than previous attempts that don’t look to just prohibit step-therapy, because we understand that that’s not reasonable. But it looks to put some guard rails in place or it looks to really protect the patient from the step therapy practices going too far.

If we look at New York, for instance, legislation was passed in our home state through the efforts of a very diverse coalition of many, many patient groups—I believe there were over 60 patient groups that worked together to get that bill passed. But that bill, what it specifically did and now does under law, it mandates that step therapy protocols are developed using clinical criteria and that that clinical criteria are really [coming from] a third party [such as] a professional society, [or] a professional college of medicine. It’s under the direction of medical information, not financial information.

Number 2, it sets out clear criteria for which a physician and their patient can use to appeal a step-therapy policy. One of the more critical parts of the legislation is that it puts in place a time requirement for which the insurer has to respond to that appeal.

So, in New York, that’s 72 hours, or in the case of an emergency [it’s] 24 hours. That’s a really important part, because when we go to state capitols across the country with other groups to advocate for this type of legislation, many times we hear from folks on the other side “well, we already have an appeals process in place.” But when you’ve seen 1 insurer’s appeals process, you’ve seen 1 insurer’s appeals process. There’s no uniformity. This drives physicians crazy, it drives patients crazy because people are changing their insurance plans from time to time and 1 of the largest complaints we hear is that I file an appeal, but just because I file an appeal doesn’t mean anything. We’ve heard patients wait up to 130 days before they get a response to an appeal.

It’s really critical that that protection be a part of the legislation, and so we’re working to pass that in many other states. I would direct folks to 1 of our websites, 

, where we track a lot of this legislation and we list out many of these kinds of principles that I just spoke about.

Stephen Marmaras, director of policy and advocacy for the Global Healthy Living Foundation, discusses step therapy and its impact on patients.

Stephen Marmaras: Step Therapy

What are some credible, patient-friendly resources that people with rheumatic diseases should access when they or their providers are considering a switch to a biosimilar?

I think the good news is that there’s a lot of resources out there right now. I would start with the FDA, they recently put out some new resources—some new educational content with everything right down to some sample social media content which is I think a great step for FDA to be moving into social media. That was encouraging to see.

I would also encourage some of our resources at a site we have, called 

, where we have some kind of bullet-point-level information about biosimilars. We try and keep it very concise and approachable for advocates in our community.

But we do not have a monopoly on this information at all. [We] absolutely encourage folks to look up other arthritis organizations that they trust and know out there. [We] would also encourage checking out some major medical institutions like the Mayo Clinic or Cleveland Clinic.

And then also looking at the biosimilar manufacturers themselves. There’s [merckclarifiesbiosimilars.com], there’s pfizerbiosimilars.com as well. I think, like anything else out there, it’s important to look at really a diverse range of resources and use that to kind of bring your understanding of the content to another level.

I think what is encouraging is that there are coalitions out there that have begun to form that are kind of collections of a lot of these stakeholders and taking on education as a number one priority. So that’s something that has missed is educational content from 1 source that is a collection of stakeholders. I would recommend the Biosimilars Forum; [it] will hopefully be producing some content soon. That could be a source for some very diverse range of opinion in 1 spot.

Stephen Marmaras, director of policy and advocacy for the Global Healthy Living Foundation, discusses credible, patient-friendly resources that people with rheumatic diseases can access when they or their providers are considering a switch to a biosimilar.

Stephen Marmaras: Patient-Friendly Biosimilars Resources

What have we learned about the uptake of biosimilars in other nations?

We’ve learned a lot about biosimilars from Europe and from Asia. They’ve been there for at least a decade. But, when it comes to the uptake in the United States, there isn’t as much we can learn because, in Europe and in Asia, they had a more direct way to influence the uptake of biosimilars. That usually occurred because, in many countries, there is a single government entity that’s responsible for buying the drugs. That’s not true in the United States.

In the United States we have a lot of choice, and it’s often times theoretical choice because while there are a lot of advertisements about drugs of all types, our insurance companies help us make the choice—to be kind&mdash;by looking primarily at cost. Physicians also direct us. So, where we might have a choice of say 9 biologics for an autoimmune disease, or 2 or 3 biologics for a cancer condition, [but] our physician or our insurance company may drive us to one drug.

We wind up in the same situation that Europe is in, but we get there in a very different way. The difference here—and the important part&mdash;is that psychologically, the patient doesn’t get to the same place as the patient in Europe does. Because the patient in Europe walks into the physician’s office, is diagnosed, gets a drug, and begins the treatment.

In the United States, there is a lot more perceived choice and a lot more perceived power on the part of the patient because of all of the advertising that we have now. And so, the patient needs to be able to understand the bigger picture and be able to have confidence in and get behind the treatment protocol that she winds up ultimately getting. And that’s one of the key issues that we deal with within the 

, which is groups of patient advocates all around the United States, as well as 

, the arthritis side of the [Global Healthy Living Foundation]. The objective here is to help the patient understand the bigger picture and help the patient ultimately do well on the drug that they wind up being prescribed.

Louis Tharp, cofounder and executive director of the Global Healthy Living Foundation, discusses lessons learned from international experience with biosimilar uptake. 

Louis Tharp: Lessons Learned From Biosimilar Uptake Worldwide

What is your practice’s experience with biosimilars?

I am involved, and yes, there will be an uptake of biosimilars in my practice, I’m sure. We’re talking to those companies. There are some complexities around, you know, reimbursement, so—we’ll kind of just have to wait and see. But I think we’re looking forward to more and more biosimilars coming to market. With us being in all these value-based contracts, I’m sure it’s going to come into play in the way our practice sets up our formularies and pathways. 

Ray Bailey, RPh, Pharmacy Director at Florida Cancer Specialists, discusses the complexities of biosimilars.


Ray Bailey, RPh: Complexities With Biosimilars

What is your understanding of the use of biosimilars at your practice?

Well there’s not too many biosimilars out right now. I do believe that there is a cost advantage to them, and I haven’t seen any difference in efficacy with the 1 that we’re currently using now. I am very much looking forward to that; I think that it will reduce cost and that’s what we need to do.

Linda Frisk, PharmD, of Arizona Oncology, discusses biosimilars and cost savings. 
 

Linda Frisk, PharmD: Biosimilars and Cost Reduction

What is your understanding of the use of biosimilars?

I know it’s a hot topic; I know I’ve been to quite a few [continuing education sessions, CEs] on it. At [Indiana University] it has not been necessarily a big topic of discussion. We have pretty much stuck with the products we’ve been using. But I think in the future, hopefully with more knowledge of biosimilars and everything we can kind of define a clear cut “when we should use what,” and how we interchange those products. It’s definitely a gray area at the moment.

Julianne Orr, outpatient oncology clinical pharmacist, Indiana University Health, explains that biosimilars remain a gray area for pharmacists.

Julianne Orr, PharmD: Biosimilars Still a Gray Area for Pharmacists

Do you see biosimilars being used more in the future?

The use of biosimilars coming to the market will be challenging. As you know, biosimilars take a lot of research and development to develop the biosimilar, so the cost savings are probably not going to be as dramatic as some people may expect. I think biosimilars will have a challenge when going up against the branded product. The reason I say that is, number 1, they’ll have to be, certainly, price-advantaged to switch to a biosimilar from a branded product, but there are other things that go into product delivery, and that can be patient assistance programs. I believe that biosimilars will have to have the same programs in place as the brands do for people to embrace their products and bring them on board.

I would say that certainly the clinical data that we’ll review will solidify our use of the biosimilars—I think they’ll be used&mdash;[but] I think there’s going to be a price break point that we [will] need to achieve widespread adoption of biosimilars. I think you’re going to need to have really significant cost reductions for practices to switch to biosimilars, and we’ll have to see where that goes.

Steven D’Amato, RPh, executive director and clinical pharmacy specialist at New England Cancer Specialists, explains the factors that he feels will impact adoption of biosimilars.
 

Steven D'Amato, RPh: Adoption of Biosimilars

We are currently using biosimilars. We’ve actually created an approval process that we accept biosimilars as an acceptable product. We have brought in the first biosimilar; we use the product Zarxio in place of Neupogen. We did a full review of the product—a clinical review, the manufacturing process of it&mdash;and made a decision based on efficacy, safety and of cost-savings.

Howard Cohen, RPh, MS, FASHP, director of oncology pharmacy services for Yale New Haven Hospital, discusses using biosimilar filgrastim.

Howard Cohen, RPh, MS, FASHP: Using Biosimilar Filgrastim

Do you see any potential for regulatory agencies, such as the FTC, to weigh in on anti-competitive practices in the biologics and biosimilars world?

Absolutely. I can’t comment on whether they’re going to come in on a particular issue, but they’ve been very active in this area already. Years ago, when there were questions about the Hatch-Waxman Act and whether companies were abusing the patent listing process, they did a big study and actually commented to the FDA and spurred the FDA to change their regulations.

Most recently, they’ve been very active in the biosimilar and REMS area. There have been lawsuits by generic companies who could not get samples from the brand purportedly because the REMS prevented it. The FTC has come in with amicus briefs, they’ve come in with amicus briefs on some of the biosimilar issues, so they’ve actually been very, very active on this and I would expect that to continue in the future.

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, discusses the role that the Federal Trade Commission (FTC) may play in encouraging biosimilar competition. 

Interviews