Do you have any concerns about using biosimilars in patients with IBD?

As far as biosimilars are concerned, or for that matter any kind of generic medication, there’s always a concern in clinicians. There are certain guidelines that the biosimilars have to follow, but still there can be a difference between them and the brand-name product. What we do in primary care is try a biosimilar, and if it seems like it’s getting us the same effect that we want, we’ll stick with it. But [for] those that don’t work so well, those that let’s say they fall short, whether it’s with side effects or efficacy, we keep those in our minds, and we tend not to go to them, and we do the brand name products.

Videos

Paul P. Doghramji, MD, FAAFP discusses using biosimilars in practice.
 

Dr Paul P. Doghramji: Using Biosimilars in Practice 

Are you or any of your colleagues beginning to prescribe biosimilars?

I haven’t started prescribing biosimilars yet for these diseases. I tend to use brand names more than anything, but sometimes I’m forced to do it because of insurance constraints. As a general rule, we like to use a medication that’s come out by that specific pharma company in that brand name because we know exactly what we’re getting.

Paul P. Doghramji, MD, FAAFP, discusses whether he has begun to prescribe biosimilars for patients with inflammatory bowel disease.
 

Dr Paul P. Doghramji: Prescribing Biosimilars in IBD

Do you see biosimilar treatments as playing a role in controlling the cost of care?

I think we’ve already seen biosimilars act as a cost-leveraging mechanism. If you look at the average sales price of original anti—tumor necrosis factor drugs, and you look at the entrance of biosimilars into the marketplace, you can see a definite competitive trend, so there is a lot of competition in this space and that is causing [average sales prices, ASPs] to go down. I think that as the field continues to grow, you’ll see more of this.

I would say that our position is that patients who are on a particular agent should remain on that agent if they’re getting efficacious therapy, because "biosimilar" does not mean "same molecule." For new starts, I think that it should be a level playing field and the competition should be on the basis of both price and service delivery as well as known outcomes. However, I think that on existing therapy, our first duty is to keep the patient safe. But overall, in this field, biosimilars will act in a market force the way other market forces have caused competition to adjust price. We’re seeing that in the marketplace and we think that’s good for the American public.

Ira Klein, MD, senior director of health care quality strategy for the strategic customer group at Johnson & Johnson Health Care Services, explains how biosimilars will help to control costs.
 

Dr Ira Klein: Biosimilars and the Cost of Care

Do you see biosimilars having a role to play in [the Oncology Care Model, OCM]? 

I do, and I don’t think we know yet how much cost savings will be involved with biosimilars, but we know it will be some. I think it will start around 15% and go up to 30%, maybe more. I think that the experience in Europe is 30%, 50% is high. The biosimilars are in a space that- so Genentech is biosimilars and is going to be impacted by biosimilars, so about a third of our spend is Genentech products, so if you reduce a third of your spend even by 10%, 15%, 20%, it’s a big number. So, we see biosimilars being very key to saving in OCM.

Jeff Patton, MD, president and CEO of Tennessee Oncology, discusses how biosimilars fit into the Oncology Care Model (OCM).

Dr Jeff Patton: Biosimilars and OCM

What are REMS programs, and why are some stakeholders concerned about them?

A: REMS programs are safety programs that, again, were enacted back in 2007 and they are designed to allow the FDA to approve a drug even if it might have some safety issues that typical risk mitigation programs can’t address.

For drug products, the main way that FDA reduces risks is by identifying them on the label so that physicians know what the risks are and can take appropriate steps with their patients. In some cases, maybe not give a particular medication to a patient if the risks are too great. I think the conclusion FDA came to is that they can’t really trust physicians. Physicians don’t read the label and will use medicines even when the label says they shouldn’t be used. [The FDA] asked congress for the authority to take stronger measures, and 1 of the measures they got was a REMS.

The REMS provisions allow FDA to impose things like distribution and use restrictions. For instance, it might require special training for a physician to be able to prescribe the medicine, or it might say you may only use it in a certain facility as safeguards. They did really restrict how a medicine can be used and distributed. The concern folks have, particularly biosimilar manufacturers, is that brand companies that have drugs that are subject to a REMS are using them to prevent generic competition. They do that in 2 ways: the first is to restrict samples of the brand. So if you’ve got a generic product or a biosimilar, you need to get samples of the brand so you can conduct your tests. For a generic, it’s bioequivalence tests, [and] for a biosimilar it’s to show biosimilarity. But the brands are essentially saying, “our product is subject to a REMS. We can’t give it to you because it just doesn’t comply with the REMS requirements.” That prevents companies from doing the testing that they need to submit the application.

The second concern is that, and this is just for generics, not for biosimilars, but for generic products there’s a requirement that the generic, if it gets approved, must have a single shared REMS. It must essentially share the REMS that the brand already has. A lot of times, companies will delay agreeing, and the generic cannot get approved unless it has a single shared REMS. The concern is that you’re supposed to negotiate with a party that really has no interest in agreeing with you, and [those are] the main 2 concerns with the REMS.

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains why REMS programs give biosimilar and generic drug developers cause for concern.

Scott Lassman: REMS Programs and Biosimilar Therapies

Why are Citizen Petitions to the FDA so controversial?

I think they’re controversial because people don’t understand exactly what they do and what they’re used for. Petitions, as the name implies, can be filed by anybody. They can be filed by citizens, they’re often filed by public interest organizations, but pharmaceutical companies also submit them and I think the concern is that they will submit them primarily to delay generic competition.

That might have been true in the past, but the law was changed back in 2007 to prevent that. The law currently says that the FDA review of a petition goes along one level and the review of the application, or the abbreviated new drug application (ANDA), goes along another. A petition cannot delay an approval of a generic application unless there’s a public health issue. The FDA actually puts out data every year about how many petitions are filed, how many will delay applications, and if you look at FDA’s own data, less than 1% of generic applications are delayed because of a petition.

The problem is really more of perception, and I think the issue is that there’s a lot of bad information out there. There have been a number of press reports, and actually academic publications, which purport to analyze petitions and have come up with the claim that they actually do delay generic competition. But, all of these publications, when they do their analyses, they rely on a lot of assumptions and they actually ignore FDA’s own data. I personally file a lot of petitions myself, so maybe I’m a little bit biased, but I’ve never had a petition that delayed a generic application. They raise issues, a lot of times the companies that submit them have the most information about the product, so they raise these issues with FDA, FDA considers them, but I think in very, very few cases, and only when public health is potentially involved, will it actually delay FDA’s decision on an application.

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains why Citizen Petitions to the FDA are so controversial among generic and biosimilar stakeholders. 

Scott Lassman: Citizen Petitions to the FDA

Are biosimilars going to play a big role in value-based design?

The question about whether biosimilars play a role, branded drugs play a role, generics play a role, I think all of these questions about specific interventions take us back to what makes VBID different from other types of payment insurance schemes which is this era of clinical nuance.

It has always been our view that the value of a service depends not on the service itself, but who gets it, when in the course of the disease, by whom, and where. So, whether that be a branded drug, a generic drug, a specialty drug, or a biosimilar, there is a time in the course of the sequence of care where drugs are considered very high value, and that exact same drug might be considered low-value.

So as opposed to talking about preferred branded drugs or specialty drugs or biosimilars or generics, as many people know, there are some generics that I would pay people to take. There are also some generic drugs I would not give my dog. The same holds true for biosimilars. If there is evidence to suggest that a biosimilar at this point in time is a first-line drug, then the patient should have access to that and the provider should not have problems in terms of having to send faxes or make phone calls or whatever else to use it.

But that requires not just transparency, not just consumerism, not just skin in the game. This requires clinical expertise that fortunately or unfortunately most patients just don’t have. So instead of relying on patients to shop around, and make these types of decisions, I think the onus should be on providers. They for the most part want to do what’s best for their patients. We need to have their compensation systems aligned with good choices, but more importantly if a provider decides that something is best for his patient, whether that be a biosimilar, whether it be a specially drug, whether it be a branded drug or generic, when that clinical situation says that this is the right service for that person at this right time, there should be unfettered access to that.

So, I think in the avdent of any innovation, like biosimilars or maybe more importantly, these new CAR-T therapies moving forward, we need to access not only the clinical benefits that have come to them, not only the cost for which it has incurred, but understanding that drug and that cost, the value of which depends on the clinical scenario that it might be. It might be so important that you want barriers to fall and in some patients to do it, the exact same drug may be a complete waste and in another patient another scenario. And I think that’s where VBID fits in.

Mark Fendrick, MD, discusses the role that biosimilars will play in value-based insurance design (VBID).

Dr Mark Fendrick: Biosimilars in Value-Based Insurance Design

What value do biosimilars bring to our healthcare system?

The first thing we have to do is to educate providers, payers, and patients, about what biosimilars are and what the benefits are. One clear benefit we see for the payer is the cost savings. To the patients, it’s their out-of-pocket costs; if the patient has to pay 20% out of pocket, for the cost of care, biosimilars will definitely reduce their out-of-pocket costs when they are used. For the providers, of course, if you’re in the alternate payment model space, and if you have an alternative that is equally effective and less expensive, it helps me to bring down my top price.

So in the European experience, you go back to Sweden and England, the health systems increased uptake and utilization of biosimilars, which indicates that when the price goes down, the access improves. This is very obviously starting the financial toxicity model. So biosimilars do have a place in improving access to drugs as well.

Kashyap Patel, MD, medical oncologist at Carolina Blood and Cancer Care, discusses the value that biosimilars bring to the health system.

Dr Kashyap Patel: Biosimilars and Value

Have biosimilars faced legal complexities in Europe similar to those in the United States?

The short answer is: not as much. The principal reason why, is in the European Patent Office, the EPO, there has been a very robust opposition proceeding for many years. What this has allowed is for biosimilar applicants to challenge patents that stand in the way of marketing a biosimilar early and effectively. We see now with IPRs (inter partes reviews) and PGRs (post-grant reviews) in the US, we see something akin to the European Patent Office (EPO) style oppositions, but IPRs and PGRs are quite a bit different. Arguably, it’s not as efficient of a mechanism. By the time the EMA approves a biosimilar, the biosimilar applicant has a number of years to use this very robust opposition proceeding in the EPO to try to clear patents away. So, it’s been easier for biosimilar applicants in Europe to actually reach market.

Robert Cerwinski, JD, partner at Goodwin, explains the differences between European and US patent challenges for biologics. 

Robert Cerwinski: Biosimilars, Legal Complexities, and Europe

Do you think there is a certain policy needed in the biosimilars market that is not currently in place?

I think, first and foremost, we want an interchangeability guidance from the FDA and that’s in progress right now. What that will do is help manufacturers come up with the right clinical trials design to give doctors, patients, and payers, the data that we need to be confident and learn about drugs that the patients can be moved from a reference biologic to a biosimilar confidently, and knowing that it’s going to work and there aren’t going to be any safety problems in switching.

Another important issue is the reform of cost-sharing that Medicare beneficiaries have in the Part D system. So, these are drugs that patients can give themselves at home, often with a subcutaneous shot. Right now, as the regulations are written, patients will be actually paying a higher percentage or a higher amount of money for a biosimilar drug than they will for a reference biologic drug. Unfortunately—and this is only until 2020 but the first few years of this era of biosimilars is critically important&mdash;for now the ways the laws are written, patients might be paying more for switching to these follow-on biosimilar drugs. I think that might stifle the system of biosimilars and create a barrier towards uptake.

Next, as I represent the American College of Rheumatology and our members—the rheumatologists across the country&mdash;we would like to have the suffix that’s attached on the end of biosimilar names, and it appears to the reference biologic name, we want those to be meaningful and memorable. Right now, as it stands, it’s 4 letters that might be a palindrome or might be interest looking, but they’re not memorable. So now that we have 5 of these drugs in our rheumatology space that are FDA-approved, it’s difficult to remember one from the next. We’d like the FDA to issue a guidance that either expands the number of letters that can be used so that something can be meaningful, or somehow makes it more memorable.

Lastly, we’d like for the reimbursement for biosimilars that are given by providers’ offices or in hospitals to be individualized. Right now, the regulations are written such that any biosimilar in a family that refers to one originator drug—all of those drugs are reimbursed at the same rate, which means that it might be difficult for a provider, group, or hospital to give a patient the best drug for them on an individual basis because one biosimilar might cost more than the other biosimilar in that family. If the reimbursement is all equal or the same, it might be difficult, financially, for that practice or hospital to give the drug that they’d like to give to the patient. So, we’re in favor of breaking down each individual drug to have its own reimbursement code.

Angus Worthing, MD, FACR, FACP, describes policy changes that are needed in the biosimilars space. 

Interviews