Do you plan to prescribe Mylan’s biosimilar trastuzumab to patients? Would you switch patients from the reference product to the biosimilar, or just begin new patients on the biosimilar, and will payer coverage decisions affect provider and patient choices?

There’s always a big question about whether or not you would—okay, now the biosimilar is available, are you going to use it in your patients? In everybody? Are you going to switch patients who are on the originator to a biosimilar?

I think that there are a number of issues that we need to understand. In the [United States], that’s very much driven by insurers and what insurers are going to mandate. For example, with biosimilars for the filgrastim, the insurers, very quickly, many of them said, “you have to use the biosimilar because it’s cheaper.” And then what happens is, the institution—I work at an academic institution&mdash;changes over wholesale to say, “Okay, that’s what we’re going to give people,” so [that] you don’t have to worry about what the insurance said beforehand.

So that’s one thing that I think often happens, and with the trastuzumab—and we also switch people because, you know, supportive care it comes and goes, right? With the trastuzumab biosimilars, I think it’s going to depend on the price points and what the insurers and institutions say about if there is a real cost savings, and then they will want us to switch over to the biosimilars, which I am very happy to do.

I think these are agents which are biosimilar, so I don’t have a problem switching over. And I don’t have a problem switching a patient either, I just took a patient off trastuzumab who has been on it for 17 years and has no evidence of disease. We had a big conversation about stopping the trastuzumab and I said, “I really would’ve stopped you at 10 years, but you said no,” and she’s moving away now. But that’s a patient where you may have a patient on it for so many years; if you could have a drug that’s 20% or 30% less, that’s a huge savings over time, so it’s possible that those people who are on forever-maintenance trastuzumab in the metastatic setting, that that will be a situation where patients are switching or switched.

I don’t think that I would switch anybody that was in the neo-adjuvant or adjuvant setting on short-term exposure to the drug. It’s going to be an interesting time to see what happens. 

Videos

Hope Rugo, MD, director of the breast oncology clinical trials program at the University of California at San Francisco, discusses the ways in which payers will drive the use of Mylan and Biocon's trastuzumab biosimilar, Ogivri, in patients once it becomes commercially available.

Dr Hope Rugo: Prescribing Ogivri to Patients

Is there anything you’re working on or excited about in HER2-positive breast cancer that you’d like to share?

We're working on a number of different things. One is trying to move neratinib earlier in the adjuvant course and seeing if we can manage the diarrhea with a novel agent. So that’s one trial my colleague Joe Chen is working on.

In terms of the metastatic setting, there are a number of novel agents, oral TKIs [tyrosine-kinase inhibitors], and then an antibody—drug conjugate from Daiichi which has shown responses in patients who had highly resistant disease, at least as reported to trastuzumab. That’s going into a phase 3 trial this year. Then there’s a novel antibody that binds to the receptors a bit differently called margetuximab that’s in a phase 3 trial called the SOPHIA trial. That drug also showed responses in phase 1 studies in patients who had disease resistant to trastuzumab.

So, I think there’s a number of different agents out there which seem as though they have potential for the future. 

Hope Rugo, MD, director of the breast oncology clinical trials program at the University of California at San Francisco, discusses advances in the treatment of HER2-positive breast cancer.

Dr Hope Rugo: Advances in HER2-Positive Breast Cancer

What is your position on non-medical switching from biologics to biosimilars?

Non-medical switching is when insurance companies reduce formulary coverage, which puts financial pressure on patients to switch their prescription medications to alternative therapies. In many cases, the alternative therapies that the patients are being pressured to switch to are made by manufacturers that have successfully produced lower bids than the existing preferred drug from a different manufacturer on the plan.

Reductions in coverage include increased out-of-pocket costs, eliminating a drug from the formulary entirely, or creating restrictions around access.

The Global Healthy Living Foundation is opposed to non-medical switching, particularly when a payer changes their formulary in the middle of a contract year because they are not honoring the contract their customers signed. Patients are not getting what they paid premiums for, or met deductible requirements to access.

This puts chronic disease patients at risk because it can often take months or years to find an effective treatment. Should access to that treatment be reduced or shifted suddenly, delays in treatment or needing to switch treatments could have very harmful health consequences.

Every year, there is something called the “open enrollment period.” (The 2018 enrollment period was between November 1 and December 15, 2017, for those purchasing health insurance through the federal marketplace.) Most people who purchase commercial health insurance will have at least a few weeks to read through proposed contracts, evaluate the doctors in the health plan network and review the available formulary to select a health insurance plan and provider from the options available to them.

Then, once the health insurance contract is signed, a patient and their covered family members, if applicable, are locked in for at least a year. But what may not be apparent is that in many states (such as Florida, Tennessee, and Massachusetts), in those states, the insurer is allowed to alter the contract by reducing their drug coverage at any time during the plan year. Therefore, not only is the contract unfair to consumers, but it puts patients’ health at risk when access to their medication becomes uncertain.

Health insurance companies claim that adjusting the formulary is a way to keep healthcare costs down. However, reducing drug costs to benefit their own profitability is quite shortsighted. Patients who get sicker (because of falling out of remission) if their treatment is altered are likely to see the doctor more, need more diagnostic tests and, generally, increase their healthcare utilization.

Seth Ginsberg, co-founder and president of the Global Healthy Living Foundation, discusses non-medical switching of patients from high-cost reference biologics to biosimilars (or to other therapies). 

Seth Ginsberg: Biosimilars and Non-Medical Switching

Can you comment on what some of the regulatory challenges would be with importing drugs from Canada, or from other well-regulated nations?

I think the main issue—there’s 2 main issues. One, if you look at it from the FDA point of view, it really undercuts FDA’s authority because what you’re saying is that, even if a drug isn’t approved in the United States, it can come in to the United States and be marketed here, and FDA really has not say over it. I think that’s something the FDA doesn’t like, just from an institutional point of view.

On the safety side, though, I think there are some real concerns, because even though some of these products may come from well-regulated companies, the way the drug distribution system is now, you don’t really know where things are coming [from]. So, things may look like they’re coming from Canada, and they’re really coming from—I don’t want to disparage any countries&mdash;but you know, from a less well-regulated country.

Particularly with all the concerns that have been swirling around in recent years about drug counterfeits, once you open the spigots that way, it makes it almost impossible to prevent and stop these counterfeit products from coming in, or at least it makes FDA’s job much more difficult.

There actually is a law on the books right now which would allow imports from Canada, I believe, but the Secretary of HHS has to make a certification that it can be done safely and thus far, I think this goes back to, I want to say back to Bush but, thus far, no HHS Secretary has been willing to make that certification, and I think that’s because of drug safety issues.

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains some of the challenges with proposals to allow the United States to import cheaper drugs from Canada or other highly regulated pharmaceutical markets.

Scott Lassman: The Challenge of Drug Importation

How important are patient assistance programs offered by reference drug makers to the patient experience with biologic drugs?

Patient assistance and patient support programs offered by drug makers are critical for patients.

These programs are often a combination of financial support for out-of-pocket or co-pay costs, as well as ongoing help from a trained medical professional such as a nurse, with many offering 24-hour access to a nurse hotline for when a question or concern may keep a patient awake at night or some reassurance is being sought. Of course, these are not intended to take the place of a patient’s own healthcare professional team, but having qualified, trained medical professionals available on-call is a feature that we encourage all patients to take advantage of and to participate in, where appropriate. 

Seth Ginsberg, co-founder and president of the Global Healthy Living Foundation, addresses the importance of patient assistance programs. 

Seth Ginsberg: Patient Assistance Programs and Biologic Drugs

CMS has proposed treating biosimilars like generics for the purpose of cost-sharing under Medicare Part D. What is your organization’s position on this proposed change?

Right now, the Global Healthy Living Foundation is still formulating our official position on this issue. However, we are huge proponents of biosimilars and we have been for quite some time. Biosimilars are not generics, and we believe that their true success or failure will be measured on biosimilars living up to their promise of safety and their promise to deliver savings directly to the patient—in the form of lower premiums, lower copay or coinsurance, and deductibles. As we consider CMS’s proposal, we keep patient impact at the center of all of those considerations.

Seth Ginsberg, co-founder and president of the Global Healthy Living Foundation, discusses CMS' proposal to treat biosimilars as generics for the purpose of cost-sharing.

Seth Ginsberg: The CMS Proposal to Treat Biosimilars as Generics for Cost-Sharing

What are the most important things for patients to know about biosimilars?

For people with inflammatory arthritis like rheumatoid arthritis, or other chronic diseases that benefit from biologic medicines such as Crohn disease, psoriasis, [multiple sclerosis, MS], lupus, and others, biosimilars represent new treatment options simply because they are nearly identical to the originator biologic, but not exactly the same.

However, like with every medication, each patient will respond a little differently. Our advice is that patients with arthritis who are prescribed a biologic or biosimilar, track their response to treatment using our ArthritisPower research registry. Patients can download the free app and use it to enter their symptoms and treatment responses. They can also participate in arthritis research. It’s a great tool to understand how you are actually responding to a medicine (and other therapies) over time. Folks can learn more an download the app at www.ArthritisPower.org.

Seth Ginsberg, co-founder and president of the Global Healthy Living Foundation, explains what patients should know about biosimilar therapies.

Seth Ginsberg: What Patients Need to Know About Biosimilars

Despite challenges from industry groups, a number of states have recently enacted drug pricing regulation. Do you expect to see more states passing such laws?

I think I just read that there were 2 more states that had either proposed or enacted similar legislation to what Maryland passed. This is an outgrowth of the whole concern about drug pricing, so I think it’s something that’s going to continue.

The pharmaceutical companies and the associations I think are going to continue to fight against those, and I think they’re going to do it for a number of reasons. One, a lot of the laws are somewhat vague and make it difficult to determine whether someone is violating the law or not.

The other big issue is, when you’ve got different requirements in different states it makes it very difficult for companies to price their products. I think there’s going to be a big push to try and get some sort of national standard.

We saw this many years ago with clinical trial disclosure requirements. A number of states started enacting laws requiring companies to disclose clinical trial information; I think Maine was the first one. Again, industry was very concerned about having multiple, disparate requirements from state to state, so they pushed for a national requirement, and that was enacted back in 2007. This is one of those issues that I think companies will want to have any national legislation, but I think they are going to fight against having different requirements in different states.

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, describes trends in state legislation on drug pricing and industry reaction to such laws.

Scott Lassman: Drug Pricing Legislation

Can you comment on how the FDA has changed under new leadership by Commissioner Scott Gottlieb, MD?

The FDA is like a big freighter ship: it doesn’t change really quickly. That being said, I actually have seen a number of changes, or what I perceive to be changes, which is that he’s not shying away from some of the most controversial issues. I thought it was telling that Dr. Gottlieb jumped right in and said that FDA has a role in drug pricing. This was something that the FDA has shied away from for years. While Dr. Gottlieb was clear that the FDA does not have a direct role, he did say they have an indirect role, and is trying to take action to actually speed up the approval of generic drugs and biosimilars. I think he actually has been doing that, if you look at some of the recent approvals for very complex generic products (almost, one would say biosimilar-like), that had been sitting at the FDA for a long time, they’re taking action to actually move those products forward and get them in the market. He seems to be—what I would say is the big issue&mdash;he’s not shying away from the controversial issues. He’s stepping right in, and they seem to be taking a lot bolder action and taking it a lot more quickly than I would have expected.

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, describes how the FDA has changed under its current leadership.

Scott Lassman: Changes to the FDA Under Scott Gottlieb, MD

Do physicians do a good enough job of educating patients about biosimilars versus biologics?

Since I’m not a doctor—although sometimes I like to joke that I could play one on the Internet&mdash;I cannot speak to their overall education about biosimilars versus biologics. But my impression, based on speaking with many rheumatologists and other doctors, is that they’re taking a wait-and-see approach before prescribing biosimilars.

Seth Ginsberg, co-founder and president of the Global Healthy Living Foundation, reflects on physician efforts to educate patients about biosimilars.

Interviews