The Role of Biosimilars in the US Healthcare System

Gillian Woollett, MA, DPhil: So, Julie, can I ask you to address how important biosimilars are to our healthcare system, but also to weave in—based on your citizen petition—what responsibility the FDA does have to deliver and make this work? How much is it about protecting and promoting the public health, the FDA mission, as Commissioner Scott Gottlieb, MD, has expressed it? Therefore, back to your petition, what does it mean if they are able to do this to the healthcare system in the United States?

Juliana Reed: Sure. Thanks, Gillian. The success of biosimilars in the United States is critical, and we are at a critical juncture. Biosimilars are a private-sector solution to lowering drug cost in this country through competition. Competition is how we want to lower drug costs. Other policies are probably not what the industry would like to see. So it’s a robust biosimilar marketplace in the United States, and driving costs down through competition is key.

It’s not just about the FDA, though. Again, we’re grateful that the commissioner and Dr Christl and the FDA are doing what they’re doing to approve biosimilars. That’s key. The safety and efficacy is there. There are no clinically meaningful differences. We need to do more education.

But we need to take it now to the other stakeholders in this industry. Industry needs to support biosimilar uptake and support the competition. Physicians need to support and prescribe biosimilars. Insurers and payers and purchasers and pharmacy benefit managers need to cover biosimilars and provide access. It’s not just about the citizen petition and the misinformation; that’s 1 component. Education is another component. Access and coverage is the third component that needs to happen. Employers need to set things up. Ten, 12 years ago, I don’t know how long ago it was, we were working on getting this very pathway set up and getting the law passed here in the United States. It was the employers who came to support biosimilars, as well as the payers, that we needed lower-cost alternatives, and we needed competition in this space.

Gillian Woollett, MA, DPhil: Kashyap, I’m going to ask you to elaborate, particularly on the role of some of the other stakeholders. But Julie, what I’m hearing you say is the FDA can give the other stakeholders basic tools, basic sound bites, basic documents, whether it’s downloadable brochures or whatever it is that helps get those very, very fundamental, indisputable, simple messages out there. But then, of course, we do have to have alignment of the stakeholders to be pro-competitive. This is not anti-originator. This is not a size debate, and it is about access and affordability and expanding the market to those who can’t currently afford these often very complicated but very expensive medicines.

Kashyap, can you say something about the other stakeholders and how this system that we currently have will or will not help foster the uptake and use of biosimilars?

Kashyap Patel, MD: Sure. There are 2 perspectives. One is we’ve walk this path. So we, being in the Oncology Care Model, adopted biosimilars early on. And as a case study, I presented our findings both at the [American Society of Clinical Oncology, ASCO] quality care symposium in Phoenix, Arizona, as well as at multiple meetings. We have been able to reduce the cost of care. In the first year we saved $34,000. That doesn’t sound like a whole lot of money, but actually, for my practice size, that’s the amount of money that came back from [The Center for Medicare & Medicaid Innovation, CMMI] as a shared savings.

We put that money back into hiring additional nurses, so we’re able to improve access because for us to expand access to same-day walk-in patients, we need to have extra money to hire employees. So the savings that we achieved, that came back to us from CMMI, we put it back into the practice for hiring more employees, so we are able to improve access indirectly, through putting money back into the system as we just said. Patients’ out-of-pocket costs have gone down.

And I remember 2 studies. One actually was specific to the product you mentioned, Carlos, Zarxio, where they showed that over the next 5 years, patients’ out-of-pocket costs, the total across the country, could be down by close to $34 million. The same study also mentioned that CMS would save close to $100 million and commercial payers would save close to $80 million dollars, give or take a little bit here or there.

But from a much more holistic perspective, every day we see a different announcement from the CMS regarding drug prices. We have the International Pricing Index as one of the models. Flat fees could be another possible alternative. You could have mandatory alternative payment models that are selected for the geographic areas. I think we have once-in-a-lifetime opportunity to address the drug pricing, and that is to use the biosimilars.

When you look at the RAND Corporation’s projections, they project that appropriate assimilation of biosimilars in the US healthcare space could save close to $50 billion in the next 10 years. We look at Dr Miller from Express Scripts: he wrote about 4 years back that appropriate assimilation of biosimilars in the mainstream space for patients’ treatment—either at infusion centers or in a hospital—could save anywhere between $100 billion to $250 billion over 10 years…beginning in 2020. So the number speaks for itself. My own case study says that there’s a significant savings that could be achieved.

But the tough job is when the FDA is doing its job and you are doing your job. Where I see there’s a silo is we need to educate the true stakeholders and the boots on the ground about extrapolation, safety, and what the class of drug is, and you have to do it for only 1 drug. Once you’re able to successfully implement strategies between the physicians, pharmacists, the PBMs [pharmacy benefit managers], commercial payers, advantage plans, and CMS, take 2019 or 2020 to put every possible effort into putting source and strategy into place. Second-drug start-up would not be a problem, I think. But next year will determine whether we are going to have biosimilars, as a class, succeed or fail, and I think the stakes are way too high. We cannot afford to make a mistake at this juncture.