Biosimilars: Addressing Roadblocks to Market Adoption

Bruce Feinberg, DO: All right, guys. You’re making me feel as if this is such a powerful argument in favor of biosimilars that they should all be incredibly successful. But that’s not the reality. There is a disconnect here. There seems to be this great alignment of patients, providers, and payers all in favor, yet that’s not what we are seeing in the marketplace. Something is not right here, and I’m not sure what it is. We started this conversation over evidence-based care. You are all, to some degree, leaders. For those who are not spending their whole day on the front lines dealing with the patients but who have more administrative roles and bigger, almost public-health-type perspectives, do they see this but the rank-and-file level is not seeing it, so they’re not doing it? Then they’re confronted with evidence and the heuristics of behavioral economics. “I’ve been giving this drug for 20 years. It’s always worked for me. I’m not trying this new thing.” I’m not quite sure what the deal is. Help me understand, because there’s some disconnect between the way you are all expressing the power and the compelling nature of the story around biosimilars and, at least in everything that I read, their market adoption. Who is going first on that?

Bhavesh Shah, RPh, BCOP: I can take that. Payers can be the biggest roadblock, obviously. We’ve seen in Europe that they have a significant conversion for biosimilars. Their conversion is anywhere from 70% to 80%.

Bruce Feinberg, DO: Hold on. When you say conversion, are we talking about a patient who is on a reference biologic being converted to a biosimilar? There are 2 things we have to establish and get into. One would be the clinical scenario. I think the potential for using something novel—even a brand-new drug or the case of a biosimilar, a new design—is a different threshold for supportive care versus palliative care versus curative intent care.

That’s 1 aspect. The other would be the conversion factor. I might start a new patient, but I’m not going to have an established patient who is being effectively treated and switch them, because it’s not fair to them. I’m introducing some, albeit small, element of the unknown. I want to make sure we address both of those issues in this part of the conversation.

Bhavesh Shah, RPh, BCOP: Sure. I’ll have Dr Diaz address some of those concerns too, but I’ll give you my perspective. I think that because Europe is actually a single-payer system, you have a much better chance of converting because the government controls what biosimilar you are going to use for the health care system. If that was the case in the US, we would actually have a pretty big conversion rate from a reference product to a biosimilar as well.

I think we leave it up to the payers to make that decision, and of course, it makes sense for them to take whatever cost savings they were able to get and to use that for their plan design.

In regard to your question about efficacy of supportive care versus cancer indications, from a pharmacist’s perspective, if a drug actually has the same mechanism of action and its pharmacokinetics and pharmacodynamics are the same, I do not anticipate that you’re going to see different results in an adjuvant setting versus a metastatic setting. If that was truly the case, the FDA would make them do a much longer clinical trial to show that. The scientific rationale has been established, and I truly believe there is no difference, but that may be 1 of the issues where there is a hesitance from providers. They think that maybe not using this in the metastatic setting is OK, but in the adjuvant setting, I don’t have data for 5 or 10 years for me to say that you’re going to have the same type of efficacy in that setting. I’ll let Dr Diaz talk about what his perspective is on that.

Bruce Feinberg, DO: I think this issue is more than that. When we take a compound and we make it orally bioavailable, even though we can measure the exact same chemical in the blood, we are still doing all that same testing. We are still starting that new orally bioavailable compound in salvage therapy, then first line, then adjuvant. There is a big difference here, and it has got to bring about some kind of emotional responses, even when you get outside pure logic.

Michael Diaz, MD: Whenever I look at it from my perspective, historically speaking, at least in the US, the biosimilars first became more available for the rheumatologic products, and they’ve been out for a while. I’ll be quite frank with you. I don’t prescribe those, so I am not going to comment a lot on those. Where the biosimilars came into play in oncology was the supportive care of medications, and we started having those available last year. This is still a little recent, and even more recently, within the past several months, we have the biosimilar therapeutics available.

It has not been a lot of time, but there are so many different factors that play into whether something is going to be entertained as an alternative. I’ll just give a generic empiric example. If you have a biosimilar that comes out that is priced the same as the originator product, what is the incentive to do or change anything, from a patient perspective, in all reality? Pricing is a little component in there, and then on top of that are the most important things, efficacy and indications.

As long as you have the same efficacy and indications, doctors will look at pricing, and that is 1 of the things that has to be taken into account. We are just starting to get our arms around it and getting comfortable with choosing a biosimilar instead of a reference product. We have been bombarded with a lot of education, in a positive way, for the past several years while oncologists have been waiting for the biosimilars to become available. I know so many doctors I talk with who were excited as the products came to market and they could actually prescribe them for the patients, and then they would see that their hands are tied. They can’t prescribe it. Why? It is not approved by the payer. It is not on formulary with the payer or in the system. That could happen for a multitude of reasons. Each different system, whether it’s Medicaid, Medicare, or commercial, is so complex and unique that you have to be a specialist just to understand what those differences are and how they function in each of those environments.

There are a multitude of factors that have made practices slow to adopt, but now that we have them, especially with the therapeutics, for example, my practice is at least at 60% conversion, and we are trying to shoot for 80% to 90%.