Navigating Biosimilar Adoption: Lessons from Global Markets and Clinical Practices

Featuring Michael Kolodziej, MD, Consultant, Canopy

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Michael Kolodziej, MD: Hi, I'm Mike Kolodziej. I'm a medical oncologist. I practiced for over 25 years in both academics and the community setting with the US Oncology Network. In 2014, I went to Aetna and ran oncology programs for about 4 years. I was at Flatiron Health briefly, and then I was a consultant in Washington, DC, for 5 years with AbbVie. I'm mostly retired now. I still work with a startup called Canopy. But most of the time, I write my health care blog and try to keep up with current events.

Are there global lessons from countries with higher biosimilar adoption rates that could inform US payer strategies?

Dr Kolodziej: It's funny because several years ago, I had a poster at ASCO that actually addressed this very question you just asked me, which is what would happen if we changed the economics and the dynamics of long-acting white cell growth factor use.

I suggested that if we followed the European lead, the health system would save a ton of money. It's funny because somebody from Europe came up to me at the poster, and he said, "In Europe, we don't even talk about the cost of white cell growth factors because in our mature biosimilar markets, they're very inexpensive." I think we can expect the same to happen here.

If you followed how quickly people have adopted the biosimilar pegfilgrastims, the biosimilar trastuzumabs, and the biosimilar rituximabs, there's a slow but steady migration to the biosimilar products. In general, that migration has been mirrored by a reduction in the price. So, I think payers should be encouraged.

I don't want them to shoot themselves in the foot. They seem to like the idea that they can contract directly with biosimilar manufacturers and try to get some of that rebate money. I think, if I were in charge, I'd let the practices choose their biosimilar of choice, and I would happily accept a 50% price reduction if they used a biosimilar compared to the single-source or reference product. But I don't work for the payers anymore, and God knows they don't listen to me.

How should payers navigate scenarios where biosimilars are less preferred by certain patient subgroups despite clinical equivalence?

Dr Kolodziej: That's a hard one because when I was in practice—it’s been a while since I practiced oncology, but I still do primary care—back when generics were really just starting to get going, there would be patients who would come in and insist that you wrote their prescription dispense as written (DAW). Over time, that essentially disappeared. I would predict that brand loyalty by both physicians and patients will disappear. I think confidence that there truly is therapeutic equivalence will become the norm.

Now, the question will be, will we see circumstances where the reference product has a clinical advantage in certain therapeutic circumstances? That hasn't happened yet, as far as I know. But remember, biosimilar approval by the FDA does not require therapeutic equivalents for every single indication. That is not the requirement.

So, it is possible that there will be scenarios where the single-source product will be the preferred one. I would suggest to you that the way the payers will manage that, of course, is through prior authorization. If you happen to have a patient that has that condition where the single-source product will be required, you will be required to prior authorize them. But if there is clear evidence of clinical superiority, I don't anticipate a problem with getting the drug for that patient, if the criteria are met.

How can payers collaborate with community oncology practices to enhance understanding and adoption of biosimilars in underserved areas?

Dr Kolodziej: I've already said the one thing they should do: they should just stop arguing about which biosimilar to use and agree on using a biosimilar. That's number one. If that occurs, nature will take its course because, of course, the economics for biosimilar use—given the really nice contracts that most practices have access to through their group purchasing organizations (GPOs) and what have you—make them, honestly, a better economic choice for the practice.

I don't think there really is an issue regarding availability in any distinct patient subset. The drugs are out there in a biosimilar formulation. If they're out there, they're available. So, I don't see that as a problem.

How do you see biosimilar strategies evolving over the next 5 years, and what should payers be planning for now?

Dr Kolodziej: We should expect that what happened with generics is going to happen with biosimilars. As I'm sure you're aware, 90% of all prescriptions in America are for generic drugs. I'm on 4 medicines. All of them are generic, and I don't pay for any of them. They're all free, with 0 copay. I would say that if we follow that same trajectory with biosimilars, it will be a very good thing.

Now, I would also say that if payers are wise, they'll exercise some restraint in being too aggressive with utilization management if they know that a biosimilar cliff is looming. Don't be tough guys in utilization management. Ultimately, if what happens is what my friend from Europe told me, this is going to become yesterday's problem, and we won't have to worry about utilization management because utilization management has no role in a world where things are inexpensive. It just doesn't make any sense. Hopefully, payers will recognize the wisdom of keeping cool about drugs where they see that a biosimilar opportunity will present itself in the short term.