Biosimilar Decision-Making Process in Clinical Settings


Marc Earl, PharmD, BCOP, and Tim Peterson, PharmD, BCOP, share their clinical experience with P&T committee decisions, the cost of switching, and the payor selection process for a patient.


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Marc Earl, PharmD, BCOP: We started about 5 years ago and worked through our P&T [pharmacy and therapeutics] and formulary committee to really set the stage for what a biosimilar is—everything that we’re talking about here today. How are we going to review these products? Are we going to bring them through P&T individually as a class? That set the groundwork for how we were going to review them. The first product was the white blood cell growth factor space and have most of the experience there.

Anthony Mato, MD, MSCE: Can I ask you a question since you brought up P&T? What is the conversation like in a P&T committee, is it primarily that the data look sound, the cost is less, and that you’ll bring it on formulary? How do you make the decision? What would be an example of a reason you wouldn’t bring a biosimilar that was approved on to the formulary?

Marc Earl, PharmD, BCOP: Our conversation was back to the analytics, the science a little bit. We had to start there and really show that this process is sound, and that we believe in the process. That took some time for everyone to embrace. I think once we got there, it was both pharmacists and physicians messaging that we believe in the biosimilar process, and we believe they’re safe and effective. We haven’t had situations where a product came, and we said that we don’t believe in this product for some reason. A lot of it comes down to patient services and cost but no efficacy or clinical concerns that caused us to pause.

Anthony Mato, MD, MSCE: I would assume if the FDA approves it, the data will be sound. I doubt that there would be reason to doubt that. But I guess my question is a little more: is there some cost-savings threshold that triggers an approval versus not on the formulary level? Is it 10% difference, 20% difference? I don’t really know what the answer should be, but I’m just curious. When these conversations happen, how do you decide it’s worth it to bring a drug into a health system?

Marc Earl, PharmD, BCOP: The 1 thing we have to think about is what I call the cost of switching. There are order sets that have to be updated, inventory that has to be depleted and moved, education that providers, nurses, and pharmacists may need. For us in a large system, that’s not cheap, and so we feel we need to overcome that cost of switching. It depends on the product, but probably it’s at least 10% to be able to account for all that time that’s lost in moving order sets or switching patients.

Anthony Mato, MD, MSCE: Finally, Tim?

Tim Peterson, PharmD, BCOP: Similarly, we would be going through the P&T committee and formulary adjustments. We started with the white blood cell growth factor area as well. We have the most experience with our tbo-filgrastim, Granix, which was the first addition to our formulary for the white blood cell growth factors. That’s where we have the most experience. Honestly, just in the past few months is when we started to unroll a more formal biosimilar pathway that we have now. Basically the provider can order a dispense as written type situation if they would like to do the reference product. But this is very much so financial services driven.

The provider will order a rituximab or trastuzumab reference product, and our financial services will reach out to the insurance, do a prior authorization, and identify which biosimilar they would prefer. If they prefer the reference product, which some buyers still do, or biosimilar A, B, or C, then the financial-services folks will actually put an order into our EMR [electronic medical record]. This is so that when the pharmacist is verifying the reference product or biosimilar, they can pick whichever agent is preferred by the patient’s insurance company.

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