Formulary Inclusion for Biosimilars

Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP: Taking a look at different types of health systems or payer-based formularies, it takes a lot of work to understand what that needs to be. When you had a health system, we’re addressing it from a patient’s safety profile, utilization, and other comparators as well. But the payers will help define what we get paid for. Insurance companies, when looking at the pharmacy and therapeutic discussion, will be looking at implementation across the board for that biosimilar.

If we have one payer, they may have a preference for one. If we have multiple payers, you have a preference for several. That also means we’re going to have to have a large amount of space on our shelves to keep those formularies in place.

When we take those next steps, looking at indications and discussions as well, we’ll also have to address both those pieces together. So you may have your own formulary. Or you may have the payer formulary, and therefore working to address what biosimilar or biologic needs to be on the formulary will be an important discussion. Because even though you may have it on your formulary for use, it may not be the one you’re going to be using for that patient itself, because you are defined by the payer to utilize that biosimilar.

Kashyap Patel, MD: Again, we bring back the PBMs [pharmacy benefit managers] and the healthcare plan. This is where we get somewhat frustrated. We’ve done our best to help educate the payers as well as other stakeholders. And from what I’ve heard, we are now going to be working directly with the employers. What we feel is that if a specific payer and the PBM work together to restrict the access to the drugs, which could be less expensive compared with the parent compound, we want to reach out to the employers and let them know that you are paying for this help and the health plan is asking you to pay for the most expensive drug.

We’ve seen a lot of movement, awareness, and concerns from the national business groups on health about such tricks played by PBMs as well as by the health plans. We definitely are doing our best to really throw sunshine on the options to reduce cost of care, and how factors that are beyond anybody else’s control can limit our success of once-in-a-lifetime reducing of the price in the US.

Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP: Will a biologic or biosimilar be implemented based on first-line therapy, like a curative index, or for relapsed-refractory discussions? That’s a very tricky question. We have seen preferences coming from ASCO [the American Society of Clinical Oncology Annual], where we had seen it earlier on, about in 2017, when a survey was done that said that physicians would prefer to use a brand-name biologic for curative therapies. But when it came to relapsed-refractory therapies, they were more available to use a biosimilar in that refractory-relapsed setting.

I don’t think we’re at the point right now to address either fail-first or curative therapy discussions, but I do think it may be a question in the future. However, the one piece we haven’t addressed is, that may not matter. If a payer defines us as using 1 biologic or biosimilar, it doesn’t matter what the preference is—you’re actually mandated to use that product alone. Therefore, that discussion may be pulled out for another scenario altogether.

It’s a great discussion. It’s a great contemporary evaluation of what’s happening. But I often think that we’re maybe jumping the shark to address what biosimilar biology to use, because we’d be payer defined early on.

Kashyap Patel, MD: This question probably may be answered more by the PBMs than the insurance companies. As far as Medicare is concerned, there is no question about it. I think the policy was, at one of the insurance companies I was talking about, they work in conjunction with the manufacturer, which is probably not the best. But we are struggling and we are fighting every day to ensure that access to less expensive, equally effective drugs is uninhibited and is not influenced by whether it’s PBM or whether it should be the insurance plan.