Biosimilars, Payers, and Formulary Changes

Amanda Forys, MSPH: I know [it’s] not just patient costs, but looking at the payer implications of biosimilars is a huge deal, because obviously, patients [don’t] even have access to biosimilars if payers aren’t covering them, or manufacturer programs aren’t there that give patients access to the products.

Let’s turn a little bit to the rheumatology space right now. We’ve looked at [rheumatoid arthritis] RA, [and] we now have 2 products on the market. We’re seeing about a year now of Inflectra, that’s been on the market, and then Renflexis is just coming out in the past few months. We’ve seen some legal battles between those 2 products: the issue around potentially bundling services or keeping the products on formulary and kind of setting the payment arrangements so that you are blocking a biosimilar from getting on a formulary.

In thinking about accessibility for a patient, it would be great if you could have the biosimilar on the same formulary and the patient can decide what tier product they want to have, but that might not necessarily be the way it goes.

The manufacturer may work out an arrangement with the payer that either the brand product stays on, or they have both, or they prefer the biosimilar. We have seen instances where the biosimilar product is being placed on formulary and the reference products are coming off of that.

Can you talk a little bit about formulary placement and how that contracting process is influencing things, what you might see from a patient perspective, [or] what would happen to them given some of those decisions?

Christy M. Gamble, JD, DrPH, MPH: So that’s really interesting, because patients who are doing well on a particular therapy want to stay on that therapy. When there’s a formulary change, particularly mid-year, that causes some concern and frustration for patients. It really comes down to sometimes being life or death. Some patients feel like when there’s a formulary change, it’s like pulling the rug out from underneath them.

There starts to be this concern about effectiveness: “Is this new therapy that’s being covered just as effective?” You also have conversations about contraindications: “How is this going to interact with the other medications and drugs that I’m taking?” Then you also have the cost conversation: “How much is this going to cost me in terms of out-of-pocket costs?”

Patients tend to want to stay on medications that are most effective, and [that] their provider sees as most effective. Then it becomes difficult in terms of price once it’s off of the formulary, or it’s not on the preferred list. Patients start to think: “Am I going to be able to cover this?”

It’s very frustrating for those that have autoimmune diseases or rheumatoid arthritis or lupus for instance. They start to think about, “What am I going to do now? Should I switch and possibly have a different reaction to a drug?” As you know, drugs interact differently for different disease states and within certain individuals. So now you’re running the risk of changing to a medication that may have some adverse effects, and now you’re going to be hospitalized, which raises the costs to the US healthcare system.

You have, like I said, this life or death situation here, and patients aren’t really willing to take that risk. It’s really sad that insurers are willing to take that risk with patients. So, you have a lot of frustration and a lot of anxiety for patients, and that’s why you’re seeing states like California and Nevada introduce policies where they prohibit any mid-year changes in the formulary, because if you sign up for a plan and this is a covered drug, and you sign up for it for a year, you should be able to stick with that covered drug for a year unless there’s a medical reason why you should not. We’re really advocating for policies just like that. Medicare does it, unfortunately Medicaid doesn’t.

But, like I said, patients really are anxious about it, and if their provider is saying, “This is the medication for you,” the patient should have access to it, and it should be covered, and cost shouldn’t be a concern.