Patient Assistance Programs and Biosimilars

Amanda Forys, MSPH: If they can’t get to it and can’t get access to that product, I know we’ve got this whole concept of the manufacturer assistance program. Innovator brand products have these programs and they offer either co-pay assistance, free drugs; for Medicare they can donate [to] independent charitable co-pay foundations that blindly have the money for the patient, so I know that the rules are set around that for the Medicare program.

I know biosimilar manufacturers are being expected to put these programs out there, they are out there; what do you think about these programs and their role? I know that there’s that dance between payers and the manufacturer programs that a lot of payers say, “This is your due diligence as a manufacturer, you should be doing this.”

Then other payers might think, “Yes but, you’re now putting a patient on a product that isn’t necessarily on our formulary, and now they can get an exception potentially or we can continue that therapy instead of leaning them clinically toward what we would like to see the patient on.”

How does that assistance program work and how do you see biosimilars having to run those?

Christy M. Gamble, JD, DrPH, MPH: So, the concept is great: helping patints. We’re seeing sky-rocketing drug prices for all drugs right now. The concept of helping patients pay for their co-pay and getting access to free medication—I know some programs even help with travel and helping patients select the right insurance plan that will cover their medication.

The concept is great. But just thinking about the effects of it on the other end…a lot of these programs are pushing patients to take drugs that are higher priced drugs, that may not be as effective as the drugs that they’re taking. Also, if you have 2 drugs that are just as effective, and 1 is lower cost, and 1 is covered through the patient assistance program that is a higher cost; patients are being pushed now to get that higher cost biosimilar or biologic.

We just don’t see that as a very wise policy to support. On the back-end, we’re seeing that these drugs are going to get paid for, and that it’s coming out of the pockets of taxpayers and we don’t want to participate in “gaming the system,” which is how we really see it.

While the concept and the mission and the goal is accurate and correct for these patients, we’re not really sure that we can support programs that push patients to these higher cost biologics and biosimilars because our goal is to make sure that patients have access to lower cost [drugs] and not have a high out of pocket cost, and that means even if its shifted to other payers such as taxpayers, we don’t think that should be the case at all.

For patients, what they’re looking for is, “Just give me the drug that treats my condition effectively, that manages my disease, and that’s a lower cost for me.” We think that patient assistance programs when having these discussions, this is the best time to talk about, “Okay, we wouldn’t need these programs if the drugs were not so high in cost. So, let’s talk about the cost of your drugs instead of providing co-pay assistance, maybe we should talk about lowering the cost of these drugs.”