Regulation, Policy, and Litigation in Biosimilars - Episode 8
Amanda Forys, MSPH: Molly, if what we have talked about is set in place and it’s hard for a patient to have coverage for a biosimilar, what effect could there be for the formulary placement of biosimilars and reference products, downstream? How do you get your product adopted by providers? What do you do? Who actually drives that uptake?
Molly Burich, MS: It’s a great question. I think we believe that health plans play an important role, certainly. They make formulary decisions—good, bad, or indifferent. I think the challenge of biosimilars is that what we’re really trying to do is help bend the cost curve and be a part of the solution for high cost specialty drugs. They’re high cost to all stakeholders. They’re high cost, certainly, to patients (as we know). They’re also high cost to health plans and employers. So, there has to be some support from the payer community as well as the physician community, and, certainly, patients who we want to buy into the promise of biosimilars. But we will need payers to be willing to push biosimilars.
It really comes down to the long-term sustainability of the market. If the first few biosimilars that are on the market as approved, are coming to the market, or whatever their status may be, if they can’t get the type of uptake that really does start to bend the cost curve, I think all stakeholders will grow tired of the hope. I think physicians will say, “This isn’t really helping my patients.” I think patients, if they don’t see a change in their cost share, will grow tired of it. And I think this will also affect the manufacturers who are investing a great deal of money in biosimilars. They are significantly more expensive than bringing a small molecule generic to the market. And they are much timelier. I think that you will see that the sustainability of the market in the United States will start to wane. I don’t think that’s good for any stakeholder, so I think it’s probably all about finding the right balance. To Angus’s point, we want to make sure that physicians are driving treatment choice and making decisions on what’s most appropriate. But at the same time, for the patient in whom a biosimilar is appropriate, and certainly when we hopefully see interchangeable biosimilars, we’ll start to see even more utilization.
I caution that we are in the early days. We have 3 products launched. No single defined the success of the generic market on the first couple of products, so I think we have to give the market some time. But I think it’s also fair to acknowledge that payers, health plans, and pharmacy benefit managers all play an important role and are important stakeholders in this, just as physicians and patients are.