Kimberly C. Chen DO, MSHLM, and Maia Kayal, MD, MS, review the challenges related to biosimilars from the payer perspective and strategies payers may employ to help improve the uptake of biosimilars.
Ryan Haumschild, PharmD, MS, MBA:Dr [Kimberly] Chen, we talked about some of the challenges from the provider’s perspective. But I know there are challenges also from the payers’ perspective. What are the challenges associated with biosimilar uptake?
Kimberly C. Chen, DO, MSHLM: I think one thing important to note is we definitely need to educate the providers and make sure there’s an incentive for providers as well. And to everybody’s point, making sure providers are also supported. From the health plan perspective, we have a whole team of pharmacists and a whole team of case managers who can further educate in making sure the patient or members are compliant with taking their medication and understanding what biosimilars are. And how everyone can work closer together to support the members?
Ryan Haumschild, PharmD, MS, MBA: Close collaboration is so important. But we also know strategy and design of the benefit also plays an important role. Dr Chen, what are some of the strategies payers can employ to improve the uptake of biosimilars? And how does that intersect with the plan design when you’re creating kind of that incentive for use?
Kimberly C. Chen, DO, MSHLM: It goes back to the strategy a lot of times and we already talked about the education. Educating the members as well as the providers. Because providers in large health systems are very familiar with biosimilars, the biologic concept. But when you go to the more rural areas, many providers do not know about biosimilars. I think definitely that education to the provider, alignment, and collaboration between the provider and health plan, is always subsequently going to be a win-win to better support our members. But to talk about the plan design, I think we all talked about incentives for the members. Patients, how can we help them with the injection of the biosimilar, especially if it burns? Or can we send a home health care nurse to go help them, even though maybe their initial health plan does not provide that service? And then tier and try to get them into the formulary. Those are all different things we can do on the plan design.
Ryan Haumschild, PharmD, MS, MBA: Excellent. Thank you for that overview. As we talk about biosimilars, there is sometimes extrapolation of data. You might have biosimilar data in rheumatology that you might need to extrapolate to GI [gastrointestinal]. And this happens sometimes just based on the cost to fund the studies and kind of the clinical overview. Dr [Maia] Kayal, what are your thoughts on the extrapolation of clinical data across multiple indications?
Maia Kayal, MD, MS: I think it’s appropriate in the setting. We talked about how a biosimilar has really no significant clinical difference in terms of safety and efficacy from the reference product. So this idea and based on the idea of extrapolation, then the FDA can approve a biosimilar for all the indications that the reference product is approved for. For example, you just mentioned if the reference product is approved for rheumatologic and gastroenterology indications, then the biosimilar can similarly be approved for the same indications. I think if we get to the reason why we even have biosimilars, it makes complete sense to extrapolate across clinical indications. If the reason that we’re pursuing this road of biosimilars is to reduce costs, to get more drugs into the patient’s hands, to reduce the time to approve a new agent and the cost that’s associated with that approval, if you have the data to support that the biosimilar is essentially very similar to the reference products in terms of pharmacodynamics and immunogenicity and safety, then it makes sense to approve across clinical indications to the reference product. I think it’s been a welcome addition in terms of the FDA approval process that all the indications for which the reference product is approved to carry the biosimilar because it just decreases the time that we get these approvals.
Ryan Haumschild, PharmD, MS, MBA: So not just highly similar of a molecule, but maybe highly similar to the reference indications.I like how you explain that.
Transcript edited for clarity.
This activity is supported by an educational grant from Boehringer Ingelheim.