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Challenges of Biosimilars With Interchangeable Designations


Maia Kayal, MD, MS, and Kimberly C. Chen, DO, MSHLM, discuss challenges for biosimilars with interchangeable designation related to automatic substitution in the pharmacy.

Ryan Haumschild, PharmD, MS, MBA: I appreciate the examples of accountable care organizations. And when we think of financial stewardship, you find organizations that have a payer arm and a health care provider are a lot more integrated, and they’re willing to create that interchangeability to help best steward health expense for their organizations and, hopefully, the patient as well. Dr [Maia] Kayal, as we know, there are some challenges for biosimilars with interchangeability designation related to the auto substitution in the pharmacy, as we see with AB-rated generics or small molecules. What are your thoughts on that as a provider about some of those challenges and some of the state laws that come into play?

Maia Kayal, MD, MS: That’s a great question. Every state in the United States has its own interchangeability laws. And the challenge is understanding that these laws vary from state to state and how that impacts getting the medication into the patient’s hands. These laws vary with respect to communicating with the prescribing health care provider that an interchangeable biosimilar is going to be substituted for the reference, they vary with respect to how that is going to be communicated to the patient. And then, of course, they also vary with respect to how this is going to be documented by the pharmacist. In addition, something that Dr [Jonathan] Kay mentioned is that the interchangeability really should only apply if there is a cost benefit to the patient. So many states are going to require that as a metric that is met only if there’s a cost benefit to the patient, and an interchangeable biosimilar is substituted for the reference product. So this adds another layer of challenges to the pharmacist because they have to understand each patient’s managed care landscape, their plan formularies, and whether this is increasing the patient’s out-of-pocket cost. So the challenges are really because the laws aren’t uniform across the states. Understanding each state’s variability is key for the pharmacist and the provider to ensure that they’re getting the right interchangeable.

Ryan Haumschild, PharmD, MS, MBA: I thought I had interchangeability down and now I’m realizing it’s so much more complex. It’s not just complex for the provider who’s having their prescription dispensed, but it’s also for the payer. Dr [Kimberly] Chen hearing these complexities regarding new start, switches, and state laws, what are some of the strategies and maybe even challenges related to this automatic substitution that you and your team will have to work with?

Kimberly C. Chen, DO, MSHLM: I think one of the biggest challenges right now is for that new start in the switches, it has to be led by the physician. And sometimes, as we have discussed earlier, that understanding and alignment between the physician and the prescribing physician’s willingness to do that. Definitely, there needs to be more efficacy, and providers are currently still seeing it as case-by-case versus that automatic substitution or the switch. I think that’s a huge challenge, especially when their patient has been doing well on a biologic and now all [of a] sudden we’re going to switch. That lack of incentive can make it much more challenging for the provider to spend time to talk to the patients, as well as patients reluctance because they’re so comfortable at what they’re currently using. I think that is one of the biggest challenges. How do we figure out incentives to really mitigate that change for both provider and the patient? I think some of the strategies are really incorporating some performance incentive to the provider, as well as value-based contracting to have those meaningful conversations with providers, formulary design, and prior authorization. I think those are some of the typical things that we usually do for our plan design. And for the patient wise, how can we decrease their out-of-pocket expense and also incentivize them to be part of this reform to decrease medical costs?

Ryan Haumschild, PharmD, MS, MBA: It really does seem like shared savings is a shared win for everyone.

Kimberly C. Chen, DO, MSHLM: Absolutely.

Ryan Haumschild, PharmD, MS, MBA: And the way we can approach it from that perspective will help us be successful, especially mitigating a lot of these technical state laws and dispensing considerations that will probably have to be built into some type of EMR [electronic medical record].

Transcript edited for clarity

This activity is supported by an educational grant from Boehringer Ingelheim.

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