Perspective on the factors that determine inclusion of biosimilars onto a formulary.
Al Heaton, BS, PharmD, RPh: We touched upon the formulary from a healthcare plan’s perspective and how we’re working with our P&T [pharmacy and therapeutics] committees on therapeutic equivalence. From a provider perspective, and you’re a supplier of many of these drugs to provider facilities, how are you approaching this formulary issue?
Kyle Skiermont, PharmD: Al, that’s a great question because I can’t tell you how much time I spend lately with the manufacturers coming to me asking, “How do I get my new product placed on your formulary? We have a biosimilar coming out. How do we ensure that we’re on your formulary, as the provider, as the health system?” And I think it really differs if we’re talking about an acute care kind of hospital-based formulary versus if we’re talking about what we may use in our infusion centers, self-administered, kind of the outpatient formulary. For a hospital formulary, it’s pretty cut and dry. We’re going to go with the most cost-effective, clinically effective medication. So when you think about branded versus generic and the more traditional small molecule, we’re going to go with the least expensive thing that we can get that’s effective.
Al Heaton, BS, PharmD, RPh: That’s generic.
Kyle Skiermont, PharmD: Right. I think in the reference product/biosimilar world, we’re looking at it similarly. If you look at the definition, they have a high degree of similarity. So generally we would pick one that is going to be the most cost-effective. What we found so far though, and again, there’s definitely more coming, the biosimilars that have come out to date, are used more in the outpatient setting in our infusion center, some even being self-administered. And there, what we’re finding is we really need to stock everything. So our formulary really needs to be broad, and that’s because if we look at our 5 or 7 major payers that we work with, if there are 3 products in the marketplace, odds are 1 of those 3 is going to be the preferred agent for any of those payers.
And so for us, to really provide the best care to our patients and to make sure that they can get what’s going to be the lowest cost option for them, we really would have all of those things on our formulary and have them be available such that if a given payer required, or if there is a definite advantage to the patient financially to use a given product, we’d make sure that we would have that product on our shelves, on our formulary ready to go for that patient’s infusion.
Al Heaton, BS, PharmD, RPh: OK, so you are listening to the payer. That’s refreshing, from a payer perspective, to hear. And the payer’s driving that, but it really comes down to the cost to the individual. In my case, member; in your case, patient.
Jonathan Ogurchak, PharmD, CSP: You bring up a good question as it relates to focusing on approaching formulary and how to ensure that a molecule might show up on the formulary. You know, it’s interesting to see how the FDA has approached this. The FDA recognized that when they set out precedent in the Affordable Care Act back in 2010, it really didn’t quite fit the needs that were necessary to build an eco-system for biosimilar uptake.
So this past July, the FDA released a biosimilar action plan, and it encouraged all parties that were involved in biosimilar development to submit information on how to build a better environment, for not only the manufacturers but the payers, the patients, the pharmacies alike, to grow and fully capture cost savings.
In this action plan there was a public hearing that was held in September of 2018 that developed some key takeaways, and it’s looking to find ways to better address some of the concerns that have come about to date.
So first and foremost, it’s looking to find ways to develop a global reference product for each molecule so that way it helps to expedite the review process for future biosimilar drugs. It looks to find ways to fix the Purple Book. It makes the Purple Book for interchangeability guidance become a little bit more clear for the pharmacist that will likely be using that on a go-forward basis.
Most importantly, it’s looking to find ways to determine what interchangeability requirements are necessary for these drugs to be approved and deemed interchangeable by the FDA so that pharmacists can now practice on a state-by-state basis to make those swaps as necessary.
It wants to find ways to improve not only education and awareness to patients and providers alike related to biosimilar drugs, but address potential misinformation that’s related to the reference product switching for patients that may already be established on a biologic medication. And lastly, it wants to find a way to fix this 4-letter suffix program with the guidance that was put out there by the FDA. Is there a way to better manage this and better maintain this on a go-forward basis?
Now at the time of this taping there are notes forthcoming. Nothing’s really been identified as true takeaways, but the FDA has recognized that there are some issues, and they are actively looking to address and fix them moving forward.