Considerations on the role of specialty pharmacies with regard to the dispensing of biosimilars versus biologics.
Al Heaton, BS, PharmD, RPh: How does the specialty pharmacy work in your environment, particularly with biosimilars?
Kyle Skiermont, PharmD: So I think this really gives the opportunity for the specialty pharmacy to do some education, quite honestly, and that may be for the provider, it may be for the patient. But because there are no interchangeable biosimilars at this point—generally if an order is coming to the specialty pharmacy to be fulfilled and either go to a patient for self-administration or back to a provider’s office for a clinic administration—if that change needs to be made, what the specialty pharmacy can really do is be the patient’s advocate, right? And quite honestly, the providers advocate a lot of times to do that education if required, about why a plan may have chosen to cover 1 medication over another, or to help the provider and the patient understand that these are medications that are highly similar and have no significant clinical differences between them. And so, it’s all really to help put that patient at ease. I think that’s the biggest thing. But then working with the health plan it’s, how can we implement the utilization management that the plan is trying to do?
So if a plan has biosimilar A on formulary, and that’s really what they’re driving toward, we can help with making that change, reaching back into the provider’s office to explain to them why the change is needed and that it will be financially beneficial, generally, for the patient. But then similarly doing that same education with the patient to help them understand the change, what the significance—or more brightly, the insignificance—really is.
Al Heaton, BS, PharmD, RPh: Insignificance, yes.
Kyle Skiermont, PharmD: Right. Of that change for them clinically. But financially, they’ll see benefits. They’ll see a lower out-of-pocket cost from making that switch.
Al Heaton, BS, PharmD, RPh: And I think on our side, we’re also very sensitive to employer groups. We have thousands of employer groups, and not one employer group that I work with has said, “We want to increase our drug cost.” They’re very attuned to the biosimilar marketplace.
Kyle Skiermont, PharmD: And as more and more patients switch, and I think as the specialty pharmacies continue to work with providers’ offices, and that’s why for us, at least, we take that opportunity to try to do the education with the provider. And so, instead of just making that connect point with the provider and saying, “Hey, here’s another patient. We’ve got to switch from A to B,” you know, really trying to help them understand why that switch is happening and, as we were talking about, I said the significance but really the insignificance clinically of what that change means for their patient, such that it becomes more routine and they understand it better and become more open to it.
And what we start to see, then, is that oftentimes the provider will start to write for, instead of saying, you know, a particular trade name or a particular reference product, they’ll start to write for the closest thing to a generic in the biologic space. The kind of the true drug name such that we can use the one that is going to be the most beneficial from a financial standpoint for the patient without having to do a lot of back and forth between the pharmacy and the provider’s office.
Jonathan Ogurchak, PharmD, CSP: With there not being any interchangeable biosimilars at this point, what truly is the role of the specialty pharmacy? And yeah, you touched on utilization management, you touched on education, and I think the education component, in particular, is going to be truly required as it relates to the naming conventions of the biosimilars.
Now, as per recommendations from the FDA, a drug’s approved molecular name for a biosimilar will match that of the reference product. But now it needs to have a 4-character suffix applied to the end of it. So for instance, in the case of filgrastim, the reference product’s name remains the same as filgrastim for now. However, the biosimilar has a suffix, either —sndz or —aafi, appended to the end. And this allows for brand medically necessary designations to come through from the provider’s perspective. But it doesn’t relegate the prescribing to the original trade name.
Now the FDA published a 15-page guidance back in January 2017 on appropriate steps for manufacturers related to submitting potential suffix candidates at the time that the drug is submitted for approval. And it also recommended how this is going to be managed on an ongoing basis by the FDA through The Purple Book. But it really doesn’t provide a framework for prescribers to have an understanding of what products might be available and what that eventual interchangeability might look like.
So from an educational perspective, it truly helps for a specialty pharmacy, or specialty pharmacist, to get involved to help to educate those prescribers as far as what might be available.