Sonia T. Oskouei, PharmD, BCMAS, DPLA, from Cardinal Health, talks about the differences between provider and pharmacist concerns and whether health organizations giving more power to pharmacists causes conflict with physicians.
Sonia T. Oskouei, PharmD, BCMAS, DPLA, is the vice president of Biosimilars at Cardinal Health.
How do providers’ concerns about biosimilars differ from those of pharmacists?
We probably can't generalize the similarities or differences with concerns with biosimilars. What we could do is look at it from a different lens to try to understand what considerations may be more prevalent for each stakeholder type. For example, given the premise of biosimilars, in that they have clinically no meaningful differences and expected to have the same outcomes, there could be a bias from a provider perspective to continue utilizing the treatment they're most familiar with. So, there's an element of "why switch," which has really been overcome by the financial assessments that show economic benefits that can be realized by the patient and the organization. But that could be concern that's more top-of-mind from a provider perspective.
Now, from a pharmacist perspective, in addition to clinical considerations, given the role they play within their organizations in evaluating products for formulary addition, for example, there's more exposure to the financial and operational components of biosimilars as well. Challenges can include conducting payer coverage assessments and the inventory management implications of varying payer policies, which can result in carrying some biosimilars, all biosimilars, and the originator biologic at times.
Additionally, there's an IT [information technology] component in which the pharmacy and P&T [pharmacy and therapeutics] committee must ensure the appropriate EHR [electronic health record] system updates are made to the preferred drug list, data or order sets, and ensure the right products are procured, administered, and billed accurately. So, there's some additional considerations, outside the clinical component, that may be more top-of-mind for pharmacists as well.
Is there a solution to the cost and complexity that health care clinics face in having to stock multiple biosimilars to meet diverse payer policy requirements?
It is definitely a significant challenge, and there's not really a one-size-fits-all perfect solution to this, unfortunately. But depending on the facility size, patient volume, and, most significantly, the payer mix naturally in their policies, different approaches to the procurement process and inventory management may be necessary. For example, we've seen clinics limit their inventory for these outpatient infused biosimilars to just a couple days' supply or a couple of weeks' supply to be reflective of the patient's schedule in that time period.
So, strategy such as just-in-time ordering from a distribution standpoint to enable that quick turnaround time needed to meet the needs. Another example of strategy is obtaining prior authorizations as part of the workflow prior to purchasing or procurement the products. So, this is to ensure the right product is available to be administered to the patient and that it will be reimbursed. This continues to be a challenge, especially as we get more and more products entering the market for the same existing biologics, and it continues to be top-of-mind as a key challenge with adopting biosimilars.
Do physicians think it controversial to allow pharmacists to switch out reference products with biosimilars?
I don't view this as a controversial move, because these decisions really are not made in silos. So, particularly in health system settings, there are often agreed-upon pharmacist-led initiatives approved through P&T committees that can ultimately provide the pharmacy team the authority to make certain substitutions and drive formulary adherence. This allows for greater efficiencies with the product review process, and given the nature of biosimilars and more of them coming to market, it can really help streamline the operations while making clinically sound and cost-effective formulary decisions.
So, you're right. We've seen these strategies implemented, where biosimilars have been defined to fall under the purview of pharmacists' authority for formulary decisions and so decisions become more of an informational item in P&T committee meetings vs an action item. But it's important to note,too, that the practice of using therapeutic interchanges is common in health systems too.
Therapeutic interchanges, or TIs, are essentially authorized exchanges of therapeutic alternatives in accordance with previously established and approved guidelines, policies, or protocols within a formulary system. So, these TIs are used with drug products that may even have different chemical structures but are expected to have the same therapeutic effects and safety profiles when administered to patients. This concept as a whole is really not new and it's been in existence for some time, particularly in the health system setting.
But again, these are agreed-upon evidence-based initiatives driven through the formulary management process that are aimed at streamlining and standardizing treatment options. I'll add that there are policies and steps and processes in place, too, that if a provider seeks to order a nonformulary product, for example, that is available as well, which may elicit some additional steps.