Sonia T. Oskouei, PharmD, vice president of biosimilars at Cardinal Health, discussed how pharmacists can impact biosimilar adoption.
Sonia Oskouei, PharmD, vice president, biosimilars at Cardinal Health, discusses her presentation on pharmacists role in driving biosimilar adoption in 2023 and on into the future.
Question: How does pharmacist’s involvement on the oncology care team impact biosimilar adoption for patients?
Sonia T. Oskouei: Pharmacists are becoming more and more involved in the care team, particularly in oncology and in the health system setting. So, pharmacists often are partnering or leading with physicians to champion the education process associated with biosimilars, and that's multistakeholder education, both physicians, other pure pharmacists, and supporting patients and their journey.
Pharmacists are also strong contributors to biosimilar adoption and management, particularly in the health system setting as a lead often for formulary decisions, P&T committee involvement, where they're looking not only at the clinical considerations of biosimilars but incorporating the economic and even operational considerations associated with these products, so understanding the complete picture and how best to optimize and leverage biosimilars within their institutions.
Question: With the FDA’s interchangeability designation, are pharmacists the primary individuals on the care team making biosimilar substitutions, or are other oncology care team members making the substitutions before they reach the pharmacist?
Sonia T. Oskouei: The impact of interchangeability designation is really most significant for those products that will fall under the pharmacy benefit or retail pharmacy classic trade. When we look at the role of interchangeability designation in the medical benefit where we see most commonly the oncology biosimilars performing today, it's somewhat limited because of the relevance there, or irrelevance there.
Within health care institutions oftentimes pharmacists are key stakeholders that are supporting formulary decisions or transitions of therapy via a process more commonly known as therapeutic interchanges. As they support formulary decisions as part of the oncology care team, there are product decisions being made that is really outside and independent of any interchangeability designation.
That is a big area of almost misperception sometimes and misinformation out there around the relevancy and the meaning of interchangeability designation, which is a regulatory term by the FDA unique to the US that enables pharmacists level of substitution, and so this is going to be most relevant for those biosimilars that fall under the pharmacy benefit starting with the first insulin biosimilar was approved, for example, and with additional biosimilar candidates seeking to come to market over the next few years that hit more of the retail pharmacy space.
Question: How many pharmacists are aware of the FDA’s interchangeability designation and the power it provides them to make medication more financially accessible to patients through biosimilar substitutions?
Sonia T. Oskouei: Interchangeability designation really has implications for those products are going to be dispensed with in retail pharmacy or specialty pharmacy that's built onto the pharmacy benefits. So when we think about pharmacist familiarity with interchangeability, pharmacist is a broad profession and multiple sites of care. For example, in the health system setting where there's been a lot of medical benefit experience with biosimilars, there could be more familiarity with the terminology of interchangeability since we had our first biosimilar available since 2015.
However, as Cardinal Health Market Research has indicated recently with retail pharmacists, there's still some opportunities for education and to fill in knowledge gaps associated with the designation. Less than half of the retail pharmacist that were recently surveyed were very familiar with an interchangeably designation. This is a big opportunity to support educational efforts with this stakeholder group with these pharmacists, especially because this designation is most applicable to the services provided in the retail setting.
Question: What would you recommend pharmacists who are interested do to learn more about FDA’s interchangeability designation and their ability to support biosimilar substitutions for patients?
Sonia T. Oskouei: Pharmacists are the medication experts, so this is a great area for pharmacists to really take a hold up and lead and champion education efforts around as well. So there's some fantastic resources that are put out, especially by the FDA, around key information on what the designation means how biosimilar candidates achieve that designation, then, ultimately, what it's supposed to allow at the end of the day, which is pharmacists level substitution.
I highly recommend reviewing the FDA resources. One of the most recent initiatives that the FDA completed was creating a curriculum program associated with biosimilars that can be incorporated into pharmacy schools, med schools, nursing programs, etc., and that also has great information.
I'll also say when it comes to operationalizing interchangeability and understanding state laws, at Cardinal Health, we've also created additional resources to help manage that. For example, we've created an interactive state interchangeability map where pharmacists can pick their states and understand Board of Pharmacy laws associated with substitution for interchangeable biosimilar. There are more and more resources being developed to help equip pharmacists with the information they need.
Question: What are your predictions for pharmacist’s role in biosimilar adoption in the future?
Sonia T. Oskouei: My prediction for the pharmacist’s role for biosimilar adoption into the future is that they're going to have a bigger role, and I say that because there's going to be expanded sites of care and therapeutic areas in which biosimilars come to market. Naturally, as you expand sites of care, you're going to have more biosimilars and more pharmacists able to support these products.
Thus far it's been heavily supported and manage in the health system standpoint or physician office where you have pharmacist that provide clinical services there as well. As we look at the future and when types of products that are coming, you're going to expand it to retail pharmacy, specialty pharmacy mail order, other sites of care where you have pharmacists serving patients, and that can create interventions and really support the future adoption of these products. I anticipate an even greater role for pharmacists in the future.