Defining Value With a Changing Biosimilar Landscape - Episode 4

Automatic Substitution With Interchangeable Biosimilars

Dr Sonia T. Oskouei focuses on automatic substitution in both the pharmacy setting and in patients’ health plans.

Sonia T. Oskouei, PharmD, BCMAS, DPLA: The impact of interchangeability designation on utilization for that biosimilar has a lot of different considerations and factors that can influence the extent of impact that that designation can have. Now interchangeably designation at the pharmacy level opens up opportunities in certain areas as it stands today, given how the US health care delivery model works. If a patient's health plan prefers the interchangeable biosimilar, yet they went to the doctor and got a prescription for the originator biologic, the pharmacist then can automatically substitute the originator biologic that was on the prescription to the interchangeable biosimilar. This is all per state laws, which creates some efficiency in dispensing the interchangeable biosimilar, where in other scenarios, it may require a call to the physician to get a new prescription. There are operational efficiencies that can come with interchangeability designation per state laws and the managed care landscape. The other opportunity that interchangeability designation really can have on supporting adoption is patients that are more exposed to list price or those that pay cash for some of these biologics. If there's an opportunity for cost savings with an interchangeable biosimilar, that is another area that pharmacists and pharmacies could help facilitate.

Interchangeability is essentially helping bring the model to biologics for what we see routinely occur with brands in generics at pharmacies. Operationalizing this designation comes down to specific state laws. Although interchangeability is a federal regulation by the FDA [United States Food and Drug Administration] that could give the designation, it is governed by each state's Board of Pharmacy. Each state might have different requirements or steps needed to implement interchangeability, which could include things like patient and provider notification, what the document retention policy is, and the acceptable methods of communication. Some of this might differ. It's important to understand state laws in terms of interchangeability, so it can be implemented in the most effective, inappropriate way possible. There are 4 states that do not enable that automatic pharmacist substitution. It is a small group; state laws may have different governing rules there. There are a handful of states that require the biosimilar the interchangeable biosimilar to be a lower cost to support the automatic substitution. That's why each state might have different requirements for the designation.

This transcript has been edited for clarity.