Biosimilars represent a significant value improvement opportunity for health system formularies nationwide. When managing the formulary at my institution, with respect to biosimilar integration and adoption, there have been issues and challenges that we have had to manage. I would like to share some of the challenges and discuss some tips and insights in managing them. Below, I discuss some of the challenges and strategies that I am commonly asked.
What is my experience approaching biosimilar utilization and adoption?
At UCSF, we began adopting biosimilars when we introduced the biosimilar for filgrastim into our adult hospitals in April of 2016. Since then, we have brought in approximately seven biosimilar agents that have resulted in significant savings for the institution. Because the market for biosimilars is growing rapidly, we have adopted a yearly review strategy where we assess payer coverage, utilization patterns, purchasing cost, safety, and efficacy to establish or re-establish which biosimilar represents the best opportunity for our patients and the institution.
What has been the greatest challenge in managing biosimilar adoption at my institution?
I cannot stress the importance of communication. Communication across multiple service providers and services, front line clinic staff, nursing, and pharmacy operations professionals is one of the most important challenges to address. Also, some biosimilars are used in both adults and pediatrics across multiple service lines and clinical indications. This requires updating each ordering tool accordingly and takes the coordination of many care providers as well as integration of the IT infrastructure. This can be an arduous, yet important, undertaking where paying attention to details and outlining the institution’s process map matter.
What initial strategies were used to facilitate adoption of biosimilars at UCSF?
The first strategy was to ensure that medical center leadership embraced the use of biosimilars conceptually and practically. This required the need for support and backing of our executive suite, medical directors, and department chairs to proceed. Naturally, we presented at our Pharmacy & Therapeutics committee and the group at large has been extremely supportive. We were consistent in highlighting FDA-approved language that biologics have “no clinically meaningful difference from the reference product” and we moved away from the “interchangeability” discussion as our providers would always be involved in determining whether they preferred to have the reference product or not.1 We believe that the reference product will be needed in a minority of circumstances. We made it a point to educate and remind our clinicians that biosimilar approval, and then later adoption, began in Europe long before the US began implementing biosimilar use with the European Medicines Agency approving its first biosimilar for recombinant growth hormone in 2006. It was also emphasized that there is always an opportunity to opt out and use the reference product should a patient’s clinical condition warrant it. Then we put together a targeted campaign and presented at grand rounds and specialists’ meetings to socialize the initiative.
What practice settings were first targeted for biosimilar integration?
Initial focus was on outpatient use (in clinic/infusion center) as this is driven by payer coverage. We began with the strategy of implementing biosimilars for all “new starts” as this allowed clinicians some assurance in knowing that they didn’t have to switch every patient and it allows each service to develop some experience and comfort with the biosimilar. We also indicated that there will be select patients in whom a switch would be reasonable at the yearly re-authorization time period. This language was included to allow the clinician to consider switching at this time point. Clinicians were also allowed the opportunity to opt out. As an example, patients with stable metastatic disease in whom the reference product was being used could continue to receive the reference product. Another example is in patients with neuromyelitis optica where a lack of efficacy during the transition could be devastating for a patient.
We are in the process of finalizing a preferred inpatient biosimilar for each type of biologic. This has involved our clinician specialists input as we create inpatient use criteria in parallel to biosimilar adoption. We do not have a formal biosimilar policy as some institutions have adopted; however, our P&T committee has allowed pharmacy to determine which products to carry.
As formulary manager, it has been a learning opportunity like no other. The most enjoyable aspect of managing a formulary is that I get to work with brilliant clinicians and highly specialized pharmacists, nurses, and providers across many different clinical areas and therefore I am always learning. We are currently tracking our savings from including biosimilars in our formulary and we are well on our way to meeting our institution’s goals while maintaining excellent clinical care.