Many health care systems use these products to provide similar but less expensive clinical results.
Biosimilars have become welcome market disruptors when it comes to chronic and life-threatening diseases, as they provide additional treatment options and broader access to therapy for patients facing challenging conditions.
Due to their biological nature and their creation in a living cell system, biosimilars (like all biologics) typically exhibit high molecular complexity and therefore a small amount of natural variability is inherent in them. Despite this heterogeneity, all biologic drugs, including biosimilars, must maintain consistent clinical performance and quality to be approved by the FDA. The molecular similarity achieved by biosimilars to their reference drugs meets appropriate standards for FDA approval and use as primary agents in therapy.
With the cost of care steadily rising in the United States, it is important for healthcare providers to bend the cost curve and create financial management of healthcare expenditures. With these goals in mind, many healthcare systems are turning to biosimilars to provide clinical outcomes similar to those provided by reference products, but at a reduced cost.
The biosimilars pipeline continues to grow based on market demand and innovation, and healthcare systems will need to turn to these therapies to reduce healthcare expenditures. Finally, managed care organizations are also beginning to prefer biosimilar agents based on the experience accumulated with their use.
Understand the situation
Based on the most recent reports available, the use of biosimilars is expected to increase significantly over the next 5 years. Although there are some barriers to adoption due to potential immunogenicity issues, vendor familiarity, and clinical trial scope, it is our responsibility as pharmacy leaders to assess these products according to their use.
It is also important to recognize that each health system or integrated delivery network will have unique barriers that may vary from peer institutions. For example, different barriers may be present from finance, information technology, patients and providers. It is the responsibility of pharmacy managers to assess these barriers and to give advice on use, taking into account the financial advantages of these products.
In January, the American Journal of Managed Care® and the Center for Biosimilars®, in partnership with Samsung Bioepis Co, Ltd, hosted an open online forum, “What’s the Hold Up?” Overcoming barriers to the use of biosimilars. During this event, biosimilars experts compared the state of the US biosimilars industry with where it should be in the future.
Panelists agreed that if incentives were aligned and competition increased, the adoption process would be smoother. Success stories were shared and I had the opportunity to discuss Emory Healthcare’s data-driven approach.
Map of Winship Cancer Institute
At the Winship Cancer Institute, we encountered some initial resistance to use when the first biosimilars hit the market. To identify the best way forward, we performed financial and clinical product reviews and conducted a benchmark survey.
The baseline survey gave us a better understanding of all the barriers that need to be overcome within our organization and who within our system could be the best physician champion. Through the survey results, it became clear that some barriers existed that we were already aware of, such as the construction and interchangeability of information technology, as well as other barriers that we were less aware of, such as finance and patient education. Given the need to overcome all these obstacles, we took this opportunity to create a strategy around the use of biosimilars and formulate a plan.
One of our first actions was to create education around biosimilars specific to nurses, patients, pharmacists and providers. By developing this training in-house, we were able to include data-driven insights and institution-specific financial benefits. We also made sure to represent the data in a fair and balanced manner, reflecting the highly similar nature of biosimilar drugs as defined by the FDA. This training created a solid foundation of understanding of biosimilars that we were able to build upon when introducing these agents to our Pharmacy and Therapeutics (P&T) committee.
Recognizing that biosimilars would increasingly come to market, we knew it was important to create a one-size-fits-all approach that could reduce P&T approval time for all biosimilars. We have created information relating to efficacy and safety, financial management, immunogenicity data and product interchangeability, allowing the P&T committee to make a uniform decision regarding these agents and to go from forward with the approvals.
We also had the ability to offer abbreviated monographs for new biosimilars, giving pharmacy the ability to select products that were in the best interests of our organization, patients and payers. This P&T policy was key to charting a sustainable path that would allow us to adopt real-time agents for the benefit of patients. As part of this P&T approved policy, we have also found it important to create effective electronic medical record (EMR) frameworks that can be executed in a timely manner and follow standard working protocols. Although we were initially concerned that creating a new biosimilar and adding it to our order set and pathways would be logistically challenging, we were able to build each drug into its generic name format so plans involving several biosimilars for a given reference product can be adopted effectively and safely.
This approach has also supported our financial standards and our National Drug Code accumulation, allowing us to demonstrate our financial strength. The construction of the EMR and the financial burden have been key elements of our operational success with the implementation of biosimilars.
One of the last, but most important, elements of our biosimilar strategy was to create patient education, both directly in the clinic by physicians and at the infusion center by members of our pharmacy team. For the sake of simplicity, we decided to create a standard and comprehensive pedagogical approach that would apply to both contexts.
This approach gave patients a better understanding of why they were switching to a biosimilar, how these drugs would still support their treatment and outcomes, and how using biosimilars would reduce healthcare costs. It is important to involve patients early in this process, and we have found it to be essential for a successful pharmacy service.
The adoption of biosimilars will continue to increase rapidly based on the proven clinical benefits of these molecules, complemented by their reduced cost. Understanding a specific organization and its unique barriers enables the implementation of an adoption plan tailored to an institution, which will drive the adoption of biosimilars more effectively. In particular, establishing an approved P&T policy can provide an expedited process for selecting biosimilars, and effective education about these agents can facilitate their acceptance by patients and providers. Healthcare systems financially impacted by the COVID-19 pandemic can leverage the reduced cost of biosimilars to generate cost savings while effectively treating patients. Recognizing the rise of biosimilars and the strong pipeline of these products should prompt healthcare systems to create timely adoption strategies that allow them to remain relevant in the healthcare market. More importantly, the incentives to adopt biosimilars must change, so that they can benefit healthcare systems and payers, and also so that patients can benefit from cost savings. All stakeholders need to be assessed to realign incentives, with the patient at the centre. ■
About the Author
Ryan Haumschild, PharmD, MS, MBA, is Director of Pharmacy Services at Emory Healthcare and Winship Cancer Institute in Atlanta, Georgia.