Many healthcare systems are using these products to provide comparable but cheaper clinical outcomes
Biosimilars have become welcome market disruptors when it comes to chronic and life-threatening diseases, as they provide complementary treatment options and wider access to therapy for patients with difficult conditions.
Because of their biological nature and because they are made in a living cell system, biosimilars (like all biologics) generally exhibit high molecular complexity, and as a result there is a small amount of natural variability inherent in them. Despite this heterogeneity, all biologics, including biosimilars, must maintain consistent clinical performance and quality in order to be approved by the FDA. The molecular similarity achieved by biosimilars compared to their reference drugs meets applicable standards for FDA approval and use as primary agents in treatment.
Given the ever-rising health care costs in the United States, it is important for health care providers to bend the cost curve and create financial stewardship of health care dollars. With these goals in mind, many healthcare systems are turning to biosimilars to provide clinical results comparable to those of reference products, but at a lower cost.
The biosimilar pipeline continues to grow based on market demand and innovation, and health systems will need to turn to these therapies to reduce health care spending. Finally, managed care organizations are also starting to favor biosimilars based on the accumulated experience of using them.
Understanding the situation
Based on the most recent available reports, the use of biosimilars is predicted to increase significantly over the next 5 years. While there are some barriers to adoption based on concerns about potential immunogenicity issues, supplier awareness, and the scope of clinical trials, it is our responsibility as pharmacy leaders to assess these products as suitable for use.
It is also important to recognize that any health system or integrated delivery network will have unique barriers that may differ when compared to comparable institutions. For example, there may be several barriers in the areas of finance, information technology, patients and caregivers. It is the responsibility of pharmacy leaders to evaluate these barriers and provide guidelines for their use, taking into account the financial benefits 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 online open forum, ‘What’s the Hold Up? Overcoming barriers to the use of biosimilars.” At this event, biosimilar experts compared the state of the US biosimilar industry to where it should be in the future.
Panelists agreed that if incentives were aligned and competition increased, there would be a smoother adoption process. Successes were shared and I had the opportunity to discuss insights into Emory Healthcare’s data-driven approach.
The plan of the Winship Cancer Institute
At the Winship Cancer Institute, we initially encountered some resistance to use when the first few biosimilars hit the market. To determine the best way forward, we conducted financial and clinical assessments of the products and conducted basic research.
The baseline survey allowed us to better understand all the barriers within our organization and discover who could be the best physician champions within our system. The research findings made it clear that there were some barriers that we were already aware of, such as information technology build-up and compatibility, as well as other barriers that we were less aware of, such as finance and patient education. Given the need to overcome all these hurdles, 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 information about biosimilars specific to nurses, patients, pharmacists and healthcare providers. Developing this education in-house allowed us to incorporate data-driven information and financial benefits specific to the institution. We also ensured that the data was presented in a fair and balanced manner, consistent with the very similar nature of the biosimilar drugs as defined by the FDA. This training created a solid foundation of biosimilar understanding that we could build on as we brought these agents to our Pharmacy and Therapeutic Committee (P&T).
We realized that more and more biosimilars would come to the market and knew it was important to create a universal approach that could reduce the time to approval by P&T for all biosimilars. We have created information related to efficacy and safety, financial management, immunogenicity and product interchangeability data, enabling the P&T committee to make a unified decision on these agents and move forward with approvals.
We also had the opportunity to present abbreviated monographs for new biosimilars, allowing the pharmacy to select products that were in the best interest of our institution, patients and payers. This P&T policy was key to finding a sustainable path forward that would allow us to use resources in real time for the benefit of patients. Under this P&T-approved policy, we also felt it was important to create efficient electronic health record (EMR) frameworks that can be executed in a timely manner and according to standard working protocols. While we were initially concerned that building a new biosimilar and adding it to our order set and pathways would be logistically difficult, we were able to build out each drug in its generic name format, allowing for multiple biosimilar plans for a given reference product. could be introduced efficiently and safely.
This approach also maintained our financial standards and our National Drug Code accumulation, enabling us to demonstrate financial strength. The EMR build-out and financial costs were key components of our operational success with the implementation of biosimilars.
One of the last but most important components of our biosimilar strategy was the creation of patient education, both directly in the clinic by physicians and in the infusion center by our pharmacy team members. For the sake of simplicity, we decided to create a comprehensive, standardized approach to education that would apply to both institutions.
This approach led patients to better understand why they were switched to a biosimilar, how these drugs would still support their treatment and outcomes, and how the use of biosimilars would reduce health care expenditures. It is important to involve patients early in this process and we have found this essential for a well-functioning pharmacy department.
The adoption of biosimilars will continue to increase rapidly based on the proven clinical benefits of these molecules, complemented by their lower cost. Understanding a specific organization and its unique barriers enables the implementation of an institution-tailored adoption plan, which will most effectively drive biosimilar adoption. In particular, establishing a P&T-approved policy can provide an accelerated process of biosimilar selection, and effective education about these agents can facilitate their acceptance by patients and healthcare providers. Health systems financially affected by the COVID-19 pandemic can leverage the lower cost of biosimilars to generate savings and treat patients effectively. Recognizing the emergence of biosimilars and the strong pipeline of such products should motivate health systems to create timely adoption strategies that allow them to remain relevant in the healthcare market. Most importantly, incentives to use biosimilars need to change so that health systems and payers can benefit and patients can benefit from cost savings. All stakeholders should be evaluated to realign incentives with the patient at the center.
About the author
Ryan Haumschild, PharmD, MS, MBA, is the director of pharmacy services at Emory Healthcare and Winship Cancer Institute in Atlanta, Georgia.