Listening and Educating: How to Build a Successful Biosimilar Adoption Plan
Many health care systems are turning to biosimilars to provide clinical outcomes that are similar to those provided by reference products, but at a reduced cost.
Biosimilars are medications that are developed to be highly similar to original branded reference products, providing similar safety and efficacy in treatment. They have become welcome market disrupters as it relates to life-threatening and chronic diseases, as they can provide additional treatment options and wider access to therapy for patients facing difficult conditions.
Due to their biologic nature and being created in a living cell system, biosimilars, like all biologics, generally exhibit high molecular complexity, and as a result, a small amount of natural variability is inherent in them. Despite this heterogeneity, all biological medicines, including biosimilars, must maintain a consistent quality and clinical performance to be approved by the FDA. The molecular similarity that is achieved by biosimilars in comparison with their reference drugs meets the appropriate standards for FDA approval and use as primary agents in treatment.
Given the ever-rising cost of care in the United States, it is important for health care providers to bend the cost curve and create financial stewardship of our health care dollars. With these goals in mind, many health care systems are turning to biosimilars to provide clinical outcomes that are similar to those provided by reference products, but at a reduced cost.
The biosimilar pipeline continues to grow based on demand and innovation within the marketplace, and health systems are going to need to turn to these therapies to reduce health care spend. Lastly, managed care organizations are also starting to prefer biosimilar agents based on the accumulated experience with their use.
Understanding the Situation
Together with other leaders in hospital pharmacy, I recognize that, based on the most recent reports available, biosimilar use is predicted to increase significantly over the next 5 years. Although there are some barriers to adoption based on provider familiarity, concerns about potential immunogenicity issues, and scope of clinical trials, it is our responsibility as pharmacy leaders to evaluate these products as appropriate for use.
It is also important to recognize that every integrated delivery network or health system will have unique barriers that may vary compared to peer institutions. For example, different barriers may be present from providers, finance, IT, and patients. It is the responsibility of the pharmacy leader to evaluate these barriers and provide guidance for use, considering the financial benefits of these products.
On January 25, I had an opportunity to be part of “What’s the Hold-Up? Overcoming Barriers to the Use of Biosimilars,” an online open forum hosted by the American Journal of Managed Care and the Center for Biosimilars in partnership with Samsung Bioepis. During this special event, biosimilar experts compared the state of the US biosimilar industry today to where it should be in the future.
Panelists agreed that if incentives were aligned and competition increased, we should start to see a smoother adoption process. We shared success cases and I had the opportunity to share insights into Emory’s data-driven approach.
Winship’s Plan to Accelerate Biosimilar Adoption
At the Winship Cancer Institute, we encountered some initial resistance to use when the first few biosimilars came on the market. To identify the best path forward, we performed finance and clinical reviews of the products, and conducted a baseline survey.
The baseline survey enabled us to understand better all the barriers to use within our organization and to uncover who within our system might be the best physician champions. Through the survey results, it became clear that some barriers existed that we were already aware of, such as the IT build and interchangeability, but also that there were other barriers of which we were less aware, such as finance and patient education. Given the need to overcome all these hurdles, we took this opportunity to create a strategy around biosimilar use and formulate a plan forward.
One of our first actions was to create education around biosimilars specific to our providers, nurses, pharmacists, and patients. By developing this education internally, we were able to include data-driven information as well as financial benefits specific to the institution. We also made sure to represent the data in a fair and balanced manner that spoke to the “highly similar” nature of the biosimilar medications, as defined by the FDA. This education created a strong foundation of biosimilar understanding that we were able to build upon as we took these agents to our Pharmacy and Therapeutics (P&T) committee.
Recognizing that biosimilars would be increasingly coming to market, we knew it was important to create a universal approach that could reduce the time to P&T approval for all biosimilars. We created information that relates to safety and efficacy, product interchangeability, immunogenicity data, and financial stewardship, enabling the P&T committee to make a uniform decision around these agents and to move forward with approvals.
We were also granted the ability to bring forward shortened monographs for new biosimilar products, giving pharmacy the ability to select products that were in the best interest of our institution, patients, and payers. This P&T policy was key to forging a sustainable path forward that would allow us to adopt agents in real time for the benefit of the patient.
Under this P&T-approved policy, we also have found it important to create efficient electronic medical record (EMR) builds that can be done in a timely manner and follow standards work. Although initially we were concerned that building a new biosimilar and adding it within our order set and pathways would be difficult logistically, ultimately we were able to build out each medication in its generic name format so that plans involving multiple biosimilars for any given reference product could be adopted efficiently and safely.
This approach also upheld our financial standards of charging and our National Drug Code (NDC) accumulation, which enabled us to demonstrate financial strength. By far, the EMR build and the financial charging were key components of our operational success with biosimilar implementation.
One of the last but most important components of our biosimilar strategy involved creating patient education, both directly in the clinic by physicians as well as in the infusion center by our pharmacy team members. For simplicity’s sake, we decided to create a standard, comprehensive educational approach that would apply to both settings.
Ultimately this approach led to patients understanding more fully why they were being transitioned to a biosimilar, how these medications would still support their treatment and outcomes, and lastly, how biosimilar use would reduce the health care spend. Engaging patients early in this process is important and we have found it to be essential to a high functioning pharmacy department.
In conclusion, biosimilar adoption will continue to increase rapidly based on the proven clinical benefits of these molecules complemented by their reduced expense. Understanding your specific organization and its unique barriers will allow you to build an adoption plan tailored to your own institution, which will drive biosimilar adoption most effectively.
In particular, establishing a P&T-approved policy can provide an expedited process of biosimilar selection, and effective education about these agents can facilitate their acceptance by providers and patients alike. Health systems affected financially by the COVID-19 pandemic can leverage the reduced cost of biosimilars to generate savings while still treating patients effectively.
Recognizing the rise of biosimilars and the strong pipeline of such products should motivate health systems to create a timely adoption strategy that will allow them to stay relevant in the health care marketplace.
Perhaps most importantly, the incentives to adopt biosimilars need to change so they can benefit not only the health system and the payer, but also so that patients actually benefit from cost savings. All stakeholders need to be evaluated to realign incentives, with the patient at the center.
About the Author
Ryan Haumschild, PharmD, is the Director of Pharmaceutical Services at Emory University Hospital Midtown and the Winship Cancer Institute.He manages pharmacy services at the integrated delivery network, the largest academic center in Georgia and the only NCI-Designated Comprehensive Cancer Center in Georgia. The Winship Cancer Institute has 11 hospitals and numerous affiliated organizations throughout the Southeast. In this article, he shares the strategy Winship used to overcome the resistance it faced when it began to introduce biosimilars into its regular, value-based medication treatment regimens.