Moffitt Cancer Center is a National Cancer Institute-designated Comprehensive Cancer Center and full-service hospital. Recently, Chief Pharmacy Officer Ken Komorny, Pharm.D. led a working group within the Pharmacy Directors Forum of the National Comprehensive Cancer Network (NCCN) to create recommendations for operationalizing safe and efficient use of biosimilars in clinical settings. We spoke to him to learn more about Moffitt's biosimilars strategy.
Q: What strategies does Moffitt have in place to manage biosimilars?
Dr. Komorny: Our goal is to be as proactive as possible with biosimilars. We want to mistake-proof the process to minimize potential for errors. We feel like the safest process is to select a default biosimilar for each biologic product.
Achieving this goal requires pharmacy to collaborate with managed care, the financial clearance unit, and the denials management team. In fact, Moffitt Cancer Center has the most progressive pharmacy and managed care integration that I've ever seen. Our managed care team maintains a living document to track biosimilar policy changes. We have quarterly meetings where we talk about those changes and what impact it may have on our formulary. That collaboration allows us to be successful.
From the pharmacy perspective, we've put robust processes in place around formulary management and medication management and storage. On the back end, we've done many root-cause analyses to help us improve and minimize errors.
Q: Can you walk us through your formulary management process when it comes to biosimilars and reference products?
Dr. Komorny: For each biologic, the P&T committee selects one "workhorse" biosimilar that will be the default product prescribed. In selecting that product, the first thing we look at is alignment with our major commercial payers to see which products are covered through their policies. This is, of course, in addition to clinical data. We also consider other factors like look-alike, sound-alike issues and a cost analysis.
We have a robust, closed formulary, which allows the pharmacist, technician, and nurse to all be on the same page about what drug is prescribed and what processes are in place for using that drug. The EHR includes the generic name along with the four-letter suffix and brand name to minimize confusion. The financial clearance unit is also familiar with appropriate processes for requesting the default biosimilar across different payers. There are pop-ups in the EHR that flag if the patient's insurer will not pay for the default biosimilar.
We do still retain the reference products on our formulary as well. When we first made our large switch from reference products to biosimilars, we only started biosimilars on new patients. We didn't switch existing patients from reference product to biosimilar. Over time, we had fewer patients on reference product and more patients on biosimilars. Now over 90% of patients are on biosimilars.
Q: What changes are you seeing in the payer landscape for biosimilars and how are you responding?
Dr. Komorny: A few years ago, we were concerned about what would happen if each insurer selected just one preferred biosimilar. We deal with hundreds of health plans—the number of iterations would be difficult to fathom. Luckily, we've only had one insurance company to date that has limited their formulary to just one brand of biosimilar. Others have been more flexible. I think payers have realized that the risks inherent in operationalizing multiple biosimilars are real, so they've allowed flexibility in allowing for multiple products. I'm hopeful that we won't see a wave of insurance companies with single-source biosimilar coverage.
As of today, we have zero mismatches between our most common Medicare Advantage and commercial plans. Because plans allow choice between biosimilars—some choose two or three, and some allow us to choose from all biosimilars—we can select a product that is aligned with all or nearly all of them.
We've learned that this is a fluid market and that payers may shuffle their preferred biosimilar every 6-12 months. We're establishing a process for managing changing payer preferences going forward.
Q: Can you tell us more about what happens when the payers' formulary does not include Moffitt's preferred biosimilar?
Dr. Komorny: Whenever we must use a non-preferred product, it creates additional opportunities for medication errors. In our cancer patients, those errors could lead to serious health issues including death. Accordingly, we take the process of ensuring patient safety very seriously
We've worked with Moffitt's process excellence team to develop a workflow to minimize the possibility for medication errors. It's a complex, 32-step process that needs to be followed carefully. The process starts when an EHR pop-up alerts the provider that the default biosimilar is not allowed and that we need to use an alternative biosimilar. The pharmacist verifies this and begins the 32-step process. Ultimately, the final step is providing the patient with the insurer's covered drug.
Q: Do you have any other recommendations for pharmacy leaders who are developing their biosimilar management strategy?
Dr. Komorny: Earlier this year, I co-authored a white paper with the National Comprehensive Cancer Network Pharmacy Directors Forum to help my fellow pharmacy leaders address operational challenges with biosimilars. We compiled a set of recommendations on how to navigate issues that may arise when adopting biosimilars into clinical practice. In addition to the recommendations, the paper also includes strategies for navigating the payer landscape, suggested workflows for biosimilar processing, and guidance on how to effectively leverage an EHR. It's a tremendous resource that we're hoping can help leaders tackle the major challenges and ultimately improve cancer care.