Operationalizing Biosimilar Adoptions at Mayo Clinic

November 2021 - Vol.18 No. 11 - Page #8
Category: Formulary Software

The introduction of biosimilars to the market creates an opportunity to reduce the cost of expensive biologic agents (see the SIDEBAR). At Mayo Clinic, an integrated health system comprising three destination medical centers in Rochester, Minnesota, Jacksonville, Florida, and Phoenix, Arizona, and a regional health system within the Midwest, we recognize that pharmacy sits in a unique position to drive adoption of these products. However, we also appreciate that these drugs present unique operational hurdles for implementation. In our experience, the initial biosimilar workflows were burdensome and often required pharmacists to retroactively correct mistakes. To combat these challenges, Mayo Clinic Enterprise devised a new workflow and policies that empowered pharmacists to adjust medications, streamline the patient care process, improve biosimilar access, and free providers from administrative duties in order to focus on patient care.

Implementation Challenges

On a fundamental level, biosimilars present unique barriers to easy formulary inclusion. The FDA approval pathway for biosimilars is different from generic drug products, the Centers for Medicare and Medicaid Services (CMS) have chosen to make billing codes different, and the FDA has not yet granted interchangeable status to any biosimilar. As such, health systems must treat biosimilars as separate drugs from their reference products.

Subsequently, indirect operational costs have increased as electronic health record (EHR) programmers need to create separate order sets and safety alerts for biosimilar products, inventory management must stock multiple biosimilars, and changes in workflow are required to ensure pharmacy selects the right product for the patient each time. These factors burden the health care system with added time and resource requirements, may cause patient care delays, increase the likelihood of medication errors, and have the potential to cause economic loss to healthcare institutions.

Another complicating factor stems from payer mandated biosimilar use, including the required use of a specific biosimilar product, which forces health care institutions to dispense the covered product to ensure payer coverage and reduce financial burden on the patient. However, these specific product mandates may not be the most economic choice for the institution; thus, resulting in higher costs and treatment delays.

At Mayo Clinic, these factors were further compounded when a payer demanded a biosimilar, but not a specific product, given that the Prior Authorization (PA) team did not have direct knowledge of contract preferred products to share with providers. Additionally, nowhere in the workflow was the pharmacy notified that a biosimilar or even a specific biosimilar product was required, and it was becoming increasingly necessary for the pharmacy to stock multiple biosimilar products to ensure patient care was not delayed. This had the potential to cause significant problems with inventory management and storage issues in an already limited space.

Establishing a formulary of preferred biosimilar products would reduce the inventory burden and save costs; however, at Mayo Clinic reference products were the default within treatment and therapy plans. If a payer would not authorize the reference product, demanding instead general biosimilar use or naming a specific biosimilar product, the provider received an in-basket message explaining the need for the change. The provider then had to update the treatment plan by removing the reference product and adding the required biosimilar.

This caused additional issues with biosimilars that have infusion rate changes in later cycles, which required plans to be built such that the EHR recognized each later cycle as a different order. Failure to manually update each cycle of the biosimilar would result in the correct product in cycle 1, but incorrect products in later cycles, as they would revert to the reference product, requiring that the order be corrected and re-signed once again. Clearly, a new process was needed to improve biosimilar use.

Developing Effective Workflows

To address the operational barriers associated with biosimilar adoption, a multidisciplinary Biosimilar Workgroup was created. This workgroup consisted of pharmacy, hematology oncology administration, finance (including revenue cycle PA, billing, and denial management), informatics, contract and payer relations, supply chain management contracting, and formulary management. The group developed a workflow that would streamline the use of biosimilars once supply chain management received the contract offers and the formulary subcommittee task force selected the preferred products (see the FIGURE). While primarily affecting the cancer center, the new workflow simplified the entire biosimilar ordering process for all areas.

Click here to view a larger version of this Figure.

Selecting a Preferred Biosimilar

In anticipation of biosimilar launches in major therapeutic categories, the formulary subcommittee task force experts were surveyed for their willingness to use biosimilars in place of reference products. Once the Hematology/Oncology Formulary Task Force unanimously approved that the biosimilars were equally safe and efficacious compared to the reference products, Supply Chain Management Pharmaceutical Contracting then sent requests for proposals to both the biosimilar and reference manufacturers to obtain contracts for reduced acquisition costs in each therapeutic category. The Formulary Subcommittee Specialty Task Forces reviewed contracting offers, evaluated the available dosage forms, and selected formulary-preferred biosimilars in each therapeutic category. Non-preferred biosimilar and reference products remained on formulary under restricted status for use when mandated by payers.

Updating Treatment Plans

Next, pharmacy and the EHR Informatics Team developed a new workflow, in which the preferred product becomes the default in all treatment plans and is listed first within the therapy plans with notation of “Preferred.” The treatment plans had links to the remaining products as part of an advanced order group to allow for easy and quick changes should a payer demand a specific product. Within therapy plans, non-preferred restricted products are listed as later options with the notation of “Restricted.”

Formulary subcommittee specialties agreed that pharmacists could perform a therapeutic interchange for biosimilars based on payer demand, which the Pharmacy and Therapeutics Committee later approved under the Mayo Clinic therapeutic substitution policy. The PA teams across the institution routinely receive a listing of formulary preferred biosimilars, non-preferred biosimilars and reference products, and corresponding Healthcare Common Procedure Coding System (HCPCS) J- or Q-codes to enable the PA team to recommend the formulary-preferred biosimilar in each therapeutic category should payers mandate biosimilar use but not a specific biosimilar.

Implementing the Workflow

Now, when the provider orders a treatment plan or therapy plan, the Mayo Clinic formulary-preferred biosimilar is set as the default in treatment plans and listed first within therapy plans. The PA team then receives a message asking for prior authorization for the Mayo Clinic preferred biosimilar product. The PA team seeks authorization for the preferred product, and, if the payer grants authorization, the patient can be scheduled to receive the medication. Should the payer demand an alternative product, reference or non-preferred biosimilar, then the PA team sends an in-basket message to the proper infusion pharmacy noting the specific product the payer demands. Through the therapeutic substitution policy, pharmacists have the authority to change the plan to include the payer-demanded product for current and future cycles and document the change in the cycle comments of the treatment plan. The advanced order set grouping within the treatment plan allows for easy switching of the products.

Because pharmacists have more exacting knowledge of which drug(s) require replacing in later cycles due to rate changes, they are charged with updating the cycles until the order no longer changes and they can propagate forward the correct drug. With this advance knowledge of upcoming scheduled doses for altered plans, the pharmacy can obtain the necessary product and avert patient care delays. This process has become a primarily pharmacy-driven workflow, which eases the burden on providers and PA teams.

Implementation Results

Mayo Clinic Enterprise implemented this workflow throughout the organization in the last quarter of 2020 targeting new patient starts only, since switching patients mid-cycle would create a burden on the PA team given the need for authorization of the new drug. We started with five biosimilars (bevacizumab, epoetin alfa, filgrastim, rituximab, and trastuzumab)—we did not implement pegfilgrastim and infliximab immediately with this project because of contracting issues at the time of implementation. While we have subsequently implemented pegfilgrastim and infliximab, the data from these two products are not included in this analysis. The initial goal was to have 75% to 80% of patients on the preferred biosimilar within one year of implementation. This workflow has proven to be remarkably successful in the cancer care setting where the treatment plans default to the preferred biosimilars. Within the first 6 months, more than 80% of new orders were for the preferred biosimilar and roughly 75% of all patients eligible for one of these products were on biosimilars. At 9 months the total savings was nearly $16 million dollars, compared to the purchases in the first 9 months in 2020, a similar period with no change in utilization.

Among the key lessons that Mayo Clinic learned during the development of this process are:

  1. Create a multi-disciplinary group. At bare minimum, this group should include pharmacy, the revenue cycle team, and contracting/formulary management. Because these teams are most affected by this workflow change, they should be key players in discussions at the outset.
  2. Commit to a formulary and contracting strategy. We chose to focus on lowering drug costs as we expected payers would demand biosimilar use, and the increasing availability of biosimilars would lower costs in historically high spend drug categories.
  3. Involve informatics early. The EHR informatics team was integral to explaining system capabilities, brainstorming workflow steps, and sharing ideas that pharmacy had not considered.
  4. Educate, educate, educate. There needs to be extensive education about the switch to biosimilars. Everyone involved in ordering, distributing, or administering these products must understand the new workflow as well as why the institution is changing to biosimilars. While we initially focused on biosimilars that affect the hematology and oncology practice, we realized that the changes would affect specialties outside hematology and oncology as well. It is important to engage with all the clinical teams that use these products. Consider incorporating an explanation of the concepts of biosimilar approval and how it compares to the generic drug approval process. We used FDA health care provider and patient education materials for biosimilars as part of our education strategy.1
  5. Review all local laws, rules, and regulations regarding biosimilars. While most states allow therapeutic substitution in health systems, there may be specific requirements that pharmacy must follow.
  6. Decide on a conversion strategy. There are two choices when implementing preferred biosimilars: You can target only those patients newly starting treatment, or convert all patients at once. Targeting new starts only may be easier, but achieving full conversion will take longer with this approach. Converting all patients at once delivers a more rapid economic benefit, but requires a more intensive effort from both the PA and pharmacy teams.
  7. Monitor conversions. Establish a target conversion percentage and set a target date to reach this goal. While a 100% conversion goal may be realistic in some circumstances, consider how specific payer demands will impact your process. Decide upon an achievable goal and periodically measure your institution’s progress. You may find that you need to adjust your approach based on these periodic assessments.

Conclusion

Biosimilars have the potential to improve the value of health care by dramatically reducing healthcare costs, but in practice, a successful adoption is predicated upon establishing an effective workflow across the medication use process. Key steps in this process include establishing a multidisciplinary team, ensuring provider buy-in and willingness to use biosimilars, utilizing contract negotiations to help ensure costs are competitive with reference and other biosimilar products, and making biosimilars easy to order through EHR enhancements. A clear commitment to developing, operationalizing, and communicating effective workflows will help move health systems toward the promised cost savings.


Reference

  1. U.S. Food & Drug Administration. Biosimilars. Updated July 28, 2021. Accessed October 14, 2021. https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars.

Scott A. Soefje, PharmD, MBA, BCOP, FCCP, FHOPA, is the director, pharmacy cancer care at Mayo Clinic and assistant professor of pharmacy at the Mayo Clinic College of Medicine and Science in Rochester, Minnesota.

Chelsee Jensen, PharmD, is a pharmaceutical formulary manager in supply chain management at Mayo Clinic and an instructor of pharmacy at the Mayo Clinic College of Medicine and Science in Rochester, Minnesota.

Trace Bartels, PharmD, is a PGY2 oncology pharmacy resident at the Moffitt Cancer Center in Tampa, Florida. At time of writing this paper, he was a PGY1 Pharmacy Resident at Mayo Clinic Arizona, Phoenix, Arizona.

Mikhaila Rice, PharmD, BCPS, is a pharmacy clinical specialist, lymphoma and multiple myeloma at the Cleveland Clinic Foundation in Cleveland, Ohio. At the time of writing this paper, she was a PGY2 Oncology Pharmacy Resident at Mayo Clinic in Rochester, Minnesota.

Adam Ewald, PharmD, MHA, is the senior pharmaceutical contract manager for the supply chain department at Mayo Clinic and an instructor of pharmacy at the Mayo Clinic College of Medicine and Science in Rochester, Minnesota.

Chris Coughlin, PharmD, BCOP, is a clinical specialist pharmacist and PGY2 oncology residency program director in Mayo Clinic Arizona, Phoenix, Arizona.

 

The Drug Price Competition and Patent Term Restoration Act of 1984 (known as the Hatch-Waxman Act) paved the way for cheaper drugs through competition by establishing the Abbreviated New Drug Application. The act created a framework and outlined a pathway for generic drug development and approval following the five-year exclusivity period for the innovator drug. This act has been remarkably successful in lowering the overall costs of drugs.

In 2009, Congress passed the Biologics Price Competition and Innovation Act (BPCIA) to create a similar approval pathway for biologics. However, recognizing the additional complexities of biologics, the BPCIA established an abbreviated Biologics License Application which defines a pathway for biosimilar approval and differentiates between biosimilars and interchangeable biosimilars. Under the BPCIA, the reference biologics have a 12-year exclusivity period after which other companies can introduce biosimilars with, hopefully, a similar impact on drug costs that have resulted from generic drugs.

 

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