Optimizing Biosimilar Implementation: A Framework for Access, Adoption, and Sustainability | Written Recap

Eric Tichy, Pharm.D., MBA, is vice chair of pharmacy formulary for the Mayo Clinic Health System, which is headquartered in Rochester, Minnesota. Tichy spoke about Mayo’s approach to biosimilars, aligning with payers, communicating with providers and patients, and interoperability in a Managed Healthcare Executive K-Cast video series. This is a written recap of that series

Minimum disruption

Tichy said the Mayo Clinic Health System takes a very proactive approach to biosimilars, anticipating launch dates, talking to practice leaders and reaching out to manufacturers. He said the Mayo system tends to drive prescriptions to a specific “workhorse product.” He said the two top priorities when implementing a biosimilar are to ensure it is clinically equivalent to the brand-name innovator product and that the biosimilar is not too disruptive for patients and providers. “Our providers are very comfortable with the use of biosimilars, and their main feedback is, ‘Make it easy for us to do this and make it as minimally disruptive to the patients as possible,’ ” Tichy said.

Factors to consider

Biosimilars are created to reduce costs, Tichy noted, so one overarching goal is to reduce overall healthcare expenses for the Mayo system. “Having the lowest-cost product is very desirable in many respects,” he said. But other factors come into play, such as eligibility for different discounts, he explained. Mayo has facilities that are eligible for the 340B Drug Pricing Program, so products that are eligible for that program may have an advantage as far as the health system is concerned. Patient assistance programs are also part of the picture. “There are a lot of patient support programs that help with copay assistance,” he noted. “We want to make sure those are equivalent for the biosimilar products.”

Working with payers

Payer contracts figure prominently in the Mayo system’s use of biosimilars, Tichy said. “If a payer is not going to cover a product, then that is a huge barrier,” he said. If a product is not available or the system loses money on it, Mayo has contacted large payers to ask for flexibility. “We need to make sure that we’re aligned with the payer,” he said. “Whether we have to make an adjustment or they make an adjustment, I think both sides recognize that it’s in everyone’s best interest, generally, to use biosimilars because of the lower cost of the products.”

Occasionally a payer insists that patients remain on an innovator product, also called the reference product. “If you can’t get the payer to cover it, then we really can’t make the switch for those patients,” Tichy said. The number of payers that do not allow the use of biosimilars is very low. But Tichy said, “Even just having a few creates a level of uncertainty that we have to navigate.”

As a healthcare provider, Mayo deals with dozens and dozens of different payers, Tichy said, “and it’s really challenging to juggle specific payers who are demanding specific products.” He said he would love to have some flexibility from payers that would result in broader coverage of biosimilars unless there’s a circumstance in which the payer is seeing a significantly higher cost.

Larger inventory and the electronic health record

Previously, Mayo would have just one biologic, according to Tichy. With biosimilars, it may carry three or four versions of the same biologic. One consequence of the greater number of products is a need for more refrigerator space. However, for some of the clinics in the Mayo system, the need for additional space is a challenge, Tichy said. The electronic health record and features such as barcode scanning help with safety and ensure that patients receive the correct biosimilar. “Our staff is aware that there are multiple products, and they do double- and triple-checks to make sure that they’re pulling the right products,” Tichy said. “They understand that you can’t use multiple different biosimilars to treat a specific patient.” The electronic health record “is the biggest safety system we have,” he said.

The electronic health record and the systems associated with them help Mayo coordinate biosimilar prescriptions, patients and payers. “We have a process with our revenue cycle where if a specific payer requires a specific product, we are able to flag that very quickly and then do a therapeutic substitution, so the actual provider never has to engage with that process,” Tichy said. Mayo has also developed financial analytics to understand reimbursement patterns and gain insights into making switches from a cost-and-reimbursement perspective.

Interchangeability

Interchangeability has made the conversion to biosimilars go more smoothly, and in retail settings, interchangeability is helpful because it lessens the need to interact with the providers, Tichy said. In provider-administered areas, Mayo has therapeutic substitution protocols that make it easy to manage changes even if interchangeability is not in the label of the product. “We’ve established standards with our providers,” Tichy said. “They’re very comfortable with the therapeutic interchange.” Mayo executives are “big fans of any efforts and initiatives that would expand that therapeutic interchange process for biosimilars and make it available for more of the biosimilars.”

Part of the culture and educating patients

Tichy said Mayo pharmacy executives started educating providers about biosimilars even before they became available. Now, providing information about biosimilars has become a routine part of onboarding new staff, he said. Mayo also takes a proactive approach to adding biosimilars to its formulary, according to Tichy. “It has become a standard within our culture that we are going to use biosimilars, we’re going to adopt them as soon as they become available, and that we see that it provides benefit to the overall health care system,” he said.

To handle their concerns, Mayo sends patients a letter that explains the advantages of biosimilars and how the conversion to a biosimilar is handled. The clinical staff is trained to answer questions not addressed in the letter and provide other information requested by patients.

The future

Tichy expects to see more biosimilars. At Mayo, there is now a standard process for electronic health records for handling biosimilars and a team of biosimilar experts, he said.

With the use of biosimilars becoming more common, Tichy said he sees a shift away from “chasing the lowest-cost product” to a greater focus on the reliability of their supply and stability in their prices.

“One of the changes I see us making is that instead of chasing the lowest-cost product, we would like to see some stability in the pricing of the product, and this would help from an operational and from a financial standpoint,” Tichy said. Sometimes the suppliers of the lowest-cost products are not as reliable, Tichy said. “Having the reliability of supply is becoming a greater and greater focus,” he added, also noting that profitability is important “so that we’re not in a situation where we’re losing money on products and it becomes unsustainable.”

Tichy predicted that other organizations are going to follow Mayo and other early adopters. “Now, we’re really seeing biosimilars get into more of the mainstream, and I think organizations are going to get faster at implementing them,” he said. “The speed to value is going to get faster and faster as biosimilars become more common and as additional biosimilars are launched in the near future.” Tichy said leaders of organizations getting started with biosimilars can do so “with a high degree of confidence.”

“I would let them know that the process is a lot less daunting than they might initially fear,” he continued. "We’ve been using them for years now, and we have not seen any clinical issues, and I think that is one of the things that can cause a lot of anxiety.”