Originally published by our sister publication Specialty Pharmacy Continuum

By Gina Shaw

With 41 biosimilar products launched for 11 branded reference products, and at least 10 more for six other reference products approved by the FDA and expected to enter the market in 2025—plus dozens of others in the pipeline—pharmacies need a standardized approach for adding new biosimilars to their formularies, said Sarah Yelenich, PharmD, CSP, a clinical services manager at the University of Arkansas for Medical Sciences Specialty Pharmacy, in Little Rock, at the 2024 NASP Annual Meeting & Expo, in Nashville, Tenn.

Dr. Yelenich outlined a 12-step protocol dubbed the “yellow brick road,” designed to avoid future pitfalls and unnecessary efforts involved with onboarding new biosimilars as more and more hit the market.

  1. Is the medication FDA approved? “That sounds obvious, but often doctors contact the pharmacy team excited about a new medication and asking that it be put on the formulary, but it’s not approved yet,” she said. “If we know something is likely coming in the pipeline, there are a few things we can do to lay the groundwork, but before approval, what we can do is fairly limited.” It’s important to wait until the agent is approved before counseling the patient and getting their buy-in, she emphasized. 
  2. Is it commercially available? “I just had this happen last week: A resident came in and told me that a drug he’d been waiting on had just been approved by the FDA and he wanted to start the process [for prescribing and dispensing it] for a particular patient,” Dr. Yelenich said. “But although it was approved, it was not yet available on the market.” If FDA approval is granted earlier than anticipated, there may be a lag time while manufacturer produces adequate supply of the medication to meet market demand, she noted. The patent litigation process also can lead to delays in availability after approval.
  3. What is the time line for payor contracting (insurance coverage)? “Payor coverage decisions may contribute significantly to patients switching from a reference product to a biosimilar,” she said. “Typically, your manufacturer representative/medical science liaison should be able to provide this information.”
  4. Is the drug in a limited drug distribution network? “This decision lies with the manufacturer,” Dr. Yelenich said. “If you have existing relationships with the manufacturer, that can be very beneficial. Additionally, if you are working in a health-system pharmacy, your institution might have been part of the research that led to FDA approval.” However, sites that are unable to gain initial access to a limited drug distribution network must determine which pharmacies are in the network so they know where to send patients for these drugs. “Then, figure out the time line for when the manufacturer will reevaluate their [limited distribution] network, set yourself a reminder, and outreach to them as soon as that time period arrives,” she said. “The squeaky wheel gets the grease.”
  5. Do your clinic providers anticipate prescribing the new biosimilar? “It may be that your clinicians have evaluated the data available and determined that the [biosimilar] is not superior to something they are already utilizing for the same disease,” Dr. Yelenich said. “If there are any biosimilars that your providers prefer, that is also important to know.” It’s important to discuss what providers plan to do about the reference product to biosimilar switch, she continued. “Do they plan to leave patients on the reference product until mandated to switch to a biosimilar by payors?”
  6. Does the biosimilar have an infusion or other healthcare-administered component? If your institution is integrated into a health system, infused agents may require extra steps for formulary inclusion, especially if the coverage involves medical versus pharmacy billing. “For example, in the gastroenterology space, a lot of our medications have IV induction dosing before moving to self-administered maintenance dosing, which involves billing to medical and then switching to pharmacy billing,” Dr. Yelenich said. “This can be a complicated and lengthy process involving your [pharmacy and therapeutics] committee.” She recommended exploring whether the new biosimilars can be grandfathered in as an addendum to any existing reference product offerings already on the institutional formulary, rather than a new request.
  7. What is the potential budget impact of drug cost and anticipated utilization? Dr. Yelenich recommended developing a chart for each biosimilar, with its wholesale acquisition cost and 340B pricing, if applicable, including differences in cost between concentrations and formulations. Provider-projected drug utilization can be used to extrapolate potential budgetary impact based on the anticipated volume of the new medication that will be prescribed.
  8. Has a proactive risk assessment been completed? “These are useful in identifying differences between reference products and biosimilars prior to stocking in the pharmacy,” she said. Factors to consider in these assessments include storage requirements, stability data, differences in dosage forms available, and risks associated with incorrect dispensing of the product. “This risk is probably significantly higher now that we have so many options available,” she said.
  9. Has the medication been added to the specialty grouper? If your health system/specialty pharmacy has a “specialty grouper”—a medication list that follows an order transmittal rule to ensure that orders placed to an integrated institutional pharmacy populate in the correct queue and are addressed by the right team—make sure that the new biosimilar has been added to that grouper.
  10. Has the medication been added to your electronic health record (EHR)/pharmacy software? “Work with your IT team to ensure that the biosimilar has been added to EPIC, Willow, or whatever your EHR and pharmacy software are,” Dr. Yelenich said. “They also need to make sure that the ordering preferences within each new biosimilar drug file are consistent with reference product drug file preferences.”
  11. Has a drug-specific initial assessment/smartphrase been created? “Ensuring that an initial assistant smartphrase has been completed for any new medication you're going to be adding to your dispense process is really important,” Dr. Yelenich said. “It highlights pertinent differences between the reference product and the biosimilar, and standardizes education and training for patients starting a new biosimilar therapy.”
  12. Has the excursion data PDF been added to the excursion library? Having excursion data readily available in a PDF library can save time, particularly since many of these medications are shipped and involve cold chain handling. “There’s not always excursion data available for medications that are newer to market; in that case, reach out to the manufacturer to find out when it’s going to be available to you,” she said.

The “yellow brick road” approach is comprehensive and thorough, said Javon Artis, PharmD, the specialty pharmacy director at Visante. “Health systems should take a close look at this structure, because it’s very helpful.” He raised another issue for pharmacies to consider: “In a health system, the pharmacy often may also have a relationship with the employee health plan, and pharmacy leaders will have to consider the impact of the biosimilar addition on their own plan, programs and budget. For example, lower list-price biosimilars typically result in lower reimbursement.”

Dr. Artis also recommended factoring any available information about rebates and how they may relate to list price into your budget comparison chart. “One limitation of lower cost biosimilars—and this is probably why we see biosimilars that have an extremely low list price and then another list price that's not much cheaper than the currently available product—is the issue of rebates, which are tied to the list price of the medication,” he said.

Pharmacists play an integral role throughout the education process for patients starting new biosimilars, Dr. Yelenich concluded. Pharmacists are often more readily accessible than prescribers, can evaluate information about how a biosimilar could impact other medications the patient is taking, and “we’re the medication access experts—navigating insurance, identifying patient assistance programs, and identifying supply chain issues,” she said. “It’s important to know what is going to be changing whenever we have selected a biosimilar and counseling the patient on these changes.”

The sources reported no relevant financial disclosures.