The sluggish acceptance of biosimilars in the United States has often been compared to that of the European Union, where biosimilars took a more accelerated course. When looking at the United States, however, one cannot overlook a key difference between its healthcare structure and that of many other countries: payers.
The advent of biosimilars in the United States brought about expectations for increased healthcare savings and greater patient access. Stakeholders anticipated that this class of drugs, touted for larger discounts compared to their reference products, would create a new means of providing expanded quality care to patients. The reality, however, was slower-than-expected uptake, as seen with Sandoz’s Zarxio (filgrastim-sndz) and Pfizer’s Inflectra (infliximab-dyyb).
This sluggish acceptance of biosimilars in the United States has often been compared to that of the European Union, where biosimilars took a more accelerated course. When looking at the United States, however, one cannot overlook a key difference between its healthcare structure and that of many other countries: payers.
The multi-payer system of the United States greatly contributes to the already fragmented nature of the system. With various segments of Medicare, Medicaid, and commercial insurers with hundreds of individual plans, payers are far from being aligned with one another. This stakeholder is often cited as the middleman between patients and access to medications. With responsibilities spanning formulary management to drug utilization reviews and more, payers are influential in driving the quality of care, treatment decisions, and cost-savings by implementing certain access barriers.
With that being said, one may question whether payers have had enough involvement in substantiating the value of biosimilars to the overall system. Is this stakeholder the gatekeeper for biosimilars to succeed in a health system notorious for its high costs? Simply put, yes.
Payers, as decision-makers, have extensive influence and opportunities that can be leveraged to facilitate biosimilar use. As patrons focused on cost-savings, increasing biosimilar uptake should theoretically be on every payer’s radar; however, this has not been the case thus far.
Insurers are in a unique position as the one group that is engaged across the healthcare spectrum with all stakeholders, from providers to patients, manufacturers and advocacy groups. There is a level of impact to be generated through appropriate engagement with each of the aforementioned, with patient and provider education being one such initiative.
At this time, only a few organizations, including CVS Health and Express Scripts, have taken a stance on biosimilars. There are, however, some controversial areas in which it is critical for payers to be vocal and proactive rather than reactive:
The FDA has yet to release its final guidance on interchangeability. This designation has generated a system-wide misconception that interchangeable biosimilars are “better than” biosimilars without this label. Manufacturers have voiced concern as to whether payers will consider an interchangeability designation as the deciding factor when considering multiple biosimilars of the same reference biologic. It is crucial for insurers to address this issue and provide further clarity on the designation and formulary positioning outside the FDA’s guidance.
Formulary and Utilization Management
At the pharmacy level, access restrictions may deter biosimilar use. With prior authorizations and step edits in place, patients are often unable to access biosimilars. In a perfect world, payers could easily expand biosimilar use through formulary inclusion and looser management criteria; however, the US healthcare system is a competitive system with too many options, including reference biologics. Therefore, payer transparency around the decision-making process for biosimilars can provide clarity to all on how to improve biosimilar uptake on a plan-by-plan basis. Formulary and utilization management overlaps with the next consideration of exclusive contracting.
In the past, there have been contracts made between manufacturers and payers that have hindered biosimilar uptake by limiting use exclusively to reference biologics. From a market access perspective, contracting is a mainstay means of negotiation between manufacturers and payers. Proactive communication from payers regarding contracting preferences, perhaps even interest in innovative contracting—may allow stakeholders, such as integrated delivery networks and manufacturers, to be creative in achieving more successful negotiations around biosimilars and their added value.
In conclusion, the US healthcare system is driven strongly by payer actions. It is critical for payers to be at the forefront of the biosimilar conversation in order to drive uptake and potential cost savings. This can be done through education initiatives, better communication with healthcare stakeholders, and improved clarity around controversial topics such as interchangeability designations, formulary management, and contracting expectations.