This article was originally published in Drug Channels.
Next year’s staggered launch of adalimumab biosimilars will mark one of the largest losses of exclusivity for a pharmaceutical company in U.S. market history.
For years, Humira has been the top-selling drug worldwide, raking in more than $20 billion in revenue last year. Manufacturers of reference biologics will be monitoring the impending upheaval, while companies with biosimilars in the pipeline will be eagerly tracking utilization data. Which drugs will secure a place on payers’ formularies, and when?
Gaining Favorable Market Access
To understand how the new biosimilars might fare, let’s examine Humira’s current market position. AbbVie’s long-term strategy has hinged on attaining favorable market access, in part by sharing cost-offset data that demonstrates Humira’s ability to reduce surgery and hospitalization costs for diseases like rheumatoid arthritis, Crohn’s disease and psoriasis.
Overall, AbbVie’s strategy has been quite successful. Data from MMIT Analytics indicates that Humira is a preferred medication for the majority (64%) of covered American lives. While many payers do require prior authorization and/or step therapy with generic alternatives before Humira can be prescribed, these policies are considered appropriate rather than restrictive, and haven’t functioned as a major deterrent.
Of the seven adalimumab biosimilars approved, the first, Amgen’s Amjevita, will debut in January 2023, followed by four others in July and the final two by year’s end. Also, there are an additional three biosimilars pending approval, which may also launch between July and September of 2023. But the key question is, how will payers respond to this anticipated influx of Humira biosimilars?
In March 2022, MMIT conducted a Rapid Response survey of 15 commercial payers representing 117 million covered lives. Most payers (53%) reported that they would likely make changes in their Humira contracting within the year, with several explaining that this transition represents a golden opportunity to recognize greater savings across the AbbVie portfolio. One-third of payers (33%) declared their reluctance to make premature contracting changes, with some noting that they would rather wait to quantify biosimilars’ potential savings before committing to a new Humira contract, despite pricing concessions.
Waiting for Biosimilar Formulary Review
This brings us to the question of when payers are likely to review the new crop of drugs. How does the timing of the biosimilars’ release factor into the equation? MMIT’s research indicates that the vast majority of payers (73%) expect to review Amjevita upon its release. Two large payers, representing one-third of commercial lives, plan to delay review until the summer’s biosimilars are released, while another will not review until December in order to assess the complete financial picture.
Regardless of when their initial review is conducted, the majority of payers agreed that they would likely offer more open coverage throughout 2023, as they would prefer to wait until all biosimilars are available before making final contracting and coverage decisions. In fact, many payers said it would likely be 2024 or 2025 before they made any formulary changes.
Of course, cost is not payers’ only consideration. Biosimilars with designated interchangeability may have a slight advantage over their counterparts, as this status eases the drug substitution process. For the adalimumab biosimilars, this designation will apply only to Cyltezo at launch time, although two other manufacturers are seeking interchangeability.
The perceived value of interchangeability varies between payers, with some telling MMIT that it is more of an added bonus than a driving factor. As one contracting pharmacist noted, “If the prices are the same, I’d pick the interchangeable biosimilar, but I’m not going to pick that if it’s a higher-priced one.” Other payers have indicated that interchangeability ranks higher than a manufacturer’s portfolio in their considerations.
As biosimilars continue to gain momentum in the U.S., pharma companies with legacy biologics—as well as those developing biosimilars—will be waiting to heed the lessons of 2023’s adalimumab rollout. But one thing is abundantly clear: Securing favorable access will not be as simple as a 1:1 formulary exchange of low-cost biosimilars for high-cost specialty drugs. Smart pharma companies will study their peers’ market access strategies to learn how to achieve long-term success.
Looking for insight into how payers might cover and manage your drug? MMIT’s Strategic Launch Report provides market insights alongside key forecasting data to help improve your commercial strategy. Learn more.
