When it comes to biosimilars, there seem to be far more questions than answers, specifically when it comes to interchangeability. Now that the FDA has granted three biosimilar products “interchangeable” status—with more to come, surely—how will this development affect the biosimilars market? What do pharma manufacturers, payers and physicians need to know about this designation? And, crucially, how might interchangeability affect biosimilar uptake in 2023 and beyond?
To learn more, we sat down with Cathy Humphries, a Senior Consultant on MMIT’s Advisory Services team, to get her take on biosimilar interchangeability, and to hear what payers are saying about interchangeability’s role in an increasingly competitive marketplace.
Q: Biosimilar interchangeability has its advocates and its detractors. What do you think about the concept?
A: Ultimately, I think interchangeability is a positive thing that could give a lot of comfort to rheumatologists and other specialists. Yet while I don’t think there’s any question that interchangeability wouldn’t be desired, there are challenges with regard to the pricing and how a biosimilar is being contracted. The biggest area in question is the Humira biosimilars space since there will be so many launching in 2023.
Payers, too, are conflicted on the role of interchangeability. In a recent MMIT Message Monitor survey, one payer said, “Interchangeability has the potential to be a major differentiator among the numerous potential biosimilar adalimumab products.”
However, others were on the fence. “Interchangeable status makes adoption easier but may not be essential. … Aggressive contracting and low pricing will be necessary to drive utilization and preference,” said one payer. Another stated, “We will likely prefer a biosimilar and use a biosimilar over an originator product regardless of interchangeability.”
Q: What are some of the mitigating factors that pharma companies should consider when it comes to interchangeability?
A: The biggest challenge will be whether biosimilars will be for new patients or if there will be patient switching. Switching has to happen for it to be a monetarily attractive contract for payers. We have to have more than just new patients starting on the biosimilars. Receiving interchangeability status means that there was some additional safety testing; it’s more than a product being molecularly the same as another, but actually tested for its safety. That gives comfort to both physicians and patients that they can switch safely, and that’s where the future lies for biosimilars.
In my opinion, with or without interchangeability, we’re going to see payers contracting for the best rate they can get. I think what will first happen is that there will be parity coverage with the brand, like we’ve seen in oncology, and then over time we’ll see a preference for the biosimilar. However, the first big hurdle is getting enough patient switching to happen.
My outstanding question about interchangeability is around state laws. We know that most states have enacted laws that require that a physician be informed if there’s a request for a move to the biosimilar from the brand. If they write a script for the brand, then most laws say that pharmacists or patients have to tell the physician when they switch the prescription to the biosimilar. But how many physicians will approve that decision?
The answer could be nuanced. Take, for example, a brand-name therapy where patients report minimal pain at the injection site. If a patient is switched to a biosimilar and says, “Hey, I didn’t like that. I felt a lot more pain at the injection site this time,” then the doctor may switch the patient back to the brand. And that depends on insurance. If there’s a payer preference for the biosimilar, then that’s not going to stick. That said, I think we could be a year or two out from this being the case. I think that if there’s parity, then the utilization could favor the brand, but that would require that the patient pushes for it.
Q: Do you think there has been enough emphasis on physician education and awareness to support biosimilar interchangeability?
A: Over time, physicians will become more comfortable with biosimilars and support them, but I don’t know if there’s that level of education and awareness yet, especially when it comes to interchangeability. According to responses from our Message Monitor tool, I keep seeing payers express a need for pharma companies to better educate both the HCPs and patients.
As patents expire, that’s when things will open up more and there will be a lot of education on what interchangeability means. But it’s the work of the makers of the biosimilars to get that across to the HCPs. And they will be educating pharmacists as well since that’s the first point of contact.
Q: What role are you seeing interchangeability play in product launches?
A: Even though a lot of companies are pursuing interchangeability, they’re still going to launch without it. I don’t think I’ve seen any biosimilar manufacturer take the strategy that they want to wait for interchangeability, but many have ongoing studies happening, so they’ll be able to message around that.
Interchangeability will also be more or less important in certain therapeutic areas. In ocular disease, for example, safety is paramount. That’s a space where it’s unclear if it’s worth it for a manufacturer to pursue interchangeability given the extra cost that it will entail. On one hand, if manufacturers spend the extra money and show that it’s safe, then HCPs will trust that your biosimilar will be as safe as the brand. But on the flip side, you have to reduce the price to encourage the switching that will be necessary. So the real question is, will the investment be worth it?
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