Molly Billstein Leber, PharmD, BCPS, FASHP: I think the biggest challenge is provider acceptance. I think that’s probably, for the supportive care agents, less of an issue now because we are able to track lab values and show that the drug is working. I think provider acceptance into some of these new curative agents is going to be difficult. I think from a payer standpoint, where a lot of organizations are struggling right now, is they would like to switch to the biosimilar product. However, some of the commercial payers do not cover the biosimilar product. And so, depending on the organization’s payer mix, you may or may not be able to switch the majority of your patients to the biosimilar. And so, you may need to continue to either maintain the originator product as your sole formulary or you may need to stock multiple products, depending on the payer coverage issues.
And I think from a pharmacy standpoint, it’s very difficult to maintain multiple products on your shelf and then decide if you’re going to pick the product based on the patient’s insurance coverage. And, as we start to see more and more drugs enter the market, price points are changing and then trying to make sure that we’re managing our budget within the pharmacy department, I think you’re going to have to start having more and more discussions about: How often do you switch? What cost savings would you be switching for? Because I don’t think we have a lot of experience in switching back and forth between biosimilar to biosimilar or biosimilar to originator. I don’t think people are entirely comfortable in making those conversions rapidly back and forth.
I would like to say that I believe in all of the analytic data that the FDA has done and that the drug is highly similar to the originator product. However, I don’t know if I personally have the comfort level to extrapolate from a molecular level to a patient care level. I think it’s very helpful in gaining acceptance, and we’ve seen at least one clinical trial to show that it is as effective as the originator product, so we know that it’s acting on the same molecules, we know that it’s acting the same way in the body, and it’s as effective as the originator product. I think as we get more comfort with biosimilars, I think we could probably go with just the analytic data and not a phase 3 clinical trial. I think if you look at generic drugs, how long it took to get that acceptance, they are the same. I think we will get there with biosimilars, I just don’t think we’re there quite yet.
I think if there’s not provider acceptance, and I would also say in addition to provider acceptance I would say insurance coverage acceptance as well, we’re not going to see drug companies continue to enter the biosimilar landscape. And, I don’t think that we’re going to see new biosimilars come to market. If we don’t see new biosimilars come to the market, I think we’re going to see healthcare costs continue to rise. We have historic data that shows that when there is no competition the biologic prices continue to increase, and I think that biosimilars do offer competition and will help bring cost of care down. I think the sooner we can start biosimilars, if you look at things like ulcerative colitis or Crohn disease, if we can bring the cost of care down so patients can receive preventative therapy, we won’t see them admitted to the hospital, and, hopefully, that will also help keep healthcare costs down and improve access for patients.
I think they [the FDA] have part of a role to play. I think that it is a new approval process and a lot of providers don’t truly understand that, as well as what it looks like and why they’re doing what they’re doing. I think it’s very important for the FDA to help educate providers on why biosimilars are highly similar and why we chose that pathway. I think that the FDA needs to help providers know that it is safe and effective and also help patients understand that as well, and that they should trust the FDA, that they’ve made these decisions. I also think that it’s the pharmacists’ responsibility as well as other providers or leaders in the field to also provide that education. I don’t think that the FDA can reach everybody, and I think that hearing it from multiple colleagues and other respected colleagues and other sources are going to help drive that education and acceptance.