Interchangeable Biosimilar Automatic Substitution

Ryan Haumschild, PharmD, MS, MBA: Dr [Jonathan] Kay, from a provider perspective, what, if any, clinical concerns do you have related to automatic substitution at the pharmacy for an interchangeable biosimilar? Or do you not have any?

Jonathan Kay, MD: I don’t have any. Biosimilars that have been reviewed and approved by the FDA have been shown to be equivalent in efficacy and comparable in safety to their reference product. So there should be no adverse effect to the patient using a biosimilar or an FDA-approved biosimilar compared to using the reference product. There should be an advantage to the patient. And, as I mentioned earlier, the advantage should be economic. The patient should share in the savings. The ideal biosimilar incentive would be for the pharmacy benefit management company if they want the biosimilar to be prescribed to eliminate prior authorization as a requirement for the biosimilar. Whereas to continue to require it for the reference product for the patient, the copayment should be waived for a biosimilar but should still be there for the reference product. However, as I alluded to earlier, the pharmacy benefit manager [PBM] is not always going to favor the biosimilar over the reference product for financial reasons. And in that situation, the reference product may be favored over the biosimilar. Biosimilars must survive as was pointed out earlier that the biosimilars induce market competition and put a brake on the inevitable and inexorable rise in the cost of reference products over time. If biosimilar manufacturers don’t survive, and biosimilars go away, the cost of biopharmaceuticals is going to continue to rise as it has prior to the advent of biosimilars. In terms of concerns about interchangeability, a provider can always right no substitution or no interchange or brand medically necessary to prevent interchange. It’s only going to apply to a few biosimilars because interchange can only occur with interchangeable biosimilars. And you have to write the prescription for the biosimilar with the 4-letter suffix, or the reference product if it’s a reference product that was approved more recently, with the 4-letter suffix. So the prescriptions are relatively specific and interchange is only going to occur in selected situations and can certainly be prevented by a provider if the provider is so concerned.

Ryan Haumschild, PharmD, MS, MBA: Absolutely. It seems like interchangeability, is something you’re going to be comfortable with. The data is there. There’s proven efficacy. And I think there’s shared savings. We talked about the shared savings, and a lot of what we’ve heard goes back to the payer. Do they decide to share that with the patient? Does it go back to the health plan? Does it stick with the PBM? Dr [Kimberly] Chen, from a payer perspective, what are some of the potential financial impacts of automatic substitution for interchangeability when we talked about it at the pharmacy?

Kimberly C. Chen, DO, MSHLM: I think automatic substitution is a win-win for everybody. As you know, we talked about a lot of administrative burden like prior authorization. The automatic substitution will take that all away. Patients will have improved accessibility to the drugs. There will be more timeliness because they won’t be tied up on the prior authorization and administrative burden providers have, and it will add overall cost savings for everybody to shift using the biosimilar rather than biologics and, hopefully, that will meet the market competitiveness that we all discussed. Hopefully, we’ll make biologics much more affordable for everybody as well.

Jonathan Kay, MD: I would agree with most of what you say, but automatic substitution is not a win-win for everybody. It’s a win-win for the patient. It’s a win-win for the provider. It’s a win-win for society. But it may not be a win-win for the PBM because if the biosimilar has a lower list price than the reference product, the PBM is going to get a lower administrative fee for dispensing that biosimilar. Also, every patient that started on the biosimilar is 1 less patient that’s on the reference product. And it may take away from the rebates and discounts that the PBM is getting for that reference product. So the system by which PBMs operate is almost directly in opposition to the intent of biosimilars is reform of PBMs needed. Perhaps, congress is now looking into PBM practices, and we may see some required reforms in the future.

Transcript edited for clarity.

This activity is supported by an educational grant from Boehringer Ingelheim.