Last year CMS proposed regulations allowing for Part D sponsors to remove a reference product from a formulary and immediately substitute it with an interchangeable biologic or an unbranded biologic product approved under the same biological license application. In the final rule, they pulled back and said they would not finalize the proposal until at least an effective date of 2025. That got us to yesterday’s proposed rule.

CMS is now expanding its proposal in ways that are likely to really tick some people off; potentially even the Food and Drug Administration (FDA.) CMS is proposing to add substitutions of biosimilar biologics products other than interchangeable biological products to the type of formulary changes that apply to all enrollees (including those already taking the reference product prior to the effective date of the change) following a 30-day notice.

Let’s pick that apart.

CMS wants to allow for more plan flexibility (savings). In this instance that means allowing them to transition patients away more quickly from branded biologics to FDA-approved biosimilars.

The FDA does approve all of these biosimilars, but some go through extra studies and regulatory hurdles to become designated as interchangeable. This allows them to be substituted by pharmacists for the reference product without a new prescription.

CMS is proposing that plans be allowed to transition patients to ANY biosimilar with 30-day notice. This could require a new prescription if the formulary biosimilar is not interchangeable.

They say that it is going to save beneficiaries money because biosimilars are less expensive and that there is precedence for a 30-day window.

Have you tried getting an appointment with a specialist in a 30-day window? And most beneficiaries are unlikely to save much money because, starting in 2025, there is a $2000 out of pocket cap in Part D. I’m not saying that it isn’t good to save money for the system, but it is also a tough transition to make quickly with little benefit to the patient who has to make the switch.

Also, let’s go back to the idea that while these drugs are safe and effective, they are technically not interchangeable. The new prescription is a workaround the FDA process and leaves beneficiaries that are stable on a medicine racing to get a new prescription.

I imagine a lot of patient groups are going to be writing in and so will those manufacturers who have done the extra work to be designated as interchangeable. The real winner seems to be plans.