Hollywood, FL—Pharmacy benefit managers (PBMs) will soon have the new challenge of dealing with the confusion of biosimilars, according to Douglas S. Burgoyne, PharmD, President and Managing Partner, VRx Pharmacy Services, Salt Lake City, UT, a full-service PBM company that provides medication therapy management, case management, and other clinical services to employer group waiver plans and commercial payers.
Dr Burgoyne is immediate Past President of the Academy of Managed Care Pharmacy (AMCP), and he described the AMCP’s position on biosimilars at the Third Annual Conference of the Association for Value-Based Cancer Care.
Biologics include a wide range of products that are generally made from human and/or animal materials. They are usually larger than and have a more complex structure than small-molecule prescription drugs. They may be manufactured through biotechnology, derived from natural sources, or produced synthetically.
“Biologics and specialty drugs, as defined by payers, generally mean the same thing—an injectable, usually—but we’ve also added a definition around cost, and that is that if the product costs more than $600 per month, then we can categorize it as a specialty product,” Dr Burgoyne said. “More and more products are going into this specialty bucket. That affects contracting downstream. It also affects member copayment, and how much the member contributes to the cost of the drug.”
Biosimilars (or follow-on biologics) are biologic products that are very similar to US-licensed reference biologic products, notwithstanding minor differences in clinically inactive components. There are no clinically meaningful differences between the biologic product and the reference product in terms of the safety, purity, and potency of the product.
The US Food and Drug Administration (FDA) has been working on a biosimilar pathway for biologic drugs for some time now, but challenges remain and no biosimilar products have yet been approved by the FDA.
The AMCP Position on Biosimilars The AMCP supports an abbreviated licensure pathway for the FDA approval of biosimilar biologic drug therapies. In addition, the AMCP believes that an expedited approval process provides a needed incentive for the development of important new therapies. Finally, the expectation is that these drugs will cost less than the originator, or reference, product.
“With biosimilars, we’re looking at an opportunity, basically, to save money, but also to create a pathway for a follow-on biologic that is safe and effective,” Dr Burgoyne said.
The issue of whether to require additional clinical trials for biosimilars remains unresolved, but the AMCP believes that the FDA should consider this on a case-by-case basis. The AMCP proposes a 2-step process: the first step is to determine the actual biosimilarity of an applicant product, and the second step is the interchangeability of the biosimilar with the reference product.
“If it’s interchangeable, that helps us. That helps pharmacies as well,” he noted. “The biosimilar would be dispensed by the pharmacist without having to go back to the physician.”
The AMCP would also prefer that the biosimilar receives the same indication profile as the reference product.
“We’re looking for an opportunity to reduce costs, have effective products that are safe, and leave regulation to the FDA,” Dr Burgoyne said. He pointed out that the PBM’s perspective can be summarized in the following:
Advantages and Disadvantages of Biosimilars Biosimilars are expected to be cost-saving—although perhaps only by 10% to 15% over the originator products, at least for the first generation. Biosimilars should, however, create opportunities to negotiate additional discounts and rebates with manufacturers of biosimilars and branded products, Dr Burgoyne predicted.
But there is expected to be considerable confusion at the patient level and at the provider level in terms of recognizing which products should be dispensed, by whom, and by which strategy.
States Taking Preemptive Action Against Biosimilars The emergence of biosimilars is not met without resistance. More than 17 states have already proposed bills that would restrict the use of biosimilars—even in the absence of available biosimilar products. The presumption, without direct evidence, is that bills have been written and assisted by the brand manufacturers in an effort to reduce the interchangeability of biosimilars, Dr Burgoyne suggested.
The AMCP considers this premature, because the FDA has yet to finalize its guidelines regarding these drugs. Until those guidelines are finalized, there is no way to know if additional steps are warranted before substituting an interchangeable product, he said.
“We’re saying to states, ‘Wait until there is a biosimilar. Wait until the FDA has determined a pathway. Wait until we know what the interchangeability status is, and then create legislation that will protect members within your states,’” Dr Burgoyne pointed out.
