Congress has spent much of the past year confronting the growing power of pharmacy benefit managers and other health-care middlemen. Bipartisan reforms have targeted practices that can increase drug costs and limit patient access, while lawmakers continue pressing for greater transparency into PBM rebates, discounts and contracting practices.
Yet tucked among dozens of bills moving through congressional committee markups this summer was a little-noticed piece of legislation that would move sharply in the opposite direction.
The Biosimilar Red Tape Elimination Act, or BRTEA, would give PBMs and insurers unprecedented power to switch patients from one biologic medicine to another without their physician’s involvement. The Senate HELP Committee advanced the legislation in June, while its House counterpart also moved through committee consideration this summer.
For 16 years, since our organization’s founding in 2010, the Alliance for Safe Biologic Medicines has worked with FDA, physicians, patients and medicines regulators around the world on biosimilar policy. We strongly support biosimilars and the competition they bring. But one scientific fact has remained constant: biosimilars are not generics.
Biologics are large, complex medicines produced in living systems. A biosimilar can be highly similar to its reference medicine, safe and effective—and still not be an identical copy like a generic. This scientific fact has long been recognized by FDA, the European Medicines Agency, Health Canada, Japan’s PMDA, Australia’s TGA, Brazil’s ANVISA, and the World Health Organization.
As a class, biologic medicines are not substitutable by third parties such as insurers or PBMs because treatment plans are not one-size-fits-all. Patients with arthritis, psoriasis, Crohn’s disease, cancer and other serious conditions may spend years trying different products until finding a biologic therapy that stabilizes their disease. An unnecessary or inappropriate switch can jeopardize that hard-won stability.
Today, FDA determines product by product whether a biosimilar has sufficient evidence to be deemed “interchangeable”—the designation that permits pharmacy-level substitution without the prescribing physician’s involvement under pharmacy practice laws in all 50 states.
BRTEA would replace that scientific determination with a congressional decree: every biosimilar would automatically be deemed interchangeable. Overnight, insurers and PBMs would be able to switch patients nationwide to the most profitable product, regardless of what an FDA scientific evaluation might have found, or whether their physician believes it to be inappropriate based on a patient’s medical history.
Physicians overwhelmingly oppose this “genericization” of biosimilars. In a survey of 270 prescribers, 88% supported FDA continuing to evaluate interchangeability individually; only 11% supported automatically declaring all biosimilars interchangeable.
Supporters of BRTEA also misleadingly claim the bill would align U.S. policy with that of the European Union. But in Europe, the term “interchangeability” refers to the physician’s ability to choose a biosimilar when prescribing—not to giving health plans or pharmacies authority to override that choice, as BRTEA would do. Like their U.S. counterparts, European physicians (73%) strongly oppose pharmacy-level substitution of biosimilars. Unsurprisingly, substitution without a physician’s involvement is rare in Europe and prohibited outright in many countries.
BRTEA would not bring the United States into line with Europe. It would make the U.S. a global outlier—handing insurers, PBMs and pharmacies substitution power that no comparable advanced regulatory system broadly permits.
That is not eliminating red tape. It is taking scientific judgment out of FDA’s interchangeability decisions—and physicians’ clinical judgment out of treatment decisions.
The irony is that even generic drugs do not receive the blanket substitution treatment BRTEA would give biologics. FDA has identified some approved generics for which the evidence did not support automatic substitution. Those drugs remain approved, safe and effective, but pharmacists cannot automatically substitute them without prescriber authorization. BRTEA would remove the FDA’s current discretion to make that same determination about medicines that are far larger and more complex.
Current law affords FDA broad discretion to decide what evidence is necessary on a case-by-case basis; in some determinations this has warranted clinical switching studies, though nearly half - 12 of the first 27 interchangeable biosimilars - were deemed interchangeable without additional clinical studies, relying on scientific analytical data.
Congress is right to scrutinize PBMs for putting financial incentives between patients and their medicines. But it makes little sense to rein in those middlemen with one law while handing them sweeping new authority over treatment decisions with another.
As Congress returns this fall, it should reject BRTEA. Biosimilars are not generics. Treatment decisions are not one-size-fits-all. And Congress should not put PBMs over patients.
• Michael S Reilly, Esq, is Executive Director of the Alliance for Safe Biologic Medicines and served in the U.S. Department of Health and Human Services from 2002 to 2008, including as Associate Deputy Secretary.
• Ralph D McKibbin, MD, FACP, FACG, AGAF, is a practicing gastroenterologist and Chairman of the Alliance for Safe Biologic Medicines. He is a past president of both the Pennsylvania Society of Gastroenterology and the Digestive Disease National Coalition.
• Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP, is Professor of Pharmacy at The Ohio State University and Chair of the Alliance for Safe Biologic Medicines’ International Advisory Board. He is a past president of the American Society of Health-System Pharmacists and served two terms as Vice President of the International Pharmaceutical Federation.
