Biosimilars Could Be in Jeopardy if ACA is Invalidated

AMCP’s roughly 8,000 members work diligently every day to improve patient care through the optimized use of medicines. As an organization, we also take a leading role in developing improvements to the overall delivery of care, which is no easy task given the size and complexity of our health care system.

Making improvements is what we’re all about. That’s why we’re concerned about efforts underway in the federal courts to invalidate the Patient Protection and Affordable Care Act (the ACA) without careful consideration of what comes next.

Regardless of our individual views on the politics behind this 2010 landmark law, the ACA has resulted in some widely accepted and even popular improvements to the system, including ensuring patients with pre-existing conditions can obtain coverage and the ability for adult children to remain on their parents’ health plans until 26 years of age.

Another improvement brought about by the ACA was the arrival of biosimilars in the U.S. The Biologics Price Competition and Innovation Act (BPCIA), which paved the way for the approval and marketing of biosimilars in the U.S., passed as a provision of the ACA.

Such improvements have become integral to our current health care system. But unfortunately, these may now be in jeopardy.

In December 2018, Texas district-court judge Reed O’Connor ruled in Texas et al. v. U.S. et al. that the individual mandate provision of the ACA was both unconstitutional and inseverable from the remainder of the law. That ruling could make the entire ACA unconstitutional, thereby invalidating the BPCIA.  The ruling is still working its way through the courts and likely will be decided ultimately by the U.S. Supreme Court.

If the ruling on severability is upheld, the BPCIA would have to be reauthorized by Congress; otherwise, biosimilars currently on the market would essentially become unapproved products.  While there would no doubt be immense pressure on Congress to reauthorize the Act given the cost savings biosimilars have the potential to create, the pathway to Congressional passage of a new law in our current divided Congress may not be an easy one.  Recall that until the BPCIA was passed, Congress had not granted the FDA authority to create an approval pathway for biosimilars even though other developed countries had been approving biosimilars for several years.  The Act itself, and especially the provisions around exclusivity periods, was hotly debated and the subject of intense lobbying efforts.

I admire the old adage that we shouldn’t “let the perfect be the enemy of the good.” The ACA may not be perfect, but the consequences of the collapse of the entire law cannot be overstated. Rest assured, AMCP will be watching this closely and managed care pharmacy’s voice will be heard.