HHS Secretary Alex Azar offered a view of hope and optimism for the future of the American healthcare market in his remarks delivered as the closing keynote address at the Association for Accessible Medicine’s Access! 2019 meeting.
HHS Secretary Alex Azar offered a view of hope and optimism for the future of the American healthcare market in his remarks delivered as the closing keynote address at the Association for Accessible Medicine’s Access! 2019 meeting.
Azar’s remarks, delivered after President Trump gave his second State of the Union address, outlined a vision for a more competitive and transparent healthcare market. Greater transparency in regard to drug pricing has become a calling card not only for the Trump administration, but for patients and biosimilar developers alike.
In addition to greater transparency, Azar is also looking to increase competition in both the generic and biosimilar space. “We’re working to ensure that we have a market that rewards competition; where negotiators are incentivized to choose the lowest-cost options—often generics—and where low-cost generic options can translate into low out-of-pocket costs for patients.”
However, in order to build on the success of the generic market, and create the same kind of success with biosimilars, the US healthcare system must also adapt its payment systems to allow for new competition.
Azar acknowledged the challenges that have been set forth in front of the biosimilars market, but he also recognizes the tremendous promise that it holds. “Biologic drugs, today, represent almost 40% of prescription drug spending. The challenges are real, but so is the potential for competition and savings. Imagine doing to 40% of the pharmaceutical market just some fraction of what generics have already done to the other 60%,” said Azar.
He was clear about how he intends to achieve these savings and uptake goals in biosimilars: pharmacy-level interchangeability. “Interchangeability is the ultimate goal of the Biosimilars Action Plan that [FDA] Commissioner [Scott] Gottlieb launched last summer,” he said.
Though this may be the ultimate goal, Azar acknowledged that this is no small feat, and before it can be accomplished, a lot of education needs to be done to clear up confusion in the space caused in part by the dissemination of misinformation about biosimilars. "Those trying to hold back biosimilars are simply on the wrong side of history,” he said.
Azar went on to discuss some other initiatives the FDA and HHS are evaluating as a means to address situations where generic and biosimilar competition has been “anemic,” such as the potential importation of drugs without patents or exclusivities or instituting the International Pricing Index. These remedies, he said, would help to “inject new competition in the event of price spikes that restrict access to medicines.”
He even took a stab at the drug market, saying that it really isn’t a market at all because there’s no other way to describe a system where higher priced products regularly beat out lower-priced products.
Overall, while Azar touted the successes of the administration in taking steps towards increasing competition and lowering the cost of drugs in the country, he agreed that there was more to be done.
"Of course, we know that a truly transparent drug market, just like a successful market for biosimilars or a competitive market for healthcare services generally, isn't right around the corner," he said. "But I think the experience and achievements of many of you in this room should give us plenty of reason for optimism... Join with us as we move forward to bring your experiences and your successes to the rest of American healthcare.”
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.