Access Insights 2024: Playing the Chess Endgame: Healthcare Policies Targeting Drug Commercialization

PC: You were recently on a panel entitled “Playing the Chess Endgame: Healthcare Policies Targeting Drug Commercialization.” What are the main points that the audience should take away from that presentation?

Sarraille: I think unfortunately, the implementation of the Inflation Reduction Act is going to be a bumpy thing, are going to be a lot of losers, at least in the short term, including patients. I think the panel was influenced by my pessimism. There were some optimists on the panel, but I was definitely the lead pessimist.

We saw some pretty significant challenges. Obviously, the statute is trumpeted as having a number of components that should help patients with a $2,000 cap on their out-of-pocket expenses over the course of the year. It’s a smoothing mechanism that will allow them to pay for their out-of-pocket costs on a smooth basis across the year. hose sound great, but unfortunately, they come with some countervailing pressures, such as higher premiums and deductibles for those patients who are under $2,000 in co-payments and co-insurance.

We also talked about some of the operational challenges that will be involved here, and I think the panel thought there were a lot of significant operational challenges. Those include whether or not the idea of having negotiated prices really are going to yield the kind of savings that MS is expecting them to, or whether plans and PBMs may actually push patients away from those drugs to high list, high rebate alternatives, whether the dynamic that's being created here will have a pretty detrimental impact on biosimilars and generic drugs generally, whether we could be on the threshold of an environment in which pharmaceutical innovation is negatively impacted. As a rare disease patient, that’s a huge source of concern for me. There are things in the IRA that are designed to make sure that rare disease development programs are not as adversely affected as other drug programs, but I don't have much confidence in those provisions, and I'm afraid that we're already seeing some very significant and negative consequences for innovation.

Full Interview Summary: The implementation of the Inflation Reduction Act is expected to be challenging, with both short-term losses and operational difficulties. While the Act aims to help patients through measures like a $2,000 out-of-pocket cap and a smoothing mechanism, it may also lead to higher premiums and deductibles. Additionally, the negotiated prices might not yield the expected savings, and there could be negative consequences for biosimilars, generic drugs, and pharmaceutical innovation.

Retail pharmacy is facing significant challenges, including a potential return to a cash-based system and increased compounding. Even large chains are under pressure, impacting patient access to treatments. Other factors affecting patient access include the potential for plans and PBMs to move away from negotiated price drugs, maximizers and accumulators, and alternative funding programs involving unapproved drugs. These issues collectively pose a significant threat to patient access to treatments.