PAP 2024: John Hoffman Discusses the Inflation Reduction Act and Current Advocacy Efforts

PC: How has the Inflation Reduction Act benefited your advocacy efforts?

Hoffman: I like to refer to it as the innovation reduction act as opposed to the Inflation Reduction Act. I think there were some unintended consequences in the IRA that are going to have significant detrimental impact on patient populations. The negotiations component of the IRA really provides a disincentive for pharmaceutical companies to invest in R&D, especially in indications that are for smaller populations that don't meet the orphan drug exclusion. But also, in terms of the sequencing, a lot of times, especially oncology drugs, are first launched to some smaller indications to make sure they're safe, for providers to get comfortable with them, and for patients to get comfortable with them. Well, now that's not going to happen, because the clock on your negotiation starts ticking on the first approval.

Pharmaceutical companies are now going to wait until their largest indication is ready from a clinical trial perspective. That's going to have a significant impact on the patients who are in those smaller indications. It's created a need to really educate the advocate organizations, especially in rare diseases, small indications, and orphan drugs to really try to advocate to get those things changed or to increase the qualifications for exclusion. Otherwise, you're only going to see pharma companies investing in blockbuster drugs.

PC: Are there any programs or reforms that you are currently advocating for that you would want to highlight?

Hoffman: I think the bigger thing is all under the health disparities. As I mentioned before, when you look at whether any of the access policy changes that we've been advocating for the last five to 10 years, whether it is non medical switching, step therapy, copay, accumulators, maximizers etc. A couple of years ago, we started looking at the data add that by underserved populations by ethnicity, income, rural versus urban, etc. In every single case that I saw, every one of those policies which are negative to patients in general, have a disparately negative impact on underserved populations. So really, the focus that I've been working on since I've started consulting is to say, how do we get politicians and policymakers who now have at least on the surface, an interest in addressing health disparities understand that these policies are contributing to worsening health disparities rather than reducing them?

PC: Is there anything else you would like to add?

Hoffman: I think one of the things that came to mind as I was preparing and meeting with my fellow panelists is that I came up with a realization. Every stakeholder in the US healthcare system has an obligation to address health disparities, we all get that. But it can't just be throwing money at it, focusing on making sure we have the correct diversity representation in our clinical trials, it has to be creating solutions that are both impactful and sustainable. The only way we're going to do that is to measure them to make sure that we are getting the outcomes that need to happen. By measuring and achieving those outcomes, we can then focus on those solutions that then create the opportunity, not just the opportunity to address health disparities and make sure that every person gets the treatment that they need, but also opportunity for the stakeholders. The more people that get treated, the more drugs and other services will be used appropriately in the system.