Lindsay Bealor Greenleaf: Hi, everyone! I’m joined with my colleague, Alicia Silver, and we were recently in Austin, Texas, at the Access Forum just about 2 weeks ago. We’d love to give you a recap of 2 panels that we were a part of. First, for me, I was moderating a panel on Trump 2.0, and what to expect out of this administration, what we’ve seen so far, and what we’re looking at in the future of big notable policies affecting life sciences and providers. 

On our panel we had Dr. Deborah Patt, Executive Vice President of Policy and Strategy from Texas Oncology, giving us that oncology/provider perspective. We also had Greg Daniel, Vice President and Head of Global Public Policy at Eli Lilly, Wendy Sussman, Head of Pharmaceuticals and US Federal Affairs at Johnson and Johnson, and lastly, our colleague here at ADVI, John Coster, who is Senior Director of Federal Regulatory Engagement and Co-lead of the IRA Center of Excellence here at ADVI Health.

That was our panel, we had great representation across providers and manufacturers, and John Coster from our team, with a very deep background of CMS experience having just left the IRA Negotiation team, he had a wealth of knowledge to share with everybody. We talked about the big issues of IRA implementation, how things are going and what we’re expecting with the IRA being implemented under Trump vs. Biden, and how things might change going forward. Of course, the biggest news of the day coming out of the Trump administration, which is Most Favored Nation, anything related to MFN, and that executive order that we had over a month now. How things are playing out, what the latest rumors are that the administration might be looking at in terms of next steps, and if those next steps were to come to fruition, what might that mean for manufacturers, patients and providers, and just really understanding how these policies could play out across all stakeholders up and down the supply chain. These are issues we talked about on our panel, issues near and dear to our hearts at ADVI. This is what we talk about all day, every day on our policy team. We are no stranger to these issues, so if you need help tracking, analyzing, or forecasting what’s coming next on all of that, obviously, please do reach out to us on the ADVI policy team. So that was us, Alicia, why don’t you tell us a little bit about your panel.

Alicia Silver: Yeah, thanks, Lindsay. Well, we are really fortunate to be joined by three experts on our Cell and Gene therapy commercialization panel. We had Rocio Manghani from Gamida Cell, we had Doug Dannison from Bayer, and then Sanket Shah from Jazz Pharmaceuticals. Really phenomenal speakers, people that have been in the trenches, launching cell and gene therapy and rare products. These are really obviously expensive, usually for rare indications, sometimes getting larger. For example, the Bayer products that are first to the pipeline in Parkinson’s disease. So we’re thinking through the complexities of moving from blood cancer CAR-T into things like Parkinson’s disease.

So the panel is really exciting, we talked about what we’ve seen with payers since the first CAR-T launched in 2017-2018, and how much the Payer dynamics have shifted. We also spent a good amount of time talking about provider economics and making sure that it’s financially feasible for providers to be able to provide cell and gene therapy products to their patients. This is like I said, a very high cost area typically. We’re thinking about this more from a high-value perspective instead of high-cost, and how we can change that dynamic. But we talked about provider reimbursement, we are also very closely monitoring what’s happening with the inpatient payment role, IPPS, the final rule should be out early August, so there’s a lot riding on that rule in terms of Medicare reimbursement from an inpatient perspective. We’re closely monitoring the soon release of the outpatient payment rule, too, which may have implications for cell and gene therapy as they start to move to the outpatient setting. We, of course, just saw the removal of REMS requirements for CAR-T last night from FDA.

So a lot happening in the cell and gene therapy space. Really just learning the lessons from the panel and taking it all in, it was wonderful. I think the audience really got a lot out of it, I did, certainly. I learned a lot from my peers, and we just love monitoring these issues and talking these things through with clients. So it’s really no issue too big or too small for us, Lindsay.