Mary Roberts: I’m Mary Roberts with the ADVI Market Access Strategy solution team and am really excited to be with you today to talk about what we’re seeing for 2025. You know, we are only three months into 2025 and already, we’ve seen significant changes across the market access landscape from a policy perspective from how payers, providers, and patients are evaluating product value, and we will see lots more changes in the year ahead. So with that, I’d like to introduce my colleague, Lindsay Greenleaf to talk about what we’re seeing from a policy perspective and how that’s impacting our manufacturing partners.

Lindsay Bealor Greenleaf: So much to talk about in the policy world, I think first and foremost, the Trump 2.0 administration has taken shape. We’ve had the confirmation hearings, we’ve had folks in key roles, we have Secretary Kennedy overseeing HHS, we have Dr. Oz overseeing CMS, and Dr. Makary at FDA. It took a while to get here, but we are here. We are now living this out and watching how the folks in these key roles are running their agencies. To start, I think top of mind what everyone is looking at right now is the layoffs, the impact of DOGE, and all of these efficiencies that the administration is working on. The 20,000 jobs being cut from HHS is certainly top of mind right now, and we are working through how we think that is going to impact policymaking going forward. 

Other key topics of the day, IRA: We say ‘IRA all day’ around here at ADVI. There’s always something going on with the IRA. Government negotiation is always top of mind. What’s happening with the IPAY 2027 drugs that are subject to the negotiation process right now, working with clients as they’re engaging with CMS on that. We’re going to see how a Trump-led CMS may implement the IRA differently than a Biden-led CMS. I think that’s the big question mark for everybody, how might this shape out differently under a new administration. We’re watching that in real-time. Also with the IRA, we have Part D redesign, redesign is here.

We’re partnering with Mary’s team, looking at access issues, ways that plan behaviors have changed, formulary coverage, out and out-of-pocket changes – that’s a big one. On the Medicare Part B – as in boy – side, we have the threat of international reference pricing and the most favored nation model, the MFN, something like that coming back around, that’s a big one we’re working on with clients, thinking through how a MFN 2.0 might look, how mitigation options, policy alternatives that maybe administration may be willing to consider. That’s a big one for our manufacturer and our provider clients that we work with. 340B is a huge topic, no matter who’s in office, but much to watch going forward with contract pharmacies, whether it’s from a policy-making perspective or tracking litigation and what’s playing out in the courts. Also, just the Federal and State level, looking at all the new State legislation that seems to keep popping up.

Lastly, seeing just how administration and authority over HRSA might play out under a Trump administration. Does it stay under HRSA? Does 340B shift to CMS? These are some really big structural questions that we’re watching and talking to our clients about. So, plenty to discuss, Mary. A lot going on.

Mary Roberts: Lots going on, Lindsay. You and I spend so much time together trying to help our clients navigate these uncharted waters that we’re headed into with all of the changes that we see ahead of us, and understanding how the policy environment will impact your brand strategies and tactics and ways that you can navigate pricing, contracting, and profitability for your brands given all of these things that are happening in the market. I look forward to seeing you at Asembia in the coming weeks, and talking more about these issues when we get a chance to meet together soon.

ADVI is attending and presenting at Asembia’s AXS25 Summit. Want to meet with us at the event? Get in Touch to book a time that works for your schedule.