In a video interview with Pharma Commerce, Albert Thigpen, co-founder, Talentwise Consulting, discussed how the panel on “Playing the Chess Endgame–Healthcare Policies Targeting Drug Commercialization” underscored the complexities of implementing the Inflation Reduction Act (IRA), predicting significant challenges for stakeholders like retail pharmacies, payers, and pharmacy benefit managers. They highlighted concerns about the unintended consequences of negotiated maximum fair prices (MFPs), particularly on the generics industry and oncology drug distribution, which could complicate decisions for companies and affect in-office dispensing practices. Overall, the panelists noted that the IRA’s intricate framework might lead to unforeseen difficulties in the healthcare landscape.
Thigpen also emphasized the importance of taking a long-term and measured perspective for manufacturers when it comes to strategic approaches to pricing and commercialization in light of future US. healthcare policies. He noted that, similar to the evolving landscape of Medicare Part D over the past 20 years, the Inflation Reduction Act (IRA) will also undergo significant changes. Manufacturers should prepare for initial challenges and be ready to reassess their strategies annually, adapting to new rules and market dynamics as they emerge. This approach may involve delaying product launches or adjusting commercialization tactics based on negotiated MFPs and market conditions, akin to the strategies seen with AbbVie and Humira. Beyond that, Thigpen dove into key trends impacting the pharmacy benefit management and specialty pharmacy spaces, while providing a crash course on retail consumerism.
A transcript of Thigpen’s conversation with PC can be found below.
PC: How has the specialty pharmacy industry grown and evolved over the years?
Thigpen: Specialty pharmacy, by itself, has been subject to a lot of what retail has been in the past, which is that specialty pharmacy is approaching and getting closer to a commoditized market, just as retail brand drugs were in general. Those are for specialty drugs that have a lot of competition, maybe some biosimilars and generics in the space, but it’s starting to commoditize. In some cases, it has commoditized in certain classes. There’s this whole other evolution of biosimilars—what do we do with them? Are biosimilars as clinically effective and equal as an innovator brand? In some cases, yes, some cases may be unknown at this point in time.
We like to use the Humira and the biosimilars that support Humira as a proxy for that one. But still, the brand innovator still holds a pretty significant share of the marketplace. I think the trend is that companies want to embrace biosimilars and actually be able to manage biosimilars, but in reality, it hasn’t quite gotten there just yet for a multitude of reasons. I think maybe one of the bigger issues in specialty in some of the evolution is that the drugs that are being launched today by the FDA are more complex and much more expensive and difficult to manage.
Think about drugs that are coming out for the cell and gene therapy-type models that are uber expensive, very personalized in nature, difficult to dispense and get to the patient at the right time; a lot of coordination of that across the board is one thing. We still have a really broad pipeline of rare, orphan, and ultra-orphan that could Eclipse a couple million dollars per patient per year, and very selective patient services and things that specialty pharmacies will need to offer and provide, of which not every specialty pharmacy can do.
We’re seeing differentiation of services. We’re seeing much more complex disease molecules being approved by the FDA in specialty, and we’ve got this quasi bio, similar model that needs to be managed in general, all of which are good problems to have if you’re a specialty pharmacy.