Access Insights 2024: Reassessing Pricing and Commercialization Approaches

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 can one strategically reassess pricing and commercialization approaches in order to anticipate the future US healthcare policy environment?

Thigpen: I think it's a couple things. If I were in a manufacturer’s shoes, you have to take the long game here. You’ve got to remember that in 2026, we would have 20 years of experience of the Medicare Part D benefit underneath our belts of expertise, and how it was originally intended to roll out is not how it looks in 2026 today, and that is because every year, the federal government allows for rule changes, business model changes, and open comment periods, and that is a fluid dynamic that evolves the program over time. I say that as context, because the IRA [Inflation Reduction Act] today is going to look like a one-year snapshot in time—it's not going to be the greatest implementation out of the gate, and it will continue to evolve.

With that in mind, the manufacturers have got to take a very long view and maybe a conservative view out of the gate. They should say, “I know this isn't going to be perfect, and I know I may lose on some and win on some others, but I've got to maybe take a measured approach to the business and continually reassess it every year.” The payers are going to do the same, the PBMs are going to do the same, the retail markets and the distributors will all do the same. They can only play the cards that they're dealt in year one, then they reassess, they re-evaluate, and then wait for rule changes to occur. They kind of figured out that plan, and lo and behold, over time, we figured out somehow to make Medicare Part D successful in 20 years.

I suspect that will be some of the same cadence with the IRA and the drug manufacturers, but I do think it changes the dynamic of where the manufacturer needs to focus. For example, being fully ready to launch on day one of the PDUFA [Prescription Drug User Fee Act] date when they launch and being ready to commercialize. Then, I follow this product life cycle, and maybe, if there's an MFP [maximum fair price] tied to a drug that I'm subject to, maybe a generic doesn't launch it, maybe I need to continue to ride that out and extend that product life cycle for a period of time. It’s similar to what we've seen AbbVie and Humira exercise with biosimilars, so I think it's a measured approach. I think it is a one-year reassess every time, every year, but knowing that the rules are going to change [I would], tread lightly this year.