What MFN Pricing Means for Future Drug Development

The discussion centers on the affordability requirement tied to obtaining a Commissioner’s National Priority Voucher (CNPV)—a pilot program launched by the FDA to offer a faster review for drugs that tackle nationa health priorities. While affordability has drawn significant attention, Ed Schoonveld, value and access advisor for Schoonveld Advisory and author of The Price of Global Health, clarifies that it is just one of five possible eligibility criteria, which also include breakthrough innovation, addressing key public health challenges, and strengthening supply chain security. Manufacturers do not necessarily need to reduce drug prices to qualify, based on how the requirement is currently written.

He emphasizes that affordability should not be narrowly interpreted as lowering list prices. For therapies that treat high-burden diseases such as cardiovascular conditions, diabetes, or Alzheimer’s, manufacturers may demonstrate affordability through reductions in total healthcare expenditures. High-value therapies can offset costly downstream care, meaning affordability can be achieved by improving outcomes rather than discounting the treatment itself. A strategy of launching products with dramatically lower prices simply to meet voucher qualifications seems counterintuitive, especially when value has yet to be fully assessed.

Schoonveld raises concerns that the FDA appears to be moving into evaluations traditionally handled by health economists and payers, such as determining fair pricing or cost-effectiveness. In the US, authority over drug pricing has historically remained outside the FDA, recognizing that pricing decisions require different expertise and policy frameworks than scientific review.

Ultimately, he argues that the FDA should remain focused on its core responsibilities: ensuring the safety and efficacy of medical products. Affordability is an important societal issue, he acknowledges, but evaluating and regulating drug costs should remain the domain of payers and other agencies better equipped to manage economic policy.

He also shares CNPVs value given their non-transferability, offers a preview of his latest Pharma Commerce column; and much more.

A transcript of his conversation with PC can be found below.

PC: When can Pharma Commerce readers expect from your next column coming out in the December issue?

Schoonveld: Of course, we see the two deals with Pfizer and AstraZeneca. Actually about a week ago or so, we saw guidance with respect to the MFN calculations, how these most-favored nation prices are going to be calculated and administered, so talking a little bit about that. But what does this mean?

And we're introducing price referencing in the US—we talked about that. What does it mean for drug development? What kind of drugs may be more favored than others, but also, what might happen in the future? Is this the end of price controls as this is shaping up, or are there any next steps that might happen, or there's a big risk of happening?