CNPV Limits May Not Slow Collaboration or Commercialization

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: How does a CNPV’s non-transferability affect its strategic value for large vs. mid-size companies, especially those without an immediate pipeline candidate ready to leverage accelerated review?

Schoonveld: The risk might be that if a company is licensing this, say, to a large pharmaceutical company, a small biotech company, usually when they go to Phase III, they need to get funding for this huge program. They need the marketing muscle. And they may go to a midsize, often to a large pharmaceutical company in a partnership, and then they will lose that voucher privilege.

In most cases, by the time that the discussion of a voucher comes into play, you're getting pretty close to launch. You certainly are at least already finished with your Phase III program. So in reality, Idon't think this is going to be an issue for many products, since that's not the stage at which these partnerships are being started in most cases.