One of the forces driving specialty medication prices is the bottleneck created by lengthy review periods for new drugs, including biosimilars. The FDA Commissioner’s National Priority Voucher program (CNPV), announced last summer, allows for the sort of expedited reviews that were previously reserved for rare, high-necessity medications. For some medications, this voucher has reduced review times from 6-12 months to as little as 1-2. Under this program, a drug must meet any one of the “five critical U.S. national health priorities” to qualify for a voucher:
- Addresses U.S. public health crisis
- Delivers innovative cure
- Addresses large unmet medical need
- Drug development and manufacturing in the U.S.
- Increases affordability
According to a CNPV dashboard, in the year since the program launched, at least seven new drugs and therapies have been approved by the FDA following receipt of their voucher. These approved products target a wide range of conditions, including deafness, pediatric sickle cell disease, and obesity.
Despite these successes, support for the voucher program is not universal. At a recent public hearing, members of the pharmaceutical and medical community criticized the voucher program, with many calling for a pause to allow for revisions that would address their concerns. The main criticisms voiced were a lack of transparency, insufficient specificity in the five national health priorities, and political interference in an otherwise nonpartisan process.
While the FDA leadership in attendance did not respond to any of these criticisms directly, their website emphasizes the safety of their procedures:
“The CNPV pilot is consistent with the FDA’s mission and maintains the FDA’s established safety and effectiveness approval standards, scientific rigor and regulatory compliance requirements. It reflects the FDA’s broader commitment to create more efficient approval processes and modernize regulatory frameworks for greater agility to meet emerging public health needs.”
Looking Ahead
Even with the program’s shortened timelines, it is still too soon to say with any certainty how the CNPV program will affect employer health plans. We may see a slight increase in medications for rare conditions, which tend to be very costly but are imperative for those who need them. Other approvals have helped close a gap in need. For example, Augmentin XR (an antibiotic) was manufactured out of the country until 2011, when they stopped manufacturing it. This approval now allows the medication to be made in the United States again. The Moreton team will continue to update and make a strategic plan with our clients as more information becomes available.
