^{Maryam Tabatabai, PharmD, is the associate vice president of clinical information at Prime Therapeutics.}

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Last summer, the U.S. Food and Drug Administration (FDA) introduced a new pilot program called the Commissioner’s National Priority Voucher (CNPV) program to expedite approval of drugs and biologics aligned with critical U.S. health priorities. Under the pilot, drugs undergo faster one- to two-month FDA reviews — compared to traditional (10 months) or priority (six months) timelines — while maintaining the FDA’s rigorous scientific and regulatory standards. 

In the latest episode of the Prime Therapeutics (Prime) “Pharmacy Friends” podcast, “Accelerated drug approvals: The big questions facing payers,” join experts Angela Sutton, senior principal government affairs policy advisor, and Bob Greer, vice president of clinical strategy and programs, as they explore the important roles clinical confidence and operational readiness play in making solid coverage decisions, and what faster drug decisions could mean for evidence review, affordability assessment and implementation planning. 
“When you accelerate one part of the pipeline, the pressure immediately shifts downstream,” Sutton said. “So, the questions that arise are not just going to reside within the FDA.” 

Experts focus on impacted areas including:

• Managing drug spend
• Assessing coverage strategies
• Determining policy risk

Which drugs have been awarded a voucher? 

To date, 22 national vouchers have been awarded, seven approved and one rejected. Of the seven approved, two are new molecular entities. Eli Lilly’s oral glucagon-like peptide-1 (GLP-1) receptor agonist medication, orforglipron (Foundayo), for weight loss, and Regeneron’s lunsotogene parvec-cwha (Otarmeni), the first gene therapy under this pilot and the first gene therapy for an inherited form of deafness. The FDA review timelines for drugs approved under the CNPV pilot so far range from approximately two days to two months, with an average of 47 days. 

Pipeline drugs granted a national voucher represent a mix of new drugs and new indications for existing drugs. These therapies encompass a wide range of medicines including those for cancer and infertility to high cholesterol, nicotine vaping and psychedelics. 

“I applaud the effort to faster approval and more secure patient access,” Greer said. “I would love to see more transparency in the selection process, (to) be able to understand why certain agents are being awarded a voucher over others and under which national priorities that’s happening.” 

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Drugs that have received FDA approval through the voucher pilot include: 

• Zenocutuzumab-zbco (Bizengri)
  • Manufacturer: Partner
  • Indication: Advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy
  • Estimated FDA review time: Two days
• Zongertinib (Hernexeos)
  • Manufacturer: Boehringer Ingelheim
  • Indication: Updated indication for human epidermal growth factor receptor 2 (HER2) lung cancer
  • Estimated FDA review time: 44 days
• Orforglipron (Foundayo) 
  • Manufacturer: Eli Lilly
  • Indication: Obesity or overweight with at least one weight-related comorbid condition
  • Estimated FDA review time: 50 days
• Semaglutide 7.2 mg subcutaneous (Wegovy HD)
  • Manufacturer: Novo Nordisk
  • Indication: New dose for obesity and related conditions
  • Estimated FDA review time: 54 days
• Teclistamab-cqyv (Tecvayli)
  • Manufacturer: Janssen
  • Indication: Expanded indication for multiple myeloma (in combination with daratumumab for relapsed/refractory disease)
  • Estimated FDA review time: 55 days
• Amoxicillin/clavulanate potassium extended-release (Augmentin XR)
  • Manufacturer: US Antibiotics
  • Indication: Bacterial infections (domestic manufacturing)
  • Estimated FDA review time: Two months
• Lunsotogene parvec-cwha (Otarmeni)
  • Manufacturer: Regeneron
  • Indication: Otoferlin (OTOF) gene variant-related hearing loss
  • Estimated FDA review time: 61 days

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Drugs in the CNPV pipeline, which were awarded a voucher but not approved yet, include: 

• Bedaquiline (Sirturo) 
  • Manufacturer: Janssen
  • Indication: Expanded indication for drug-resistant tuberculosis in young children
  • CNPV award date: Nov. 6, 2025
• Bitopertin (received a Complete Response Letter)
  • Manufacturer: Disc Medicine
  • Indication: Porphyria
  • CNPV award date: Oct. 16, 2025
• Cenegermin-bkbj (Oxervate) intranasal
  • Manufacturer: Dompe
  • Indication: New formulation for blindness
  • CNPV award date: Oct. 16, 2025
• Cytisinicline
  • Manufacturer: Achieve Life Sciences
  • Indication: Nicotine vaping addiction
  • CNPV award date: Oct. 16, 2025
• Daraxonrasib (RMC-6236)
  • Manufacturer: Revolution Medicines
  • Indication: Pancreatic cancer
  • CNPV award date: Oct. 16, 2025
• Dostarlimab-gxly (Jemperli)
  • Manufacturer: GlaxoSmithKline
  • Indication: New indication for rectal cancer
  • CNPV award date: Nov. 6, 2025
• Enlicitide decanoate
  • Manufacturer: Merck
  • Indication: Low-density lipoprotein cholesterol (LDL-C) lowering
  • CNPV award date: Dec. 19, 2025
• Exagamglogene autotemcel (Casgevy)
  • Manufacturer: Vertex
  • Indication: Expanded indications for sickle cell disease and thalassemia
  • CNPV award date: Nov. 6, 2025
• Ketamine
  • Manufacturer: Not reported
  • Indication: Anesthesia (domestic manufacturing)
  • CNPV award date: Oct. 16, 2025
• Methylone 
  • Manufacturer: Transcend
  • Indication: Post-traumatic stress disorder (PTSD)
  • CNPV award date: April 24, 2026
• Orforglipron (Foundayo) 
  • Manufacturer: Eli Lilly
  • Indication: Expanded indication for type 2 diabetes (CNPV awarded for obesity and related health conditions)
  • CNPV award date: Nov. 6, 2025
• Pergoveris
  • Manufacturer: EMD Serono
  • Indication: Infertility
  • CNPV award date: Oct. 16, 2025
• Psilocybin
  • Manufacturer: Compass
  • Indication: Treatment-resistant depression, major depressive disorder
  • CNPV award date: April 24, 2026
• Psilocybin
  • Manufacturer: Usona
  • Indication: Treatment-resistant depression, major depressive disorder
  • CNPV award date: April 24, 2026
• Sacituzumab tirumotecan
  • Manufacturer: Merck
  • Indication: Oncology
  • CNPV award date: Dec. 19, 2025
• Teplizumab-mzwv (Tzield)
  • Manufacturer: Sanofi
  • Indication: Expanded indication for type 1 diabetes
  • CNPV award date: Oct. 16, 2025

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An FDA public hearing on the CNPV on June 4 received stakeholder input regarding the pilot. The purpose of the session was to obtain feedback on the eligibility criteria, voucher selection process, sponsor and FDA responsibilities, FDA review timeline and procedures, program evaluation, and future direction of the program. The agency is accepting more comments through June 29, 2026. According to Mallika Mundker, the FDA’s deputy chief medical officer, “Your input will directly inform how FDA evaluates the program’s future.” 

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Special thanks to Carole Kerzic and Nicole Kjesbo for assisting with pipeline research.

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Listen to the latest “Pharmacy Friends” episode