NPC Policy & Evidence Briefs
NPC Policy & Evidence Briefs are published by the National Pharmaceutical Council. They feature original research and analysis intended to provide decision-makers with timely evidence and data.
Generic Entry and the Early Impact on U.S. Pharmaceutical Spending
National Pharmaceutical Council Policy & Evidence Brief. 2025:07.
October 2025
Competition from generic drugs generates significant savings for patients and the U.S. healthcare system. This part of a medicine’s lifecycle is often overlooked in drug pricing policy discussions, which often reference launch prices. This Brief offers an analysis of annual pharmaceutical spending patterns between two to three years after generic entry to quantify the financial impact.
The CAR T-Cell Therapy Transformation: Understanding the Technology, Current Landscape, and Future Directions
National Pharmaceutical Council Policy & Evidence Brief. 2025:06.
September 2025
This NPC Policy & Evidence Brief defines what makes a CAR T-cell therapy, describes what differentiates CAR T-cell therapies from other treatment options available today, provides the current landscape of CAR T-cell therapies approved in the U.S., explores the future of CAR T-cell treatments; and discusses how future directions hinge on patient access.
Early Signals of the IRA on Orphan Drugs
National Pharmaceutical Council Policy & Evidence Brief. 2025:05.
May 2025
The Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program’s (DPNP) well-intended Orphan Drug Exclusion (ODE) aimed to prevent the selection of orphan drugs used to help people living with rare diseases. However, there are concerns about the ODE’s impact on incentives for ongoing rare disease clinical development. For this brief, NPC analyzed patterns of orphan drug designations over time to explore this potential early signal of the IRA’s impact on orphan drug development.
30+ Years of 340B: What Does the Evidence Say?
National Pharmaceutical Council Policy & Evidence Brief. 2025:04.
April 2025
Over the past 30 years, the 340B program has grown dramatically. Patients are not
benefiting as intended. 340B now functions beyond its original intent, with many stakeholders supporting program growth without receiving clear benefits. Future policy efforts that increase program integrity, compliance, and transparency are needed to ensure the program's original intent is restored.
The IRA’s New Public Engagement Events.
National Pharmaceutical Council Policy & Evidence Brief. 2025:03.
April 2025
CMS has initiated public engagement events for the second round of drugs selected for the Medicare Drug Price Negotiation Program (DPNP). NPC compared CMS’s approach to patient engagement for the first round of drugs to these latest changes. This Policy & Evidence Brief captures top takeaways regarding the changes ahead of the second round of patient engagement opportunities.
Ongoing Accelerated Approval Trends and What They Mean for Patients.
National Pharmaceutical Council Policy & Evidence Brief. 2025:02.
January 2025
After Independence Blue Cross’ January 2025 drug coverage policy update to exclude non-oncology drugs from reimbursement within 18 months of accelerated drug approval, NPC researchers analyzed the FDA accelerated approval program drug list at different timeframes to understand the ongoing accelerated approval drug mix by therapeutic area for non-oncology drugs.
“Maximum Fair Price” Explanations for IPAY 2026 Drugs.
National Pharmaceutical Council Policy & Evidence Brief. 2025:01.
January 2025
On December 20, 2024, the Centers for Medicare and Medicaid Services released the “maximum fair price” (MFP) explanations for the first round of drugs selected for negotiation in the Medicare Drug Price Negotiation Program. NPC analyzed the MFP explanation files for insights about implementation.