In this issue: Cost of 340B to states, PBM reform, Americans’ health priorities, denying access in Medicaid, and more.

February 11, 2025

Welcome to NPC This Week! We hope you'll join us each week for a look-ahead at the policy, research, and industry conversations that matter to the future of biopharmaceutical innovation. The DMs are open if you have suggestions — and please share with your network. - Michael Pratt, Devon Bortz, and Haley McKeefer

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NPC Highlights

The Cost of the 340B Program to States: While many view the 340B Drug Pricing Program as "free," a new report from 艾昆纬 found that the program raised costs for employer-sponsored plans by $6.6 billion and for state and local government plans by $1 billion in 2023.

• The analysis of a national sample of pharmacy claims and drug sales data shows 340B utilization varies greatly between states by an order of magnitude, ranging from 4% (New Jersey) to 43% (Vermont).
• The report models the potential cost effects of current and proposed state-level laws prohibiting drug manufacturers from applying any conditions on contract pharmacy access. So far, contract pharmacy bills have passed in eight states and have been proposed in? 20 more. If enacted nationally, these bills could increase costs by $1.88 billion for all employer-sponsored plans.

Value Viewpoint: In her latest "Value Viewpoint," NPC Chief Strategy Officer Kimberly Westrich reviews a value tracing framework for evaluating social determinants of health (SDOH) interventions and two ICER Evidence Reports assessing treatments for acute pain and advanced retinitis pigmentosa.

Industry News

FDA Outpaces EMA in Novel Oncology Approvals: Friends of Cancer Research assessed FDA review times for 152 novel oncology drugs approved in the past 20 years. They found that 94% of medicines were greenlit by the FDA before the European Medicines Agency (a median of 207 vs. 422 days), resulting in novel cancer treatments reaching patients in the U.S. more quickly than their European counterparts. The organization attributes this, in part, to drug sponsors utilizing the FDA’s available expedited programs.

• Go Deeper: An NPC analysis in AJMC - The American Journal of Managed Care supports the FDA’s conclusion?that the Accelerated Approval (AA) Program is successfully working to address unmet medical needs for cancer patients.

Coalition Pushes for PBM Reform: In Modern Healthcare, Michael McAuliff reports that a broad group of healthcare companies, employers, labor unions, and trade associations are calling on federal policymakers to include reforms to PBM practices in an upcoming legislative spending package. “Numerous PBM bills advanced in the Senate and House in the last Congress on a bipartisan basis, but never quite made it into law.”

Medicaid Denials Increase Expenses and Utilization: Research published by JAMA Network Open finds that some procedural prescription drug denials among Medicaid plans may “perversely increase acute care utilization and costs,” outweighing any short-term savings with prescription medications.

Access and Affordability Top Americans’ Health Priorities: A new poll from Gallup and Emory University reports that a quarter of Americans rank healthcare access and affordability as top public health concerns they want policymakers to prioritize, beating out other public health issues like addressing the opioid epidemic or food and water safety.

ICYMI

Tariffs Could Impact Drug Pricing, Shortages: The Association for Accessible Medicines and the Healthcare Distribution Alliance shared warnings that potential tariffs on pharmaceutical products entering the U.S. could raise prices and worsen existing drug shortages for American patients. Tina Reed of Axios reports that 7 out of 10 industry professionals expect that the China tariff on active pharmaceutical ingredients will increase drug costs by 10%.

March-In Rights Counterproductive to Cost Reduction: In a blog post for the American Enterprise Institute , Kirsten Axelsen and Peter Pitts outline why the use of federal “march-in rights” to break patents on medicines would upend a system that has encouraged investment in new drugs and generic options, and won’t deliver lower drug costs for patients.

FDA Downsizing Could Impact Drug Reviews: Endpoints News and BioCentury discuss concerns raised by former FDA officials about potential personnel reductions within the agency and how they could affect the FDA’s ability to meet Prescription Drug User Fee Act (PDUFA) goals and expedite the drug review and approval process.

State Efforts to Import Medicines Revived: Several states, including New York and Illinois, are re-introducing proposals to import prescription drugs from Canada to reduce costs, though Celine Castronuovo of Bloomberg Law reports that doubts remain across the pharmaceutical industry about the viability of such programs.

Mark Your Calendar

February 28: NPC President and CEO John O'Brien will speak at the Wharton Health Care Business Conference in Philadelphia, PA. The theme of this year’s conference is “Beyond Disruption: Building Lasting Health Care Transformation.” Dr. O’Brien will join Angela Banks of the Pharmaceutical Care Management Association (PCMA), Hollie Caupp-Maxfield of the Senior Care Action Network (SCAN), Ross Hoffman of FFF Enterprises, and Katheryne Richardson of the Berkeley Research Group (BRG) for a discussion on “Innovative Drug Pricing Models.”?

March 1: NPC will join policymakers, key opinion leaders, and the next generation of policy leaders at the David A. Winston Health Policy Ball in Washington, D.C.

March 18-20: NPC Chief Strategy Officer Kimberly Westrich will speak at the 2025 ACCESS USA Hub and Specialty Pharmacy Models East conference in Philadelphia, PA. On Thursday, March 20, Ms. Westrich will join Meredith McDonald of Exelixis and Vicki Karlan of Pfizer for a panel session on "The Changing Landscape of Patient Access — Accumulators, Maximizers, and Alternative Funding." To join and save 10% on your registration, use Ms. Westrich's referral code at checkout: 25HUB10.

March 19: Join NPC Chief Strategy Officer Kimberly Westrich at the Center for Innovation & Value Research’s Sixth Annual Methods Summit in Washington, D.C.! This year’s conference will focus on “Exploring Patient-Centered Value Research From Definition to Dissemination.” Ms. Westrich will discuss “From Research to Real-World Impact: Leveraging Research Insights in the Final Stages of Value Research — Blueprint Dissemination & Assessment Phases” alongside Jessica Johnson of the National Eczema Association (NEA) and Bridget Doherty of Johnson & Johnson Innovative Medicine.?

March 31 - April 2: Planning to attend the 2025 Western PharmacoEconomics Conference (WPEC) hosted by the University of Washington’s CHOICE Institute? On Tuesday, April 1, at UW’s Seattle campus, NPC Chief Science Officer Jon Campbell will join Kelly Anderson of the University of Colorado and Josh Carlson of the University of Washington for a compelling workshop on “Dynamic Pricing in Models.”?

April 1-3: Join NPC at AMCP 2025 in Houston, TX! More details about NPC’s research and podium presence to come.