Navigating 340B reform, PBM issues, the IRA’s impact on OOP spending, improvements to patient listening sessions, and more.

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 and Devon Bortz

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Note: NPC This Week will be off on July 2. We look forward to being back in your inbox on July 9! Wishing you a safe and celebratory Independence Day.?

NPC Highlights

Protecting the 340B Program: Experts shared with AJMC’s Julia Bonavitacola that any reforms to the 340B program should not compromise care for people living with HIV, while ensuring the program works as intended. Research from NPC and IQVIA , quoted by Bonavitacola, showed that the 340B program is costing self-insured employers and their workers upwards of $5.2 billion due to lost rebates for products purchased under the program.

Value Viewpoint: In her latest “Value Viewpoint,” NPC Chief Strategy Officer Kimberly Westrich discusses incorporating health equity into European health technology assessments, a Health Economics article on measures for valuing health, and a new commentary by ICER founder Steve Pearson on the societal effects of new innovative therapies.

Industry News

Does the IRA Increase OOPs?: A new report published by Milliman found that the drug pricing provisions of the Inflation Reduction Act could reduce the benefits of the new out-of-pocket cap for seniors: 3.5 million Part D beneficiaries taking a medicine subject to an MFP would potentially see higher out-of-pocket costs in 2026.?

The New York Times Takes on PBMs: Journalists Rebecca Robbins and Reed Abelson published the first in a series of articles on “how pharmacy benefit managers prioritize their interests, often at the expense of patients, employers and taxpayers.” The piece is informed by more than 300 interviews and highlights evergreen PBM issues such as perverse system incentives, insurer consolidation, and increased rebates and fees from manufacturers that PBMs fail to pass on to patients.

WSJ Takes on Mail-Order Pharmacies: “Mail-order drugs were supposed to keep costs down. It’s doing the opposite ,” reads the headline of Jared Hopkins’s story published in The Wall Street Journal this morning.

Prior Authorization Affecting Care: More than 90% of practicing physicians say that prior authorization provisions applied by insurers have had a negative impact on patient clinical outcomes, while 24% report that the restrictions have led to a serious adverse event for a patient in their care, according to a survey conducted by the American Medical Association.

• More on Insurers: The Wall Street Journal’s David Wainer describes how large U.S. health insurers have created potential conflicts of interest after years of market consolidation and the vertical integration of healthcare services.

340B Spending Growth: According to new data from the Congressional Budget Office , 88% of the growth in 340B program spending from 2010 to 2021 can be attributed to medicines prescribed by hospitals and their affiliated contract pharmacies.

Improving CMS Patient Listening Sessions: In response to proposed improvements on how Medicare administrators conduct patient-focused listening sessions in the Drug Price Negotiation Program, four researchers writing for Health Affairs Forefront shared several recommendations to “enhance [the] process to collect valuable information without increasing the burden on CMS staff.”

• NPC Analysis of First CMS Sessions: An NPC content analysis of CMS-sponsored patient-focused listening sessions in fall 2023 found that the passive listening format provided the agency with, on average, less than 15 minutes of patient-focused input per session.

ICYMI

ISPOR IRA Webinar: After a standing-room-only spotlight session at the 2024 ISPOR international conference discussing their research on the implementation of IRA price negotiation, Drs. Inma Hernandez, Sean Sullivan, and Emma Cousin will preview which drugs may be next for negotiations in a public webinar scheduled for Thursday, July 11. Register here .

CMMI Visits Capitol Hill: Elizabeth Fowler, director of the CMS Center for Medicare and Medicaid Innovation, appeared before the House Energy and Commerce Committee to answer questions about, among many topics, the agency’s cell and gene therapy model aimed at managing the uptake of innovative sickle cell disease therapies in state Medicaid programs.

Hepatitis C Savings: Expanding hepatitis C treatment would “more than offset direct spending on that treatment,” avoiding about $7 billion in healthcare costs over a decade if twice the amount of Medicaid enrollees could access treatments, according to a Congressional Budget Office report.

Colorado PDAB Amended: Colorado Governor Jared Polis signed a bill into law that would require the state’s prescription drug affordability board to consider input from the state’s rare disease advisory council in determining which drugs are “unaffordable” for patients in the state and in setting potential upper payment limits.

Federal Investment and IRA Negotiations: In Health Affairs Forefront , researchers warn the incentives that drive drug development could be upended if the federal government “tries to extract returns from its investment” in the form of price controls.

Pediatric Priority Review Voucher: In a public policy commentary published by the American Enterprise Institute, authors Brian J. Miller and Steven White break down the fundamental importance of the pediatric priority review voucher program. They explain that “children are not little adults” but rather a unique group with a narrow window for treatment after a rare disease diagnosis.

Mark Your Calendar

Thursday, June 27: Join The Hill for a deep dive into Medicare and drug pricing! Sponsored by the Alliance for Aging Research, this hybrid program will convene academic experts, lawmakers, and advocates to discuss lessons learned from the first round of Medicare direct negotiation, how CMS can improve the program in year two, how Washington can address the IRA’s unintended consequences, and more. Register here to attend the live event in D.C. or virtually.?

Saturday, June 29: Members of the NPC team will speak on panels and contribute to research presentations at AcademyHealth’s 2024 Annual Research Meeting (ARM), which will be held in Baltimore from June 29–July 2.?

• During a special session on “Navigating the Changing DEIA Landscape as Organizations, Leaders, and Researchers” from 2:15 – 3:15 PM ET, NPC’s Research Coordinator Gabri’el Shabazz will join a discussion on how researchers and research institutions are staying true — or not — to diversity, equity, inclusion, and accessibility (DEIA) initiatives.
• A session on “Emerging Evidence on Racial and Ethnic Disparities” will include examine a study conducted by NPC and the University of Washington’s Institute for Health Metrics and Evaluation on “Variation in Prescription Drug Utilization and Spending by Race/Ethnicity and U.S. State, Payer, and Health Condition.”?