MFP and IRA reactions, health-related concerns of older Americans, insulin copay caps, 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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NPC Highlights

CMS’s MFP Announcement Lacks Details: CMS administrators released the Maximum Fair Prices (MFPs) of 10 prescription drugs last Thursday, resulting in mixed reactions from outlets such as BioCentury, Pink Sheet, and AJMC. Clarity around the agency’s approach to price setting will likely not be disclosed until up to another six months, meaning manufacturers in the next round of “negotiations” will remain in the dark on how best to navigate the process.

• From NPC's John O'Brien: “CMS told us the prices they’ve set for drugs millions use to stay healthy. We don’t yet know, in spite of what they said, what the impact for patients at the pharmacy counter will be. They didn’t offer specifics about what evidence they used, if they listened to patients or clinicians, or how they’ll protect patient access or out-of-pocket spending. And when they do, it may be too late to inform the next round…"
• From NPC’s Kimberly Westrich: Speaking to The Evidence Base on the importance of clarity and consistency in the process, NPC Chief Strategy Officer Kimberly Westrich said, “In addition to the critical unknown impact on patients at the pharmacy counter, there are unknown impacts for life sciences and managed care companies that need to make big decisions based on CMS’s process. Today’s announcement doesn’t just affect the companies with selected drugs. Those involved in generating or evaluating evidence have called for a more transparent and predictable process. It remains to be seen how much CMS will listen.”
• Is the IRA’s Medicare DPNP Working?: In the latest “Eye on the IRA” report from Health Affairs, Laura Tollen outlines four categories of outcomes to evaluate the Medicare Drug Price Negotiation Program (DPNP) and the first round of MFPs: beneficiary access, prices and spending, promotion of value, and the effects on innovation. The publication leans heavily on two NPC studies.

Value Viewpoint: In her latest “Value Viewpoint,” Ms. Westrich reviews stakeholder reactions to CMS’s MFP announcement, the societal value of neffy — a new, FDA-approved epinephrine nasal spray, Value in Health’s August issue, and two new articles (one from NPC in AJMC, one in Value in Health) on the value that oncology drugs approved under the FDA Accelerated Approval Program can bring to patients.

Industry News

State Insulin Copay Caps on OOP Costs: In response to a rise in insulin rationing due to high costs for more than one-quarter of insulin users, many states have enacted legislation to cap monthly insulin out-of-of pocket (OOP) spending. Two studies published last week in Health Affairs and JAMA Network Open found that while the legislation has helped insulin users who had been spending above the cap, the majority of patients were already paying OOP costs below the cap — leading to no meaningful increase in insulin therapy adherence or reduction in OOP expenses for patients covered under commercial health plans.

Health-Related Concerns of Older Adults: In reviewing health-related concerns of older Americans ahead of the 2024 election, a new nationally representative survey in JAMA found that more than half of adults 50 and older reported being “very concerned” about the costs of medical care and prescription drugs. Additionally, a third (33.7%) of respondents reported being "very worried" about the quality of care they’re receiving.

Real-World Data on Cancer Treatments: Friends of Cancer Research formed a collaboration to assess whether electronic health record data from various providers could be used to better understand how cancer treatments work in the real world. By evaluating clinician assessments and radiology reports of patients with metastatic non-small cell lung cancer, the observational study published in JCO Clinical Cancer Informatics demonstrates the feasibility of data providers adhering to a common data model and integrating disparate data sources to evaluate end points — supporting the use of real world data as a reliable and consistent source of evidence in oncology R&D and clinical decision making. 

ICYMI

Employer Health Plan Costs Expected to Increase in 2025: Aon, a professional insurance and risk management services firm, predicts that employer-sponsored health plan costs will rise by 9%, in part due to increased demand for high-cost gene and cell therapies and GLP-1s. Aon’s Janet Faircloth told Modern Healthcare that payers are expecting employers to apply cost-sharing strategies that could raise employee out-of-pocket costs.

Heatwave Affecting Mail-Order Medicines: During another record-hot summer, the New York Times reports that many mail-order medications were found to have been transported in trucks whose inside temperature can reach upwards of 150 degrees Fahrenheit, far above the recommended range for safety. Though the FDA regulates drug packaging and storage during transportation to manufacturers, wholesalers, and pharmacies, these rules do not apply to patient delivery.

EU Rules Threaten Rare Disease R&D: New guidelines prioritizing mass trials have met backlash from almost 40 patient groups, pharmaceutical companies, and researchers in Europe, who warn EU regulators that the new rules threaten the development and approval of rare disease drugs. According to the Financial Times, the strict curbs on medical trials were adopted in May by the European Commission in hopes to expedite medication authorization.

GLP-1s Found Cost Effective as Medicare Weighs Coverage: A study by the SOA Research Institute found that GLP-1 medicines are cost effective when compared to insulin or no treatment at all — even before rebates on GLP-1s are factored into calculations. Meanwhile, new research in Health Affairs projects that expanded Medicare coverage of GLP-1 medicines could increase annual federal spending by at least $3.1 billion.

Mark Your Calendar

• September 5 – October 2: Join the National Health Council (NHC) for its upcoming webinar series on patient-centered value assessment and the methodology behind value models! The four webinars will set a foundation to understanding value assessment in the U.S. and will explore alternatives to the QALY such as the Generalized Risk-Adjusted-QALY (GRA-QALY), Health Years in Total (HYT), and the Equal Value of Life Years Gained (evLYG). Learn more and register for the NHC webinar series here.
• September 30: On the first day of the 2024 Fierce Biotech Summit in Boston, NPC President and CEO John O’Brien will join Christie Bloomquist, Vice President of Government Affairs and Policy at Astellas Pharma, Andrew Kaplan, Senior Vice President of U.S. Public Affairs at Takeda, and Joy Russell, Vice President of External Affairs at Genentech, for a panel discussion on “Political Pathways: Navigating the 2024 Election Cycle in Biotech.” The session aims to empower biotech industry leaders with actionable insights and strategic approaches to thrive amidst the complexities of the 2024 election cycles and its implications on the industry landscape. Learn more and register for the 2024 Fierce Biotech Summit here.
• October 15: At AMCP Nexus 2024 in Las Vegas, NPC Chief Strategy Officer Kimberly Westrich will participate in a panel on “What You Need to Know About Copay Accumulators, Maximizers, and Alternative Funding Programs.” The session will take place from 8:30 – 9:45 AM PT and will include a deep dive into the regulation and potential employer implementation of accumulators, maximizers, and AFPs. Learn more and register for AMCP Nexus 2024 here.
• October 16-18: Save the date for the 14th Annual Association for Value-Based Cancer Care (AVBCC) Summit and Educational Program! This year’s conference will take place in New York City (and virtually) and provides exclusive networking and educational opportunities with 300+ diverse experts representing every stakeholder of the cancer care ecosystem. Learn more and register for the AVBCC Summit here.