Impact of IRA Seen as ISPOR 2024 Heads to Atlanta

Members of the pharmaceutical industry say the effects of the Inflation Reduction Act (IRA) are already here, as negotiations are underway for the first 10 drugs selected for Medicare price talks. Drug makers have gone to court to block IRA provisions, and the Biden administration is trying to spread the word about the law’s consumer-friendly features that will arrive in 2025, namely a $2000 annual cap on out-of-pocket costs for Part D prescription drugs.

All this will be top of mind as ISPOR—The Professional Society for Health Economics and Outcomes Research gathers in Atlanta, Georgia, May 5-8, 2024, for its annual conference, under the theme, “HEOR: A Transformative Force for Whole Health.”

ISPOR officials said that the conference is expected to draw a global audience of nearly 5000 health care stakeholders. Besides the sessions, ISPOR’s meeting offers smaller health economics and outcomes research (HEOR) organizations opportunities to gather, such as the Women in HEOR Initiative and groups dedicated to study of specific regions.

Inmaculada Hernandez, PharmD, PhD | Image credit: LinkedIn

Impact of the IRA. Following the law’s adoption in 2022, proving a drug’s value will be more important than ever. Some say this means HEOR should start early, given the tight time frames companies will have to achieve a return on their investment before a therapy could be selected for price negotiation. For small molecule drugs, this can occur 9 years after launch. ISPOR 2024 will feature sessions, posters, and case studies highlighting the law’s impact thus far.

Monday’s session, “Medicare Drug Price Selection: Lessons From the First 10 Drugs Selected,” promises to highlight some of the challenges of this new process. To be moderated by Sean Sullivan, BScPharm, PhD, professor, the CHOICE Institute School of Pharmacy at the University of Washington, the session will feature Inmaculada Hernandez, PharmD, PhD, professor at the University of California San Diego, and Kristi Martin, MPA, chief of staff and senior advisor to the deputy administrator in the Center for Medicare, CMS.

In an email with The American Journal of Managed Care^®, Hernandez shared that she will be discussing a project supported by the Commonwealth Fund, which she said, “aims to replicate externally the CMS negotiation process.” Among the challenges the investigators encountered is what to do when a selected therapy has multiple indications and, thus, multiple therapeutic alternatives.

“I will present hot-off-the-press data on price benchmarks for the drugs subject to negotiation and their therapeutic alternatives,” she said. “I will conclude with some challenges for the negotiation process.”

Plenary sessions. The “whole health” theme of ISPOR 2024, and how HEOR can address today’s health care challenges, will be carried out in 3 plenary sessions Monday through Wednesday:

• On Monday, driving innovation and finding evaluation gaps will be discussed in “Advancing Whole Health: How Do We Know When We’re Succeeding?” Charlene Wong, MD, MSHP of CDC will moderate the session featuring Seth Berkowitz, MD, MPH, of the University of North Carolina Chapel Hill; Eric C. Schneider, MS, MSc, FACP, of the National Committee for Quality Assurance; and Denise Webb of The Partnership for Southern Equity.
• Tuesday’s plenary, “Missing Link for HEOR: A Path Forward for HEOR Data Integration,” will address connecting real-world data (RWD) with HEOR. Moderator Nancy Dreyer, MPH, PhD, FISPE, of UNC Chapel Hill and Dreyer Strategies will join Niall Brennan, MPP, of CDC; Joe Franklin, JD, PhD, of Verily; and Keri Monda, PhD, of Amgen.
• Wednesday’s session, “AI Enabling Whole Health: Opportunities and Challenges for HEOR and HTA,” will address where artificial intelligence fits into the HEOR and health technology assessment (HTA) framework, featuring moderator Thomas Senderovitz, MD, of Novo Nordisk; Alexandra Berk, PhD, of CVS Health; and Rachael Fleurence, PhD, of National Institutes of Health (NIH).

Poster tours. ISPOR is well-known for its poster presentations, and attendees can choose from curated poster sessions on Monday and Tuesday. One Monday poster tour themes is Drug Price Negotiations, featuring data on whether the IRA will delay timelines for launching orphan drugs and which populations of Medicare beneficiaries will be affected by price negotiations on the first 10 selected drugs. Monday’s other poster tour theme is patient engagement and will include results on including patient insights in health technology assessments and understanding barriers to seeking care among Black patients with lung cancer and peripheral artery disease.

Tuesday’s poster tour themes include a session on oncology, cover data on economic burdens of treating resected non-small cell lung cancer, tamoxifen adherence in early-stage breast cancer, the cost-effectiveness of multi-gene panel sequencing, and the use of RWD in rare cancers.

Use of RWD. Sessions that cover the use of RWD in improving both research and regulatory processes include Tuesday’s “Harmonizing Real-World Data Networks: Bridging Regulatory, Patient, and Research Perspectives,” which will address challenges of merging RWD networks and coming up with criteria to allow data sets from different countries and continents to be shared. The session, to be moderated by Keith Marsolo, PhD, of Duke University School of Medicine, will feature Daniel Leaver Morales of the European Medicines Agency; Donna Rivera, PharmD, MSc, of FDA; and James Wiggins, of Amazon Web Services.

Also on Tuesday, “Revolutionizing Regulatory Pathways,” will be moderated by Renee J. Arnold, PharmD, RPh, entrepreneur-in-residence at NIH and BioHealth Innovation, Inc. This discussion of using real-world evidence, adaptive trials, and collaborations to speed approval of medical devices will feature Douglas Kelly, MD, deputy director for science, FDA; Steven Farmer, MD, PhD, chief strategy officer for coverage, CMS; and Peter Neumann, ScD, professor and director of the Center for the Evaluation of Value and Risk and Health, Tufts University.

Chronic conditions. Much of more granular research presented at ISPOR demonstrates the value of specific therapies or approaches in reducing costs, improving outcomes, or both. Monday’s podium session, “Healthcare Resource Utilization and Cost Burden of Selected Chronic Conditions,” will highlight outcomes research in chronic kidney disease, multiple sclerosis, schizophrenia, and opioid prescribing; research presented throughout the meeting covers diseases that affect large populations, such as diabetes and chronic obstructive pulmonary disease, as well as a host of rare diseases.

In addition, the ISPOR Patient-Centered Research Summit 2024 will take place Sunday carrying the theme, “Advancing Patient-Centered Research.” Several HEOR short courses will be offered Sunday as well.