Looking Back on ISPOR 2024: Hot Policy Topics, Welcome Focus on Employers, and More

I connected with colleagues, researchers, students, and health care leaders at the 2024 meeting of ISPOR—The Professional Society for Health Economics and Outcomes Research. The meeting offered a valuable forum for constructive health policy debate, and I’ve distilled several takeaways from the rich conversations and presentations.

Kimberly Westrich, MA | Image credit: National Pharmaceutical Council

1. The Inflation Reduction Act (IRA) remained a hot topic.

Discussion of the IRA took place as uncertainties and potential unintended consequences continue to loom in the wake of CMS’ issuance of draft guidance for the second cycle of Medicare drug price negotiation.

Implementation of the IRA’s drug pricing provisions is underway, yet many unknowns remain about the process and ultimate impact. While some parts of the IRA will help patients—such as caps on out-of-pocket payments and the ability to predictably spread payments over the year—other provisions including changes to Medicare Part D benefit design and the Medicare Drug Price Negotiation Program (DPNP) may result in unintended consequences for biopharmaceutical research and development and patient access to needed medications.

• In an interactive panel discussion on the IRA and health technology assessment (HTA) policy changes in Europe, I shared new research from the National Pharmaceutical Council (NPC) that highlights how price-setting policies like those underlying the DPNP may result in the development of fewer treatments and delayed access for patients.
• In the ongoing spirit of collaboration and learning, Kristi Martin, MPA, senior advisor at CMS, joined Sean Sullivan, PhD, BScPharm, professor, The CHOICE Institute School of Pharmacy at the University of Washington, and Inmaculada Hernandez, PharmD, PhD, professor at the University of California San Diego, to discuss lessons learned from the negotiation process for the first 10 drugs. In the draft guidance, CMS appears to recognize some of NPC’s concerns about the potential for a reduction in patient access to selected drugs and the shortcomings of its first-round attempt at collecting patient input. CMS is seeking input on the draft guidance by July 2, 2024.

My favorite session on DPNP was the cleverly titled, “Cookbooks vs Blenders: Paradigms for Integrating Factors Relevant to the CMS Drug Price Negotiation Process.” As described by Steve Pearson, MD, MSc, the founder of the Institute for Clinical and Economic Review (ICER), the cookbook approach involves “every factor quantified, or at least explicit weights applied to each factor” and the blender, “every factor qualitative with no categories linked to specific price adjustments.” The best approach may depend on what CMS aims to achieve, which is still unclear. Possible CMS goals identified by Pearson included:

• Achieving an arbitrary political savings target
• Reverse engineering a price consistent with generic competition
• Identifying a price that reflects a treatment’s value

Panelists Kyle Hvidsten, MPH, vice president and head of global health economics and value assessment at Sanofi; Brett McQueen, PhD, assistant professor at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences; and Marina Richardson, PhD, MSc, associate director of HTA methods and health economics at ICER, each recommended some variation of a hybrid approach, with McQueen advocating for the benefits of structured deliberation and Hvidsten highlighting the crucial role of transparency in establishing the credibility of experimental findings. Audience polling on what CMS should/would do showed:

• Should do: slightly more than half of the audience suggested that CMS should go with a hybrid approach (with about one-third suggesting the full cookbook approach)
• Would do: approximately 60% expected CMS would go with the full blender approach (with about one-third expecting it would land on a hybrid approach)

2. Value assessment sessions pushed back on one-size-fits-all methods.

This year’s ISPOR program offered a wide range of panels, breakouts, and research posters on innovative value assessment methods that challenge traditional, one-size-fits-all approaches to assessing the relative value of health care treatments and services. Sessions on distributional cost-effectiveness analysis, multicriteria decision analysis, and generalized risk-adjusted cost-effectiveness identified opportunities for health care decision makers to leverage nontraditional methodologies to inform more holistic value assessments.

• I moderated a workshop built around a disease-agnostic survey template developed by Kayleigh Majercak, MS, a graduate research assistant at the University of Maryland School of Pharmacy, in collaboration with patients to address current gaps in capturing the patient experience to inform processes such as HTA. Joe Vandigo, PhD, MBA, principal scientist and director of value at Applied Patient Experience, shared insights on leveraging the template for success in health care decision-making, and McQueen explored situations where qualitative or quantitative patient experience data are better fit for purpose.
• The conference also included numerous research posters that explored the role of ICER’s value appraisals and other work in the US health system and the methods underlying them, including:
  1. Beyond the Headline: Inflation-Adjusting ICER’s Unsupported Price Increase Results
  2. Payer Perspectives on the Use of ICER Evidence Reports Over the Past 24 Months
  3. A Preliminary Assessment of ICER's New HTA Methods That Support Health Equity
  4. Navigating Uncertainty: Trends in ICER’s Evidence Ratings
  5. Better Late Than Never? Payer Appetite and Vision for a National Value Assessment Body

3. A welcome focus on employers was evident.

Employers are critical but often overlooked health care stakeholders whose actions have important health care access and affordability implications. I was pleased to see this year’s ISPOR program include dedicated sessions and research posters on crucial topics related to the employer perspective.

An issue panel entitled, “Is the Employer Perspective Sufficiently Reflected in Common Value Frameworks?” highlighted how common value assessment tools such as ICER’s framework and ISPOR’s value flower are primarily focused on the insurer’s perspective and aren’t appropriate for employer decision contexts:

• Employers often make program-specific choices and cannot curate drug- or health service–specific choices.
• Additionally, employers face unique considerations that are not part of our traditional value tools, such as the importance of employee retention and minimizing disruption, the tax implications of providing health benefits vs other types of expenditures, and the unusual incentives associated with pharmacy benefit manager (PBM) rebates.
• Ironically, these unusual incentives can result in employers needing to go around their PBM and other third-party vendors to align with value.
• Interestingly, an employer value scorecard example shared during the session embodied the spirit of multicriteria decision analysis.

An issue panel moderated by Ulrich Neumann, MBA, MSc, director for market access at Janssen, “Skin in the Game or Financial Overdose? Navigating the Future of Patient Cost-Sharing on Prescription Drugs,” grappled with the realities and unintended consequences of patient cost sharing.

• As eloquently described by Darius Lakdawalla, PhD, director of research, Schaeffer Center for Health Policy & Economics at the University of Southern California, cost sharing is a transfer payment from the sick to the healthy and needs to be used thoughtfully and carefully to ensure the benefits outweigh the costs.
• Although cost sharing can disincentivize the use of unnecessary treatments, too often, it is a barrier to necessary care; A. Mark Fendrick, MD, director of the University of Michigan Center for Value-Based Insurance Design, reminded us that many patients are insured, but not covered, for needed care.
• As illustrated by Kimberly Hooks, an advocate for patients with inflammatory bowel disease, it can leave patients feeling disempowered and even traumatized as they navigate the health care system.
• Annette James, MAAA, FSA, FCA, chair of the American Academy of Actuaries’ Health Equity Work Group, used a powerful phrase that all researchers should remember: data empathy. There are real people represented by each and every data point we analyze.

Other employer-focused content included new NPC research highlighting the hidden costs of the 340B program to US employers and employers’ viewpoints on alternative funding programs to pay for patients’ medication costs:

• Revenue-Sharing or Revenue Lost? The Hidden Costs of 340B to Employers (this research with IQVIA was also featured in an AJMC interview)
• Employer Perspectives on Alternative Funding Programs

These insights are just a fraction of the breadth and depth of the full conference, so I encourage everyone to take advantage of ISPOR’s Digital Conference Pass Recordings, available from May 22 through June 24. I look forward to hearing others’ key takeaways, and to the digital opportunity to explore some of the many concurrent sessions that I missed!