E.V.I.dently September 2019

Message From NPC

More Than Just One Number: Assessing the Value of Innovative Treatments

Value assessment frameworks are expected to play an increasingly influential role in health care decisions that could affect patient choice and access to innovative treatments. In his latest commentary, National Pharmaceutical Council (NPC) President and CEO Dan Leonard, MA, outlines the steps needed to ensure a more inclusive, timelier process in which patient voices carry meaningful weight when groups like the Institute for Clinical and Economic Review (ICER) are assessing value.

NPC Now: A Look at Our Latest Work

Health Spending: Moving from Theory to Action

There’s no shortage of debate and talking points on the issue of health spending, but what solutions and strategies hold the most promise for reining in costs and driving high-value care? Experts recently weighed in at “Health Spending: Moving From Theory to Action,” a conference co-hosted by NPC, Health Affairs and several Going Below The Surface partners.

Discussion focused on a core question: Should the U.S. prioritize “bottom-up” strategies that identify and reduce the use of low-value services at the provider or patient level, or should more emphasis fall on “top-down” approaches that leverage a regulatory or budgetary approach to better allocate health care resources?

To catch up on the discussion, check out Health Affairs' video archive of the event and summaries from the American Journal of Managed Care and Healthcare Dive. Look for additional reads on the Going Below The Surface (GBTS) website, including takeaways from North Carolina’s system-wide efforts to shift toward paying for value.

NPC Weighs in on the Value Assessment Debate and ICER’s Latest Activities

As ICER works to deepen its role in health care decision-making, is its value assessment framework headed in the right direction? NPC Chief Science Officer and Executive Vice President, Robert W. Dubois, MD, PhD, published a commentary in The American Journal of Managed Care on the need for multiple measures of value assessment, a topic recently raised by former FDA Commissioner Scott Gottlieb, MD. He also co-authored with NPC Vice President for Health Services Research Kimberly Westrich, MA, a commentary in Value in Health titled, “Are Value Assessment Frameworks Ready for Prime Time?” which cautioned that more progress is needed before widespread adoption and use of value frameworks.

On Aug. 6, ICER requested public comment on a newly released proposal to define “Value Assessment Methods for ‘Single or Short-Term Transformative Therapies (SSTs).’” At ICER’s Valuing Cures Summit, held on Sept. 17, NPC Vice President of Research Mike Ciarametaro, MBA, highlighted core points and recommendations from NPC’s public comments regarding the proposed methods, which focused on four key areas, including how SSTs are defined, uncertainty is characterized, societal benefits are represented and affordability concerns are handled. In particular, he described a pitfall in ICER’s methodology, which includes a scenario that does not consider all the cost offsets that accrue over a patient’s lifetime.

NPC Comments on CMS’ Proposed Physician Fee Schedule Rule

The Centers for Medicare and Medicaid Services (CMS) released the CY2020 Physician Fee Schedule (PFS) Proposed Rule, which proposes updates to multiple physician payment policies for Medicare patients. NPC submitted comments focused on the proposed “Drug Cost Transparency” provision within the Merit-based Incentive Payment System (MIPS), the development of the MIPS Value Pathways and the use of bundled payments in the Physician Fee Schedule.

Applications Open for NPC/Duke-Margolis Center for Health Policy Post-Doctoral Fellowship in Health Care Policy

Are you looking for a post-doctoral fellowship in health policy, or do you know someone who is? NPC, in partnership with the Duke-Margolis Center for Health Policy, is now accepting applications for a post-doctoral fellowship in health policy based in Washington, D.C. This position will provide the fellow with access to respected researchers and mentors from both the biopharmaceutical industry at NPC and academic mentors at Duke-Margolis. The fellow will have the opportunity to explore the policy implications of health services research, design studies to help inform policy options and engage with a diverse set of stakeholders in Washington, D.C., and at Duke University. Learn more about the fellowship and how to apply.

Wondering if NPC’s fellowship is right for you? Learn more about the experience from our former fellows, Chuck Shih, PhD, MHS, Ilene Hollin, PhD, MPH, and our current fellow, Taruja Karmarkar, PhD, MHS

Research and Info You Need to Know

FDA Considers Real-World Evidence

On Oct. 3, the Food and Drug Administration (FDA) will host a public meeting to discuss the use of real-world evidence (RWE) in regulatory decisions, as mandated in the 21st Century Cures legislation. The discussion will focus on emerging topics related to the FDA’s RWE framework, including whether 1) real-world data (RWD) are fit-for-use, 2) the trial or study design used to generate RWE provides adequate scientific evidence to answer or help answer the regulatory question of interest and 3) the conduct of a study meets FDA regulatory requirements. Read the comments NPC submitted to the FDA

Drawing Ideas on Health Spending from Outside the Beltway

This summer, NPC and the Healthcare Leadership Council (HLC) hosted multiple regional town halls to explore health care concerns and ideas for improvement. NPC President and CEO Dan Leonard, MA, captured key discussion points in a recent commentary published in Chain Drug Review. The town halls are driven by the Going Below The Surface forum, a group of more than 20 organizations dedicated to tackling the drivers of health care spending.

ICYMI: Articles of Note

  • Less Is More in Critical Care Is Supported by Evidence-Based Medicine. Catherine L. Auriemma, et al., September 18, 2019, Intensive Care Medicine
  • U.S. Food and Drug Administration Approvals of Drugs and Devices Based on Nonrandomized Clinical Trials: A Systematic Review and Meta-Analysis. Razavi M, et al., September 4, 2019, JAMA Network Open
  • Observational Studies Have a Critical Role to Play in Cancer Comparative Effectiveness Research. Jennifer R. Rider and Ludovic Trinquart, August 29, 2019, Journal of Clinical Oncology

Events and Education

NPC’s experts will be speaking at a variety of events during the next several weeks. Check out when and where. Hope you can join us!