by Amy M. Miller, Ph.D., PMC Executive Vice President

The Institute for Clinical and Economic Review (ICER) is a non-profit organization that uses available evidence to examine the value of therapeutics and suggest reasonable prices for them. The organization bases these judgments on a conceptual framework that combines its estimation of the clinical value of a particular drug with several other factors, including the drug’s overall budget impact.

This process may not work for personalized medicines, as became evident earlier this year when ICER examined therapies for multiple myeloma.  As the Multiple Myeloma Research Foundation pointed out in their letter to ICER, “the promise of precision medicine is that each patient is unique and will consequently respond to treatment differently based on their particular genetic profile and further understanding of the biology of their disease.” This statement is particularly true for patients with non-small cell lung cancer (NSCLC).

ICER is now evaluating some targeted treatments for NSCLC, but not all of them. It is unclear how the group is considering individual variation and the diagnostic tests that determine them, which are the foundation for progress in personalized medicine and health care generally.

PMC invited the organization’s chief methodologist to address the membership. Our members appreciated that he took time to explain the assessment methodology and the process stakeholders can use to provide feedback. Because ICER plays a unique role in health policy, with health plans being the primary audience for their work, PMC will suggest improvements to ICER’s system to ensure that resulting work accounts for the challenges involved in assessing value of treatments that work for specific subgroups of patients.

PMC then sent a letter to ICER asking for an open, inclusive and responsive public engagement process. This is more important than ever, since ICER’s evaluations have now been recognized by the Centers for Medicare and Medicaid Services (CMS) as a useful tool for evaluating how much the agency should pay for drugs as part of its Part B demonstration project, which would test new ways for CMS to pay for drugs delivered in a hospital or doctor’s office.

This summer, PMC will propose improvements to ICER’s public engagement process and methodology and comment on its draft NSCLC therapeutic evaluation once it is published in late August. We urge all PMC members to do the same.

You can find more information on ICER’s NSCLC work here: https://icer-review.org/topic/nsclc/.