HTA criteria used to evaluate diagnostics

When evaluating a new diagnostic, HTA agencies must assess two separate issues: analytical and clinical validity. Analytical validity basically indicates whether the test works; is it able to accurately predicts the presence or absence of a particular biomarker of interest. Clinical validity is whether the test matters in clinical practice.  It could be the case…

How to justify your survival curve extrapolation methodology

Clinical trials are typically of (relatively) short duration, but innovative treatments may impact patient survival over multiple years. Health economists and outcomes researchers often are faced with the challenge of extrapolating clinical trial survival curves to estimate long-term survival gains for the typical patient. These estimates may be done parameterically (e.g., exponential, Weibull, Gompertz, log-logistic,…

Payer use of ICER reports

The Academy of Managed Care Pharmacy (AMCP) held an interesting webinar titled “5 Years of ICER – Insights and Impact on Payers“. Some highlights form the presentation. Most relevant information Jeremy Lee from MedImpact–a pharmacy benefits manager (PBM)–noted that their Pharmacy and Therapeutics (P&T) committee used four key pieces of evidence when making coverage and…

Are open-source approaches to value measurement the wave of the future?

My colleagues Jeroen Jansen, Devin Incerti along with Jeff Curtis think so. In JMCP they write: In the United States, there is an increased interest to understand the value of health technologies. Cost-effectiveness analysis is arguably the most appropriate framework to quantify value and to inform reimbursement decision making regarding medical interventions; however, a thorough…

What Do Value Assessments Miss?

To find out the answer to this question, check out a live webinar on Wednesday, March 13th at 1:30pm EDT led by Dr. Anupam Jena, MD, PhD. Dr. Jena is a Harvard Professor and Precision Health Economics Scientific Advisor. In this unique one-hour webinar, Dr. Jena will outline a broader framework for assessing value to improve identification of not…

ICER and Unsupported Price Increases

The Institute for Clinical and Economic Review (ICER) recently announced that it would annually review treatments with significant price increases to determine if these changes are unsupported by evidence on value. I was recently interviewed by Radar on Specialty Pharmacy to discuss the topic. Jason Shafrin, Ph.D., a senior director of policy and economics at…