What kind of HTA does the US need?

Should the US have a formal, centralized health technology assessment (HTA) organization? In the United Kingdom, the National Institute for Health and Care Excellence (NICE) plays this roles and has a significant impact on drug pricing in the UK. However, the UK relies on a single payer system and NICE’s recommendations can be directly implemented…

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…