Unbiased Analysis of Today's Healthcare Issues
The FDA approval process is slow. Even for COVID-19 vaccines, the process can be time consuming. However, regulators around the world do have some expedited programs. However, a number of countries have programs that expedite review, particularly for the diseases with unmet need, orphan drugs, or when new treatments represent a significant advance over the…
While many health technology assessment (HTA) organizations acknowledge that many new treatments reduce the burden placed on caregivers, the value that these new treatments provide is rarely incorporated into formal cost effectiveness analyses. This is the finding from Pennington (2020) based on a review of ll published technology appraisals (TAs) and highly specialized technologies (HSTs).…
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…
Check out my interview on the Redeeming Value podcast with Brian Reid. PRECISIONheor Vice President Jason Shafrin pops in to talk about the Institute of Clinical and Economic Review and the broader question of where the group’s influence is centered and the elements of ICER reports that stakeholders are paying attention to. Do listen to…
A nice (pun intended) paper by Thokala et al. (2020) compares the Institute for Clinical and Economic Review (ICER) with the National Institute for Health and Care Excellence (NICE) along 4 dimensions: structure, methods, process, and use in decision-making. While ICER and NICE methods are fairly similar, ICER is a non-governmental body without any explicit…
Is it clinical benefit? Cost? Value? The availability of treatment alternatives? To answer this question, a paper by Wranik et al. (2019) conducted a discrete choice experiment DCE to determine HTA stakeholders stated preferences. The sample consisted of HTA stakeholders from 5 countries: Australia, Canada, Germany, Poland, and the United Kingdom. The stakeholders included not…
Many health technology assessment (HTA) agencies give additional consideration to treatments if there is unmet need. But what really defines unmet need? According to an article by Vreman et al. (2019), there are three key elements. First, there should be no or limited treatment alternatives. If there are lots of good treatment options available, then…
A recent report by the National Pharmaceutical Council provides an overview of seven different value frameworks. Specifically, the overview includes value frameworks developed by: American College of Cardiology and the American Heart Association (ACC-AHA), American Society of Clinical Oncology (ASCO), Avalere/FasterCures Patient-Perspective Value Framework (PPFV) Innovation and Value Initiative (IVI) Open-Source Value Project (OSVP) Institute…