Unbiased Analysis of Today's Healthcare Issues
That is the topic of a recent paper by Augustovski et al. (2021). The authors conduct a targeted literature review of previous diagnostics value frameworks in other countries. A full list of these articles is below. Then the researchers pool the criteria and created a proposed value framework. A panel of experts was then met…
A new drug comes on the market. Is the health benefit worth the cost? What is it’s value? Value assessment frameworks are one way to answer this question. Value frameworks take the evidence of the treatments benefits, risk and cost and output some notion of the treatment’s value. Ideally, if anyone applied a given value…
What is a rare disease? The definition varies across countries, but according to the European Medicines Agency (EMA) rare diseases are those with a prevalence of <5 cases per 10,000 people; ultra-rare diseases are those with <1 case per 50,000 people. In most cases, rare disease must not only be rare but also severe, often…
Standard cost-effectiveness analysis assumes that any gain in quality-adjusted life years (QALYs) should be valued equally. This does not sound unreasonable, but is it true in practice? Consider two potential violations of constant value of QALY gains: scope insensitivity and severity independence. I define each of these below: Scope insensitivity. This assumes that individuals value…
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…