How ICER will conduct it’s “Barriers to Fair Access” Assessment

Last fall, ICER published a white paper titled “Cornerstones of ‘Fair’ Drug Coverage: Appropriate Cost-Sharing and Utilization Management Policies for Pharmaceuticals.” To paraphrase, ICER’s goal is to limit access restrictions (e.g., cost sharing, coverage limitations, prescriber restrictions, step therapy) when a drug is deemed to be cost effective. How will they do this? Their Barriers…

ISPOR Summit on Value Assessment

On June 10, I will be presenting at ISPOR’s Summit on “Value Assessment: New Insights, Approaches, and Applications,” which will highlight evolving practices, new methods, and practical applications in value assessment. The Summit will provide a multistakeholder perspective, including recent developments in the incorporation of uncertainty and risk aversion into value measures, covering both the…

Is the value of a QALY constant?

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…

HTA are ignoring the value of reduced caregiver burden

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).…

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…