Disease Severity Modifier in the NICE Single Technology Appraisal of Trastuzumab Deruxtecan: External Assessment Group Perspective

Excerpt

The National Institute for Health and Care Excellence (NICE) introduced decision-making severity modifiers in their latest methods guidance [1]. The severity modifier replaces the end-of-life premium criteria. While quality-adjusted life-years (QALYs) are considered equal in every circumstance in the reference case, decision makers may consider a QALY modifier. Disease severity is such a modifier. The severity of the disease is defined as the future health lost by people living with the condition with standard care in the National Health Service (NHS) when compared with the health expected for the general population. In technology appraisals (TAs), this disease severity will be assessed by considering the associated absolute and proportional QALY shortfall. The upshot of modifiers is that they effectively increase the NICE willingness-to-pay threshold for an unweighted QALY gain. Trastuzumab deruxtecan (T-DXd) is one of the first NICE submissions where the disease severity modifier was a consideration for the NICE appraisal committee. This commentary piece sets out the key learnings from the External Assessment Group (EAG) perspective of this new development in NICE decision making based on TA862 (ID3909): Trastuzumab deruxtecan for treating HER2-positive unresectable or metastatic breast cancer after 1 or more anti-HER2 treatments [2]. …