New Opportunities to Capture Wider Aspects of Value
Non-traditional aspects of value have been highlighted at ISPOR previously, with the value flower often used to exemplify aspects of value to the patient and society which are not well captured in traditional value assessment.1 However, the industry is currently faced with the opportunity to re-evaluate non-traditional value drivers through the Inflation Reduction Act (IRA) in the US. Therefore, at this year’s ISPOR International, there was abundant discussion around the IRA and its implications on health economics and outcome research (HEOR) and the pharmaceutical industry in the US as a whole. Further information on the implications of the IRA can be found in a separate commentary here (‘The IRA is Law – Now What?’). There is still no clarity as to what value drivers the US Centers for Medicare and Medicaid Services (CMS) will assess when actioning the IRA. However, negotiations with the Department of Health and Human Services (HHS) may push manufacturers to consider innovative, non-traditional ways to demonstrate post-market launch value.
One example of a non-traditional concept of value – or lack of value – that could be relevant post-market launch is time toxicity, which was discussed in Educational Symposia 142.2 This idea captures the negative consequences of the time an individual must spend accessing a treatment, encompassing time spent making appointments and making insurance claims as well as visiting their healthcare provider. Though some aspects of time spent interacting with the medical system, such as time spent in medical appointments, may be captured in estimates of healthcare resource use (HCRU) from the payer perspective, the aspects of time toxicity which primarily impact individuals, their families and broader society may not be. Time toxicity is particularly important in time-limited settings, such as advanced cancer, where the consideration of how a patient might spend their time, and the survival benefits they gain from treatment, are important.3 However, this concept affects all individuals who interact with the healthcare system, and considering the time toxicity associated with therapies could be an important differentiator between the value of different treatment options. Despite this, there are likely to be challenges associated with assessing time toxicity away from end-of-life settings or where therapies are associated with significant administration times, as the amount of time spent interacting with healthcare may show significant heterogeneity between individuals. Additionally, consideration should be given to whether time toxicity is best accounted for as part of value assessments for new treatments or as part of healthcare decisions made between patients and clinicians.