Toward Modified Impact Inventory Tables to Facilitate Patient-Centered Value Assessment

Abstract

Value assessment is emerging as a key policy lever for pharmaceutical coverage and reimbursement decision making in the United States. Value frameworks largely rely on traditional value assessment methods such as comparative effectiveness research (CER), literature-based cost-effectiveness analyses (CEAs), and appraisal committees that deliberate the relative value of pharmaceutical interventions [1]. Main findings from value frameworks, in particular CEAs, can influence appraisal committee votes and policy recommendations, which may flow to coverage and reimbursement decisions [2]. Given value frameworks often take a population-level reimbursement perspective focused on clinical outcomes and payer costs, value assessments may omit the explicit evaluation of additional criteria important to patients [3, 4]. Specifically, there is a wide variety of value criteria that can be included in value assessment applications depending on decision context and perspective (e.g., additional measures of risk or uncertainty, equity, caregiver burden, stigma, etc.) [5–9]. However, health economists have not reached a consensus on how to measure and incorporate additional value criteria important to patients and broader society into value assessment applications [1, 4, 9]. Further, ISPOR’s Special Task Force on Value Assessment Frameworks explicitly called for increased patient engagement and perspectives in value assessment applications [10]. To address the call for increasing patient-centricity in value assessments [3, 4], we propose disease-specific modifications of a simple, yet powerful tool that has been recommended by the Second Panel on Cost-Effectiveness in Health and Medicine—the impact inventory table [11]. The impact inventory table provides researchers and consumers of value assessments a checklist of which value criteria are included to facilitate comparability with past and future assessments. While the impact inventory table includes the most important costs and societal effects, the criteria are largely generic across diseases and are often missing value criteria most important to patients. Our proposed approach includes the following two-step process for modifying the generic impact inventory table to include additional patient-centric value criteria: (1) elicit and prioritize value criteria through patient engagement efforts; and (2) engage clinicians, value assessment researchers, and other stakeholders in a mapping exercise to determine the placement of prioritized and refined criteria to a modified disease-specific impact inventory table. Additionally, we provide a discussion on applications of modified disease-specific impact inventory tables using existing and potentially emerging novel value assessment methods. Our proposed approach refers to value assessment as defined by ISPOR’s Special Task Force on Value Assessment where health care decisions can be made both at the population and individual level [10]. We define additional value criteria as diseaseor treatment-specific attributes associated with health benefits, risks, and costs that are often not adequately captured by current value assessment applications.