A Conceptual Framework for Life-Cycle Health Technology Assessment

• Published in: Value in health Vol. 25; no. 7; pp. 1116 - 1123
• Main Authors: Kirwin, Erin, Round, Jeff, Bond, Ken, McCabe, Christopher
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.07.2022
• Subjects: Cost-Benefit Analysis; economic evaluation; health technology assessment; Humans; Internal Medicine; life-cycle; Public Health; research oriented market access; Technology Assessment, Biomedical - methods; Uncertainty; value of information; health technology assessment; economic evaluation; value of information; life-cycle; research oriented market access
• ISSN: 1098-3015; 1524-4733; 1524-4733
• DOI: 10.1016/j.jval.2021.11.1373

Health technology assessment (HTA) uses evidence appraisal and synthesis with economic evaluation to inform adoption decisions. Standard HTA processes sometimes struggle to (1) support decisions that involve significant uncertainty and (2) encourage continued generation of and adaptation to new evidence. We propose the life-cycle (LC)-HTA framework, addressing these challenges by providing additional tools to decision makers and improving outcomes for all stakeholders. Under the LC-HTA framework, HTA processes align to LC management. LC-HTA introduces changes in HTA methods to minimize analytic time while optimizing decision certainty. Where decision uncertainty exists, we recommend risk-based pricing and research-oriented managed access (ROMA). Contractual procurement agreements define the terms of reassessment and provide additional decision options to HTA agencies. LC-HTA extends value-of-information methods to inform ROMA agreements, leveraging routine, administrative data, and registries to reduce uncertainty. LC-HTA enables the adoption of high-value high-risk innovations while improving health system sustainability through risk-sharing and reducing uncertainty. Responsiveness to evolving evidence is improved through contractually embedded decision rules to simplify reassessment. ROMA allows conditional adoption to obtain additional information, with confidence that the net value of that adoption decision is positive. The LC-HTA framework improves outcomes for patients, sponsors, and payers. Patients benefit through earlier access to new technologies. Payers increase the value of the technologies they invest in and gain mechanisms to review investments. Sponsors benefit through greater certainty in outcomes related to their investment, swifter access to markets, and greater opportunities to demonstrate value. •We propose the life-cycle (LC)-health technology assessment (HTA) framework to address 3 challenges faced under standard HTA: (1) health system sustainability, (2) evolving evidence, and (3) uncertainty.•The LC-HTA framework is built around on-market evidence generation and risk-based pricing strategies. Where decision uncertainty exists, we recommend risk-based pricing and research-oriented managed access. Contractual procurement agreements define the terms of reassessment and provide additional decision options to HTA agencies. LC-HTA extends value-of-information methods to inform research-oriented managed access agreements, leveraging routine, administrative data, and registries to reduce uncertainty.•There are 6 stages to LC-HTA: (1) preassessment, (2) safety and efficacy assessment, (3) HTA, (4) adoption, (5) deadoption, and (6) reassessment. These stages are sequenced to minimize analytic time while optimizing decision certainty. The use of this framework could improve outcomes for patients, sponsors, and payers.