A Conceptual Framework for Life-Cycle Health Technology Assessment

Abstract

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.Methods: 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.Results: 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. Conclusions: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.

Effective and Efficient Delivery of Genome-Based Testing-What Conditions Are Necessary for Health System Readiness?

“…The rate of proposals for new tests and testing modalities necessitates a clear process for the managed adoption and obsolescence of tests [ 41 ]. A single point of entry for considering new tests using an application procedure coupled with an evaluation process and formulary is one increasingly used approach that allows multiple stakeholders to engage with the healthcare system [ 42 ].…”

Planning and Budgeting of Medical Devices Among Ethiopian Public Hospitals

“…The assessment addressed the management cycle of a medical device including planning, budgeting, technical specification preparation, and procurement aspects. 24 , 25 The roles of biomedical engineers in medical device management were also assessed. Engaging biomedical engineers in the planning and management of medical devices is important.…”

Living Health Technology Assessment: Issues, Challenges and Opportunities

“…In the current static HTA approach, the agencies provide evidence-based recommendations about health technologies near the time of regulatory approval. Recently, there has been a push towards a ‘life-cycle’ approach to HTA, where the recommendations are updated regularly in light of new evidence [ 1 , 36 – 39 ]. Living HTA can help decision makers in this regard with a frequently updated, living approach to HTA.…”

“…Furthermore, a living HTA approach necessitates a commitment to disinvest in technologies that are no longer cost effective and remove them from clinical practice. To understand the potential policy impact of living HTA, readers are referred to a paper outlining ‘Life cycle HTA’, which suggests a framework for constant HTA process to feed into reassessment, adoption, and no adoption decisions [ 1 ].…”

“…There is growing recognition of the need for the HTA process to respond to an evolving evidence base, particularly in reimbursement decisions with high uncertainty. A recent paper on ‘Life-cycle HTA’ suggests that HTA must explore the value of health technologies from inception through maturity, and proposes a model for integrating changes arising from new evidence to feed into adoption, no adoption and disinvestment decisions [ 1 ]. However, as far as we know, there is no literature on the practicalities of performing a responsive, dynamic HTA (which we call ‘Living HTA’).…”