Health technology assessment (HTA) is a process that evaluates the safety, efficacy, and cost-effectiveness of medical technologies, such as drugs, medical devices, and diagnostic tests, in order to inform decision-making about their use in healthcare. It is a multidisciplinary approach that explores health technologies from clinical, economic, and the larger societal viewpoint. (1)
Living HTA is a relatively new approach in the field of HEOR (health economics and outcomes research) in which the HTA methodology is applied in real-time or in a ‘living’, continuous manner, as opposed to traditional HTA that makes recommendations on an evidence base at a fixed point in time (2).
Traditional HTA is analogous to a snapshot in time: any change in the set of potentially relevant interventions and comparators since the time of publication of the HTA report, or any methodological changes including updates in the structural assumptions of health economic models and the model inputs as well as the methods used to estimate the cost-effectiveness, can make the HTA report outdated. (3,4) These factors cumulatively create a significant risk of making incorrect decisions that may not deliver the promised value in healthcare. While certain HTA agencies update HTAs regularly if specific criteria are satisfied, these updates often take years, and at times the decision becomes outdated by the time these updates are published. (5) All these factors bring to the fore the importance of Living HTAs.
Living HTA entails conducting frequent updates to the HTA, either manually or in a semi-automated manner. Each part of the HTA is rendered ‘alive’ in the living HTA by regularly applying updates and integrating different HTA elements, including literature searches, data extractions, updating the meta-analysis and cost-effectiveness model, and updating the entire HTA report. (2) There is no set interval for conducting living HTA, as it is typically an ongoing process that involves continuous monitoring and assessment of the technology in question. The frequency of conducting living HTA depends on the specific technology being assessed, the availability of new evidence, changes in the regulatory landscape, emergence of new technologies, as well as the context and objectives of the assessment.
Manual living HTAs usually requires a team of committed researchers to update at specific points of the HTA process. It also necessitates the use of secure web-based user interfaces to exchange data across various processes to accomplish real-time live HTA. (2) Considering these challenges, and utilizing ongoing technological advances, researchers have explored automating certain aspects of living HTA to make the process simpler. These attempts include technologies to automate literature searching, trial identification, data extraction, performing systematic reviews, meta-analyses, and health-economic modelling, to name a few. Additionally, there have been attempts for automating HTA documentation as well.(6,7) However, automating the multiple steps involved in a HTA process is by itself a challenge since it requires adaptation of the model source code. Further, the process requires manual input from experienced HTA researchers to check the updates and ensure that the output from each stage is appropriate. Automation may also have ethical concerns, and may also lead to potential errors during the automation processes. Perhaps as a result of all these challenges, none of the HTA agencies at present have accepted automated procedures in HTA submissions.(6)
There are a lot of challenges that the ‘Living HTA’ may face to cope-up with the increasing evidence base. Perhaps the most important challenge concerns new data: its availability, nature, access, and quality. Without sufficient data, it may be difficult to conduct an accurate and reliable assessment of the technology’s safety, efficacy, and cost-effectiveness. The next challenge pertains to the resource constrains: since living HTA is an ongoing process, the resource (monetary as well as manpower) demands are considerably higher. Next, there are concerns about data management, particularly for automated living HTA (which requires storing data in the cloud). There are also concerns surrounding the regulatory framework about HTA methodology, data requirements, and conditions for approval. Further, since Living HTA involves ongoing engagement with multiple stakeholders, including patients, healthcare providers, industry, and regulatory bodies, ensuring effective engagement and communication can be a challenge, particularly in cases where there are conflicting perspectives or priorities. Finally, HTA recommendations that change frequently may be difficult for the healthcare system to implement because, in practice, it takes time to procure and supply interventions that are newly deemed cost-effective and to decimate existing supplies of interventions that are no longer cost-effective. (6)
Thus, while living HTA has the potential to provide more responsive, adaptive, accurate, and recent evidence for healthcare decision-making, it also requires careful consideration of various challenges to ensure that the assessment is accurate, reliable, and useful for guiding healthcare policy and practice.
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- Oortwijn W, Jansen M, Baltussen R. Use of evidence-informed deliberative processes by health technology assessment agencies around the globe. International journal of health policy and management. 2020 Jan;9(1):27.
- Thokala P, Srivastava T, Smith R, et al. Living Health Technology Assessment: Issues, Challenges and Opportunities. Pharmacoeconomics. 2023 Jan 18:1–11. doi: 10.1007/s40273-022-01229-4. Epub ahead of print. PMID: 36652184; PMCID: PMC9848020.
- Garritty C, Tsertsvadze A, Tricco AC, et al. Updating systematic reviews: an international survey. PloS one. 2010 Apr 1;5(4):e9914.
- Gutiérrez-Ibarluzea I, Chiumente M, Dauben HP. The life cycle of health technologies. Challenges and ways forward. Frontiers in pharmacology. 2017 Jan 24;8:14.
- Kirwin E, Round J, Bond K, McCabe C. A conceptual framework for life-cycle health technology assessment. Value in Health. 2022 Jul 1;25(7):1116-23.
- Smith RA, Schneider PP, Mohammed W. Living HTA: Automating Health Economic Evaluation with R. Wellcome Open Research. 2022 Oct 11;7:194.
- Khalil H, Ameen D, Zarnegar A. Tools to support the automation of systematic reviews: a scoping review. Journal of Clinical Epidemiology. 2022 Apr 1;144:22-42.