Hostname: page-component-78c5997874-s2hrs Total loading time: 0 Render date: 2024-11-05T00:50:41.714Z Has data issue: false hasContentIssue false
  • English
  • Français

A toolkit of methods of development-focused health technology assessment

Published online by Cambridge University Press:  23 August 2021

Janet Bouttell Open the ORCID record for Janet Bouttell [Opens in a new window] ,
Andrew Briggs  and
Neil Hawkins
Janet Bouttell*
Affiliation:
Health Economics and Health Technology Assessment, University of Glasgow, 1 Lilybank Gardens, Glasgow, G12 8RZ, UK
Andrew Briggs
Affiliation:
Department of Health Services Research & Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK
Neil Hawkins
Affiliation:
Health Economics and Health Technology Assessment, University of Glasgow, 1 Lilybank Gardens, Glasgow, G12 8RZ, UK
*
Author for correspondence: Janet Bouttell, E-mail: [email protected]
Get access Rights & Permissions [Opens in a new window]

Abstract

Health technology assessment conducted to inform decisions during technology development (development-focused or DF-HTA) has a number of distinct features compared with HTA conducted to inform reimbursement and usage decisions. In particular, there are a broad range of decisions to be informed related to the development of a technology; multiple markets and decision makers to be considered; a limited (and developing) evidence base; and constrained resources for analysis. These features impact upon methods adopted by analysts. In this paper, we (i) set out methods of DF-HTA against a timeline of technology development; (ii) provide examples of the methods’ use; and (iii) explain how they have been adapted as a result of the features of DF-HTA. We present a toolkit of methods for analysts working with developers of medical technologies. Three categories of methods are described: literature review, stakeholder consultation, and decision analytic modeling. Literature review and stakeholder consultation are often used to fill evidence gaps. Decision analytic modeling is used to synthesize available evidence alongside plausible assumptions to inform developers about price or performance requirements. Methods increase in formality and complexity as the development and evidence base progresses and more resources are available for assessment. We hope this toolkit will be used in conjunction with the framework of features of DF-HTA presented in our earlier article in order to improve the clarity and appropriateness of methods of HTA used in DF-HTA. We also seek to contribute to a continuing dialogue about the nature of, and the best approach to, DF-HTA.

Keywords

Cost-effectiveness analysisTechnology assessmentTranslational researchResearch and developmentEarly HTA
Type
Article Commentary
Information
International Journal of Technology Assessment in Health Care , Volume 37 , Issue 1 , 2021 , e84
Copyright
Copyright © The Author(s), 2021. Published by Cambridge University Press

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Bouttell, J, Briggs, A, Hawkins, N. A different animal? Identifying the features of health technology assessment for developers of medical technologies. Int J Technol Assess Health Care. 2020;36:285–91.CrossRefGoogle Scholar
Waring, MJ, Arrowsmith, J, Leach, AR, Leeson, PD, Mandrell, S, Owen, RM, et al. An analysis of the attrition of drug candidates from four major pharmaceutical companies. Nat Rev Drug Discov. 2015;14:475–86.CrossRefGoogle ScholarPubMed
Hay, M, Thomas, DW, Craighead, JL, Economides, C, Rosenthal, J. Clinical development success rates for investigational drugs. Nat Biotechnol. 2014;32:40–51.CrossRefGoogle ScholarPubMed
Lehoux, P, Williams-Jones, B, Miller, F, Urbach, D, Tailliez, S. What leads to better health care innovation? Arguments for an integrated policy-oriented research agenda. J Health Serv Res Policy. 2008;13:251–4.CrossRefGoogle ScholarPubMed
DiMasi, JA, Grabowski, HG, Hansen, RW. Innovation in the pharmaceutical industry: New estimates of R&D costs. J Health Econ. 2016;1:20–33.CrossRefGoogle Scholar
Claxton, K, Martin, S, Soares, M, Rice, N, Spackman, E, Hinde, S, et al. Methods for the estimation of the national institute for health and care excellence cost-effectiveness threshold. Health Technol Assess (Winch Eng). 2015;19:1.CrossRefGoogle ScholarPubMed
Ijzerman, MJ, Steuten, LM. Early assessment of medical technologies to inform product development and market access. Appl Health Econ Health Policy. 2011;9:331–47.CrossRefGoogle ScholarPubMed
Hartz, S, John, J. Contribution of economic evaluation to decision making in early phases of product development: A methodological and empirical review. Int J Technol Assess Health Care. 2008;24:465–72.CrossRefGoogle ScholarPubMed
Bartelmes, M, Neumann, U, Lühmann, D, Schönermark, MP, Hagen, A. Methods for assessment of innovative medical technologies during early stages of development. GMS Health Technol Assess. 2009;5:1–9.Google ScholarPubMed
Mikudina, B, Redekop, K. Early medical technology assessments of medical devices and tests. J Health Serv Res Policy. 2013;1:26–37.Google Scholar
Markiewicz, K, van Til, JA, IJzerman, MJ. Medical devices early assessment methods: Systematic literature review. Int J Technol Assess Health Care. 2014;30:137–46.CrossRefGoogle ScholarPubMed
Graziadio, S, Winter, A, Lendrem, BC, Suklan, J, Jones, WS, Urwin, SG, et al. How to ease the pain of taking a diagnostic point of care test to the market: A framework for evidence development. Micromachines. 2020;11:291.CrossRefGoogle ScholarPubMed
Miller, P. Role of pharmacoeconomic analysis in R&D decision making. PharmacoEconomics. 2005;23:1–12.CrossRefGoogle Scholar
Chapman, AM. The use of early economic evaluation to inform medical device decisions: An evaluation of the headroom method [PhD thesis]. Birmingham, UK: University of Birmingham; 2013.Google Scholar
Dranitsaris, G, Leung, P. Using decision modeling to determine pricing of new pharmaceuticals: The case of neurokinin-1 receptor antagonist antiemetics for cancer chemotherapy. Int J Technol Assess Health Care. 2004;20:289–95.CrossRefGoogle ScholarPubMed
Brandes, A, Sinner, MF, Kääb, S, Rogowski, WH. Early decision-analytic modeling – A case study on vascular closure devices. BMC Health Serv Res. 2015;15:486.CrossRefGoogle ScholarPubMed
Vallejo-Torres, L, Steuten, LM, Buxton, MJ, Girling, AJ, Lilford, RJ, Young, T. Integrating health economics modeling in the product development cycle of medical devices: A Bayesian approach. Int J Technol Assess Health Care. 2008;24:459–64.CrossRefGoogle ScholarPubMed
Markiewicz, K, Van Til, JA, Steuten, LM, Ijzerman, MJ. Commercial viability of medical devices using headroom and return on investment calculation. Technol Forecast Soc Change. 2016;112:338–46.CrossRefGoogle Scholar
McAteer, H, Cosh, E, Freeman, G, Pandit, A, Wood, P, Lilford, R. Cost-effectiveness analysis at the development phase of a potential health technology: Examples based on tissue engineering of bladder and urethra. J Tissue Eng Regen Med. 2007;1:343–9.CrossRefGoogle Scholar
Kluytmans, A, Tummers, M, Van Der Wilt, GJ, Grutters, J. Early assessment of proof-of-problem to guide health innovation. Value Health. 2019;22:601–6.CrossRefGoogle ScholarPubMed
Clark, J, Glasziou, P, Del Mar, C, Bannach-Brown, A, Stehlik, P, Scott, AM. A full systematic review was completed in 2 weeks using automation tools: A case study. J Clin Epidemiol. 2020;121:81–90.CrossRefGoogle ScholarPubMed
Pham, B, Bagheri, E, Rios, P, Pourmasoumi, A, Robson, RC, Hwee, J, et al. Improving the conduct of systematic reviews: A process mining perspective. J Clin Epidemiol. 2018;103:101–11.CrossRefGoogle ScholarPubMed
Abel, L, Shinkins, B, Smith, A, Sutton, AJ, Sagoo, GS, Uchegbu, I, et al. Early economic evaluation of diagnostic technologies: Experiences of the NIHR diagnostic evidence co-operatives. Med Decis Making. 2019;39:857–66.CrossRefGoogle ScholarPubMed
Iglesias, CP, Thompson, A, Rogowski, WH, Payne, K. Reporting guidelines for the use of expert judgement in model-based economic evaluations. PharmacoEconomics. 2016;34:1161–72.CrossRefGoogle ScholarPubMed
Ryan, M, Scott, DA, Reeves, C, Bate, A, Van Teijlingen, ER, Russell, EM, et al. Eliciting public preferences for healthcare: A systematic review of techniques. Health Technol Assess. 2001;5: 1–186.CrossRefGoogle Scholar
Oakley, J, O'Hagan, A. [Internet] SHELF: the Sheffield Elicitation Framework (version 2.0). Sheffield: School of Mathematics and Statistics, University of Sheffield; 2010. Available from: http://tonyohagan.co.uk/shelf/.Google Scholar
Bojke, L, Soares, MFO, Claxton KP, Colson A, Fox, A, Jackson, C, et al. Developing a reference protocol for structured expert elicitation in health-care decision making. Health Technol Assess. 2021; 25(37)CrossRefGoogle Scholar
Peel, A, Jenks, M, Choudhury, M, Lovett, R, Rejon-Parrilla, JC, Sims, A, et al. Use of expert judgement across NICE guidance-making programmes: A review of current processes and suitability of existing tools to support the use of expert elicitation. Appl Health Econ Health Policy. 2018;16:819–36.CrossRefGoogle ScholarPubMed
Hummel, JM, Boomkamp, IS, Steuten, LM, Verkerke, BG, Ijzerman, MJ. Predicting the health economic performance of new non-fusion surgery in adolescent idiopathic scoliosis. J Orthop Res. 2012;30:1453–8.CrossRefGoogle ScholarPubMed
Wissing, TB. The bioartificial pancreas “A clinical case scenario analysis to assess and support the development of a device to improve type I diabetes care” [Masters thesis]. Enschede, Netherlands: University of Twente; 2012.Google Scholar
Grutters, JP, Govers, T, Nijboer, J, Tummers, M, Van Der Wilt, GJ, Rovers, MM. Problems and promises of health technologies: The role of early health economic modeling. Int J Health Policy Manag. 2019;8:575.CrossRefGoogle ScholarPubMed
Annemans, L, Genesté, B, Jolain, B. Early modelling for assessing health and economic outcomes of drug therapy. Value Health. 2000;3:427–34.CrossRefGoogle ScholarPubMed
Gc, VS, Manca, A, Casson, AJ, Antrobus, S, Iglesias, CP. Assessing the potential value of wearable digital health technologies in chronic kidney disease using early HTA methods. Value Health. 2021;24: S12CrossRefGoogle Scholar
Steuten, L, van de Wetering, G, Groothuis-Oudshoorn, K, Retèl, V. A systematic and critical review of the evolving methods and applications of value of information in academia and practice. PharmacoEconomics. 2013;31:25–48.CrossRefGoogle Scholar
Vallejo-Torres, L, Steuten, L, Parkinson, B, Girling, AJ, Buxton, MJ. Integrating health economics into the product development cycle: A case study of absorbable pins for treating hallux valgus. Med Decis Making. 2011;31:596–610.CrossRefGoogle ScholarPubMed
National Institute for Health and Care Excellence. [Internet] Guide to the Methods of Technology Appraisal. Available from: https://www.nice.org.uk/process/pmg9/chapter/the-reference-case.Google Scholar
Craven, MP, Allsop, MJ, Morgan, SP, Martin, JL. Engaging with economic evaluation methods: Insights from small and medium enterprises in the UK medical devices industry after training workshops. Health Res Policy Syst. 2012;10:29.CrossRefGoogle ScholarPubMed
Cosh, E, Girling, A, Lilford, R, McAteer, H, Young, T. Investing in new medical technologies: A decision framework. J Commer Biotechnol. 2007;13:263–71.CrossRefGoogle Scholar
Girling, A, Young, T, Brown, C, Lilford, R. Early-stage valuation of medical devices: The role of developmental uncertainty. Value Health. 2010;13:585–91.CrossRefGoogle ScholarPubMed
de Graaf, G, Postmus, D, Westerink, J, Buskens, E. The early economic evaluation of novel biomarkers to accelerate their translation into clinical applications. Cost Eff Resour Alloc. 2018;16:23.CrossRefGoogle ScholarPubMed
Markiewicz, K. Health technology assessment of medical devices during development [PhD thesis]. Enschede, Netherlands: University of Twente; 2017.Google Scholar
Støme, LN, Moger, TA, Kidholm, K, Kvaerner, KJ. Early assessment of innovation in a healthcare setting. Int J Technol Assess Health Care. 2019;35:17–26.CrossRefGoogle Scholar
Love-Koh, J. How useful are early economic models?: Comment on ”Problems and promises of health technologies: The role of early health economic modelling”. Int J Health Policy Manag. 2020;9:215.Google Scholar
Supplementary material: File

Bouttell et al. supplementary material

Tables S1 and S2

Download Bouttell et al. supplementary material(File)
File 32.6 KB