Hostname: page-component-78c5997874-8bhkd Total loading time: 0 Render date: 2024-11-05T15:31:59.376Z Has data issue: false hasContentIssue false
  • English
  • Français

Health Technology Agency insights: informing modification of a qualitative benefit risk framework for Health Technology Reassessment of prescription medications

Published online by Cambridge University Press:  16 September 2019

Mary Alison Maloney ,
Lisa Schwartz ,
Daria O'Reilly  and
Mitchel Levine
Mary Alison Maloney*
Affiliation:
Department of Health Research Methods, Evidence, and Impact, Centre for Health Economics and Policy Analysis, McMaster University,Hamilton, Ontario, Canada Bayer HealthCare LLC, Whippany, NJ, USA
Lisa Schwartz
Affiliation:
Department of Health Research Methods, Evidence, and Impact, Centre for Health Economics and Policy Analysis, McMaster University,Hamilton, Ontario, Canada
Daria O'Reilly
Affiliation:
Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada Telus Health, Toronto, Ontario, Canada
Mitchel Levine
Affiliation:
Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada
*
Author for correspondence: Mary Alison Maloney, E-mail: [email protected] or [email protected]
Get access Rights & Permissions [Opens in a new window]

Abstract

Objectives

This study's intent was to determine if a qualitative benefit risk framework could be used or modified to further enable Health Technology Reassessment (HTR) of prescription medicine recommendations. The purpose of this research was to understand Canadian Health Technology Agency assessors past experiences and insights to inform any modifications to the Universal Methodology for Benefit−Risk Assessment (UMBRA) qualitative framework. The UMBRA framework consists of an eight-step process, used during the assessment phase, to aid in decision making and dissemination.

Methods

A qualitative descriptive study was conducted and included a purposeful, criterion-based sample of eight assessors who had participated in Health Technology Assessment (HTA) or HTR for prescription medicines or in qualitative decision-making frameworks.

Results

Participant interviews lead to four common themes: “adoption of a qualitative benefit risk framework,” “data (either too much or not enough),” “importance of incorporating stakeholder values,” and “feasibility of the UMBRA framework.” Methodological challenges with HTR were highlighted including the lack of clinical outcome data and the ability to compare clinically relevant meaningful differences. The implementation of a ranking or weighing process found within the UMBRA framework was not favored by half of the participants.

Conclusions

Research participants did not consider all steps of the UMBRA framework to be transferable to the assessment phase of HTR given the need for simplicity, resource efficiency, and stakeholder input throughout the process. The assessor experiences and insights and the resultant key themes can be used in future research to aid in the development of a qualitative recommendation framework for HTR.

Keywords

Technology assessmentDisinvestmentQualitative benefit risk frameworkReassessment
Type
Policy
Information
International Journal of Technology Assessment in Health Care , Volume 35 , Issue 5 , 2019 , pp. 384 - 392
Copyright
Copyright © Cambridge University Press 2019 

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

1.Hughes, D, Waddingham, EAD, Mt-Isa, S et al. (2013) Recommendations for the methodology and visualisation techniques to be used in the assessment of benefit and risk of medicines. Available at: http://www.imi-protect.eu/documents/HughesetalRecommendationsforthemethodologyandvisualisationtechniquestobeusedintheassessmento.pdf. Accessed October 2016.Google Scholar
2.Phillips, LD, Fasolo, B, Zafiropoulos, N et al. (2010) Benefit-risk methodology project. Work package 2 report: Applicability of current tools and processes for regulatory benefit-risk assessment. 31 August 2010. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2010/10/WC500097750.pdf. Accessed October 2016.Google Scholar
3.Leong, J, Salek, S, Walker, S (2014) Strategy for communicating benefit-risk decisions: a comparison of regulatory agencies' publicly available documents. Front Pharmacol. 5(269), 1–9.Google Scholar
4.Mt-Isa, S, Wang, N, Hallgreen, CE et al. (2013) Review of methodologies for benefit and risk assessment of medication. Available at: http://protectbenefitrisk.eu/documents/ShahruletalReviewofmethodologiesforbenefitandriskassessmentofmedicationMay2013.pdf. Accessed October 2016.Google Scholar
5.Mt-Isa, S, Hallgreen, CE, Wang, N et al. (2014) Balancing benefit and risk of medicines: a systematic review and classification of available methodologies. Pharmacoepidemiol Drug Saf 23(7), 667–678.Google Scholar
6.Mt-Isa, S, Ouwens, B, Robert, V et al. (2016) Structured benefit-risk assessment: a review of key publications and initiatives on frameworks and methodologies. Pharma Stat. 15, 4.Google Scholar
7.Pignatti, F, Ashby, D, Brass, EP et al. (2015) Structured frameworks to increase the transparency of the assessment of benefits and risks of medicines: current status and possible future direction. Clin Pharmacol Ther. 98(5), 522–533.Google Scholar
8.European Medicines Agency (2012) Benefit-risk methodology project. Work package 4 report: benefit-risk tools and processes. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2012/03/WC500123819.pdf. Accessed October 2016.Google Scholar
9.US Food and Drug Administration (2018) Benefit-risk assessment in drug regulatory decision-making. Draft PDUFA VI implementation plan (FY 2018–2022). March 2018. Available at: https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM602885.pdf. Accessed October 2018.Google Scholar
10.Walker, S, McAuslane, N, Liberti, L, Leong, J, Salek, S (2015) A universal framework for the benefit-risk assessment of medicines: is this the way forward? Ther Innov Regul Sci. 49(1), 17–25.Google Scholar
11.Centre for Innovation in Regulatory Science (2016) UMBRA Initiative. Available at: http://www.cirsci.org/decision-making-frameworks/umbra-initiative/. Accessed October 2016.Google Scholar
12.MacKean, G, Noseworthy, T, Elshaug, AG et al. (2013) Health technology reassessment: the art of the possible. Int J Technol Assess Health Care. 29, 418–423.Google Scholar
13.Maloney, MA, Schwartz, L, O'Reilly, D, Levine, M (2017) Drug disinvestment frameworks: components, challenges and solutions. Int J Technol Assess Health Care. 33, 261–269.Google Scholar
14.Seo, HJ, Park, JJ, Lee, SH (2016) A systematic review on current status of health technology reassessment: insights for South Korea. Health Res Policy Sys. 14, 1–10.Google Scholar
15.Soril, LJ, MacKean, G, Noseworthy, TW, Leggett, LE, Clement, FM (2017) Achieving optimal technology use: a proposed model for health technology reassessment. SAGE Open Med. 5, 1–7.Google Scholar
16.Canadian Agency for Drugs and Technologies in Health (2016) Therapeutic Review Framework and Process. Aug 2016 Version 2.5. Available at: https://www.cadth.ca/sites/default/files/pdf/CADTH_ExternalTherapeuticReviewProcess.pdf. Accessed June 2016.Google Scholar
17.Centre for Innovation in Regulatory Science (2013) Is there a commonality across the structured decision frameworks used by HTA and regulatory agencies? Workshop report. October 2013. Available at: http://www.cirsci.org/past-workshops-and-publications/. Accessed July 2018.Google Scholar
18.Sullivan-Bolyai, S (2005) Developing and refining interventions in persons with health disparities: the use of qualitative description. Nurs Outlook. 53, 127–133.Google Scholar
19.Neergaard, MA, Olesen, F, Andersen, RS, Sondergaard, J (2009) Qualitative description—the poor cousin of health research? BMC Med Res Methodol. 9, 52–57.Google Scholar
20.Sandelowski, M (2000) Whatever happened to qualitative description? Res Nurs Health. 23, 334–340.Google Scholar
21.Creswell, JW (2013) Qualitative inquiry and research design: choosing among five traditions. 3rd ed. Thousand Oaks: Sage Publications.Google Scholar
22.Miles, MB, Huberman, AM (1994) Qualitative data analysis—an expanded sourcebook. 2nd ed. Thousand Oaks: Sage Publications.Google Scholar
23.Smith, JA (2007) Qualitative psychology: a practical guide to research methods. 2nd ed. London: Sage Publications.Google Scholar
24.Glaser, BG (1965) The constant comparative method of qualitative analysis. Soc Probl. 12(4), 436–445.Google Scholar
25.Fram, S (2013) The constant comparative analysis method outside of grounded theory. Qual Rep. 18(1), 1–25.Google Scholar
26.Emden, C, Sandelowski, M (1998) The good, the bad, and the relative, part one: conceptions of goodness in qualitative research. Int J Nurs Pract. 4, 206–212.Google Scholar
27.Whittemore, R, Chase, S, Mandle, C (2001) Validity in qualitative research. Qual Health Res. 11, 522–537.Google Scholar
28.Milne, J, Oberle, K (2005) Enhancing rigor in qualitative description: a case study. J Wound Ostomy Continence Nurs. 32, 413–420.Google Scholar
29.Canadian Agency for Drugs and Technologies in Health (2016) Recommendation framework for CADTH Common Drug Review and pan-Canadian Oncology Drug Review programs: Guidance for CADTH's drug expert committees. March 2016. Available at: https://www.cadth.ca/media/cdr/templates/pre-sub-phase/pCODR_CDR_recommendations_framework.pdf. Accessed June 2016.Google Scholar
30.Canadian Agency for Drugs and Technologies in Health (2016) pCODR expert review committee deliberative framework. August 2016. Available at: https://www.cadth.ca/sites/default/files/pcodr/The%20pCODR%20Expert%20Review%20Committee%20%28pERC%29/pcodr_perc_deliberative_frame.pdf. Accessed June 2016.Google Scholar
31.DECIDE GRADE (2017) DECIDE 2011–2015. Available at: http://www.decide-collaboration.eu/evidence-decision-etd-framework. Accessed June 2017.Google Scholar
32.Elshaug, A, Watt, A, Moss, J, Hiller, J (2009) Policy perspectives on the obsolescence of health technologies in Canada. Available at: http://www.cadth.ca/collaboration-and-outreach/advisory-bodies/policy-forum/discussion-papers/policy-perspectives-obsolescence-health. Accessed 6 February 2016.Google Scholar
33.Henshall, C, Schuller, T, Mardhani-Bayne, L (2012) Using health technology assessment to support optimal use of technologies in current practice: the challenge of “disinvestment”. Int J Technol Assess Health Care. 28, 203–210.Google Scholar
34.Esmail, R, Hanson, H, Holroyd-Leduc, J, Niven, DJ, Clement, F (2018) Knowledge translation and health technology reassessment: identifying synergy. BMC Health Serv Res. 18(1), 674–682.Google Scholar
35.Giorgi, A (1992) Description versus interpretation: competing alternative strategies for qualitative research. J Phenomenol Psychol. 23, 119–135. 10.1163/156916292X00090.Google Scholar
Supplementary material: File

Maloney et al. supplementary material

Tables S1-S2

Download Maloney et al. supplementary material(File)
File 20.3 KB