Hostname: page-component-cd9895bd7-fscjk Total loading time: 0 Render date: 2024-12-25T18:13:03.524Z Has data issue: false hasContentIssue false
  • English
  • Français

Value assessment of antimicrobials and the implications for development, access, and funding of effective treatments: Australian stakeholder perspective

Part of: Special Collection - Methods

Published online by Cambridge University Press:  03 November 2020

Nadine T. Hillock Open the ORCID record for Nadine T. Hillock [Opens in a new window] ,
Tracy L. Merlin ,
Jonathan Karnon ,
John Turnidge  and
Jaklin Eliott
Nadine T. Hillock*
Affiliation:
School of Public Health, University of Adelaide, Adelaide, SA5000, Australia
Tracy L. Merlin
Affiliation:
School of Public Health, University of Adelaide, Adelaide, SA5000, Australia
Jonathan Karnon
Affiliation:
College of Medicine and Public Health, Flinders University, Bedford Park, SA5042, Australia
John Turnidge
Affiliation:
School of Medical Sciences, University of Adelaide, Adelaide, SA5000, Australia
Jaklin Eliott
Affiliation:
School of Public Health, University of Adelaide, Adelaide, SA5000, Australia
*
Author for correspondence: Nadine T. Hillock, E-mail: nadine.hillock@adelaide.edu.au
Get access Rights & Permissions [Opens in a new window]

Abstract

Background

The frameworks used by Health Technology Assessment (HTA) agencies for value assessment of medicines aim to optimize healthcare resource allocation. However, they may not be effective at capturing the value of antimicrobial drugs.

Objectives

To analyze stakeholder perceptions regarding how antimicrobials are assessed for value for reimbursement purposes and how the Australian HTA framework accommodates the unique attributes of antimicrobials in cost-effectiveness evaluation.

Methods

Eighteen individuals representing the pharmaceutical industry or policy-makers were interviewed. Interviews were transcribed verbatim, coded, and thematically analyzed.

Results

Key emergent themes were that reimbursement decision-making should consider the antibiotic spectrum when assessing value, risk of shortages, the impact of procurement processes on low-priced comparators, and the need for methodological transparency when antimicrobials are incorporated into the economic evaluation of other treatments.

Conclusions

Participants agreed that the current HTA framework for antimicrobial value assessment is inadequate to properly inform funding decisions, as the contemporary definition of cost-effectiveness fails to explicitly incorporate the risk of future resistance. Policy-makers were uncertain about how to incorporate future resistance into economic evaluations without a systematic method to capture costs avoided due to good stewardship. Lacking financial reward for the benefits of narrower-spectrum antimicrobials, companies will likely focus on developing broad-spectrum agents with wider potential use. The perceived risks of shortages have influenced the funding of generic antimicrobials in Australia, with policy-makers suggesting a willingness to pay more for assured supply. Although antibiotics often underpin the effectiveness of other medicines, it is unclear how this is incorporated into economic models.

Keywords

Value assessmentResource allocationInnovationCost-effectivenessAntimicrobials
Type
Method
Information
International Journal of Technology Assessment in Health Care , Volume 37 , Issue 1 , 2021 , e28
Copyright
Copyright © The Author(s), 2020. 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

Garrison, L, Pauly, M, Willke, R, Neumann, P. An overview of value, perspective and decision context—A health economics approach: An ISPOR special task force report. Value Health. 2018;21:124–30.CrossRefGoogle ScholarPubMed
Lakdawalla, D, Doshi, J, Garrison, L, Phelps, C, Basu, A, Danzon, P. Defining elements of value in health care—A health economics approach: An ISPOR special task force report (3). Value Health. 2018;21:131–9.CrossRefGoogle Scholar
Walter, E. Approaches to capturing value in oncology. Recent Results Cancer Res. 2019;213:85–108.CrossRefGoogle Scholar
Gutierrez, L, Patris, J, Hutchings, A, Cowell, W. Principles for consistent value assessment and the sustainable funding of orphan drugs in Europe. Orphanet J Rare Dis. 2015;10.CrossRefGoogle ScholarPubMed
Hampson, G, Towse, A, Pearson, SD, Dreitlein, WB, Henshall, C. Gene therapy: Evidence, value and affordability in the US health care system. J Comp Eff Res. 2018;7:15–28.CrossRefGoogle ScholarPubMed
Carter, D, Vogan, A, Haji Ali Afzali, H. Governments need better guidance to maximise value for money: The case of Australia's pharmaceutical benefits advisory committee. Appl Health Econ Health Policy. 2016;14:401–7.CrossRefGoogle ScholarPubMed
Neumann, P, Willke, R, Garrison, L. A health economics approach to US value assessment framworks—Introduction: An ISPOR Special Task Force Report (1). Value Health. 2018;21:119–23.CrossRefGoogle Scholar
Karnon, J, Edney, L, Afzali, H. The political economy of the assessment of value of new health technologies. J Health Serv Res Policy. 2018;23:116–22.CrossRefGoogle ScholarPubMed
World Health Organisation. Global survey on health technology assessment by National Authorities: Main findings. Geneva; 2015 [cited 2019 May 27]; Available from: https://www.who.int/health-technology-assessment/en/.Google Scholar
National Institute for Health and Care Excellence (NICE). Guide to the methods of technology appraisal (PMG9). 2013 [cited 2019 May 27]; Available from: https://www.nice.org.uk/process/pmg9/chapter/glossary#technology-assessment.Google Scholar
Australian Government Department of Health. Guidelines for preparing a submission to the Pharmaceutical Benefits Advisory Committee (version 5.0). Canberra; 2016; Available from: https://pbac.pbs.gov.au/content/information/files/pbac-guidelines-version-5.pdf.Google Scholar
Pearson, S. The ICER value framework: Integrating cost effectiveness and affordability in the assessment of health care value. Value in Health. 2018;21:258–65.CrossRefGoogle ScholarPubMed
World Health Organisation. Global action plan on antimicrobial resistance. Geneva; 2015; Available from: http://apps.who.int/iris/bitstream/10665/193736/1/9789241509763_eng.pdf?ua=1.Google Scholar
Schaffer, S, West, P, Towse, A, Henshall, C, Mestre-Ferrandiz, J, Masterton, R et al. Assessing the value of new antibiotics: additional elements of value for Health Technology Assessment decisions. London; 2017; Available from: https://www.ohe.org/system/files/private/publications/OHE%20AIM%20Assessing%20The%20Value%20of%20New%20Antibiotics%20May%202017.pdf.Google Scholar
Rothery, C, Woods, B, Schmitt, L, Claxton, K, Palmer, S, Sculpher, M. Framework for value assessment of new antimicrobials: Implications of alternative funding arrangements for NICE appraisal. University of York; 2018; Available from: www.eepru.org.uk/wp-content/uploads/2017/11/eepru-report-amr-oct-2018-059.pdf.Google Scholar
Colson, A. Review of the health technology assessment (HTA) process for antibiotics in Europe (slides). University of Strathclyde; 2016 [cited 2017 June 12]; Available from: http://drive-ab.eu/wp-content/uploads/2014/09/Colson-SMDM-slides-2016-06.pdf.Google Scholar
Antibiotic Expert Groups. Therapeutic guidelines: antibiotic (version 16, online). Melbourne: Therapeutic Guidelines Ltd; 2019.Google Scholar
Collignon, P. Antibiotic resistance. MJA. 2002;177:325–9.Google ScholarPubMed
Verhoef, T, Morris, S. Cost-effectiveness and pricing of antibacterial drugs. Chem Biol Drug Des. 2015;85:4–13.CrossRefGoogle ScholarPubMed
Paulden, M. Recent amendments to NICE's value-based assessment of health technologies: Implicitly inequitable? Expert Rev Pharmacoecon Outcomes Res. 2017;17:239–42.CrossRefGoogle ScholarPubMed
Gibson, W, Brown, A. Working with qualitative data. London: Sage Publications Ltd; 2009.CrossRefGoogle Scholar
Ritchie, J, Lewis, J, McNaughton Nicholls, C, Ormston, R. Qualitative research practices: a guide for social science students and researchers. London: Sage Publications Ltd; 2014.Google Scholar
Palinkas, L, Horwitz, S, Green, C, Wisdom, J, Duan, N, Hoagwood, K. Purposive sampling for qualitative data collection and analysis in mixed method implementation research. Adm Policy Ment Health. 2015;42:533–44.CrossRefGoogle Scholar
Mason, M. Sample size and saturation in PhD studies using qualitative interviews. Forum Qual Soc Sci. 2010;11; Art. 8. Available from: http://nbn-resolving.de/urn:nbn:de:0114-fqs100387.Google Scholar
Saunders, B, Sim, J, Kingstone, T, Baker, S, Waterfield, J, Bartlam, B, et al. Saturation in qualitative research: exploring its conceptualization and operationalization. Qual Quant. 2018;52:1893–907.CrossRefGoogle ScholarPubMed
Saldana, J. The coding manual for qualitative researchers. London: Sage Publications Ltd; 2013.Google Scholar
Hillock, N, Merlin, T, Karnon, J, Turnidge, J, Eliott, J. Feasibility of de-linking reimbursement of antimicrobials from sales: the Australian perspective as a qualitative case study. JAC-Antimicrob Resist. 2020;2. doi:10.1093/jacamr/dlaa023.CrossRefGoogle Scholar
National Antimicrobial Utilisation Surveillance Program (NAUSP). Antimicrobial utilisation surveillance in Australian hospitals July 2016 to June 2018 (All contributors). Adelaide; 2018; Available from: https://www.sahealth.sa.gov.au/wps/wcm/connect/public+content/sa+health+internet/resources/antimicrobial+utilisation+surveillance+in+australian+hospitals+january+2016+to+december+2017.Google Scholar
Australian Medicines Handbook Pty Ltd. Australian Medicines Handbook (online). Adelaide; 2019; Available from: https://amhonline.amh.net.au.Google Scholar
Phuong, J, Penm, J, Chaar, B, Oldfield, L, Moles, R. The impacts of medication shortages on patient outcomes: A scoping review. PLoS ONE. 2019;14:e0215837.CrossRefGoogle ScholarPubMed
Society of Hospital Pharmacists of Australia (SHPA). Medicines shortages in Australia—a snapshot of shortages in Australian hospitals. Collingwood, VIC; 2017 [cited 2019 Aug 11]; Available from: https://www.shpa.org.au/sites/default/files/uploaded-content/website-content/shpa_medicines_shortages_in_australia_report_june_2017.pdf.Google Scholar
Gerber, J, Hersh, A, Kronman, M, Newland, J, Ross, R, Metjian, T. Development and application of an Antibiotic Spectrum Index for benchmarking antibiotic selection patterns across hospitals. Infect Control Hosp Epidemiol. 2017;38:993–7.CrossRefGoogle ScholarPubMed
Ardal, C, Findlay, D, DSavic, M, Carmeli, Y, Gyssens, I, Laxminarayan, R, et al. DRIVE-AB Report. Revitalizing the antibiotic pipeline: Stimulating innovation while driving sustainable use and global access; 2018 [cited 2018 Jan 31]; Available from: http://drive-ab.eu/drive-ab-outputs/drive-ab-reports/.Google Scholar
Rex, JH, Outterson, K. Antibiotic reimbursement in a model delinked from sales: A benchmark-based worldwide approach. Lancet Infect Dis. 2016;16:500–5.CrossRefGoogle Scholar
Outterson, K. New business models for sustainable antibiotics. Working group on antimicrobial resistance: Paper 1. US Centers for Disease Control and Prevention; 2014; Available from: http://petrieflom.law.harvard.edu/assets/publications/Outterson_Health_Law_Workshop_paper.pdf.Google Scholar
Supplementary material: File

Hillock et al. supplementary material

Hillock et al. supplementary material

Download Hillock et al. supplementary material(File)
File 18.1 KB