Health technology assessment in Australia: a role for clinical registries?
Anna Mae ScottNHMRC Clinical Trials Centre, University of Sydney, 92–94 Parramatta Road, Camperdown, NSW 2050, Australia. Email: anna.m.e.scott@gmail.com
Australian Health Review 41(1) 19-25 https://doi.org/10.1071/AH15109
Submitted: 15 June 2015 Accepted: 9 February 2016 Published: 31 March 2016
Abstract
Objective Health technology assessment (HTA) is a process of assessing evidence to inform policy decisions about public subsidy of new drugs and medical procedures. Where evidence is uncertain but the technology itself is promising, funders may recommend funding on an interim basis. It is unknown whether evidence from clinical registries is used to resolve uncertainties identified in interim-funded decisions made by Australian HTA bodies. Therefore, the present study evaluated the role of evidence from clinical registries in resolving evidence uncertainties identified by the Medical Services Advisory Committee (MSAC).
Methods All HTAs considered by MSAC between 1998 and 2015 were reviewed and assessments that recommended interim funding were identified. The MSAC website was searched to identify reassessments of these recommendations and sources of evidence used to resolve the uncertainties were identified.
Results Of 173 HTA reports considered by MSAC, 17 (10%) contained an interim funding recommendation. Eight recommendations cited uncertainty around safety, 15 cited uncertainty around clinical effectiveness and 13 cited uncertainty around economics (cost-effectiveness and/or budget impact). Of the 17 interim funding recommendations, 11 (65%) have been reassessed. Only two reassessments relied on clinical registry evidence to resolve evidence gaps identified at the time of the interim funding recommendation.
Conclusions Clinical registries are underused as a source of evidence for resolving uncertainties around promising new health technologies in Australia. An open dialogue between stakeholders on the role of registries in this context is needed.
What is known about the topic? HTA is a process of assessing the evidence to inform policy decisions about public subsidy of new health technologies (e.g. pharmaceuticals, diagnostic tests, medical procedures). Where evidence is uncertain but the technology under evaluation is promising, funders may recommend the funding of the technology on a temporary basis while additional evidence is collected. Clinical registries have been suggested as a means of collecting additional evidence in these situations.
What is does this paper add? It is currently unknown whether evidence from clinical registries is used to resolve uncertainties identified at the time that temporary (interim) funding decisions are made by Australia’s HTA bodies, in particular MSAC. The present study found that MSAC rarely relies on the interim funding mechanism (17/173 assessments). Of the 11 subsequent reassessments of interim recommendations, two relied on registry evidence to provide Australian-specific data for addressing uncertainties around long-term safety, effectiveness and cost-effectiveness. These findings suggest that clinical registries, although a feasible source of evidence for HTAs, are rarely used for this purpose.
What are the implications for practitioners? Given the registries’ ability to resolve both a wider range of questions than those typically addressed by randomised control trials and applicability to a wider group of patients (and, hence, providing estimates of outcomes that are more generalisable), the potential of clinical registries to resolve HTA issues needs more attention from both researchers and decision makers. Stakeholder collaboration to define the evidence requirements for new technologies early in their development phase would be valuable to determine the potential role for clinical registries.
Additional keywords: coverage with evidence development (CED), evidence, interim funding, uncertainty.
References
[1] Government of Australia. Review of health technology assessment in Australia: December 2009. 2009. Available at: http://www.health.gov.au/internet/main/publishing.nsf/Content/AF68234CE9EB8A78CA257BF00018CBEB/$File/hta-review-report.pdf [verified 30 April 2015].[2] Banta D. Considerations in defining evidence for public health. Int J Technol Assess Health Care 2003; 19 559–72.
| Considerations in defining evidence for public health.Crossref | GoogleScholarGoogle Scholar |
[3] McGregor M, Brophy J. End-user involvement in health technology assessment (HTA) development: a way to increase impact. Int J Technol Assess Health Care 2005; 21 263–7.
| 15921068PubMed |
[4] Saarni S, Hofmann B, Lampe K, Luhmann D, Makela M, Velasco-Garrido M, Autti-Ramo I. Ethical analysis to improve decision-making on health technologies. Bull World Health Organ 2008; 86 617–23.
| Ethical analysis to improve decision-making on health technologies.Crossref | GoogleScholarGoogle Scholar | 18797620PubMed |
[5] ten Have H. Medical technology assessment and ethics: ambivalent relations. Hastings Cent Rep 1995; 25 13–9.
| Medical technology assessment and ethics: ambivalent relations.Crossref | GoogleScholarGoogle Scholar | 1:STN:280:DyaK28%2Fpslehtw%3D%3D&md5=5adb4482a053d90c46aabe99754fc5aeCAS | 8530260PubMed |
[6] Velasco-Garrido M, Gerhardus A, Rottingen J, Busse R. Developing health technology assessment to address health care system needs. Health Policy 2010; 94 196–202.
| Developing health technology assessment to address health care system needs.Crossref | GoogleScholarGoogle Scholar | 19889471PubMed |
[7] Walley T. Health technology assessment in England: assessment and appraisal. Med J Aust 2007; 187 283–5.
| 17767433PubMed |
[8] Daniel G. Coverage with evidence development for Medicare beneficiaries: challenges and next steps. J Am Med Assoc Internal Med 2013; 173 1281–2.
[9] Hutton J, Trueman P, Henshall C. Coverage with evidence development: an examination of conceptual and policy issues. Int J Technol Assess Health Care 2007; 23 425–35.
| Coverage with evidence development: an examination of conceptual and policy issues.Crossref | GoogleScholarGoogle Scholar | 17937829PubMed |
[10] Longworth L, Youn J, Bojke L, Palmer S, Griffin S, Spackman E, Claxton K. When does NICE recommend the use of health technologies within a programme of evidence development? A systematic review of NICE guidance. Pharmacoeconomics 2013; 31 137–49.
| When does NICE recommend the use of health technologies within a programme of evidence development? A systematic review of NICE guidance.Crossref | GoogleScholarGoogle Scholar | 23329429PubMed |
[11] Stafinski T, McCabe C, Menon D. Funding the unfundable: mechanisms for managing uncertainty in decisions on the introduction of new and innovative technologies into healthcare systems. Pharmacoeconomics 2010; 28 113–42.
| Funding the unfundable: mechanisms for managing uncertainty in decisions on the introduction of new and innovative technologies into healthcare systems.Crossref | GoogleScholarGoogle Scholar | 20085389PubMed |
[12] McCabe CJ, Stafinski T, Edlin R, Menon D. Access with evidence development schemes: a framework for description and evaluation. Pharmacoeconomics 2010; 28 143–52.
| Access with evidence development schemes: a framework for description and evaluation.Crossref | GoogleScholarGoogle Scholar | 20085390PubMed |
[13] Menon D, McCabe C, Stafinski T, Edlin R. Principles of design of access with evidence development approaches. Pharmacoeconomics 2010; 28 109–11.
| Principles of design of access with evidence development approaches.Crossref | GoogleScholarGoogle Scholar | 20085388PubMed |
[14] Bulfone L, Younie S, Carter R. Health technology assessment: reflections from the antipodes. Value Health 2009; 12 S28–38.
| Health technology assessment: reflections from the antipodes.Crossref | GoogleScholarGoogle Scholar | 19523182PubMed |
[15] Commonwealth Department of Health. Medical Services Advisory Committee (MSAC) terms of reference. 2014. Available at: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/msac-tor-1 [verified 7 May 2015].
[16] Chalkidou K, Lord J, Fischer A, Littlejohns P. Evidence-based decision making: when should we wait for more information? Health Aff 2008; 27 1642–53.
| Evidence-based decision making: when should we wait for more information?Crossref | GoogleScholarGoogle Scholar |
[17] Chew D. Cost-effectiveness of drug-eluting stents: if only all things were equal. Med J Aust 2005; 182 376–7.
| 15850431PubMed |
[18] Campbell B, Stainthorpe A, Longson C. How can we get high quality routine data to monitor the safety of devices and procedures? BMJ 2013; 346 1–3.
| How can we get high quality routine data to monitor the safety of devices and procedures?Crossref | GoogleScholarGoogle Scholar |
[19] Dreyer N, Garner S. Registries for robust evidence. JAMA 2009; 302 790–1.
| Registries for robust evidence.Crossref | GoogleScholarGoogle Scholar | 1:CAS:528:DC%2BD1MXhtVWhurrM&md5=c8592a9680cc7ed71266a8398367ebc0CAS | 19690313PubMed |
[20] Gliklich R, Dreyer N, Leavy M. Registries for evaluating patient outcomes: a user’s guide. 3rd edn. Rockville: Agency for Healthcare Research and Quality; 2014.
[21] Commonwealth Department of Health. Framework for the introduction of a managed entry scheme for submissions to the Pharmaceutical Benefits Advisory Committee. 2011. Available at: http://www.pbs.gov.au/info/publication/factsheets/shared/framework-for-introduction-of-managed-entry-scheme-for-PBAC-submissions [verified 7 May 2015].
[22] IMS Health. Critical appraisal: PillCam® capsule endoscopy register report. Canberra: Medical Services Advisory Committee; 2007.
[23] O’Malley S, Selby W, Jordan E. A successful practical application of coverage with evidence development in Australia: Medical Advisory Committee interim funding and the PillCam® capsule endoscopy register. Int J Technol Assess Health Care 2009; 25 290–6.
| A successful practical application of coverage with evidence development in Australia: Medical Advisory Committee interim funding and the PillCam® capsule endoscopy register.Crossref | GoogleScholarGoogle Scholar | 19619347PubMed |
[24] Australian Safety and Efficacy of New Interventional Procedures – Surgical (ASERNIP-S). Australian audit of endovascular aneurysm repair. Canberra: Medical Services Advisory Committee; 2006.
