Methodological Issues Relating to Decision Analysis for Resource Allocation in Health Care

Lead Research Organisation: MRC Health Services Resrch Collaboration

Abstract

In any health care system, decisions have to be taken about which technologies (e.g. medicines, tests, procedures) should be made available within the system. Because of the huge number of different ways that available resources can be used, and the fact that budgets are ultimately always limited, such decisions need to consider both the health benefits of technologies and their costs. However, the evidence to inform such decisions is invariably uncertain and, in many cases, wholly or partly absent. ||In order to bring together available evidence, expert opinion and values in a coherent way that appropriately reflects this uncertainty and the gaps, an analytical framework is required. Such a framework must facilitate decisions about whether a particular technology is cost-effective based on current evidence. It must also indicate when additional evidence gathering would be cost-effective to support a review of the decision in the future. The use of Bayesian decision theory and value of information methods provides such a framework. ||This project will address a number of methodological issues associated with the framework and apply it to policy-relevant case studies in order to learn more about the value and potential of these approaches.||

Technical Summary

The focus of the programme is on developing decision analytic methods in general, and expected value of information analysis in particular. The benefits and practicality of adopting this approach will be assessed through its application to a number of case studies relevant to NICE and NHS Health Technology Assessment (HTA) programmes.||The framework has the potential to improve the consistency and efficiency of decision-making in health care delivery, research prioritisation, research design and regulation. However, it is necessary to address a number of methodological challenges, if these methods are to become routinely used. These can be categorized into five related elements. ||Modelling clinical decision problems: Methods work includes populating models with input parameters, fully characterising structural and parameter uncertainty, updating models as new evidence accumulates and revising the estimates of cost-effectiveness and expected value of information. Methods work also includes handling structural uncertainty and propagating uncertainty in complex models.||Setting research priorities: Developing and applying expected value of information methods to real world decision problems. This includes work on the specification of the useful lifetime of a new technology and handling correlations.||Identifying appropriate research designs: The expected value of sample information (EVSI) is the reduction in the expected cost of uncertainty surrounding the decision to adopt a technology as sample size increases. Methods work will handle simulation methods to complex decision problem and multiple design space.||Development decisions: The objectives are to demonstrate that Bayesian decision theory can be used to establish socially and commercially optimal drug development programmes, and identify the societal and commercial optimal portfolio of research to support the use of a new technology. ||Implementation and regulation: The objectives include to address the problem of irreversibilities in decisions through methods such as option pricing, estimation of maximum sunk costs and risk sharing. Secondly, the decision to adopt a technology or invest in research should be placed in the context of the objective and all constraints faced within the health care system. This may require a mathematical programming approach to the allocation problem. Thirdly, the full implementation of system-wide decisions to adopt or reject health care technologies on the basis of cost effectiveness requires resources to support implementation strategies.

Publications

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Barbieri M (2009) Who does the numbers? The role of third-party technology assessment to inform health systems' decision-making about the funding of health technologies. in Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

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Bojke L (2010) Eliciting distributions to populate decision analytic models. in Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

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Bojke L (2008) Identifying research priorities: the value of information associated with repeat screening for age-related macular degeneration. in Medical decision making : an international journal of the Society for Medical Decision Making

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Bojke L (2009) Characterizing structural uncertainty in decision analytic models: a review and application of methods. in Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

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Claxton K (2008) Value based pricing for NHS drugs: an opportunity not to be missed? in BMJ (Clinical research ed.)

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Claxton K (2007) Rights, responsibilities and NICE: a rejoinder to Harris. in Journal of medical ethics

 
Description European Health Leadership Network
Geographic Reach Europe 
Policy Influence Type Participation in advisory committee
Impact As a member of the Breast cancer working group, we considered how best to improve innovation through better alignment of incentives and communication of value from payers to manufacturers. The advice of this working group was used to design the next phase of this work which is being rolled out involving many European countries, regulatory and reimbursement agencies and manufacturers
 
Description House of Commons Health Committee
Geographic Reach National 
Policy Influence Type Participation in advisory committee
Impact Written and verbal evidence was provided about the reform of drug pricing proposed by the office of Fair Trading. The report of the Health Committee was published in January 2008 and informed the flexible pricing arrangements adopted in the reformed PPRS. Subsequently this has informed the new government's policy of value based pricing which is due to be introduced in 2014.
 
Description Member of the National Institute for Health and Clinical Excellence (NICE), Medical Techologies Appraisal Committee
Geographic Reach National 
Policy Influence Type Participation in advisory committee
Impact Appraisal and guidance on the use of non pharmaceutical medical technologies which are likely to improve the efficiency of the NHS.
 
Description Review and update of NICE methods guide
Geographic Reach National 
Policy Influence Type Participation in a national consultation
Impact We have been told that this research and this topic will be included as a theme in the forthcomming review and update of the NICE guide to methods of appraisal, expected in 2011.
 
Description Review of the NICE guide to the methods of technology appraisals (2008)
Geographic Reach National 
Policy Influence Type Participation in advisory committee
Impact The methodological guidance for the assessment of health technologies was reviewed and revised during 2007. We contributed to this process in a number of ways. , in June 2007. Co-authored the briefing paper for the methods working party on the cost-effectiveness threshold, September 2007. Participated in the methods review workshop on Health-related utility measurement in June 2007and the methods review workshop on Evidence synthesis, May 2007. Participated in Methods Review Working Party meeting August 2007 and the review of consultation in 2008. The influence is evident in the current guidance on the methods of technology appraisal for those submitting to NICE and those reviewing submissions
 
Description Sir Ian Kennedy's report Appraising the Value of Innovation.
Geographic Reach National 
Policy Influence Type Participation in a national consultation
Impact As member of the NICE Decision Support Unit we provided a report which formed part of the NICE submission to the Kennedy review. Sir Ian also invited members of our team to present at the two workshops which where a key part of gathering evidence for the review. We also participated in the publish consultations which followed publication of his final report. The influence of our work and analysis is evident in his final report.
 
Description National Institute of Clinical Excellence Decision Support Unit/NICE
Amount £750,000 (GBP)
Organisation National Institute for Health and Care Excellence (NICE) 
Sector Public
Country United Kingdom
Start 09/2006 
End 09/2009
 
Description Programme grant (DH)/Department of Health
Amount £1,850,000 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 01/2011 
End 01/2016
 
Description Project Grant (OIR)
Amount £285,000 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 01/2010 
End 07/2011
 
Description VAC Therapy for Pressure Ulcers: Value of Information Analysis and Feasibility Study
Amount £324,000 (GBP)
Funding ID G0501814 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 10/2007 
End 10/2009
 
Title Analytic framework and analysis of case studies 
Description We have brought together diverse and sometimes complex methods which previously have only addressed different parts of the problem in isolation. Now and for the first time we have an algorithm for policy choice, with associated methods of analysis and reporting which address each type of assessment that must be made 
Type Of Material Data analysis technique 
Year Produced 2010 
Provided To Others? Yes  
Impact The core material from 2 workshops was provided in briefing documents for workshop participants (published on web in December 2010 and June 2011) which included other researchers involved in NICE appraisal as one of a number of stakeholder groups. Extended versions of this material is also included in the HTA monograph due to be published in 2013 and is already available in the CHE research Report published in September 2011 
 
Title Probabilistic analysis 
Description Demonstrated why characterisation of uncertainty is important in CEA and provided methods of analysis which allow this to be done in feasible time frames and reported in a way that is useful to decision makers 
Type Of Material Data analysis technique 
Year Produced 2006 
Provided To Others? Yes  
Impact Probabilistic analysis and representation of uncertainty is now routine part of any CEA and technology appraisal in the UK and around the world 
 
Title Value of information 
Description Demonstrated why evidence is valuable for health care decisions and provided a set of analytic methods to provide estimates based on probabilistic models. This includes value of information associated with a decision, the value of information about particular sources of information and the value of same information and alternative research designs 
Type Of Material Data analysis technique 
Year Produced 2006 
Provided To Others? Yes  
Impact The application of value of information analysis has grown considerably. It is recommended by NICE, it is increasingly being commissioned as part of MRC and NIHR funded research and is currently being used in the US to inform priorities for comparative effectiveness research 
 
Description Prenatal preventive strategies to prevent group B streptococcal and other bacterial infections in early infancy: cost-effectiveness and expected value of information analyses 
Organisation University of Bristol
Department School of Social and Community Medicine
Country United Kingdom 
Sector Academic/University 
PI Contribution Development of an probabiistic economic model and vlaue of infiramtion analysis
Collaborator Contribution Statisitcal methods of analysis and synthesis
Impact Multi-disciplinary, stastics, economics and eipdemiology
 
Description Prenatal preventive strategies to prevent group B streptococcal and other bacterial infections in early infancy: cost-effectiveness and expected value of information analyses. 
Organisation University College London
Department Institute of Child Health
Country United Kingdom 
Sector Academic/University 
PI Contribution Development of probabilistic cost-effectiveness model and value of information analysis
Collaborator Contribution Development and communication of methods relevant to clinical and policy audience
Impact Multi-disciplinary: economics, clinical, epidemiology and statistics Journal paper in BMJ (Colbourn et al 2007) HTA Monograph (Colbourn et al 2007) See publications
 
Description VAC Therapy for Pressure Ulcers: Value of Information Analysis and Feasibility Study 
Organisation University of York
Department Department of Health Sciences
Country United Kingdom 
Sector Academic/University 
PI Contribution Advice on methods for economic modelling, probabilistic analysis and value of information
Collaborator Contribution Developing methods for application where data is sparse and the development and application of formal methods of elicitation for use with nurses
Impact Multi-disciplinary, clinical, epidemiology, statistics and economics A number of jounral papers are in submission.
Start Year 2007
 
Description Briefing paper for methods review working party on uncertainty and only in research recommendations 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? Yes
Primary Audience Policymakers/politicians
Results and Impact Breifing document with key finding and summary of the resarch presented to the working group updating the NICE Methods guide

Update to the methods guide expected early 2013
Year(s) Of Engagement Activity 2011
 
Description Informing a decision framework for when NICE should recommend the use of health technologies only in the context of an appropriately designed programme of evidence development 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Primary Audience Health professionals
Results and Impact Presented the key results of this work to the NICE Technical forum

Nice to consider finding in update to methods guide and implactions for other programmes
Year(s) Of Engagement Activity 2011
 
Description NICE Citizens Council 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? Yes
Primary Audience Public/other audiences
Results and Impact Expert witness and presented evidence to the NICE Citizens Council when they considered 'only in research' recommendations. NICE Citizens Council is a lay representative and deliberative committee that advised NICE on questions of social value.

Our contribution was reflected in the final report of the council which influenced further research on this question and subsequent funding from the MRC
Year(s) Of Engagement Activity 2007
 
Description NICE Only in Research (second) Workshop 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Primary Audience Policymakers/politicians
Results and Impact The relevance of this work to NICE was evaluated through a series of two workshops which involved key stakeholders. This 2nd workshop included 50 participants from a range for stakeholder groups. It considered: i) Whether the revised algorithm of assessments and the associated check list has identified the key judgements that need to be made when considering OIR and AWR guidance. ii) Based on the application of this check list to the series of case studies, can such assessments be made based on existing information and analysis provided to NICE and in what circumstances could additional information and/or analysis be useful? iii) What implications this more explicit assessment of OIR and AWR might have for policy (e.g. NICE guidance and drug pricing), the process of appraisal (e.g. greater involvement of research commissioners) and methods of appraisal (e.g. should additional information, evidence and analysis be required).

It is expected that the out but of this and first workshop will inform the review of NICE methods of appraisal which will take place in 2011. The second workshop took place on 13th June 2011. The briefing documents and summary of feedback from the workshop are published on the web. The HTA monograph was submitted in August 2011 and a CHE Research Report was published in September 2011. The HTA monograph is under revision and expected to be published in early 2013.
Year(s) Of Engagement Activity 2011
 
Description NICE Only in Research Workshop 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Primary Audience Policymakers/politicians
Results and Impact The relevance of this work to NICE is evaluated through a series of two workshops which will involve key stakeholders. This first workshop included 50 participants from a range for stakholder groups. It considered: i) the relevance to NICE of existing literature; ii) the insights from a detailed review of previous NICE guidance and iii) whether the conceptual framework and the key principles and assessment that follows from it is a suitable basis for informing NICE guidance. The primary output of this workshop was a set of principles and explicit criteria (a sequence of assessment and decisions) to support only in research (OIR) and approval with evidence development (AED) recommendations. The workshop also considered the range of options for informing these assessment through additional information, evidence and analysis which could be part of the Technology Appraisal process.

It is expected that the out but of this and the next workshop will inform the review of NICE methods of appraisal which will take place in 2011. The brefing documents and sumary of feedbakc from the workshop will be published on the web on 2nd December. The second workshop will take palce on 13th June 2011 and HTA monograph is due to be submitted in July 2011
Year(s) Of Engagement Activity 2010
 
Description Review of the NICE guide to the methods of technology appraisals (cost-effectiveness threshold) 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Primary Audience Policymakers/politicians
Results and Impact Prepared and presented the briefing paper for the methods review workshop on the cost-effectiveness threshold used by NICE. 60 participants representing key stakeholder groups provided feedback that informed the updates guide to the methods of technology appraisal

Documents and feedback from participants informed the updated guide to the methods of technology appraisal issued in 2008
Year(s) Of Engagement Activity 2007
 
Description Review of the NICE guide to the methods of technology appraisals (subgroups) 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Primary Audience Policymakers/politicians
Results and Impact Prepared and presented the briefing paper for the methods review workshop on analysis of subgroups. 60 participants representing key stakeholder groups provided feedback that informed the updates guide to the methods of technology appraisal

Documents and feedback from participants informed the updated guide to the methods of technology appraisal issued in 2008
Year(s) Of Engagement Activity 2007
 
Description Review of the NICE guide to the methods of technology appraisals (uncertainty) 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Primary Audience Policymakers/politicians
Results and Impact Prepared and presented the briefing paper for the methods review workshop on exploring uncertainty. 60 participant representing key stakeholder groups provided feedback

Documents and feedback from participants informed the updated guide to the methods of technology appraisal issued in 2008
Year(s) Of Engagement Activity 2007