Innovative Approach To Keeping Evidence Current And Guidelines Living

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costs is done using the standard country-specific salary (human capital or friction cost method). Center recruitment is ongoing, with data collection planned during Q3-Q4 2016 and results dissemination in early 2017.  Conclusion: Results will provide large-scale, representative, real-world data to characterize the individual and society burden of cardiovascular events across Europe, with local indirect costs suitable for economic modelling. PRM217 Innovative Approach To Keeping Evidence Current And Guidelines Living Lewis SZ, Newton M Doctor Evidence, Santa Monica, CA, USA

Background: The evolving science of evidence-based guideline development contributes to improved methodological rigor, transparency, and reliability. The Institute of Medicine (IOM) reports set standards establishing scientific credibility in the US and beyond for trustworthy guidelines and for systematic reviews. This was followed by several international efforts, including the Guidelines International Network. Among the many challenges imposed, the most daunting were the systematic reviews and keeping guidelines updated. In traditional approaches, each update was actually a de novoexercise since original extractions were painstaking, manual spreadsheet entries. Decisions about grouping terms and characteristics, selecting research arms and time points for analyses, and other such choices left traditional reviews without sufficient transparency and incapable of being updated.  Approach: Today’s technologies provide the solutions with high quality, transparent, and methodologically rigorous evidence reviews. Digitizing the data from the screened studies permits direct and indirect meta-analyses, subgroup, and sensitivity analyses with greater efficiency and precision than traditional methods. Bodies of evidence can be easily visualized to demonstrate the frequency or level of heterogeneity on selected patient or intervention characteristics or outcomes. Importantly, new data can be pooled with an existing dataset as new research is published to keep the evidence current.  Practical Implications: The capacity to monitor the literature for new studies that meet the pre-defined elements and inclusion criteria for a clinical guideline enhances the ability to build onto existing datasets as new research is published. Pooling newly digitized data with existing digital assets will then quickly allow the same analyses to be run to determine whether and how the new data will impact the strength or direction of the existing recommendations. This ability removes the traditional limitations and promotes living guidelines.  Conclusions: With these technologies, guideline developers can meet the standards of today, produce more and better guidelines, and keep them living. PRM218 Comparison Between Cancer Drugs Assessment In Portugal And United Kingdom Carmo S1, Ramos R2, Crespo N1 1ISCTE-IUL, Lisbon, Portugal, 2INFARMED, I.P., Lisbon, Portugal

The number of new cancer drugs and expenditure on oncologic diseases are increasing year after year. Nevertheless reimbursement policies for the same cancer drugs vary among countries, even though they rely on the same clinical evidence due to different processes and factors taken in consideration for the evaluation. This study aims to assess the differences between Portugal and United Kingdom in terms of their respective processes of assessment. The National Institute of Health and Care Excellence (NICE), in the United Kingdom, carries out a centralized evaluation and makes decision about funding, based on the assessment submitted by the manufacturer and their decisions are follow by the National Health Service in a similar way of the INFARMED – National Authority of Medicines and Health Products, I.P., the national agency responsible for health technologies evaluations. The similarities between the two organizations just got bigger with the creation, in 2015, of the National System of Health Technology Assessment (SiNATS), and more recently, the creation, under SiNATS, of the Health Technology Assessment Committee (CATS), in Portugal, with the objective to analyze the added value of technology and economic evaluation studies, contribute to the revision of the methods for health economic evaluation and issue recommendations. In order of this new paradigm, the focus of this analysis is to compare all the assessments from 2010 to 2015, for new cancer drugs submitted to NICE and INFARMED, I.P., and critically reviews the number of drugs assessed, the decision taken and the timelines concerning both organizations’ procedures at the time. PRM219 Application Of Quality Indicators To Enable Economic Evaluation Of Quality Improvements – A Bayesian Decision Theoretical And Value Of Information Analytical Framework Vestergaard AS, Holger Ehlers L Aalborg University, Aalborg, Denmark

Background: Quality indicators (QIs) aim at quantifying the effect of quality improvements, but are often measures that do not reflect health gains, per se. Identification of cost-effective quality improvements may be precluded if their value for money cannot be established by use of conventional health economic methods. This hampers informed decision making. This research applies a Bayesian decision theoretical and value of information (VOI) analytical framework to the area of quality improvement to investigate 1) the requirements for QIs to be usable for economic evaluation and 2) under which circumstances QIs may be used to improve informed decision making.  Methods: Bayesian decision theory and VOI analysis were used to establish a framework for identification of requirements for acceptable QIs and for evaluation of uncertainty when applying QIs to estimate cost-effectiveness of interventions. Use of QIs for economic evaluation introduces an extra intermediate link in the relationship between interventions and expected netbenefit (ENB). This increases study uncertainty and carries a potential cost, interpreted as expected value of perfect parameter information.  Results and Conclusions:

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Bayesian decision theory and VOI analysis may comprise a workable framework for economicevaluation of quality improvements. Requirements for acceptable QIs include an expected correlation between 1) the intervention and the QI and 2) the QI and patient-relevant outcomes. If these correlations are misspecified, the validity of analyses may be compromised. The cost of uncertainty, introduced when using QIs as intermediate links, should be compared to the expected resources required to eliminate said uncertainty. Use of QIs in economic evaluation remains a secondary option if acquisitionof patient-related outcomes is possible as it may increase the uncertainty pertaining to expected cost-effectiveness substantially. If the parameter uncertainty of using QIs does not affect decision uncertainty, the uncertainty of the ENB may be accepted in the decision process. PRM220 Methods For The Design And Conduct Of Medical Record Reviews In Oncology Wilke T1, Baeten S2, Solem CT3, Penrod JR4, Verleger K5, Lees M4, Manley Daumont M4 1INGRESS-Health HWM GmbH, Wismar, Germany, 2SiRM - Strategies in Regulated Markets B.V., Den Haag, The Netherlands, 3Pharmerit International, Bethesda, MD, USA, 4Bristol-Myers Squibb, Paris, France, 5Pharmerit International, Berlin, Germany

Objectives: A substantial part of real-world evidence data in oncology are generated based on medical record reviews (MRRs). This study aims to (1) summarize methodology recommendations for oncology studies based on a MRR, (2) describe methodological trade-offs MRR studies in oncology might face, and (3) provide guidance on how to do MRR studies, in particular, how to deal with potential tradeoffs.  Material and Methods: A review of existing guidelines and methodology publications involving MRRs was conducted. We compared the review results with the outcomes of a large MRR study in advanced non-squamous lung cancer (LENS study) and a supplementary validation study that retrieved additional data and assessed study protocol adherence from participating study centers.  Results: A 42-item MRR checklist was developed based on the methodology recommendations identified in our literature review. The MRR checklist provides methodological guidance on MRR-based oncology studies. Main items on this checklist included: general study methodology, site and patient selection, definition of outcomes and confounders, data collection procedures, methods to assess and control bias, data storage, security and privacy procedures, quality assessment and validation of data, statistical analysis including handling of missing data, and reporting. Even when a MRR study generally follows all of these 42 methodology recommendations, a series of additional design decisions need to be made. Major areas in this respect which strongly influence internal or external validity of study results are study site and patient selection (convenience, consecutive or randomized sampling), selection of variables to be documented including minimum requirements for available data, and choice of methods to deal with missing data.  Conclusions: MRR studies in oncology could benefit from the recommendations outlined in our checklist. In addition, we recommend that, when designing a MRR study in oncology, a principal decision should be made on the degree of external validity required. PRM221 Health Economics Analysis Plans: Where Are We Now? Thorn JC1, Ridyard CH2, Hughes D2, Wordsworth S3, Mihaylova B3, Noble S1, Hollingworth W1 1University of Bristol, Bristol, UK, 2Bangor University, Bangor, UK, 3University of Oxford, Oxford, UK

Background: The use of statistical analysis plans (SAPs), drawn up in advance of the analysis phase, is an accepted means of reducing bias in reporting the results of randomised controlled trials (RCTs). However, while health economics analysis plans (HEAPs) to guide trialists in conducting economic evaluations alongside RCTs are becoming more widespread, they lag behind SAPs in terms of standardisation and acceptance, and there is a fundamental question over whether they add value to the trial process.  Aim: To map current practice and beliefs about the appropriate implementation (or otherwise) of HEAPs, with a view to drawing up good practice guidelines in future work.  Methods: A workshop was held to discuss issues around HEAPs, providing a forum in which health economists (predominantly university-based) and other interested parties engaged in applied economic evaluations could open a dialogue on appropriate methods of standardisation. Sessions were presented on experiences of using HEAPs in trials, and participants discussed topics including the appropriate content of HEAPs, the circumstances in which changes are permissible and the appropriate oversight and governance.  Results: There are few guidelines available to aid health economists in compiling HEAPs. There is currently substantial variation in the structure, format and content of HEAPs, and there are questions over their purpose and appropriate methods of oversight. Although concerns remain over the impact of the bureaucratic burden involved in producing a plan in advance (particularly given the relatively small health economic workforce), the potential loss of useful post hoc analyses if a plan is too rigid, and the timing of completion, there was a general feeling that HEAPs would be useful.  Conclusion: Clarity on the appropriate usage of HEAPs would be advantageous. We plan to conduct a Delphi survey of practising health economists to determine suitable content for a HEAP. PRM222 Multi-Criteria Decision Analysis From The Cost-Effectiveness Perspective: Is Mcda A Coherent Way To Allocate Healthcare Resources? O’Mahony JF Trinity College Dublin, Dublin, Ireland

Background: Multi-criteria decision analysis (MCDA) is attracting growing interest as a potential alternative to conventional cost-effectiveness analysis (CEA). It can be used to assess the broader range of attributes that decision makers typically consider alongside costs and health effects. However, the application MCDA presents profound practical questions that demand careful consideration.  Objective: To describe four key challenges to MCDA as a coherent guide to healthcare resource