The cost-effectiveness of endovascular therapy (EVT) compared to tissue plasminogen activator (tPA) alone for acute ischemic stroke (AIS) has been established in the literature. However, decision-makers still face challenges of how to best deliver EVT in a timely manner to maximize patient outcomes while minimizing the burden to the healthcare system, given that AIS has time-dependent treatment outcomes. The objective of this presentation is to report an optimization approach for improving health system value and outcomes for patients with AIS who are eligible for EVT in Alberta.

An economic model was developed to compare combinations of “mothership” (transport directly to a comprehensive stroke center [CSC] to receive tPA and EVT) and “drip-and-ship” (transport to a primary stroke centre to receive tPA, followed by transport to a CSC to receive EVT) methods across Alberta. The model considered geographical variation and searched for the best delivery methods through a pairwise comparison of all possible strategies. The controlled variables including in the model were population densities, disease epidemiology, time/distance to hospitals, available medical services, treatment eligibility and efficacy, and costs. Patient outcomes were measured by functional independence. The model defined optimal strategies by identifying the transport methods that produced the highest probability of improved health outcomes at the lowest cost.

The analysis produced an optimization map showing optimal strategies for EVT delivery. The lifetime cost (standard deviation [SD]) per patient and likelihood (SD) of good outcomes was CAD 291,769 (CAD 11,576) [USD 226,207 (USD 8,975)] and 41.82 percent (0.013) when considering optimal clinical outcomes, and CAD 287,725 (CAD 4,141) [USD 223,097 (USD 3,211)] and 41.67 percent (0.016) when considering optimal economic efficiency.

Our model reduces the gap that exists between health technology implementation and cost-effectiveness analysis; namely, neither fully addresses relative efficiency driven by geographical variation, which may misrepresent system value in local settings. Implementation strategies generated in our model capture full values in terms of patient outcomes and costs.

Fully probabilistic analyses are now standard for economic models, with all parameters varied according to probability distributions. Using univariate sensitivity analyses to explore the influence of different parameters on the model results are also standard. Although there are several approaches available, there has been little discussion of the merits of each or justification for the method used in any given analysis. The aim of this study was to compare three approaches to univariate sensitivity analysis using a case study.

We considered three univariate sensitivity analysis approaches: (i) set one parameter at its upper and lower bounds while all others are set at their mean value; (ii) analysis of variance; and (iii) set one parameter at its mean and vary all others. We compared these approaches using an economic model of mechanical thrombectomy for the treatment of acute ischemic stroke, considering outcomes of incremental costs, incremental quality-adjusted life-years (QALYs), and net monetary benefit (NMB).

For incremental costs and QALYs the correlation between the approaches was moderate to high, with correlation coefficients between 0.46 and 0.94. For NMB the correlation between approaches was also high (range 0.89 to 0.98), but some of the most influential parameters were ranked differently. Setting one parameter at its upper and lower bounds was the only method that facilitated an analysis of direction of influence.

The three approaches addressed different but relevant questions. Setting individual parameters at their bounds is effectively a systematic scenario analysis and may be misleading to decision makers. Analysis of variance may be more easily interpreted, but it has disadvantages. Setting a parameter at its mean, while varying other parameters, is similar to value of information analysis. As with any sensitivity analysis, it is imperative that the uncertainty associated with each parameter is adequately captured in the model.

People with traumatic brain injuries (TBIs) commonly report memory impairments which are persistent, debilitating, and reduce quality of life. As part of the Rehabilitation of Memory in Brain Injury trial, a cost-effectiveness analysis was undertaken to examine the comparative costs and effects of a group memory rehabilitation program for people with TBI.

Individual-level cost and outcome data were collected. Patients were randomized to usual care (n=157) or usual care plus memory rehabilitation (n=171). The primary outcome for the economic analysis was the EuroQol-5D quality of life score at 12 months. A UK NHS costing perspective was used. Missing data was addressed by multiple imputation. One-way sensitivity analyses examined the impact of varying different parameters, and the impact of available cases, on base case findings whilst non-parametric bootstrapping examined joint uncertainty.

At 12 months, the intervention was GBP 26.89 (USD 35.76) (SE 249.15) cheaper than usual care; but this difference was statistically non-significant (p=0.914). At 12 months, a QALY loss of −0.007 was observed in the intervention group confidence interval (95% CI: −0.025–0.012) and a QALY gain seen in the usual care group 0.004 (95% CI: -0.017–0.025). This difference was not statistically significant (p=0.442). The base case analysis gave an ICER of GBP 2,445 (USD 3,252) reflecting that the intervention was less effective and less costly compared to usual care. Sensitivity analyses illustrated considerable uncertainty. When joint uncertainty was examined, the probability of the intervention being cost-effective at a willingness-to-pay threshold of GBP 20,000 per QALY gain was 29 percent and 24 percent at GBP 30,000.

Our cost-utility analysis indicates that memory rehabilitation was cheaper but less effective than usual care but these findings must be interpreted in the light of small statistically non–significant differences and considerable uncertainty was evident. The ReMemBrIn intervention is unlikely to be considered cost-effective for people with TBI.

There is growing evidence that many people attending annual screening for diabetic retinopathy in the United Kingdom (UK) are at low risk of developing the disease. This has led to new policy statements. However, the basis on which to establish a risk-based individualized variable-recall screening program has not yet been determined. We present a methodology for using information on an individual's risk factors to improve the allocation of resources within a screening program.

We developed a patient-level state-transition model to evaluate the cost-effectiveness of risk-based screening for diabetic retinopathy in the UK. The model incorporated a recently developed risk calculation engine that predicts an individual's risk of disease onset, and allocated individuals to alternative screening recall periods according to this level of risk. Using the findings, we demonstrate a means of estimating: (i) a threshold level of risk, above which individuals should be invited to screening, and (ii) the optimum screening recall period for an individual, based on the expected cost-effectiveness of screening and treatment.

The cost-effectiveness analysis demonstrated that standardized screening (current practice) is the least cost-effective program. Individualized screening can improve outcomes at a reduced cost. We found it feasible – though computationally expensive – to incorporate a risk calculation engine into a decision model in Microsoft Excel. In an optimized screening program, the majority or patients would be invited to attend screening at least two years after a negative screening result.

Individualized risk-based screening is likely to be cost-effective in the context of diabetic eye disease in the UK. It is expected that risk calculation engines will be developed in other disease areas in the future, and used to allocate screening and treatment at the individual level. It is important that researchers develop robust methods for combining risk calculation engines into decision analytic models and health technology assessment more broadly.

Recently developed direct-acting antiviral (DAA) treatments for hepatitis C virus (HCV) are groundbreaking in their high efficacy across disease genotypes and lack of severe side effects. This study used a cost-of-illness (COI) approach to estimate the net value conferred by one of these novel drug combinations, sofosbuvir and velpatasir (SOF/VEL), recently licensed for generic manufacture in India.

This study considered COI from lifetime earnings lost due to disability and premature death from HCV infection. Risk of death and disability in future years was calculated using a Markov state-transition model with parameters determined from the literature. The future earnings of sampled patients were predicted using an empirical earnings model, with coefficients determined from India Human Development Survey data. Costs to both the patient and secondarily infected individuals were considered.

Preliminary results suggested that curing individuals diagnosed with chronic HCV in India would preserve INR 3.7 million (USD 55,750) in earnings per person. For non-cirrhotic (NC) and compensated cirrhotic (CC) individuals, the expected benefits associated with preventing secondary infections were worth between one and forty-one percent of the value of benefits conferred to the diagnosed individuals (depending on sex and extent of liver damage). Treating decompensated cirrhotic (DC) individuals with DAAs alone offered minimal earnings benefits because these individuals will likely remain disabled and unable to work without a liver transplant. Expected net benefits of treatment were substantial for NC and CC patients, ranging from INR 640,349 (USD 9,531) for NC women to INR 10.7 million (USD 158,968) for CC men. The cost of treatment for DC individuals exceeded the expected earnings benefits.

For average NC and CC individuals, the cost of treatment with SOF/VEL is offset by the benefits of increased future productivity. Increased earnings are not sufficient to offset the cost of treatment for DC individuals, but treatment may still be justified on the basis of the intrinsic value of health improvements and other treatment benefits.

The high prevalence, disability, and work absenteeism associated with back pain make it the single most costly musculoskeletal health condition in developed countries. However, the majority of back pain has no identifiable pathological cause and resolves without surgery or imaging. This paradox suggests that we need to change how back pain is managed to reduce unnecessary burden to individuals and the healthcare system. This study evaluated the cost of a new model of early triage-based, interprofessional care for patients with back pain.

We evaluated the outcomes and cost of implementing a provincial care pathway for early assessment of patients with back pain at three sites: (i) adjacent to an emergency department in a community hospital; (ii) co-located with an orthopedic surgeon's clinic in a hospital; and (iii) in a primary care network (PCN) with private practice physiotherapists and chiropractors. Time-driven activity-based costing (TDABC), in combination with discrete event simulation, was used to estimate costs.

Costs were significantly lower in the models that used hospital-based physiotherapists and in the PCN model that used private practice physiotherapists and chiropractors to triage patients. These costs ranged from CAD 20 (USD 16) to manage patients identified with low severity back pain to CAD 175 to 200 (USD 137 to 156) for those with moderate to severe back pain. Models that implemented the care pathway using family physicians and surgeons to review non-surgical patients were more expensive at CAD 339 (USD 265) and CAD 514 (USD 402), respectively.

New models of care that use the skills of physiotherapists and chiropractors to assess and triage patients with back pain adjacent to emergency departments and in the primary care sector are cost effective, compared with traditional physician-led models. The overarching intent is to use these data to enable evidence-informed policy and practice changes, so that more appropriate and cost-effective care is provided to patients with back pain.

Proponents of precision oncology report that genomic testing has the potential to reduce health system costs and improve patient health. Yet, testing also involves significant expenditures that challenge the sustainability of adopting technologies into routine practice. Our study explores the availability and scope of economic evaluations of precision oncology informed by next-generation sequencing (NGS).

We searched Medline (PubMed), Embase (Ovid), and Web of Science databases for English-language full-text peer reviewed articles published between 2000 and 2016. We focused our search on articles that estimated the benefit of precision oncology in relation to its costs. We excluded studies that did not undertake full economic evaluations or did not focus on NGS. We reviewed all included studies and summarized key methodological and empirical study characteristics.

Fifty-five economic evaluations met our inclusion criteria. The first study was published in 2005 and the number of published studies increased steadily, from three studies between 2005 and 2007 to twenty-six between 2014 and 2016. Most studies evaluated multiplex panels (86 percent). Testing was frequently used to diagnose patients (24 percent) or predict prognosis (67 percent), rather than identify targeted therapies (7 percent). Methods varied considerably and cost-effectiveness differed according to test type, test strategy, and cancer type. Deterministic and probabilistic analyses were typically used to characterize uncertainty (91% percent and 75% percent).

While the availability of economic evidence examining precision oncology increased over time, methods used often did not align with current guidelines. Future evaluations should undertake extensive sensitivity analysis to address all sources of uncertainty associated with rapidly changing NGS technologies. Further, additional research is needed evaluating the cost-effectiveness of more comprehensive next-generation technologies prior to implementing these on a wider scale.

Technology advances have resulted in cheaper and quicker genomic sequencing (panels, exomes, whole genomes). Uptake into clinical practice has been rapid despite limited consideration of workforce, patient safety, consent, practice standards, guidelines and cost benefit. AUD 150M (USD 113M) has been independently allocated to genomic initiatives by Australian state and federal governments that don't reflect a national approach to genomics.

Modified horizon scanning (HS) methodology identified issues around genomic sequencing to be considered by governments regarding their support, or otherwise, before appropriate implementation and diffusion into local healthcare systems. A national jurisdictional advisory group was subsequently established that undertook extensive stakeholder consultation across Australia, including written submissions, over a four-month period.

HS identified that genomic sequencing is diffusing rapidly through the health system and flagged issues of pressing concern, including: workforce requirements; education, training and literacy for the medical workforce and community; infrastructure; data; and ethical, legal and social implications (ELSI). HealthPACT recommended a national coordinated approach to policy development across jurisdictional boundaries to ensure appropriate adoption of genomics. Stakeholder consultation confirmed overwhelming support for greater national coordination of the application of genomic knowledge in healthcare. Five strategic priorities were developed to support appropriate integration of genomics into health care for Australians: person-centered approach; workforce; financing; services; and, data. Three principles underpin strategic priorities: i) application of genomic knowledge is ethically, legally and socially responsible and community trust is promoted; ii) access and equity are promoted for vulnerable populations; and, iii) application of genomic knowledge to health care is supported and informed by evidence and research.

HS identified significant policy, workforce, funding and sustainability issues already facing state and territory governments that would, in time, face the federal government. The National Health Genomics Policy Framework outlines an agreed high-level national approach to policy, regulatory and investment decision-making for genomics and was approved by all Australian health Ministers in November 2017.

Tumor profiling tests can help to identify whether women with breast cancer need chemotherapy due to their risk of relapse, and some may be able to predict benefit from chemotherapy. We focused on four genetic tests: Oncotype DX (O-DX), MammaPrint (MMP), EndoPredict and Prosigna, and one immunohistochemistry test, IHC4, for the National Institute of Health and Care Excellence as part of their Diagnostic Appraisal Programme.

A systematic review was undertaken, including searching of nine databases in February 2017 plus other sources including a previous review published in 2013. The review included studies assessing clinical effectiveness of the five tumor profiling tests, with or without clinicopathological factors, to guide decisions about adjuvant chemotherapy in people with ER-positive, HER-2 negative, Stage I-II cancer with 0 to 3 positive lymph nodes (LN). The PROBAST tool and Cochrane risk of bias tools were used to assess risk of bias.

A total of 153 studies were included; the strength of evidence base for individual tests was varied. Results suggest all tests are prognostic for risk of relapse, though results were more varied in LN positive (+) patients than in LN negative (0) patients. Evidence was limited about whether tests can predict benefit from chemotherapy (available for MMP and O-DX only). Studies that assessed the impact of the tests on clinical decisions indicate that the net change in chemotherapy recommendations or decisions pre-/post-test ranged from an increase of one percent to a decrease of 23 percent among UK studies, and a decrease of zero percent to 64 percent across European studies.

The studies included in the review suggest that all of the tests can provide prognostic information on the risk of relapse; however results were more varied in LN+ patients than in LN0 patients. There is limited and varying evidence for prediction of chemotherapy benefit.

Methods that accommodate heterogeneity in outcomes are not widely used in economic evaluation. With the growth of precision medicine (PM), where choice of treatment is informed by the molecular characteristics of the patient or disease, we expect to see greater heterogeneity in effectiveness and cost of interventions. Our objective was to compare analytical frameworks for valuing heterogeneity in economic evaluation, and consider their strengths and weaknesses for applications in PM.

We conducted a literature review to identify papers that proposed an analytical framework for economic evaluation of a health intervention, and that placed a value on heterogeneous effects. We compared the frameworks considering the purpose of the analysis, including where in the product lifecycle the framework could be used, the types of PM interventions where the framework could be applied, and its ability to address methodological challenges of evaluating PM.

Five analytical frameworks were identified: covariate adjustment methods, value of stratification, value of heterogeneity (VoH), expected value of individualized care (EVIC), and loss with respect to efficient diffusion (LED) metrics. Each framework addresses a slightly different research question, and is suited to different settings and interventions. With the exception of covariate adjustment, all focus on maximizing net benefit within certain constraints and quantify the opportunity cost of ignoring heterogeneity. Only VoH considers the relationship between heterogeneity and uncertainty, and no framework explicitly includes the cost or uncertainty associated with identifying subgroups.

The ability to value heterogeneity is a critical component of economic evaluations of PM. The choice of an appropriate analytical framework will help strengthen the quality of economic evidence available to support health technology assessment of PM technologies, informing PM adoption decisions, and supporting efficient allocation of health care resources.

To facilitate moving from research findings to conclusions when conducting systematic reviews (SRs) and health technology assessments (HTAs), evidence grading systems (EGSs) have been developed to assess the quality of bodies of evidence and communicate (un)certainty about the effects of evaluated technologies. Use of EGSs has become an essential step in conducting SRs and HTAs and those relying on review conclusions should be aware of EGSs’ potential limitations.

This study aims to identify EGSs used in SR and HTA practice, and summarize findings on their inter-rater reliability (IRR). Relevant sources were searched to identify EGSs used in recently published SRs and IRR studies of available EGSs. Members of the International Network of Agencies for Health Technology Assessment were surveyed regarding their current approaches.

Preliminary results indicate that only two conceptually similar EGSs are currently used by several organizations in SR and HTA practice: (i) the Grading of Recommendations Assessment, Development and Evaluation (GRADE) and (ii) the Agency for Healthcare Research and Quality Evidence-based Practice Center Program (AHRQ-EPC). Both approaches emphasize a structured and transparent method. However, results from published IRR studies suggest there is a risk for variability in their application due to researchers’ diverse levels of training and experience in using them, and the complexity and heterogeneity of evidence in SRs.

Validated EGSs can play a critical role in whether and how research findings are eventually translated into practice. However, our results indicate a low level of uptake of EGSs in HTA practice. Both currently used EGSs are susceptible to misuse that allows different researchers to grade the same body of evidence differently, and their performance has not been robustly explored in terms of IRR. If these results stand up to replication, one cannot rely on conclusions of published SRs, which has implications for the decisions they inform.

Although individual patient data meta-analysis (IPD MA) is considered the gold standard of systematic reviews (SRs), a recent International Network of Agencies for Health Technology Assessment survey indicates that IPD MA is not frequently included in a health technology assessment (HTA), or conducted by HTA researchers. The objective of this presentation is to describe our first experience with including an IPD MA in a HTA report, discuss the added value for an evidence-based decision-making process, and advocate for expanding work in this field.

An overview of SRs on endovascular therapy for acute ischemic stroke included one IPD MA and six study-level SRs/MAs. Methodological quality was appraised by two reviewers independently using the tool recommended by the Cochrane IPD MA working group for the IPD MA, and the AMSTAR (A MeaSurement Tool to Assess systematic Reviews) for the study-level reviews. Pooled results from subgroup analyses based on access to primary patient data were compared to those reported in SRs that conducted subgroup analyses based on the published data to identify patients or clinical factors that would impact clinical outcomes.

The overall findings were similar between the IPD MA and other SRs/MAs. However, when compared to aggregated data used in study-level SRs/MAs, subgroup analyses based on patient data allowed for adjustment of confounders, multiple categories within a subgroup, standardization of outcomes across trials, and detailed data checking. Larger sample sizes of each pre-defined subgroup permitted for more precise estimates of treatment effects. A number of methodological issues in the IPD MA were identified; particularly, no assessment of risk of bias of included trials was conducted.

Access to original patient data is demanding and conducting IPD MA requires extensive resources. The advantages of having an improved quality analysis, an appropriate quantification of the effects in the analyzed subgroups, and precision of results may justify additional efforts, and may increase confidence in the decision-making process.

Novel health technologies are being developed at a dizzying pace. The need to avoid unnecessary innovations and accelerate the adoption of valuable innovations is among the most important challenges facing healthcare systems today. To contribute to this challenge, we performed 30 so-called ‘early health technology assessments’ (HTA) over the last three years. We quantified the potential value, both in effects and cost. We will present our experience with performing these constructive assessments, as well as their feasibility and value in informing decisions.

We performed secondary analyses on an existing database of 30 assessments. We analyzed the phase of development, stakeholders involved, type of decision informed, and the technology's next steps.

Out of the 30 technologies, four (13 percent) were in the idea screening phase, and had not yet started the development. Here, the room for improvement (headroom) was assessed. For 16 (53 percent) technologies that were under development but not yet studied, we performed headroom and threshold analyses. For the 10 (33 percent) developed technologies where some (pilot) data were already available, scenario and/or cost-effectiveness analyses were performed. The assessments, that were commissioned by developers, clinicians or hospital managers informed evidence-based decisions on (further) development, focus, research design or adoption in clinical practice. Preliminary results suggest that after the assessment, decisions were made to stop further development (n=2), continue outside healthcare (n=1), change the target population (n=3) or change the proposed positioning in the care pathway and/or value proposition (n=4).

Stakeholders deemed an early, formative assessment useful in informing development, research and adoption decisions, in different stages of development. Even before developing a technology, headroom analyses appeared to be feasible and useful. Consequences of the assessments mostly related to a shift in focus, which may result in more efficient research and development, as well as more valuable innovations.

Commissioners of systematic reviews have differing requirements in terms of breadth of scope, level of analysis required, and timescales available. Planning a review requires consideration of the trade-off between these elements. This applies to both “rapid” reviews and “traditional” reviews with a broad or complex scope.

Approaches for tailoring review methods to commissioner requirements are described. These will be illustrated via case studies of reviews conducted for the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) and Health Services & Delivery Research (HS&DR) programs and other organizations.

An initial step is to discuss with commissioners the trade-off between timescales/resource available, breadth of review scope, and level of analysis; for example, broad overview of many studies or in-depth analysis of a narrower set. Where the evidence base is unknown, one option is to undertake an initial mapping review to assess the volume and type of evidence available. This may assist in refining the selection criteria for the main review, to prioritize the most relevant evidence. In complex reviews, a further option is to develop a conceptual model (logic model) with input from commissioners and experts, to help identify factors which may influence outcomes. This can enable design of focused mini-reviews (not necessarily exhaustive) around each factor. These methodological approaches will be illustrated through three case studies including an HTA on cannabis cessation (trade-off of breadth versus depth); a review of yoga and health (initial mapping to refine selection criteria); and a rapid review of congenital heart disease services (conceptual model to identify areas for focused reviews).

Different approaches may enable discussion with review commissioners around the trade-off between scope, methods and timescales, in order to tailor the review method to best meet commissioner requirements within the timescales available.

The Health Technology Assessment (HTA) Program at the Institute of Health Economics (IHE) has conducted rapid assessments (RAs) for 25 years. The presentation draws on this experience to chart the evolution of RAs over a 25-year relationship between a policy maker and an arms-length HTA agency to quantify the effects of this partnership on the RAs produced.

The number, types, and methodological attributes of RAs produced over a 25-year partnership with a single requestor were reviewed. The reasons for developmental changes in RA products over time were charted to document the push-pull tension between requestor needs and HTA best practice. The elements contributing to the relevance and impact, or not, of the RAs were also identified.

Results demonstrated the dynamic relationship required for HTA researchers to meet best practice and requestor needs. As literature search spans lengthened and data analyses became more complex, limitations were imposed on RAs to fulfill the requirements of timeliness, utility, and best practice. Adaptations were driven by requestor, researcher, and the external policy environment. Facilitators of RA utility for HTA requestors include: asking focused, well-articulated questions; specifying the request's purpose; providing detailed information about local context and other relevant issues; and understanding the risk of bias associated with RAs. Considerations for HTA doers include: assembling a team using a triage process; involving requestors throughout RA development; negotiating deliverables and timelines using a HTA product matrix; transparently reporting methods; narratively describing methodological issues; and internally reviewing the draft RAs.

RAs are a useful component of HTA programs. To keep these products relevant and useful, HTA agencies must allow RAs to evolve according to need, but with grounding in good practice. Negotiating the line between rigor and relevance is a key skill for HTA agencies. Having the right team is helpful.

Ethics is a set of moral principles that guide our behavior when it affects others. HTAi acknowledges the fundamental values of “service, collaboration, professionalism and integrity, transparency, accountability”. Ethical conduct balances self-interest with consequences of that behavior for others. Unethical behavior has serious personal consequences and in the case of HTA practitioners it can damage stakeholder trust and thereby hinder implementation of evidence by policy makers. Compliance with regulation alone may not suffice in building stakeholder confidence. There is need for individuals and agencies to develop a ‘culture of integrity’ at all levels in the HTA process above and beyond compliance with the law. A strong ethical culture will foster trust of stakeholders, strengthen collaboration, improve implementation of recommendations and benefit society. This is the importance of developing a code of ethics to guide conduct and detail standards of professional practice expected of HTA practitioners affiliated to HTAi and related agencies.

I will argue for the development of a detailed code of ethics for HTAi and related agencies. To do this, I will explain how the code of ethics gives guidance and informs the users (HTA practitioners), and how they can guide stakeholders in the HTA processes. The public relations benefits of a code of ethics will also be discussed. I will explain why having a mere list of seven words as “values” is not sufficient guidance to professionals with diverse backgrounds who are collaborating in a multidisciplinary team.

The role of a code of ethics in helping professionals to choose their actions well is an effective way to integrate ethics in HTA, safeguard the integrity of HTA processes, and improve evidence implementation by stakeholders.

HTAi should develop a detailed code of ethics for its membership.

Recent equity review guidance encourages reviewers to consider whether it is likely that their findings may impact on health inequalities. Much of the guidance assumes that health inequalities have either already been identified as the focus of the review, or that reviewers are able to recognize if and how health inequalities matter. However, our experience is that this is not necessarily true. Furthermore, theorizing if and how health inequalities matter is not normally integrated into the HTA review process. This presentation describes a novel approach to the development of a theory-led meta-framework to inform health inequality considerations in systematic reviews. The meta-framework aims to increase the usefulness of systematic reviews in informing and implementing changes to practice.

Following the best-fit framework synthesis approach, a meta-framework was generated by ‘deconstituting’ concepts from theories relating to complex interventions and socio-economic health inequalities into a single framework. Feedback was sought from health inequality experts and reviewers.

Complex intervention theories identify four domains and key factors that may influence effectiveness; intervention design, implementation, context and participant response. Applying an equity lens, socio-economic health inequality theories identify key factors and mechanisms associated with these domains that may lead to differential effects across disadvantaged populations.

The meta-framework has the potential to i) facilitate the identification and understanding of when, why and how interventions may impact on socio-economic health inequalities, ii) promote a theory-led approach to incorporating health inequalities in systematic reviews iii) help reviewers identify data to extract and inform a priori analysis on what factors are associated with differential effects, iv) help reviewers to decide whether it is likely that their review findings may have the potential for an intervention to indirectly widen or narrow socio-economic health inequalities, even when evidence of an impact in the primary research is lacking.

Different disciplinary frameworks in the field of Health Technology Assessment (HTA) may hold different, and potentially contradictory, assumptions about a technology's value or optimal use. For example, economic analyses may be based on outcome measures that are socially controversial or ethically problematic. This can result in economic and ethical evaluations that are difficult to reconcile, leaving HTA short of its goal to provide policy decision-makers with a holistic assessment of technology. We use the case of non-invasive prenatal testing (NIPT) to explore whether the capabilities approach can be used to align economic and ethical concepts of value in assessments of morally challenging health technologies. The capabilities approach is an economic framework which bases wellbeing assessments on a person's abilities, rather than their expressed preferences.

To develop concepts for capabilities relevant to NIPT, we started with Nussbaum's capabilities framework, and conducted a directed qualitative content analysis of interview data from twenty-seven Canadian women with personal experience of this technology.

We found that eight of Nussbaum's ten capabilities related to options or choices that women valued in the context of NIPT, and identified one new capability, Care Taking. NIPT has a meaningful impact on women's capabilities, and capabilities concepts can capture the value of NIPT without relying on health outcomes of ambiguous social and ethical value. A capabilities approach may help reconcile ethical and economic value frameworks for NIPT.

The capabilities approach can contribute to economic evaluations of morally challenging health technologies that better reflect patient preferences and ethical concerns, and may contribute to more holistic HTAs. It provides a framework within which policy analysts from diverse disciplines can communicate about the social and ethical value of morally challenging health technologies. Future research should focus on operationalizing the capabilities approach for use in evaluations of NIPT and other morally challenging health technologies.

It is widely recognized that the incorporation of patient and public perspectives can enrich health policy decision-making. Methodological and practical advice on engaging patients and the public has proliferated in recent years, with many health technology assessment (HTA) agencies working to formalize their processes in this area. However, despite growing enthusiasm for patient and public engagement, many ethical issues remain unaddressed including: balancing risks and benefits to participants; recruitment methods; reimbursement for time spent participating; representation; and, information disclosure.

In this critical analysis, we draw on our collective experiences engaging with patients and public in the context of HTA. We use principles from two theories, i) research ethics, and ii) participatory governance, to analyze these challenges. The purpose of this analysis is to explore the ways in which risks and benefits to patient and public participants might be balanced in HTA activities.

We begin by describing some ethically challenging experiences we have faced when soliciting views and values from patients and members of the public, some anticipated and some unexpected. These challenges include unexpected disclosures of information, navigating power differentials when working with vulnerable populations, eliciting information about potentially traumatizing experiences, and fairly representing controversial and conflicting opinions. We offer examples about what types of patient engagement activities may subject participants to unreasonable risk, and suggest some guiding principles to help plan ethical patient and public engagement activities.

Patient and public engagement requires more than just procedural methodological expertise- it also requires the ability to identify and analyze relevant ethical issues. We posit that health technology assessors have a moral obligation to ensure that the risks of patient and public engagement activities do not outweigh the benefits. We call upon the HTA community to engage in thoughtful deliberation about what can be learned from experiences within HTA and in other contexts.

While methods for ethics analysis in health technology assessment (HTA) exist, there have been relatively few applications and assessments of these methods. The Canadian Agency for Drugs and Technologies in Health (CADTH) began to include an explicit analysis of ethical issues within its HTAs in 2015. To examine some of the differences among ethics analyses, we critically compared the conduct and contribution of the analysis of ethical issues for four CADTH HTAs.

Two experts in ethics in HTA examined ethics analyses conducted by CADTH for four technologies: DNA mismatch repair testing for colorectal cancer, treatments for obstructive sleep apnea, dialysis for end-stage liver disease, and human papillomavirus screening for cervical cancer. The methods of analysis and presentation of results, extent to which the ethics analysis was used in committee deliberations was gathered via meeting notes, recommendation documents, and discussion, and were summarized narratively.

The amount of literature explicitly discussing ethical issues pertaining to particular technologies varied and was not predicted by the age and maturity of a technology. The axiological approach proved a helpful starting point for ethical reflection, but other methods were used for analysis and presentation. Explicit discussion of ethical issues identified the need for additional information to ensure robust deliberation. Committee members expressed the belief that ethics analysis “brought together” individual sections of the HTA.

While many methods exist for ethics analysis, ethics expertise is required to identify and explicitly discuss the complete range of ethical issues relevant to a particular HTA. Ethics analyses create space to challenge assumptions underlying the clinical and economic evidence, raise issues about the value of technologies, and help to integrate the HTA results.