Evidence Of Cost-effectiveness Research Articles

MiCare study, an evaluation of structured, multidisciplinary and personalised post-ICU care on physical and psychological functioning, and quality of life of former ICU patients: a study protocol of a stepped-wedge cluster randomised controlled trial

IntroductionOver 70% of the intensive care unit (ICU) survivors suffer from long-lasting physical, mental and cognitive problems after hospital discharge. Post-ICU care is recommended by international guidelines, but evidence for...

A David and Goliath set-up: a qualitative study of the challenges of ensuring the introduction of cost-effective new cancer medicines in Finland

BackgroundTo combat the global challenge of cancer, priority has been placed on the research and development of new cancer medicines (NCMs). NCMs are often approved for marketing in accelerated processes. Despite significant advances in treating cancer, the overall added value and high prices of NCMs has been questioned. While market authorisations for NCMs are granted at the EU level, the assessment of added value, price negotiations and purchase or reimbursement decisions are made by member states. This article explores the practices in Finland for assessing and deciding on purchasing or reimbursing NCMs.MethodsSemi-structured interviews were conducted with 26 civil servants, hospital employees, scientists, and representatives of cancer NGOs and of the pharmaceutical industry in 2019 and 2020. The transcribed interviews were coded inductively using Atlas.ti software and analysed thematically under 3 major themes and 11 sub-themes.ResultsThe clinical value of NCMs is considered to be high, especially regarding NCMs for certain types of cancer. Proper patient selection is important but difficult and not all NCMs can be considered as adding value. The prices are considered to often be very high, leading to concerns about the sustainability and equity of health systems. Equity concerns among cancer patients are raised concerning differences in the availability of NCMs between hospital districts and cost differences for patients between those receiving outpatient and inpatient treatment. The systems and processes in Finland for deciding on the introduction of NCMs are fragmentary, involving separate approaches for outpatient care and hospital medicines by under-resourced evaluation bodies. The scientific evidence available is often limited for evidence-based decisions on introduction. Individual hospital districts sometimes introduce NCMs without assessment by national bodies. This can hamper the proper assessment of some NCMs before their uptake and lead to unequal access to NCMs by hospitals. There is an increasing lack of transparency about pricing, due to the rapid increase of market entry agreements. Lack of transparency on information on prices poses a challenge for authorities responsible for equitable access to cost-effective care within the available resources.ConclusionsRobust reform of the national introductory systems is needed. Internationally, efforts are needed to increase price transparency, to revise incentives within the system of market approval and to accumulate and assess evidence of comparable value and cost-effectiveness after the market approval of NCMs.

Assessment of the clinical and cost-effectiveness evidence in the reimbursement decisions of new cancer drugs

BackgroundThis study aimed to describe the clinical and cost-effectiveness evidence supporting reimbursement decisions of new cancer drugs and analyze the influence of trial characteristics and the cost per quality-adjusted life years (QALYs) on the likelihood of reimbursement in Sweden.Patients and methodsData were extracted from all appraisal dossiers for new cancer drugs seeking reimbursement in Sweden and claiming added therapeutical value between the years 2010 and 2020. The data were analyzed using descriptive statistics, and logistic regression models were also used with the cost per QALY, study design, comparator, and evidence on final outcomes in the clinical trials as predictors of reimbursement.ResultsAll 60 included appraisals were based on trial evidence that assessed at least one final outcome (overall survival [OS] or quality of life [QoL]), although rarely as a primary outcome. Of the appraisals with a final decision (n = 58), 79% were approved for reimbursement. Among the reimbursed drugs, only half had trial evidence demonstrating improved OS or QoL. Only one drug had trial evidence supporting improvements in both OS and QoL. The average cost per QALY for reimbursed cancer drugs was estimated to be 748 560 SEK (€73 583). A higher cost per QALY was found to decrease the likelihood of reimbursement by 9.4% for every 100 000 SEK (€9830) higher cost per QALY (P = 0.03). For cost-effectiveness models without direct evidence of improvements in final outcomes, a larger QALY gain was observed compared with those with evidence mainly relying on intermediate and surrogate outcomes.ConclusionsThere are substantial uncertainties in the clinical and cost-effectiveness evidence underlying reimbursement decisions of new cancer drugs. Decision makers should be cautious of the limited evidence on patient-centered outcomes and the implications of allocating resources to expensive treatments with uncertain value for money.

Health-Economic Evaluation of the German Osteoporotic Fracture Prevention Program in Rural Areas (OFRA): Mobility and Falls Prevention Classes, Examination of Bone Health, and Consultation on Safety in the Living Environment

BackgroundFragility fractures are one of the leading causes of disability in older adults. Yet, evidence for effectiveness and cost-effectiveness of preventive approaches combining bone health and fall prevention is rare.ObjectiveTo conduct a health-economic evaluation of the German osteoporotic fracture prevention program in rural areas (OFRA).DesignSecondary cluster–randomized intervention study based on routine data.ParticipantsAll districts in five federal states in Germany were cluster-randomized as intervention or control districts. OFRA was offered to community-living (a) women aged 75–79 years or (b) women and men aged 70–84 years with a prior fragility fracture in the intervention districts. Individuals who meet these criteria in the control districts were assigned to the control group.InterventionOFRA comprised mobility and falls prevention classes, examination of bone health by bone density measurement, and consultation on safety in the home living environment.Main MeasuresWe measured health-care costs and effectiveness in terms of time to fragility fracture or death within 1 year after initial contact, based on health insurance claims data. Implementation costs were recorded by the intervention performers. We calculated an incremental cost-effectiveness ratio (ICER) and employed the net-benefit approach to construct a cost-effectiveness acceptability curve (CEAC).Key ResultsThere were 9408 individuals in the intervention group and 27,318 in the control group. Mean time to fragility fracture or death (difference: 0.82 days) and health-care costs (difference: 111.73€, p < .01) were reduced, but mean intervention costs (difference: 260.10€) increased total costs (difference: 148.37€, p < .001) in the intervention group. The ICER per fracture-free year of survival was 66,094.63€. The CEAC showed no acceptable probability of cost-effectiveness at a reasonable willingness to pay.ConclusionOFRA showed reduced rates of fragility fractures, but had high implementation costs, resulting in an unfavorable ICER. The cost-effectiveness of OFRA may improve with a longer follow-up.

Digital interventions for people with dementia and carers: effective, cost-effectiveand equitable?

Digital interventions for people with dementia and carers: effective, cost-effectiveand equitable?

‘Diagnostic shock’: the impact of results from ultrarapid genomic sequencing of critically unwell children on aspects of family functioning

Rapid genomic sequencing (rGS) is being increasingly used in neonatal and paediatric intensive care units. While there is emerging evidence of clinical utility and cost-effectiveness, concerns have been raised regarding the impact of delivering genomic results in an acute care setting. To help investigate these concerns, we analysed survey data collected from caregivers whose children had received rGS through a national rapid genomic diagnosis program. The impact of rGS on families was assessed through the PedsQL2.0 Family Impact Module and the State-Trait Anxiety Inventory (STAI-6). Sixty-one parents/carers completed the survey during the study period (response rate 48%; 61/128). Mean parent and family functioning was reduced in this sample, reflecting the stressful conditions facing families with critically unwell children. We found caregivers whose children had received a diagnostic result through rGS reported a reduced family relationships score compared to caregivers of children who did not receive a diagnosis. These findings have implications for genetic counselling practice in this setting.

Belimumab for Treating Active Autoantibody-Positive Systemic Lupus Erythematosus: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

As part of its Single Technology Appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer (GlaxoSmithKline [GSK]) of Benlysta (belimumab) to submit evidence regarding its clinical and cost effectiveness, for the review and possible extension of a previously conditionally approved intravenous formulation of belimumab for the treatment of active autoantibody-positive systemic lupus erythematosus (SLE). Kleijnen Systematic Reviews Ltd, in collaboration with Maastricht University Medical Centre+, was commissioned to act as the independent Evidence Review Group (ERG). This paper summarises the company submission (CS), presents the ERG’s critical review of the clinical and cost-effectiveness evidence in the CS, highlights the key methodological considerations, and describes the development of the NICE guidance by the NICE Appraisal Committee.This appraisal is different to the previous appraisal in three ways: (1). This appraisal expands its definition of ‘high disease activity’. (2). In TA397, belimumab was approved, with a managed access arrangement (MAA), for adults only. This appraisal includes subjects aged 5 years or older. (3). The original appraisal included an intravenous formulation only, but the current appraisal also includes a new subcutaneous formulation in the form of a prefilled pen.The company was required to collect real-world data from the British Isles Lupus Assessment Group Biologics Register (BILAG-BR), including data on the efficacy, safety, and effect on health-related quality of life of belimumab versus rituximab. This appraisal considers these data as well as additional clinical trial evidence presented in the company’s updated submission to address uncertainties identified during the original appraisal. The ERG identified three major concerns with the evidence presented on the clinical effectiveness in the current submission; namely, short follow-up in the main comparative trials (BLISS-SC, BLISS-52 and BLISS-76); using the propensity score-matching (PSM) analysis in calibrating the cost-effectiveness model can severely bias the results in favour of belimumab; and BILAG-BR data are not suitable for a comparison of belimumab with rituximab.The main issue in the economic analysis was the uncertainty about long-term disease activity progression and resulting organ damage. The company’s approach of calibrating modelled organ damage to longer-term data analysed using the PSM analysis was methodologically inappropriate. The final analysis comparing belimumab with standard treatment for the intravenous formulation resulted in an incremental cost-effectiveness ratio of £12,335 per quality-adjusted life-year (QALY) gained and £30,278 per QALY gained in the company’s and ERG’s base-case analyses, respectively. For the subcutaneous formulation, the final analysis resulted in £8480 per QALY gained and £29,313 per QALY gained in the company’s and ERG’s base-case analyses, respectively. NICE recommended belimumab in both intravenous and subcutaneous formulations as an add-on treatment option for active autoantibody-positive SLE in the HDA-2 subgroup.

Model parameters influencing the cost-effectiveness of sacubitril/valsartan in heart failure: evidence from a systematic literature review

ObjectivesTo summarize cost-effectiveness (CE) evidence of sacubitril/valsartan for the treatment of heart failure (HF) patients with reduced ejection fraction (HFrEF). The impact of different modeling approaches and parameters on the CE results is also described.MethodsWe conducted a systematic literature review using multiple databases: Embase®; MEDLINE®; MEDLINE®-In Process; NIHR CRD database including DARE, NHS EED, and HTA databases; and the Cost Effectiveness Analysis registry. We also reviewed HTA countries’ websites to identify CE reports of sacubitril/valsartan, published up to 25-July-2021. Articles published in English as full-texts, conference-abstracts, or HTA reports were included.ResultsWe included 44 CE models [39 from 37 publications (22 full-texts; 15 conference-abstracts) and 5 HTAs; Europe, n = 20; North and South Americas, n = 14; Asia and Australia, n = 10]. Most models adopted a Markov structure with constant transition probabilities of events (n = 27) or a mix of Markov and regression-based models (n = 16), with variations in structural assumptions and chosen parameters. Study authors concluded sacubitril/valsartan to be a cost-effective therapy in 37/41 models in chronic HFrEF patients and 2/3 models in hospitalized patients stabilized after an acute decompensation for HF. CE models showing sacubitril/valsartan not to be a cost-effective treatment generally modeled a shorter time horizon. Effect of sacubitril/valsartan on cardiovascular and all-cause mortality, cost, duration of effect and time horizon was the main model drivers.ConclusionsMost evidence indicated sacubitril/valsartan is cost-effective in HFrEF. The use of a lifetime horizon is recommended in future models as HF is a chronic disease. Data on the CE of sacubitril/valsartan in the inpatient setting were limited and further research is warranted.

An Economic Evaluation of a Proactive Consultation-Liaison Psychiatry Pilot as Compared to Usual Psychiatric Consultation on Demand for Hospital Medicine.

A growing literature demonstrates the value of the proactive consultation-liaison psychiatry model for health care systems through reductions in hospital length of stay. Few studies include financial outcomes. We evaluated the return on investment of a 1-year proactive consultation-liaison psychiatry pilot in a hospital medicine unit. We used a pre-post method with an active comparison of three hospital medicine units with regular psychiatric consultation on demand. We staffed the pilot unit with one full-time psychiatrist who focused on early case finding, close communication with unit staff, frequent follow-up visits, and proactive discharge planning. We assessed the 1-year change in mean length of stay for all patients receiving psychiatric consultation, from which we estimated the direct contribution margin from bed-backfills and the program's return on investment. On the pilot unit, the percent of discharges that received psychiatric consultation increased from 7.34% to 13.79%, and the length of stay for patients who consulted declined by a mean of 1.82 days (P < 0.05), as compared to an increase of 0.15 days (P > 0.05) on the usual-care units. The pilot unit reduction in length of stay saved 451.71 days in total, allowing for 73.81 bed-backfills, a direct contribution margin of $419,343 (95% confidence interval, $50,754 to $787,933), a net direct contribution margin of $298,245 (-$70,344 to $666,835), and an return on investment of 132% (-31% to 295%). This study strengthens existing evidence for the relative cost-effectiveness of proactive consultation-liaison psychiatry for hospital medicine compared with usual psychiatric consultation on demand.

EE174 Economic Evaluation of Seasonal Influenza Vaccination in Elderly and Health Workers: A Systematic Review and Meta-Analysis

A number of cost-effectiveness analysis of influenza vaccination have been conducted to estimate value of influenza vaccines in elderly and health workers (HWs). This study aims to summarize cost-effectiveness evidence by pooling the incremental net monetary benefit (INMB) of influenza vaccination.

EE450 Treatments and Diagnostics for COVID-19: A Living Systematic Review of Economic Evaluations

EE450 Treatments and Diagnostics for COVID-19: A Living Systematic Review of Economic Evaluations

Behaviours that challenge in adults with intellectual disability: overview of assessment and management

SUMMARYUp to a fifth of people with intellectual disabilities display challenging behaviour that has a significant impact on their health and quality of life. Psychotropic medication does not appear to confer any clinical benefits beyond risk reduction in acute situations. However, very few non-pharmacological treatments have clear evidence of clinical and cost-effectiveness and there is therefore often a dearth of advice as to which components or interventions would be helpful. To our knowledge no single model has been developed to provide a clear path from understanding the behaviour to the implementation of a therapeutic approach for such a complex clinical problem. In this article we describe a stepped-care model that needs to be further operationalised in the assessment and management of behaviours that challenge in adults with intellectual disabilities.

Elizabeth Casson Memorial Lecture 2022: Optimising performance, clinical and economic outcomes in occupational therapy service delivery

The rise in health and social care costs has prompted a critical look at the way health and social care services are managed and delivered. There has been a significant change in assessing the performance and evaluating the outcomes of services. Where once only performance outcome data related to service efficiency were required, now evidence of clinical effectiveness and cost-effectiveness is demanded. When evaluating the outcomes of service delivery, it is important to measure performance outcomes (related to service efficiency), clinical outcomes (related to service effectiveness) and economic outcomes (related to cost-effectiveness). This lecture examines the interdependent relationship between performance, clinical and economic outcomes in service delivery which is underpinned by strong leadership, the application of various service improvement strategies and collaborative research between managers, clinicians, researchers and health economists, with patient and public involvement. Service improvement strategies based on practice-based and research-based evidence will be suggested to optimise performance, clinical and economic outcomes. My lecture concludes that occupational therapists should adopt these service improvement strategies and conduct clinical researches and economic evaluations to develop an efficient, effective and cost-effective service which can meet the client’s needs by using allocated resources and is value for money from a commissioning perspective.

Effectiveness and cost-effectiveness for the treatment of depressive symptoms in refugees and asylum seekers: A multi-centred randomized controlled trial.

SummaryBackgroundCurrent evidence points towards a high prevalence of psychological distress in refugee populations, contrasting with a scarcity of resources and amplified by linguistic, institutional, financial, and cultural barriers. The objective of the study is to investigate the overall effectiveness and cost-effectiveness of a Stepped Care and Collaborative Model (SCCM) at reducing depressive symptoms in refugees, compared with the overall routine care practices within Germany's mental healthcare system (treatment-as-usual, TAU).MethodsA multicentre, clinician-blinded, randomised, controlled trial was conducted across seven university sites in Germany. Asylum seekers and refugees with relevant depressive symptoms with a Patient Health Questionnaires score of ≥ 5 and a Refugee Health Screener score of ≥ 12. Participants were randomly allocated to one of two treatment arms (SCCM or TAU) for an intervention period of three months between April 2018 and March 2020. In the SCCM, participants were allocated to interventions tailored to their symptom severity, including watchful waiting, peer-to-peer- or smartphone intervention, psychological group therapies or mental health expert treatment. The primary endpoint was defined as the change in depressive symptoms (Patient Health Questionnaire-9, PHQ-9) after 12 weeks. The secondary outcome was the change in Montgomery Åsberg Depression Rating Scale (MADRS) from baseline to post-intervention.FindingsThe intention-to-treat sample included 584 participants who were randomized to the SCCM (n= 294) or TAU (n=290). Using a mixed-effects general linear model with time, and the interaction of time by randomisation group as fixed effects and study site as random effect, we found significant effects for time (p < .001) and time by group interaction (p < .05) for intention-to-treat and per-protocol analysis. Estimated marginal means of the PHQ-9 scores after 12 weeks were significantly lower in SCCM than in TAU (for intention-to-treat: PHQ-9 mean difference at T1 1.30, 95% CI 1.12 to 1.48, p < .001; Cohen's d=.23; baseline-adjusted PHQ-9 mean difference at T1 0.57, 95% CI 0.40 to 0.74, p < .001). Cost-effectiveness and net monetary benefit analyses provided evidence of cost-effectiveness for the primary outcome and quality-adjusted life years. Robustness of results were confirmed by sensitivity analyses.InterpretationThe SSCM resulted in a more effective and cost-effective reduction of depressive symptoms compared with TAU. Findings suggest a suitable model to provide mental health services in circumstances where resources are limited, particularly in the context of forced migration and pandemics.FundingThis project is funded by the Innovationsfond and German Ministry of Health [grant number 01VSF16061]. The present trial is registered under Clinical-Trials.gov under the registration number: NCT03109028. https://clinicaltrials.gov/ct2/show/NCT03109028

Cost Effectiveness of Patient Self-Managed Warfarin Compared with Direct Oral Anticoagulants in Atrial Fibrillation: An Economic Evaluation in a Danish Healthcare Sector Setting.

BackgroundPatient self-managed anticoagulant treatment with warfarin (PSM) has been proposed as an alternative to direct oral anticoagulants (DOACs) in patients with non-valvular atrial fibrillation (NVAF); however, direct evidence on the cost effectiveness of PSM compared with DOACs is lacking. We aimed to evaluate the cost effectiveness of PSM versus DOACs for NVAF patients in the Danish healthcare setting using a model-based cost-utility analysis.MethodsA cost-utility analysis was performed using a decision-analytic model including two treatment alternatives: continuous PSM and DOACs. The analysis was performed from an extended Danish healthcare sector perspective, including patient-paid costs of medication related to the anticoagulant treatment, with a lifetime horizon. Inputs for the model comprised of probabilities of events, costs in Danish estimates, when possible, and effect in utilities. The probabilities of events are primarily based on real-life data from a direct comparison of PSM and DOACs. The results are presented as the incremental cost-effectiveness ratio (ICER) with an assumed cost-effectiveness threshold of £20,000/quality-adjusted life-year (QALY). Both deterministic and probabilistic sensitivity analyses were performed to investigate the robustness of the results.ResultsThe base-analysis showed that PSM was dominant, with a decreased cost of £8495 and an increased QALY accumulation of 0.23 per patient (ICER = −£36,935/QALY). All deterministic sensitivity analyses indicated that PSM was dominant or at least cost effective. The probabilistic sensitivity analysis showed that 95% of the iterations were cost effective.ConclusionsThe present study found that PSM is dominant (i.e., both more effective and cost saving) compared with DOACs, adding to the scarce evidence of the comparative cost effectiveness of PSM and DOACs in NVAF.Supplementary InformationThe online version contains supplementary material available at 10.1007/s41669-022-00337-3.

Clinical and cost-effectiveness of a personalised health promotion intervention enabling independence in older people with mild frailty (‘HomeHealth’) compared to treatment as usual: study protocol for a randomised controlled trial

BackgroundFrailty is clinically associated with multiple adverse outcomes, including reduced quality of life and functioning, falls, hospitalisations, moves to long-term care and mortality. Health services commonly focus on the frailest, with highest levels of need. However, evidence suggests that frailty is likely to be more reversible in people who are less frail. Evidence is emerging on what interventions may help prevent or reduce frailty, such as resistance exercises and multi-component interventions, but few interventions are based on behaviour change theory. There is little evidence of cost-effectiveness.Previously, we co-designed a new behaviour change health promotion intervention (“HomeHealth”) to support people with mild frailty. HomeHealth is delivered by trained voluntary sector support workers over six months who support older people to work on self-identified goals to maintain their independence, such as strength and balance exercises, nutrition, mood and enhancing social engagement. The service was well received in our feasibility randomised controlled trial and showed promising effects upon outcomes.AimTo test the clinical and cost-effectiveness of the HomeHealth intervention on maintaining independence in older people with mild frailty in comparison to treatment as usual (TAU).MethodsSingle-blind individually randomised controlled trial comparing the HomeHealth intervention to TAU. We will recruit 386 participants from general practices and the community across three English regions. Participants are included if they are community-dwelling, aged 65 + , with mild frailty according to the Clinical Frailty Scale. Participants will be randomised 1:1 to receive HomeHealth or TAU for 6 months. The primary outcome is independence in activities of daily living (modified Barthel Index) at 12 months. Secondary outcomes include instrumental activities of daily living, quality of life, frailty, wellbeing, psychological distress, loneliness, cognition, capability, falls, carer burden, service use, costs and mortality. Outcomes will be analysed using linear mixed models, controlling for baseline Barthel score and site. A health economic analysis and embedded mixed-methods process evaluation will be conducted.DiscussionThis trial will provide definitive evidence on the effectiveness and cost-effectiveness of a home-based, individualised intervention to maintain independence in older people with mild frailty in comparison to TAU, that could be implemented at scale if effective.Trial registrationISRCTN, ISRCTN54268283. Registered 06/04/2020.

Cost-Utility Analysis of Open Hernia Operations in Bulgaria

Abstract Background: Hernia surgery procedures are among the most frequently performed in Bulgaria. An open, mesh-based repair is a standard method for hernia repair. From a societal perspective, a cost-utility analysis of open hernia surgical procedures performed in Bulgaria is necessary in light of the economic and social burden that poses this health issue. The aim of the study was to perform an economic evaluation of the quality of health results after a conventional elective hernia operation with implanted light and standard meshes. Methods: The cost of elective hernia operation with standard and light meshes was calculated as a sum of direct and indirect costs. Incremental cost-effectiveness ratio (ICER) for conventional hernia operation was calculated as health improvement was measured in quality-adjusted life years (QALY) reported in a previous study. Deterministic sensitivity analysis was applied to evaluate the changes in the ICER values in case of planned inguinal hernia operation. Results: The cost of operation with standard meshes is less than operation with light meshes. The difference is in the range 55-200 EUR. The additional costs per one QALY gained for light meshes are far below the recommended threshold values which identified these meshes as cost-effective. Conclusions: The study presents evidence for cost-effectiveness of light meshes.

The prototype of a preference-based index of weight-related quality of life: demonstrating the possibilities.

Evidence for comparative and cost-effectiveness of weight-loss interventions is lacking as there are no obesity-specific measures fit for this purpose. This study aimed to estimate the extent to which a prototype of a brief, multi-dimensional obesity-specific Preference-Based Index of Weight-Related Quality of Life (PBI-WRQL) could fill this gap. Longitudinal data from a Canadian bariatric cohort was used. Forty-eight items from the IWQoL-Lite, EQ-5D-3L, and SF-12V2 were mapped ontotheWHO ICF domains, and one item was chosen for the dimension based on fit to the Rasch model. Individuals' health ratings (0-100) were regressed on each dimension, and the regression coefficients for the response options were used as weights to generate a total score. Generalized estimation equations were used to compare measure parameters across groups and levels of converging constructs. Pre-surgery data were available on 201 people (Women: 82%; BMI: 48.8 ± 6.7kg/m2; age: 43 ± 9.0years) and on 125 (62%) at 6 months post-bariatric surgery. Seven dimensions with three response options formed the PB-WRQL prototype: Mobility/Physical Function, Pain, Depression, Participation, Energy, Peripheral Edema, and Dyspnea. The prototype showed substantial change (mean + 40) with bariatric surgery, higher than the EQ-5D (mean + 11.5). The prototype showed the strongest relationship with BMI at baseline (t = - 3.68) and was the most sensitive to change in BMI (t = - 3.42). This study demonstrates that a brief, 7-dimension index weighted by health impact performed as well as the 31-item IWQoL-Lite and better than the EQ-5D-3L. These findings demonstrate the potential value of the brief PB-WRQL prototypeindex and support its further development using preference weights to reflect the current generation's needs and concerns.

Chief Medical Officers meeting on implementing a public health genomics approach

During the Italian Presidency of the Council of European Union, on October, 2014, the Italian Ministry of Health invited the Chief Medical Officers in Rome for a meeting on the European policies of public health genomics. Following reports on the current policies of public health genomics in Italy and Europe, the policy implications for health systems of advancements in genomics were discussed. Specifically, participants at the CMOs’ Meeting acknowledged the challenge faced in effectively and responsibly integrating genomics into public health research, policy and practice. Additionally, the participants agreed that the translation process need to be supported by empirical evidence of effectiveness and cost-effectiveness. The participants agreed that the application of genome-based technologies and information for the prevention, diagnosis and treatment of diseases of public health significance still holds a great promise. These advances also raise certain ethical, legal and social issues concerning the potential of genomics to undermine the collectivistic approach in public health and thus equity. The CMOs also acknowledge the importance of research on genomics to improve patienttargeted care and for technological development in EU Member States, and appreciate the role that EU research programs can contribute to this field. • Those present also argued that public health professionals and those who are responsible for designing health systems should engage with the genomics agenda in order to ensure proper balance, and to make policy makers aware of its relevance; • That the financial burden imposed by genomic-related technologies has the potential to overwhelm the available resources for health systems and to broaden health inequalities, highlighting the need for careful planning; • Member States could, in line with their-own national policies on health, take additional steps to: develop and implement comprehensive strategies or plans in the field, also (1) Section of Hygiene-Institute of Public Health-Faculty of

Precision medicine in the era of potent antiviral therapy for chronic hepatitis B

With the wide use of potent and safe nucloes(t-)ide analogues (NAs) treatment, patient-centered care is getting important. Intensive care for comorbidity has gain utmost importance in care of aging chronic hepatitis B (CHB) patients with life-long antiviral treatment. Linkage to care of patients with CHB is essential for the goal of hepatitis B virus (HBV) eradication. As long-term suppression of HBV DNA replication does not prevent hepatocellular carcinoma (HCC), prevention of HCC is another challenge for NAs treatment. There is a possibility of hepatocarcinogenesis in the immune-tolerant phase and risk of loss of patients during active monitoring seeking the time point for antiviral treatment initiation. Initiation of NAs treatment from the immune-tolerant phase would improve the linkage to care. However, universal recommendation is premature and evidence for cost-effectiveness needs to be accumulated. Early initiation of NAs in the evidence of significant disease progression, either HBV associated or comorbidity associated, would be a better strategy to reduce the risk of HCC in patients located in the gray zone.