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Background: The HEcoPerMed consortium developed a methodological guidance for the harmonization and improvement of economic evaluations in personalized medicine. Materials & methods: In three therapeutic areas, health economic models were developed to scrutinize the recommendations of the guidance. Results: Altogether, 20 of the 23 recommendations of the guidance were addressed by the models. Seven recommendations were applied in all studies, six in two of the studies and seven in one of the studies. Recommendations with an essential role on the final conclusions of the analyses were identified in each study. Conclusion: The guidance was found to be best used as a tool to identify and prioritize issues, verify solutions and justify decisions during the economic analysis of personalized interventions. [ABSTRACT FROM AUTHOR]

Background: Correct diagnosis of maturity-onset diabetes of the young (MODY), which is often misdiagnosed as Type 1 or 2 diabetes, is important for providing appropriate treatment. Materials & Methods: A diabetes model was adapted to Hungary, the Netherlands, and the UK to analyse the cost–effectiveness and budget impact of different screening strategies for MODY with 20 years time horizon. Results: Compared with no screening, screening with the MODY calculator then genetic testing is considered cost-effective with respect to each country's willingness to pay threshold. The addition of autoantibody testing dominated the no screening strategy. The budget impact of the strategies ranges between 0.001 and 0.025% of annual public healthcare spending. Conclusion: The analysed strategies are considered good value for money with potential cost savings in the long term. [ABSTRACT FROM AUTHOR]

The cost–effectiveness and budget impact of introducing extended DPYD testing prior to fluoropyrimidine-based chemotherapy in metastatic breast cancer patients in the UK, The Netherlands and Hungary were examined. DPYD testing with ToxNav© was cost-effective in all three countries. In the UK and The Netherlands, the ToxNav strategy led to more quality-adjusted life years and fewer costs to the health systems compared with no genetic testing and standard dosing of capecitabine/5-fluorouracil. In Hungary, the ToxNav strategy produced more quality-adjusted life years at a higher cost compared with no testing and standard dose. The ToxNav strategy was found to offer budget savings in the UK and in The Netherlands, while in Hungary it resulted in additional budget costs. The cost–effectiveness and budget impact of extended DPYD testing with ToxNav prior to capecitabine/5-fluorouracil in metastatic breast cancer in the UK, The Netherlands and Hungary were examined. ToxNav was cost-effective in all three countries and budget-saving in the UK and The Netherlands. [ABSTRACT FROM AUTHOR]

Maturity-onset diabetes of the young (MODY) is often misdiagnosed as Type I or II diabetes. This study was designed to assess the cost–effectiveness of MODY screening strategies in Hungary, which included a recent genetic test compared with no routine screening for MODY. A simulation model that combined a decision tree and an individual-level Markov model was constructed to assess the costs per quality-adjusted life year of screening strategies. Stratifying patients based on age and insulin treatment followed by a risk assessment questionnaire, a laboratory test and genetic testing was the most cost-effective strategy, saving EUR 12 and generating 0.0047 quality-adjusted life years gained per screened patient. This screening strategy could be considered for reimbursement, especially in countries with limited resources. [ABSTRACT FROM AUTHOR]

The implementation of adequate financing and reimbursement of personalized medicine (PM) in Europe is still turbulent. The views and experience of stakeholders about barriers in financing and reimbursing PM and potential solutions were elicited and supplemented with literature findings to draft a set of recommendations. Key recommendations to overcome the barriers for adequately financing and reimbursing PM in different healthcare systems in Europe included the provision of legal foundations and establishment of large pan-European databases, use of financial-based agreements and regulation of transparency of prices and reimbursement, and creating a business-friendly environment and attractive market for innovation. The recommendations could be used by health authorities for designing a sequence of policy steps to ensure the timely access to beneficial PM. [ABSTRACT FROM AUTHOR]

The aim of this study was to evaluate the cost–effectiveness of ToxNav©, a multivariant genetic test, to screen for DPYD followed by personalized chemotherapy dosing for metastatic breast cancer in the UK compared with no testing followed by standard dose, standard of care. In the main analysis, ToxNav was dominant over standard of care, producing 0.19 additional quality-adjusted life years and savings of £78,000 per patient over a lifetime. The mean additional quality-adjusted life years per person from 1000 simulations was 0.23 savings (95% CI: 0.22–0.24) at £99,000 (95% CI: £95–102,000). Varying input parameters independently by range of 20% was unlikely to change the results in the main analysis. The probabilistic sensitivity analysis showed ~97% probability of the ToxNav strategy to be dominant. [ABSTRACT FROM AUTHOR]

Health economists are increasingly interested in integrated care in order to support decision-makers to find cost-effective solutions able to tackle the threat that chronic diseases pose on population health and health and social care budgets. However, economic evaluation in integrated care is still in its early years, facing several difficulties. The aim of this paper is to describe the unique nature of integrated care as a topic for economic evaluation, explore the obstacles to perform economic evaluation, discuss methods and techniques that can be used to address them, and set the basis to develop a research agenda for health economics in integrated care. The paper joins the voices that call health economists to pay more attention to integrated care and argues that there should be no more time wasted for doing it. [ABSTRACT FROM AUTHOR]

Aims: This study presents a cost-effectiveness and budget impact analysis comparing cost and outcomes for UK patients with COPD treated with either tiotropium, ipratropium or salmeterol. Methods: A previously-published COPD cost-effectiveness model was adapted for the UK, then used to estimate the cost-effectiveness of tiotropium compared to salmeterol and ipratropium. Additional epidemiological data were used to estimate the budget impact of switching patients from ipratropium or salmeterol to tiotropium. Results: In England, the estimated annual cost per patient on tiotropium was £1350, on salmeterol was £1404, and on ipratropium was £1427; in Scotland/Wales/Northern Ireland (S/W/NI) these costs were £1439, £1565, and £1631, respectively. Tiotropium patients experienced better quality-adjusted life-years (QALYs) across all comparisons, and this option was therefore dominant compared to salmeterol and ipratropium. The probability of tiotropium being dominant ranged from 72% to 87% across comparisons. At a willingness-to- pay threshold of £20,000 per QALY, tiotropium had at least a 97% chance of being cost-effective. The estimated annual saving per primary care trust (PCT) of switching patients from salmeterol and ipratropium to tiotropium in England was £230,000 and in S/W/NI was £160,000. Conclusions: Tiotropium is a cost-effective alternative to ipratropium and salmeterol, and switching COPD patients from ipratropium and salmeterol to tiotropium could result in considerable cost savings for PCTs along with improvements in quality-of-life. [ABSTRACT FROM AUTHOR]

Patients with COPD experience respiratory symptoms, impairments of daily living and recurrent exacerbations. The aim of integrated disease management (IDM) is to establish a programme of different components of care (ie, self-management, exercise, nutrition) in which several healthcare providers (ie, nurses, general practitioners, physiotherapists, pulmonologists) collaborate to provide efficient and good quality of care. The aim of this Cochrane systematic review was to evaluate the effectiveness of IDM on quality of life, exercise tolerance and exacerbation related outcomes. Searches for all available evidence were carried out in various databases. Included randomised controlled trials (RCTs) consisted of interventions with multidisciplinary (>2 healthcare providers) and multitreatment (>2 components) IDM interventions with duration of at least 3 months. Two reviewers independently searched, assessed and extracted data of all RCTs. A total of 26 RCTs were included, involving 2997 patients from 11 different countries with a followup varying from 3 to 24 months. In all 68% of the patients were men, with a mean age of 68 years and a mean forced expiratory volume in 1 s (FEV1) predicted value of 44.3%. Patients treated with an IDM programme improved significantly on quality of life scores and reported a clinically relevant improvement of 44 m on 6 min walking distance, compared to controls. Furthermore, the number of patients with >1 respiratory related hospital admission reduced from 27 to 20 per 100 patients. Duration of hospitalisation decreased significantly by nearly 4 days. [ABSTRACT FROM AUTHOR]

Introduction: The prevalence of multi-morbidity is rising and the provision of person-centred integrated health and social care is seen as an appropriate response to the needs of people with multi-morbidity. To contribute to a better evidence-base of integrated care for multimorbidity, the Horizon2020-funded project SELFIE (Sustainable intEgrated care modeLs for multi-morbidity: delivery, FInancing and performance) adopted an innovative evaluation approach: Multi-Criteria Decision Analysis (MCDA). MCDA includes a more comprehensive set of outcomes compared to conventional health technology assessment while still summarising these outcomes in a single value. This workshop presents results of the MCDAs of 4 of the 17 integrated care programmes that were evaluated in SELFIE: the Croatian National Strategy for Palliative Care, the Care Chain for Frail Elderly in the Netherlands, the Catalan Population Health Management approach in Barcelona-Esquerra, and the Better Together in Amsterdam North programme for people facing problems in multiple life domains like health, employment, and housing. Methods: All case studies used a common MCDA methodology in which the performance of the programmes, in comparison to usual care, was measured longitudinally on a core set of 8 outcomes and some programme-specific outcomes. The core set includes Physical Functioning, Psychological Well-being, Social Relationships and Participation, Enjoyment of Life, Resilience, Person-centeredness, Continuity of Care, and Costs. The choice of outcomes was largely driven by focus groups with people with multi-morbidity. The outcomes were weighted by their importance and summed into an overall value score. The weights were obtained in a Discrete Choice Experiment among different stakeholders: 1) patients with multi-morbidity, 2) partners and informal caregivers, 3) professionals, 4) payers, and 5) policy makers (n=150 per group per country). Swing Weighting was used also. Results: Preliminary results showed that the overall value score for integrated care was (slightly) higher than for usual care, in all programmes. For the Croatian palliative care strategy this was mainly due to higher partial value scores for Psychological Wellbeing and Person-centeredness, resulting from the combination of improvements in these outcomes and their relatively high weights. The higher value score for the Dutch frail elderly programme was driven by Enjoyment of Life and Person-centeredness, the first of which had the highest weight of all outcomes. The higher value score of the Spanish population health management programme resulted from an improvement in Physical Functioning and a reduction in costs of acute, potentially avoidable, hospitalizations, despite the relatively low weight of the latter. The improvement due to the programme for people with multiple problems was driven by improvements in Enjoyment of Life, and Psychological Wellbeing. Results were consistent across stakeholder groups. Sensitivity analysis with Swing Weights showed similar results. Probabilistic sensitivity analyses indicated that in the vast majority of repetitions the value score was highest for integrated care. Discussion: These results were obtained in quasi-experimental studies, using propensity score matching to improve the comparability between groups. Conclusion: MCDA, which combines the effects on and weights of Triple Aim outcomes, suggests that integrated care is preferred to usual care by all stakeholders, although some differences were small. [ABSTRACT FROM AUTHOR]

Background: The aim of the current study is to perform a multi-criteria decision analysis (MCDA) of the proactive, person-centred integrated primary care programme U-PROFIT for frail elderly in the Netherlands. Although, the cost-effectiveness of U-PROFIT has been assessed in a large trial, this MCDA includes a more comprehensive set of outcomes that are summarized in a single value to inform decision making from multiple perspectives. A unique feature of U-PROFIT is the twosteps frailty screening combining information from the Electronic Medical Record and self-reported data. The frail elderly receive a holistic assessment from a registered nurse that is translated into an individualised care plan. The nurse provides integrated care in collaboration with the GP and other relevant disciplines. Methods: The population consisted of frail elderly aged ≥ 69 years from three general practices in the Utrecht region. This study was a 12-month prospective cohort study applying a regressiondiscontinuity design. The cut-off score to define an intervention and control group was an age of 75; frail patients aged ≥ 75 years from the three GP practices received the U-PROFIT intervention, and frail patients aged 69-74 years were assigned to the control group based on the two-steps frailty screening. In both age groups elderly had to meet the same frailty criteria. Data on the performance of U-PROFIT was collected by questionnaires and is ongoing until September 2018. Outcomes included physical functioning, psychological well-being, social participation and relationships, enjoyment of life, person-centeredness and continuity of care. Inverse probability weighting was applied and linear regression analyses were performed including the treatment variable, age, baseline outcome and the interaction between treatment and age. The weights for the MCDA were obtained by a discrete choice experiment among patients, partners (informal caregivers), professional care providers, payers and policy makers (n~150 in each stakeholder group). The performance was multiplied by the weights to obtain the overall value score for UPROFIT and usual care. Results: In the MCDA-analysis, the overall value for integrated care was higher than for usual care due to higher partial value scores of psychological well-being, enjoyment of life, personcenteredness and continuity of care. Results were consistent across stakeholder groups and also deterministic sensitivity analysis with Swing Weights showed similar results. Probabilistic sensitivity analyses indicated that in approximately 95% of the repetitions, the overall value score was higher for integrated care compared to usual care. Discussion: Preliminary results showed that U-PROFIT seems to add value when multiple criteria are considered in an MCDA including health and well-being outcomes and experience with care and explicating the perspectives of patients, partners, professionals, payers and policy makers. This study had an innovative methodological approach by combining a regression discontinuity design with MCDA. A limitation of this study was that the significant differences between the intervention and control group at baseline that were not entirely eliminated by inverse probability weighting. Policy implications are that in order to obtain high overall value, integrated care programmes should aim at improving health and well-being outcomes for people with multimorbidity such as frail elderly. [ABSTRACT FROM AUTHOR]

Introduction: In the Netherlands, bundled payments were introduced gradually after 2010 to stimulate the integration of primary care services for different chronic conditions including diabetes, vascular risk management, COPD, depression, asthma, as well as for the elderly. The expectation for this reform was that integrated care could control healthcare expenditure by improving efficiency in primary care and promoting prevention. However, little is known whether this expectation is fulfilled. The aim of this study was to investigate the association between integrated care and healthcare costs in the Netherlands. Methods: Claims data from 2008 to 2017 from all Dutch health insurers was used. Enrolment of individuals in an integrated care programme was identified based on payment codes for integrated care services. Individuals entered integerated care at different points during this period. The control cohort consisted of individuals who were not enrolled in any integrated care programme and who were matched with individuals in the intervention cohort based on gender, age, socio-economic status, and type and number of chronic conditions. Cost were available on spending from basic health insurance in multiple categories e.g. GP, medication, and medical-specialist per person per half year from 2008 to 2015. Descriptive statistics and a preliminary analysis with an ordinary least squares were conducted. Preliminary Results: The intervention group consists of 2.8 million and the control group of 1 million persons. In 2008, both were of similar age median 70 and gender female 51%, and had similair costs €1600, semi-annual. More people in the intervention group used medical care, for example, for medication 87% vs. 77% and secondary care 64% vs. 53%. The largest integrated care programme in 2015 was for diabetes 675,000 people. From the people who started integrated care in 2008 over 55% stayed in the full 8 years. Patients with more than one chronic condition had higher costs €3640 vs €1236. For indivduals who had been enrolled in integrated care at the time, mean total costs remained virtually stable between the first half-year of 2008 and the first half-year of 2015 from €2558 to €2543. For those who had not been enrolled in integrated care at the time, the costs increased €1538 to €1964. Preliminary regression analysis showed that people in integrated care had increased costs of around €180 and that this amount did not reduce over time. Discussion: Preliminary results indicate that integrated care programmes were associated with higher costs. Further analysis based on type of costs needs to indicate whether cost differences were likely to be due to severity of disease for integrated care patients or due to integrated care itself. Sensitivity analysis will be performed to assess robustness of the results. Future analysis will focus on the effect of different types of financing for these programmes and whether integrated care has a different effect on people with multimorbidity. [ABSTRACT FROM AUTHOR]

Introduction: 'Better Together in Amsterdam North' Dutch acronym: BSiN is a promising integrated care programme for multi-morbidity in the Netherlands. BSiN is made up of an alliance of more than ten health- and social care provider organisations. The population consists of people older than 18 with complex problems in multiple life domains e.g. financial problems alongside social isolation and with limited self-sufficiency. The core of the BSiN intervention is that each participant is assigned a case manager who provides holistic advice over a minimum of 6 months. BSiN was selected as one of the case studies for further evaluation using Multi-Criteria Decision Analysis in the Horizon2020 project SELFIE www.selfie2020.eu. This study represent a first evaluation of the BSiN programme. Methods: The study design is quasi-experimental. Care providers and welfare workers in Amsterdam North recruit participants for the intervention. Participant had to score three or lower on at least three of the 11 domains of the Self Sufficiency Matrix. The control group participants were identified from respondents of two waves of the Amsterdam Health Monitor survey, who, given their answers on the health survey, were deemed to have low selfsufficiency. Three face-to-face interviews are held with participants in both groups 0, 6, and 12 months to collect questionnaire data. The questionnaire evaluates the self-sufficiency, health, costs, and lifestyle of the participants. As of November 2017, the sample size at the first follow-up is 52 for the intervention group and 53 for the control group. Data collection is ongoing until the end of 2018. The outcomes are compared using mixed effects models. Results: The control group scored better on all outcomes than the intervention group at baseline. For example, 50% of the intervention group had financial problems but this was only 19% of the control group. A total of 13 outcome measures were measured. The results show that BSiN had a positive and statistically significant effect on the outcomes of planning for the future increased 4%, whereas the control group was reduced by 14% and independence in planning the day +6% vs. -2%. For all other outcomes, BSiN has a positive effect but these were not significantly different from the control group. For example, in the control group self-reported general health decreased but it increased for BSiN respondents. The same was the case for energy, independent problem solving, employment, volunteer-work, contact with neighbors, and loneliness. Discussion: BSiN appears to have a positive effect but the small sample size makes statistical evaluation challenging. In the first instance, future analysis will focus on including a larger sample and on using propensity score matching to improve the comparability of the intervention and control groups. [ABSTRACT FROM AUTHOR]

Background: When evaluating innovative integrated care programmes for persons with multi-morbidity a broader approach is necessary than the traditional cost-per-QALY analysis. Namely, it’s important to gain better insight into what persons with multi-morbidity value in health and in care, in order to let evaluations capture this. The aim of this study is to determine what is important to persons with multi-morbidity when it comes to health and care. Methods: In the context of the EU Horizon2020 SELFIE project (www.selfie2020.eu) 8 focus groups were conducted in 8 European countries: the Netherlands, Austria, Croatia, Germany, Hungary, Norway, Spain, and the UK. In total, 58 persons with multi-morbidity participated the focus group discussions between June and September 2016. During these focus groups participants discussed how they defined good health and well-being and subsequently how they defined a good care process. Participants listed facets of health/well-being and care and next tried to make a prioritisation in what was most important to them. Preliminary results: Persons with multi-morbidity in the different European countries placed a lot of emphasis on having ‘enjoyment and pleasure in life’, ‘freedom and independence’, and ‘maintaining social relationships and contacts’. Interestingly, clinical health-type indicators were mentioned to a much lesser extent. Furthermore, a lot of value was placed on the interactions with care providers: a respectful treatment, shared decision-making, and good communication both between provider and participant as between multiple providers. Especially relevant in the case of multi-morbidity and mentioned by participants was that the care providers had insight into and attention for their entire situation. Not only their different health problems but also their preferences and wishes should be taken seriously. These findings will be elaborated on during the presentation, and cross-country similarities and differences will also be described. Conclusions: When evaluating integrated care programmes for persons with multi-morbidity, it is important to define outcomes that correspond to what persons with multi-morbidity define as good health/well-being and a good care process. This is necessary in order to enable better design, implementation and evaluation of these programmes that match the needs and desires of their target group. [ABSTRACT FROM AUTHOR]

The rise of multi-morbidity constitutes a serious challenge in the organisation of care and requires successful integration to counter the threat of fragmentation. The EU Horizon2020- funded project 'Sustainable Integrated Care Models for Multi-Morbidity: Delivery, Financing and Performance' (SELFIE) aims to increase the knowledge-base on integrated care for multimorbidity. During this session four presentations on initial findings will be presented. First, (1) a conceptual framework for integrated care for multi-morbidity will be presented that was developed on the basis of an extensive scoping review and workshops with stakeholders. The framework was subsequently used to describe 17 promising integrated care programmes for multi-morbidity in the 8 SELFIE partner countries. (2) The overarching barriers and facilitators to their implementation will be presented. Next, (3) the different financial and payment schemes applied in these programmes will be described and compared. Lastly, (4) the planned Multi-Criteria Decision Analysis evaluations will be presented. [ABSTRACT FROM AUTHOR]

Aim To develop pragmatic recommendations for Central and Eastern European (CEE) policymakers about transferability assessment of integrated care models established in higher income European Union (EU) countries. Methods Draft recommendations were developed based on Horizon 2020-funded SELFIE project deliverables related to 17 promising integrated care models for multimorbid patients throughout Europe, as well as on an online survey among CEE stakeholders on the relevance of implementation barriers. Draft recommendations were discussed at the SELFIE transferability workshop and finalized together with 22 experts from 12 CEE countries. Results Thirteen transferability recommendations are provided in three areas. Feasibility of local implementation covers the identification and prioritization of implementation barriers and proposals for potential solutions. Performance measurement of potentially transferable models focuses on the selection of models with proven benefits and assurance of performance monitoring. Transferability of financing methods for integrated care explores the relevance of financing methodologies and planning of adequate initial and long-term financing. Conclusions Implementation of international integrated care models cannot be recommended without evidence on its local feasibility or scientifically sound and locally relevant performance assessment in the country of origin. However, if the original financing method is not transferable to the target region, development of a locally relevant alternative financing method can be considered. [ABSTRACT FROM AUTHOR]

Purpose: To quantify the relationship between severity of chronic obstructive pulmonary disease (COPD) as expressed by Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage and the annual exacerbation frequency in patients with COPD., Methods: We performed a systematic literature review to identify randomized controlled trials and cohort studies reporting the exacerbation frequency in COPD patients receiving usual care or placebo. Annual frequencies were determined for total exacerbations defined by an increased use of health care (event-based), total exacerbations defined by an increase of symptoms, and severe exacerbations defined by a hospitalization. The association between the mean forced expiratory volume in one second (FEV(1))% predicted of study populations and the exacerbation frequencies was estimated using weighted log linear regression with random effects. The regression equations were applied to the mean FEV(1)% predicted for each GOLD stage to estimate the frequency per stage., Results: Thirty-seven relevant studies were found, with 43 reports of total exacerbation frequency (event-based, n = 19; symptom-based, n = 24) and 14 reports of frequency of severe exacerbations. Annual event-based exacerbation frequencies per GOLD stage were estimated at 0.82 (95% confidence interval 0.46-1.49) for mild, 1.17 (0.93-1.50) for moderate, 1.61 (1.51-1.74) for severe, and 2.10 (1.51-2.94) for very severe COPD. Annual symptom-based frequencies were 1.15 (95% confidence interval 0.67-2.07), 1.44 (1.14-1.87), 1.76 (1.70-1.88), and 2.09 (1.57-2.82), respectively. For severe exacerbations, annual frequencies were 0.11 (95% confidence interval 0.02-0.56), 0.16 (0.07-0.33), 0.22 (0.20-0.23), and 0.28 (0.14-0.63), respectively. Study duration or type of study (cohort versus trial) did not significantly affect the outcomes., Conclusion: This study provides an estimate of the exacerbation frequency per GOLD stage, which can be used for health economic and modeling purposes.