Evolving assessment pathways for precision oncology medicines to improve patient access: a tumor-agnostic lens.

BACKGROUND: Genomic and molecular alterations are increasingly important in cancer diagnosis, and scientific advances are opening new treatment avenues. Precision oncology (PO) uses a patient's genomic profile to determine optimal treatment, promising fewer side effects and higher success rates. Within PO, tumor-agnostic (TA) therapies target genomic alterations irrespective of tumor location. However, traditional value frameworks and approval pathways pose challenges which may limit patient access to PO therapies. OBJECTIVES: This study describes challenges in assessing PO and TA medicines, explores possible solutions, and provides actionable recommendations to facilitate an iterative life-cycle assessment of these medicines. METHODS: After reviewing the published literature, we obtained insights from key stakeholders and European experts across a range of disciplines, through individual interviews and an industry workshop. The research was guided and refined by an international expert committee through 2 sounding board meetings. RESULTS: The current challenges faced by PO and TA medicines are multiple and can be demonstrated through real-world examples of the current barriers and opportunities. A life-cycle approach to assessment should be taken, including key actions at the early stages of evidence generation, regulatory and reimbursement stage, as well as payment and adoption solutions that make use of the evolving evidence base. Working toward these solutions to maximize PO medicine value is a shared responsibility and stands to benefit all stakeholders. CONCLUSIONS: Our call to action is to expand access to comprehensive genomic testing, foster a learning health care system, enable fast and equitable access to cost-effective treatments, and ultimately improve health outcomes.

Investigating the Cost-Effectiveness of Telemonitoring Patients With Cardiac Implantable Electronic Devices: Systematic Review.

BACKGROUND: Telemonitoring patients with cardiac implantable electronic devices (CIEDs) can improve their care management. However, the results of cost-effectiveness studies are heterogeneous. Therefore, it is still a matter of debate whether telemonitoring is worth the investment. OBJECTIVE: This systematic review aims to investigate the cost-effectiveness of telemonitoring patients with CIEDs, focusing on its key drivers, and the impact of the varying perspectives. METHODS: A systematic review was performed in PubMed, Web of Science, Embase, and EconLit. The search was completed on July 7, 2022. Studies were included if they fulfilled the following criteria: patients had a CIED, comparison with standard care, and inclusion of health economic evaluations (eg, cost-effectiveness analyses and cost-utility analyses). Only complete and peer-reviewed studies were included, and no year limits were applied. The exclusion criteria included studies with partial economic evaluations, systematic reviews or reports, and studies without standard care as a control group. Besides general study characteristics, the following outcome measures were extracted: impact on total cost or income, cost or income drivers, cost or income drivers per patient, cost or income drivers as a percentage of the total cost impact, incremental cost-effectiveness ratios, or cost-utility ratios. Quality was assessed using the Consensus Health Economic Criteria checklist. RESULTS: Overall, 15 cost-effectiveness analyses were included. All studies were performed in Western countries, mainly Europe, and had primarily a male participant population. Of the 15 studies, 3 (20%) calculated the incremental cost-effectiveness ratio, 1 (7%) the cost-utility ratio, and 11 (73%) the health and cost impact of telemonitoring. In total, 73% (11/15) of the studies indicated that telemonitoring of patients with implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy ICDs was cost-effective and cost-saving, both from a health care and patient perspective. Cost-effectiveness results for telemonitoring of patients with pacemakers were inconclusive. The key drivers for cost reduction from a health care perspective were hospitalizations and scheduled in-office visits. Hospitalization costs were reduced by up to US $912 per patient per year. Scheduled in-office visits included up to 61% of the total cost reduction. Key drivers for cost reduction from a patient perspective were loss of income, cost for scheduled in-office visits and transport. Finally, of the 15 studies, 8 (52%) reported improved quality of life, with statistically significance in only 1 (13%) study (P=.03). CONCLUSIONS: From a health care and patient perspective, telemonitoring of patients with an ICD or a cardiac resynchronization therapy ICD is a cost-effective and cost-saving alternative to standard care. Inconclusive results were found for patients with pacemakers. However, telemonitoring can lead to a decrease in providers' income, mainly due to a lack of reimbursement. Introducing appropriate reimbursement could make telemonitoring sustainable for providers while still being cost-effective from a health care payer perspective. TRIAL REGISTRATION: PROSPERO CRD42022322334; https://tinyurl.com/puunapdr.

Transcatheter aortic valve implantation versus surgical aortic valve replacement in severe aortic stenosis patients at low surgical mortality risk: a cost-effectiveness analysis in Belgium.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 device has recently shown significant clinical benefits, compared to surgical aortic valve replacement (SAVR), in patients at low risk for surgical mortality (PARTNER 3 trial, NCT02675114). Currently in Belgium, TAVI use is restricted to high-risk or inoperable patients with severe symptomatic aortic stenosis (sSAS). This cost-utility analysis aimed to assess whether TAVI with SAPIEN 3 could lead to potential cost-savings compared with SAVR, in the low-risk sSAS population in Belgium. METHODS: A previously published, two-stage, Markov-based cost-utility model was used. Clinical outcomes were captured using data from PARTNER 3 and the model was adapted for the Belgian context using cost data from the perspective of the Belgian National Healthcare System, indexed to 2022. A lifetime horizon was chosen. The model outputs included changes in direct healthcare costs, survival and health-related quality of life using TAVI versus SAVR. RESULTS: TAVI with SAPIEN 3 provides meaningful clinical and cost benefits over SAVR, in terms of an increase in quality-adjusted life years (QALYs) of 0.94 and cost-saving of €3 013 per patient. While initial procedure costs were higher for TAVI compared with SAVR, costs related to rehabilitation, disabling stroke, treated atrial fibrillation, and rehospitalization were lower. The cost-effectiveness of TAVI over SAVR remained robust in sensitivity analyses. CONCLUSION: TAVI with SAPIEN 3 may offer a meaningful alternative intervention to SAVR in Belgian low-risk patients with sSAS, showing both clinical benefits and cost savings associated with post-procedure patient management.

Health Policy for Prostate Cancer Early Detection in the European Union and the Impact of Opportunistic Screening: PRAISE-U Consortium.

With the new policy recommendation in 2022 to explore the possibilities of screening for prostate cancer by the European Commission, the landscape for prostate cancer early detection is evolving. In line with this recommendation, the PRAISE-U project aims to evaluate the early detection and diagnosis of prostate cancer through customised and risk-based screening programmes, with the goal to align protocols across European Union member states. This systematic review is part of the PRAISE-U project, with the goal to review the policy, medical guideline recommendations, and the current level of opportunistic screening presented in the scientific literature on prostate cancer early detection from 2016 to 2023 in European Union member states. An extensive literature search was performed on 1 June 2023 in a large number of databases, including Embase.com, Medline (Ovid), Web of Science Core Collection, Google Scholar, and Policy Commons. We identified 318 articles (qualitative, quantitative, and reviews), of which 41 were included in the full-text screening. Seventeen articles were ultimately identified as eligible for inclusion. The included articles revealed significant variations towards PSA-based early detection policies for prostate cancer in nine European countries. Despite official recommendations, opportunistic screening was prevalent across all nine countries regardless of recommendations for or against PSA-based early detection. This systematic review suggests that the current early detection policies are not fit for purpose. High levels of opportunistic screening and overdiagnosis persist, prompting policy recommendations for standardised guidelines, informed decision making, and increased awareness to improve efficiency and effectiveness in early detection.

Cost-Utility of an Exercise Referral Scheme Versus Doing Nothing in Flemish Adults: Exploring the Impact of Key Assumptions.

BACKGROUND: This health-economic evaluation assessed the cost-effectiveness of an exercise referral scheme (ERS) versus doing nothing in the Flemish region (Belgium), with a particular focus on the impact of several scenarios. METHODS: A 14-state Markov model was applied to compare the expected costs and quality-adjusted life years (QALYs) of 2 alternatives: the Flemish ERS (2019 data, mean age 52 y, 69.1% women) and doing nothing. A health care payer perspective was adopted and a lifetime time horizon was applied. A set of 18 scenario analyses is presented. In addition, univariate and probabilistic sensitivity analyses were performed. RESULTS: Under the assumptions selected for the base-case analysis, the Flemish ERS is moderately cost-effective compared with doing nothing, with an incremental cost-utility ratio of €28,609/QALY. Based on the scenario analyses, the results largely depend on the assumptions regarding the continuation of the intervention effect and the frequency with which the intervention is repeated. The greatest health gains can be made when a sustainable behavioral change is achieved among participants. The probabilistic sensitivity analysis confirmed that the cost-effectiveness results were not robust. CONCLUSIONS: If it is possible to induce a sustainable behavioral change with an intervention delivered at 2- or 5-year intervals, then the Flemish ERS is potentially cost-effective compared with doing nothing (given a €40,000/QALY threshold). These results suggest the importance of repeated implementation of the program together with careful monitoring of the adherence and the sustainability of the observed effects in a real-world setting.

The evolution of the subjective well-being of the general population during the COVID-19 pandemic period: the case of Belgium.

The consequences of the COVID-19 pandemic period on a nation's well-being remain inadequately understood, especially over time. Therefore, this research aims to map the changes in the subjective well-being (SWB) of the general Belgian adult population during the COVID-19 pandemic. Analyses of variances (ANOVA) were performed to evaluate the changes in SWB during the pandemic at five different time points during the period from February 2020 until December 2022 using repeated cross-sectional representative samples of the Belgian population. The differences over time in subjective well-being were investigated in terms of life evaluation, positive affect, and negative affect. The changes in autonomy, competence, relatedness, loneliness and peace of mind were also explored as explanatory variables. Moderation analyses were performed to investigate the differential changes in well-being for different age groups. Our results show the subjective well-being of the Belgian population decreased during the COVID-19 pandemic, notably during the second lockdown and the fifth wave. Furthermore, younger individuals are significantly more susceptible to negative changes in well-being during the pandemic period. Finally, our results show that peace of mind is an important predictor of all SWB components during the pandemic. Based on these results several policy recommendations are formulated.

Cost effectiveness review of text messaging, smartphone application, and website interventions targeting T2DM or hypertension.

Digital health interventions have been shown to be clinically-effective for type 2 diabetes mellitus (T2DM) and hypertension prevention and treatment. This study synthesizes and compares the cost-effectiveness of text-messaging, smartphone application, and websites by searching CINAHL, Cochrane Central, Embase, Medline and PsycInfo for full economic or cost-minimisation studies of digital health interventions in adults with or at risk of T2DM and/or hypertension. Costs and health effects are synthesised narratively. Study quality appraisal using the Consensus on Health Economic Criteria (CHEC) list results in recommendations for future health economic evaluations of digital health interventions. Of 3056 records identified, 14 studies are included (7 studies applied text-messaging, 4 employed smartphone applications, and 5 used websites). Ten studies are cost-utility analyses: incremental cost-utility ratios (ICUR) vary from dominant to €75,233/quality-adjusted life year (QALY), with a median of €3840/QALY (interquartile range €16,179). One study finds no QALY difference. None of the three digital health intervention modes is associated with substantially better cost-effectiveness. Interventions are consistently cost-effective in populations with (pre)T2DM but not in populations with hypertension. Mean quality score is 63.0% (standard deviation 13.7%). Substandard application of time horizon, sensitivity analysis, and subgroup analysis next to transparency concerns (regarding competing alternatives, perspective, and costing) downgrades quality of evidence. In conclusion, smartphone application, text-messaging, and website-based interventions are cost-effective without substantial differences between the different delivery modes. Future health economic studies should increase transparency, conduct sufficient sensitivity analyses, and appraise the ICUR more critically in light of a reasoned willingness-to-pay threshold.Registration: PROSPERO (CRD42021247845).

How job demands and job resources contribute to our overall subjective well-being.

Objectives: How the work environment contributes to employees' overall subjective well-being remains inadequately explored. Building upon the seminal Job Demands-Resources model, this study aims to test a complex model that combines leadership, job demands, and job resources, as factors contributing either indirectly (via job satisfaction) or directly to employees' subjective well-being (SWB). Methods: The cross-sectional data (N = 1,859) of the Belgian National happiness study (2020) were used. Leadership (satisfaction with leadership; perceived supervisor support), job demands (role conflict; job insecurity; work-private conflict; perceived working conditions), job resources (autonomy; relatedness; competence; skill utilization; personal growth), job satisfaction and subjective well-being (life evaluation; positive affect; negative affect) were assessed via self-report questionnaires. The proposed model investigates the direct impact of job demands and resources on SWB, as well as the indirect impact with job satisfaction as mediating factor, and was tested using the Structural Equation Modeling technique. Results: Findings supported the proposed model. Both job demands and job resources have a direct relationship with SWB. Job resources are positively related to overall SWB, whereas job demands negatively affected SWB. Moreover, job resources are more strongly related to SWB compared to job demands. The demands and resources also indirectly contribute to employee's SWB via job satisfaction as job satisfaction appeared to mediate these relationships. Conclusion: The current study shows that both job demands and resources directly and indirectly contribute to employees' SWB. Creating a supportive and healthy work environment is thus of paramount importance in order to foster employees' SWB. In particular, investing in improving job resources may be a fruitful approach to promote employees' overall subjective well-being.

Inequities in kidney health and kidney care.

Health inequity refers to the existence of unnecessary and unfair differences in the ability of an individual or community to achieve optimal health and access appropriate care. Kidney diseases, including acute kidney injury and chronic kidney disease, are the epitome of health inequity. Kidney disease risk and outcomes are strongly associated with inequities that occur across the entire clinical course of disease. Insufficient investment across the spectrum of kidney health and kidney care is a fundamental source of inequity. In addition, social and structural inequities, including inequities in access to primary health care, education and preventative strategies, are major risk factors for, and contribute to, poorer outcomes for individuals living with kidney diseases. Access to affordable kidney care is also highly inequitable, resulting in financial hardship and catastrophic health expenditure for the most vulnerable. Solutions to these injustices require leadership and political will. The nephrology community has an important role in advocacy and in identifying and implementing solutions to dismantle inequities that affect kidney health.

Physicians' views on optimal use and payment system for telemedicine: a qualitative study.

BACKGROUND: Telemedicine is already in use in daily practice, but appropriate reimbursement and physician payment is falling behind in many countries. One reason is the limited availability of research on the matter. This research therefore examined physicians' views on the optimal use and payment modalities for telemedicine. METHODS: Sixty-one semi-structured interviews were conducted with physicians from 19 medical disciplines. Interviews were encoded using thematic analysis. RESULTS: Telephone and video televisits tend not to be used as a first patient contact, except for triage of patients in urgency situations. Several minimum required modalities for the payment system of televisits and telemonitoring were identified. For televisits these were: (i) remuneration of both telephone- and videovisits to increase healthcare equity, (ii) little or no differentiation between videovisit and in-person visit fee to make videovisits financially attractive and sustainable for physicians, (iii) differentiation of televisit fee per medical discipline, and (iv) quality requirements such as mandatory reporting in the patient's medical file. The identified minimum required modalities for telemonitoring were: (i) an alternative payment scheme than fee-for-service, (ii) remunerating not only physicians but also other involved health professionals, (iii) designating and remunerating a coordinator, and (iv) distinguishing sporadic vs. continuously follow-up. CONCLUSIONS: This research investigated the telemedicine usage behavior of physicians. Moreover, several minimum required modalities were identified for a physician-supported payment system of telemedicine, as these innovations necessitate challenging and innovation of the healthcare payment systems as well.

Cost of illness in patients with post-treatment Lyme disease syndrome in Belgium.

BACKGROUND: A proportion of patients with Lyme borreliosis (LB) report long-term persisting signs and symptoms, even after recommended antibiotic treatment, which is termed post-treatment Lyme disease syndrome (PTLDS). Consensus on guidance regarding diagnosis and treatment is currently lacking. Consequently, patients suffer and are left searching for answers, negatively impacting their quality of life and healthcare expenditure. Yet, health economic data on PTLDS remain scarce. The aim of this article is therefore to assess the cost-of-illness related to PTLDS, including the patient perspective. METHODS: PTLDS patients (N = 187) with confirmed diagnosis of LB were recruited by a patient organization. Patients completed a self-reported questionnaire on LB-related healthcare utilization, absence from work and unemployment. Unit costs (reference year 2018) were obtained from national databases and published literature. Mean costs and uncertainty intervals were calculated via bootstrapping. Data were extrapolated to the Belgian population. Generalized linear models were used to determine associated covariates with total direct costs and out-of-pocket expenditures. RESULTS: Mean annual direct costs amounted to €4618 (95% CI €4070-5152), of which 49.5% were out-of-pocket expenditures. Mean annual indirect costs amounted to €36 081 (€31 312-40 923). Direct and indirect costs at the population level were estimated at €19.4 and 151.5 million, respectively. A sickness or disability benefit as source of income was associated with higher direct and out-of-pocket costs. CONCLUSIONS: The economic burden associated with PTLDS on patients and society is substantial, with patients consuming large amounts of non-reimbursed healthcare resources. Guidance on adequate diagnosis and treatment of PTLDS is needed.

Trends in appropriateness of end-of-life care in people with cancer, COPD or with dementia measured with population-level quality indicators.

INTRODUCTION: Measuring changes in the appropriateness of end-of-life care provided to patients with advanced illness such as cancer, COPD or dementia can help governments and practitioners improve service delivery and quality of life. However, an assessment of a possible shift in appropriateness of end-of-life care across the population is lacking. AIM: Measuring quality indicators with routinely collected population-level data, this study aims to evaluate the appropriateness of end-of-life care for people with cancer, COPD or dementia in Belgium. DESIGN: A population-level decedent cohort study, using data from eight population-level databases, including death certificate and health claims data. We measured validated sets of quality indicators for appropriateness of end-of-life care. SETTING/PARTICIPANTS: All people who died from cancer or COPD or with dementia between 1st January 2010 and 1st January 2016 in Belgium. RESULTS: We identified three main trends over time across the three disease groups of increasing use of: family physicians in the last 30 days of life (+21.7% in cancer, +33.7% in COPD and +89.4% in dementia); specialist palliative care in the last 14 days of life (+4.6% in cancer, +36.9% in COPD, +17.8% in dementia); and emergency department in the last 30 days of life (+7.0% in cancer, +4.4% in COPD and +8.2% in dementia). CONCLUSIONS: Although we found an increase of both specialized palliative care and generalist palliative care use, we also found an increase in potentially inappropriate care, including ED and ICU admissions. To increase the quality of end-of-life care, both timely initiating (generalist and specialist) palliative care and avoiding potentially inappropriate care transitions, treatments and medications need to be quality performance targets.

Effectiveness, reach, uptake, and feasibility of digital health interventions for adults with hypertension: a systematic review and meta-analysis of randomised controlled trials.

BACKGROUND: Digital health interventions are effective for hypertension self-management, but a comparison of the effectiveness and implementation of the different modes of interventions is not currently available. This study aimed to compare the effectiveness of SMS, smartphone application, and website interventions on improving blood pressure in adults with hypertension, and to report on their reach, uptake, and feasibility. METHODS: In this systematic review and meta-analysis we searched CINAHL Complete, Cochrane Central Register of Controlled Trials, Ovid Embase, Ovid MEDLINE, and APA PsycInfo on May 25, 2022, for randomised controlled trials (RCTs) published in English from Jan 1, 2009, that examined the effectiveness of digital health interventions on reducing blood pressure in adults with hypertension. Screening was carried out using Covidence, and data were extracted following Cochrane's guidelines. The primary endpoint was change in the mean of systolic blood pressure. Risk of bias was assessed with Cochrane Risk of Bias 2. Data on systolic and diastolic blood pressure reduction were synthesised in a meta-analysis, and data on reach, uptake and feasibility were summarised narratively. Grading of Recommendations, Assessment, Development, and Evaluation criteria were used to evaluate the level of evidence. The study was registered with PROSPERO CRD42021247845. FINDINGS: Of the 3235 records identified, 29 RCTs from 13 regions (n=7592 participants) were included in the systematic review, and 28 of these RCTs (n=7092 participants) were included in the meta-analysis. 11 studies used SMS as the primary mode of delivery of the digital health intervention, 13 used smartphone applications, and five used websites. Overall, digital health intervention group participants had a -3·62 mm Hg (95% CI -5·22 to -2·02) greater reduction in systolic blood pressure, and a -2·45 mm Hg (-3·83 to -1·07) greater reduction in diastolic blood pressure, compared with control group participants. No statistically significant differences between the three different modes of delivery were observed for both the systolic (p=0·73) and the diastolic blood pressure (p=0·80) outcomes. Smartphone application interventions had a statistically significant reduction in diastolic blood pressure (-2·45 mm Hg [-4·15 to -0·74]); however, there were no statistically significant reductions for SMS interventions (-1·80 mm Hg [-4·60 to 1·00]) or website interventions (-3·43 mm Hg [-7·24 to 0·38]). Due to the considerable heterogeneity between included studies and the high risk of bias in some, the level of evidence was assigned a low overall score. Interventions were more effective among people with greater severity of hypertension at baseline. SMS interventions reported higher reach and smartphone application studies reported higher uptake, but differences were not statistically significant. INTERPRETATION: SMS, smartphone application, and website interventions were associated with statistically and clinically significant systolic and diastolic blood pressure reductions, compared with usual care, regardless of the mode of delivery of the intervention. This conclusion is tempered by the considerable heterogeneity of included studies and the high risk of bias in most. Future studies need to describe in detail the mediators and moderators of the effectiveness and implementation of these interventions, to both further improve their effectiveness as well as increase their reach, uptake, and feasibility. FUNDING: European Union's Horizon 2020 Research and Innovation Programme.

Effectiveness, reach, uptake, and feasibility of digital health interventions for adults with type 2 diabetes: a systematic review and meta-analysis of randomised controlled trials.

BACKGROUND: Digital health interventions have shown promising results for the management of type 2 diabetes, but a comparison of the effectiveness and implementation of the different modes is not currently available. Therefore, this study aimed to compare the effectiveness of SMS, smartphone application, and website-based interventions on improving glycaemia in adults with type 2 diabetes and report on their reach, uptake, and feasibility. METHODS: In this systematic review and meta-analysis, we searched CINAHL, Cochrane Central, Embase, MEDLINE, and PsycInfo on May 25, 2022, for randomised controlled trials (RCTs) that examined the effectiveness of digital health interventions in reducing glycated haemoglobin A1c (HbA1c) in adults with type 2 diabetes, published in English from Jan 1, 2009. Screening was carried out using Covidence, and data were extracted following Cochrane's guidelines. The primary endpoint assessed was the change in the mean (and 95% CI) plasma concentration of HbA1c at 3 months or more. Cochrane risk of bias 2 was used to assess risk of bias. Data on reach, uptake, and feasibility were summarised narratively and data on HbA1c reduction were synthesised in a meta-analysis. Grading of Recommendations, Assessment, Development, and Evaluation criteria was used to evaluate the level of evidence. The study was registered with PROSPERO, CRD42021247845. FINDINGS: Of the 3236 records identified, 56 RCTs from 24 regions (n=11 486 participants), were included in the narrative synthesis, and 26 studies (n=4546 participants) in the meta-analysis. 20 studies used SMS as the primary mode of delivery of the digital health intervention, 25 used smartphone applications, and 11 implemented interventions via websites. Smartphone application interventions reported higher reach compared with SMS and website-based interventions, but website-based interventions reported higher uptake compared with SMS and smartphone application interventions. Effective interventions, in general, included people with greater severity of their condition at baseline (ie, higher HbA1c) and administration of a higher dose intensity of the intervention, such as more frequent use of smartphone applications. Overall, digital health intervention group participants had a -0·30 (95% CI -0·42 to -0·19) percentage point greater reduction in HbA1c, compared with control group participants. The difference in HbA1c reduction between groups was statistically significant when interventions were delivered through smartphone applications (-0·42% [-0·63 to -0·20]) and via SMS (-0·37% [-0·57 to -0·17]), but not when delivered via websites (-0·09% [-0·64 to 0·46]). Due to the considerable heterogeneity between included studies, the level of evidence was moderate overall. INTERPRETATION: Smartphone application and SMS interventions, but not website-based interventions, were associated with better glycaemic control. However, the studies' heterogeneity should be recognised. Considering that both smartphone application and SMS interventions are effective for diabetes management, clinicians should consider factors such as reach, uptake, patient preference, and context of the intervention when deciding on the mode of delivery of the intervention. Nine in ten people worldwide own a feature phone and can receive SMS and four in five people have access to a smartphone, with numerous smartphone applications being available for diabetes management. Clinicians should familiarise themselves with this modality of programme delivery and encourage people with type 2 diabetes to use evidence-based applications for improving their self-management of diabetes. Future research needs to describe in detail the mediators and moderators of the effectiveness and implementation of SMS and smartphone application interventions, such as the optimal dose, frequency, timing, user interface, and communication mode to both further improve their effectiveness and to increase their reach, uptake, and feasibility. FUNDING: EU's Horizon 2020 Research and Innovation Programme.

How to Pay for Telemedicine: A Comparison of Ten Health Systems.

Telemedicine has the opportunity to improve clinical effectiveness, health care access, cost-savings, and patient care. However, payment systems may form important obstacles to optimally use telemedicine and enable its opportunities. Little is known about payment systems for telemedicine. Therefore, this research aims to increase knowledge on paying for telemedicine by comparing payment systems for telemedicine and identifying similarities and differences. Based on the countries' official physician fee schedules, listing all reimbursed medical services performed by physicians, a comparative analysis of telemedicine payment systems in ten countries was conducted. Findings show that many countries lacked tele-expertise and telemonitoring payment, with the exception for some specific payments such as for telemonitoring in patients with cardiac implantable electronic devices. Moreover, a wide variety of benefit specifications were implemented in all countries to specify which type of clinician contact should be used (remote versus physical) in which circumstances. Payment parity between video and in-person visits was established only in a few countries. Furthermore, fee-for-service was the dominant payment system, although two countries used a capitation-based or hybrid system. The results imply several potential payment challenges when implementing telemedicine: complex benefit specifications, payment parity discussions, and risk of overconsumption due to the dominant fee-for-service system. These challenges appear to be less present in capitation-based or hybrid systems. However, the latter needs to be further explored to harness the full potential of telemedicine.

Last year of life of adults with congenital heart diseases: causes of death and patterns of care.

AIMS: Although life expectancy in adults with congenital heart diseases (CHD) has increased dramatically over the past five decades, still a substantial number of patients dies prematurely. To gain understanding in the trajectories of dying in adults with CHD, the last year of life warrants further investigation. Therefore, our study aimed to (i) define the causes of death and (ii) describe the patterns of healthcare utilization in the last year of life of adults with CHD. METHODS AND RESULTS: This retrospective mortality follow-back study used healthcare claims and clinical data from BELCODAC, which includes patients with CHD from Belgium. Healthcare utilization comprises cardiovascular procedures, CHD physician contacts, general practitioner visits, hospitalizations, emergency department (ED) visits, intensive care unit (ICU) admissions, and specialist palliative care, and was identified using nomenclature codes. Of the 390 included patients, almost half of the study population (45%) died from a cardiovascular cause. In the last year of life, 87% of patients were hospitalized, 78% of patients had an ED visit, and 19% of patients had an ICU admission. Specialist palliative care was provided to 17% of patients, and to only 4% when looking at the patients with cardiovascular causes of death. CONCLUSIONS: There is a high use of intensive and potentially avoidable care at the end of life. This may imply that end-of-life care provision can be improved. Future studies should further examine end-of-life care provision in the light of patient's needs and preferences, and how the healthcare system can adequately respond.

Facilitating [corrected] More Efficient Negotiations for Innovative Therapies: A Value-Based Negotiation Framework.

OBJECTIVES: An increasing number of innovative therapies (e.g., gene- and cell-based treatments) have been developed in the past 20 years. Despite the significant clinical potential of these therapies, access delays may arise because of differing perspectives of manufacturers and payers regarding issues such as the value of the product, clinical and financial uncertainties, and sustainability.Managed entry agreements (MEAs) can enable access to treatments that would not be reimbursed by conventional methods because of such concerns. However, although MEA typologies exist, there is currently no structured process to come to agreements on MEAs, which can be difficult to decide upon and implement.To facilitate more structured MEA negotiations, we propose a conceptual "value-based negotiation framework" with corresponding application tools. METHODS: The framework was developed based on an iterative process of scientific literature review and expert input. RESULTS: The framework aims to (i) systematically identify and prioritize manufacturer and payer concerns about a new treatment, and (ii) select a mutually acceptable combination of MEA terms that can best address priority concerns, with the lowest possible implementation burden. CONCLUSIONS: The proposed framework will be tested in practice, and is a step toward supporting payers and manufacturers to engage in more structured, transparent negotiations to balance the needs of both sides, and enabling quicker, more transparent MEA negotiations and patient access to innovative products.

A public health value-based healthcare paradigm for HIV.

BACKGROUND: HIV patients face considerable acute and chronic healthcare needs and battling the HIV epidemic remains of the utmost importance. By focusing on health outcomes in relation to the cost of care, value-based healthcare (VBHC) proposes a strategy to optimize quality of care and cost-efficiency. Its implementation may provide an answer to the increasing pressure to optimize spending in healthcare while improving patient outcomes. This paper describes a pragmatic value-based healthcare framework for HIV care. METHODS: A value-based HIV healthcare framework was developed during a series of roundtable discussions bringing together 16 clinical stakeholder representatives from the Belgian HIV reference centers and 2 VBHC specialists. Each round of discussions was focused on a central question translating a concept or idea to the next level of practical implementation: 1) how can VBHC principles be translated into value-based HIV care drivers; 2) how can these value-based HIV care divers be translated into value-based care objectives and activities; and 3) how can value-based HIV care objectives and activities be translated into value-based care indicators. Value drivers were linked to concrete objectives and activities using a logical framework approach. Finally, specific, measurable, and acceptable structure, process and outcomes indicators were defined to complement the framework. RESULTS: Our framework identifies 4 core value areas where HIV care would benefit most from improvements: Prevention, improvement of the cascade of care, providing patient-centered HIV care and sustaining a state-of-the-art HIV disease management context. These 4 core value areas were translated into 12 actionable core value objectives. For each objective, example activities were proposed. Indicators are suggested for each level of the framework (outcome indicators for value areas and objectives, process indicators for suggested activities). CONCLUSIONS: This framework approach outlines how to define a patient- and public health centered value-based HIV care paradigm. It proposes how to translate core value drivers to practical objectives and activities and suggests defining indicators that can be used to track and improve the framework's implementation in practice.