Belgian Health Care Research Articles

Health economic modelling of diabetic kidney disease in patients with type 2 diabetes treated with Canagliflozin in Belgium

ABSTRACT Objectives The Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial showed reduced renal and cardiovascular (CV) events in patients with type 2 diabetes (T2D) and diabetic kidney disease (DKD) treated with canagliflozin 100 mg added to Standard of Care (SoC) versus SoC alone. This led to an extension of the canagliflozin 100 mg European marketing authorisation, making canagliflozin the first pharmacological therapy to receive authorisation for the treatment of DKD since the RENAAL and IDNT trials more than 20 years ago. Given the importance of cost-effectiveness analyses in health care, this study aimed to leverage the CREDENCE trial outcomes to estimate the cost-effectiveness of canagliflozin 100 mg from the perspective of the Belgian healthcare system. Methods A microsimulation model (CREDENCE Economic Model of DKD), developed using patient-level CREDENCE trial data, was leveraged to model the progression of DKD and CV outcomes, associated costs, and life quality. Unit costs and quality-adjusted life years (QALYs) were sourced from the literature. The time horizon was 10 years and sensitivity analyses were performed. Results Canagliflozin was associated with sizable gains in life-years and QALYs over 10 years, and the incremental cost-effectiveness ratio cost offsets associated with reductions in CV and renal complications resulted in overall net cost savings from the perspective of the Belgian healthcare system. Conclusion Model-based results suggest that adding canagliflozin 100 mg to SoC can improve outcomes for patients with DKD while reducing overall net costs for the Belgian healthcare system.

Langdurige Covid: de contouren worden langzaam duidelijk

Long Covid: what is already known about this new condition? Long COVID affects people who have experienced a severe form of COVID-19, as well as patients who suffered a mild form. Six months after infection with the coronavirus, at least 1 out of 7 patients still have symptoms. These symptoms are very diverse and are probably related to a combination of different mechanisms: direct organ damage due to the viral infection, abnormal immune and inflammatory responses that can lead to dysfunctions on several levels (microcirculation, coagulation, fibrosis, autoimmunity, metabolism), consequences of the hospitalisation (muscle atrophy, post-intensive care syndrome) or worsening of existing comorbidities. The Belgian Healthcare Knowledge Centre (KCE) surveyed the experience of Belgian patients by means of an extensive online survey of 1,320 people, followed by an online forum and in-depth interviews. It showed that the perception of the symptoms was very diverse, with a clear reduction in the quality of life, some loss of autonomy and difficulties when returning to work. The psychological consequences could be severe. Based on the current state of science, it is not known which treatments are effective for long COVID. A symptom-oriented approach, focused on gradual multidisciplinary rehabilitation, seems appropriate. Therefore, the main recommendation of the KCE is to investigate the possibility of introducing an ‘interdisciplinary bilan’ for patients with different and interrelated complaints.

Enhancing the value of the sFlt-1/PlGF ratio for the prediction of preeclampsia: Cost analysis from the Belgian healthcare payers' perspective.

To evaluate the economic impact of introducing the soluble fms-like tyrosine kinase (sFlt-1) to placental growth factor (PlGF) ratio test into clinical practice in Belgium for the prediction of preeclampsia (PE). We developed a one-year time-horizon decision tree model to evaluate the short-term costs associated with the introduction of the sFlt-1/PlGF test for guiding the management of women with suspected PE from the Belgian public healthcare payers' perspective. The model estimated the costs associated with the diagnosis and management of PE in pregnant women managed in either a test scenario, in which the sFlt-1/PlGF test is used in addition to current clinical practice, or a no test scenario, in which clinical decisions are based on current practice alone. Test characteristics were derived from PROGNOSIS, a non-interventional study in women presenting with clinical suspicion of PE. Unit costs were obtained from Belgian-specific sources. The main model outcome was the total cost per patient. Introduction of the sFlt-1/PlGF ratio test is expected to result in a cost saving of €712 per patient compared with the no test scenario. These savings are generated mainly due to a reduction in unnecessary hospitalizations. The sFlt-1/PlGF test is projected to result in substantial cost savings for the Belgian public healthcare payers through reduction of unnecessary hospitalization of women with clinical suspicion of PE that ultimately do not develop the condition. The test also has the potential to ensure that women at high risk of developing PE are identified and appropriately managed.

The impact of Covid-19 on Belgian mental health care: A Delphi study among psychosocial health professionals, patients, and informal caretakers

The Covid-19 pandemic is primarily viewed as a threat to physical health, and therefore, biomedical sciences have become an integral part of the public discourse guiding policy decisions. Nonetheless, the pandemic and the measures implemented have an impact on the population’s psychosocial health. The impact of Covid-19 on the psychosocial care system should be thoroughly investigated to mitigate this effect. In this context, the present study was conducted to establish a consensus about the impact of Covid-19 on psychosocial health and the care system in Belgium. Using the Belgian Superior Health Council’s expert database, a three-round Delphi consensus development process was organized with psychosocial experts (i.e., professionals, patients, and informal caregiver representatives). Overall, 113 of the 148 experts who participated in round 1 fully completed round 2 (76% response rate). Consensus (defined as >70% agreement and an interquartile interval (IQR) of no more than 2) was reached in round 2 for all but three statements. Fifty experts responded to round 3 by providing some final nuances, but none of them reaffirmed their positions or added new points to the discussion (44.25% response rate). The most robust agreement (>80%) was found for three statements: the pandemic has increased social inequalities in society, which increase the risk of long-term psychosocial problems; the fear of contamination creates a constant mental strain on the population, wearing people out; and there is a lack of strategic vision about psychosocial care and an underestimation of the importance of psychosocial health in society. Our findings show that experts believe the psychosocial impact of Covid-19 is underappreciated, which has a negative impact on psychosocial care in Belgium. Several unmet needs were identified, but so were helpful resources and barriers. The Delphi study’s overarching conclusion is that the pandemic does not affect society as a whole in the same way or with the same intensity. The experts, thereby, warn that the psychosocial inequalities in society are on the rise.

OP248 A Minimum Data-Set For Left Ventricular Assist Device On Destination Therapy: Cross-Border Collaboration Pilot On Real World Data

IntroductionThe European Health Technology Assessment Network (EUnetHTA) Work Package 5B1, is focused on testing the levels of cross-border collaboration on real world data for supporting reimbursement/pricing decision-making. Within this Work Package, we are conducting a pilot on Left Ventricular Assist Device on destination therapy in collaboration with the National Institute for Health and Care Excellence (NICE, UK), the Belgian Health Care Knowledge Centre (KCE, Belgium) and the Italian National Agency for Regional Health Services (AGENAS, Italy). This pilot aims to define the minimum data set for gathering and sharing high quality registry data on key uncertainties found at the time of the health technology assessment (HTA). Furthermore, the pilot will assess the feasibility of carrying out a common analysis or reusing this data for National or Joint Reassessments.MethodsEvidence gaps were based on the four national assessments. Collaborating partners were responsible for agreeing on the key outcomes and proposing the minimum dataset to be registered. European clinical experts and patients rated and prioritized the dataset using a two round Delphi technique (not relevant, important but not critical; critical). The dataset will confirm the basis for the Spanish LVAD registry, implemented at the national health service level to inform inclusion into the healthcare portfolio.ResultsThe key outcomes agreed upon by agencies relate to safety, effectiveness, satisfaction and acceptability of the patient and cost-effectiveness, budget impact and organizational impact. Expert cardiologists and cardiac surgeons representing the European and Spanish Society, among others, participated in the prioritization of basic data. The final dataset is expected by December 2020.ConclusionsThe variation in the quality and definition of outcome measures for measuring key evidence gaps reduces the utility of registries for HTA, making it difficult to compare, link, and aggregate data across countries. The EUnetHTA pilot is intended to offer a model for cross-border collaboration on real world data for supporting the decision-making process for pricing and reimbursement.

The process to obtain reimbursement for enzymatic debridement in clinically deep burns

Introduction Burn eschar removal by enzymatic debridement with NexoBrid® (EDNX) results in a maximum preservation of all viable tissue, which is the main advantage over traditional tangential excision. The authors participated in a marketing authorization holder process to obtain reimbursement from the national health authorities in Belgium. Material and methods The reimbursement process consisted of three phases, as specified by the reimbursement regulations required by the Belgian National Institute for Health and Disability Insurance (NIHDI). Results Forty-one patients with clinically deep 2nd and 3rd degree burns, treated with EDNX in two Belgian burn centers, were included in the registry for the first phase of the reimbursement process. The total success rate of the EDNX treatment was 95.1% (39/41). Over half of the burn wounds treated with NexoBrid® (55.2%) did not require any additional surgical debridement or skin grafting. To obtain definitive reimbursement, an extra 16 patients were included. In this population, 51.4% did not require any surgical intervention. The total success rate of the EDNX debridement in this group was 100%. Based on an estimated market share of 12% and around 75 patients in the third year after final reimbursement, a market access consultant calculated that NexoBrid® will realize yearly savings for the Belgian Healthcare budget of at least €30.000. Conclusion Based on the results of this Belgian registry study in combination with the yearly healthcare budget savings, the NIHDI granted a final reimbursement for EDNX treatment in adults, endorsed by the Minister of Health on November 5th, 2019.

Sufficient personal protective equipment training can reduce COVID-19 related symptoms in healthcare workers: A prospective cohort study

BackgroundThe association between inadequate personal protective equipment during the COVID-19 pandemic and an increased risk of SARS-CoV-2 infection in frontline healthcare workers has been proven. However, frontline healthcare workers with an adequate supply of personal protective equipment still showed an increased risk of contracting COVID-19. Research on the use of personal protective equipment could provide insight into handling present and future pandemics. ObjectivesThis study aims to investigate the impact of the availability, training and correct selection of personal protective equipment on the incidence of SARS-CoV-2 infection or positive suspect cases in healthcare workers during the COVID-19 pandemic in Belgium. DesignThis was a prospective cohort study involving Belgian healthcare workers: nurses, nursing aides, and midwives working in hospitals, home care services, and residential care services. MethodsRespondents were invited from May to July 2020 (period 1) followed by a second time in October 2020 (period 2) to complete a digital survey on personal protective equipment availability, training, personal protective equipment selection, screening ability, COVID-19 testing and status, and symptoms corresponding with the COVID-19 suspect case definition. The main outcome was a composite of COVID-19 status change (from negative to positive) during the study or a positive suspect case definition in period 2. ResultsFull data were available for 617 participants. The majority of respondents were nurses (93%) employed in a hospital (83%). In total, 379 respondents provided frontline care for COVID-19 patients (61%) and were questioned on personal protective equipment availability and personal protective equipment selection. Nurses were more likely to select the correct personal protective equipment compared with nursing aides and midwives. Respondents working in residential care settings were least likely to choose personal protective equipment correctly. Of all healthcare workers, 10% tested positive for COVID-19 during the course of the study and a composite outcome was reached in 54% of all respondents. Working experience and sufficient personal protective equipment training showed an inverse relation with the composite outcome. The relationship between personal protective equipment availability and the composite outcome was fully mediated by personal protective equipment training (-0.105 [95% confidence interval -0.211 — -0.020]). ConclusionsProper training in personal protective equipment usage is critical to reduce the risk of COVID infection in healthcare workers. During a pandemic, rapid dissemination of video guidelines could improve personal protective equipment knowledge in practitioners.Tweetable abstract: Proper training in personal protective equipment usage is critical to reduce the risk of COVID infection in healthcare workers.

Remdesivir plus standard of care versus standard of care alone for the treatment of patients admitted to hospital with COVID-19 (DisCoVeRy): a phase 3, randomised, controlled, open-label trial

BackgroundThe antiviral efficacy of remdesivir against SARS-CoV-2 is still controversial. We aimed to evaluate the clinical efficacy of remdesivir plus standard of care compared with standard of care alone in patients admitted to hospital with COVID-19, with indication of oxygen or ventilator support.MethodsDisCoVeRy was a phase 3, open-label, adaptive, multicentre, randomised, controlled trial conducted in 48 sites in Europe (France, Belgium, Austria, Portugal, Luxembourg). Adult patients (aged ≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection and illness of any duration were eligible if they had clinical evidence of hypoxaemic pneumonia, or required oxygen supplementation. Exclusion criteria included elevated liver enzymes, severe chronic kidney disease, any contraindication to one of the studied treatments or their use in the 29 days before random assignment, or use of ribavirin, as well as pregnancy or breastfeeding. Participants were randomly assigned (1:1:1:1:1) to receive standard of care alone or in combination with remdesivir, lopinavir–ritonavir, lopinavir–ritonavir and interferon beta-1a, or hydroxychloroquine. Randomisation used computer-generated blocks of various sizes; it was stratified on severity of disease at inclusion and on European administrative region. Remdesivir was administered as 200 mg intravenous infusion on day 1, followed by once daily, 1-h infusions of 100 mg up to 9 days, for a total duration of 10 days. It could be stopped after 5 days if the participant was discharged. The primary outcome was the clinical status at day 15 measured by the WHO seven-point ordinal scale, assessed in the intention-to-treat population. Safety was assessed in the modified intention-to-treat population and was one of the secondary outcomes. This trial is registered with the European Clinical Trials Database, EudraCT2020-000936-23, and ClinicalTrials.gov, NCT04315948.FindingsBetween March 22, 2020, and Jan 21, 2021, 857 participants were enrolled and randomly assigned to remdesivir plus standard of care (n=429) or standard of care only (n=428). 15 participants were excluded from analysis in the remdesivir group, and ten in the control group. At day 15, the distribution of the WHO ordinal scale was: (1) not hospitalised, no limitations on activities (61 [15%] of 414 in the remdesivir group vs 73 [17%] of 418 in the control group); (2) not hospitalised, limitation on activities (129 [31%] vs 132 [32%]); (3) hospitalised, not requiring supplemental oxygen (50 [12%] vs 29 [7%]); (4) hospitalised, requiring supplemental oxygen (76 [18%] vs 67 [16%]); (5) hospitalised, on non-invasive ventilation or high flow oxygen devices (15 [4%] vs 14 [3%]); (6) hospitalised, on invasive mechanical ventilation or extracorporeal membrane oxygenation (62 [15%] vs 79 [19%]); (7) death (21 [5%] vs 24 [6%]). The difference between treatment groups was not significant (odds ratio 0·98 [95% CI 0·77–1·25]; p=0·85). There was no significant difference in the occurrence of serious adverse events between treatment groups (remdesivir, 135 [33%] of 406 vs control, 130 [31%] of 418; p=0·48). Three deaths (acute respiratory distress syndrome, bacterial infection, and hepatorenal syndrome) were considered related to remdesivir by the investigators, but only one by the sponsor's safety team (hepatorenal syndrome).InterpretationNo clinical benefit was observed from the use of remdesivir in patients who were admitted to hospital for COVID-19, were symptomatic for more than 7 days, and required oxygen support.FundingEuropean Union Commission, French Ministry of Health, Domaine d'intérêt majeur One Health Île-de-France, REACTing, Fonds Erasme-COVID-Université Libre de Bruxelles, Belgian Health Care Knowledge Centre, Austrian Group Medical Tumor, European Regional Development Fund, Portugal Ministry of Health, Portugal Agency for Clinical Research and Biomedical Innovation.TranslationFor the French translation of the abstract see Supplementary Materials section.

Van patiëntenrechten naar patiëntenwaarden

From patients' rights to patients' values In 2022, the Patient’s Rights Act will be 20 years old. This Act has created a permanent recognition of the central position of the patient and his autonomy within the Belgian healthcare system. The Act did undergo some limited changes, but generally remained the same. Nevertheless, the evolution of the healthcare reveals new points of interest and demands attention to so-called patient values, namely quality, care innovation and patient participation. These patient values also reflect the critics formulated on the Patient’s Rights Act. The Belgian patient’s rights framework today consists of a number of other regulations besides the Patient’s Rights Act itself. All these regulations currently form a diffuse patient’s rights framework. In order to guarantee the central position of patient’s rights in our health care system for the next 20 years, a new approach of patient’s rights protection through the patient values is suggested in this article, focusing on quality, care innovation and patient participation and based on the existing legal patient’s rights framework.

P-011. sFLT-1, PLGF e sFLT-1/PLGF levels in preeclampsia: correlation with mediated maternal results

To evaluate the economic impact of introducing the soluble fms-like tyrosine kinase (sFlt-1) to placental growth factor (PlGF) ratio test into clinical practice in Belgium for the prediction of preeclampsia (PE).Study design: We developed a one-year time-horizon decision tree model to evaluate the short-term costs associated with the introduction of the sFlt-1/PlGF test for guiding the management of women with suspected PE from the Belgian public healthcare payers’ perspective. The model estimated the costs associated with the diagnosis and management of PE in pregnant women managed in either a test scenario, in which the sFlt-1/PlGF test is used in addition to current clinical practice, or a no test scenario, in which clinical decisions are based on current practice alone. Test characteristics were derived from PROGNOSIS, a non-interventional study in women presenting with clinical suspicion of PE. Unit costs were obtained from Belgian-specific sources. The main model outcome was the total cost per patient.Introduction of the sFlt-1/PlGF ratio test is expected to result in a cost saving of €712 per patient compared with the no test scenario. These savings are generated mainly due to a reduction in unnecessary hospitalizations.The sFlt-1/PlGF test is projected to result in substantial cost savings for the Belgian public healthcare payers through reduction of unnecessary hospitalization of women with clinical suspicion of PE that ultimately do not develop the condition. The test also has the potential to ensure that women at high risk of developing PE are identified and appropriately managed.

Validation of a Novel Forecasting Method for Estimating the Impact of Switching Pneumococcal Conjugate Programs: Evidence from Belgium.

IntroductionSince 2010, 10-valent (PCV10) and 13-valent pneumococcal conjugate vaccines (PCV13) have been available as part of infant national immunization programs. Belgium is as one of the few countries that implemented PCV13 (2007–2015), switched to PCV10 (2015–2018) and then switched back to PCV13 (2018–present) after observing increases in disease. We assessed the impacts of both historical and prospective PCV choice in the context of the Belgian health care system and used this experience to validate previously developed economic models.MethodsUsing historical incidence (2007–2018) of pneumococcal disease for Belgian children aged < 16 years, observed invasive pneumococcal disease (IPD) trends from surveillance data were used to estimate future disease in a given PCV13- or PCV10-based program. We compared observed incidence data with two modeled scenarios: (1) the 2015 switch to PCV10 and (2) a hypothetical continuation of PCV13 in 2015. Finally, we explored the potential impact of PCV choice from 2019 to 2023 by comparing three scenarios: (3) continued use of PCV10; (4) a switch back to PCV13; (5) a hypothetical scenario in which Belgium never switched from PCV13.ResultsModel predictions underestimated observed data from 2015 to 2018 by 100 IPD cases among ages < 16 years. Comparing observed data with scenario 2 suggests that PCV13 would have prevented 105 IPD cases from 2015 to 2018 compared with PCV10. Switching to PCV13 in 2019 would avert 625 IPD cases through 2023 compared with continuing PCV10. Scenario never switching from PCV13 would have resulted in a reduction of 204 cases from 2016 to 2023 compared with switching to PCV10 and switching back to PCV13.ConclusionThe findings from this study suggest that previously published modeling results of PCV13 versus PCV10 in other countries may have underestimated the benefit of PCV13. These results highlight the importance of continually protecting against vaccine-preventable pneumococcal serotypes.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40121-021-00485-9.

IMPACT OF THE COVID‐19 PANDEMIC ON THE DIAGNOSIS OF MATURE LYMPHOID NEOPLASMS IN BELGIUM: RESULTS FROM THE BELGIAN CANCER REGISTRY

Introduction: Health care in Belgium was affected by the corona pandemic and the corresponding measures taken by the government since March 2020. The aim of this study is to make an estimate of the decrease in the number of new diagnoses of mature lymphoid neoplasms (MLN) due to the COVID-19 crisis in Belgium. Methods: For its standard cancer reporting, the Belgian Cancer Registry uses two data sources: • The oncological care programs from the hospitals provide structured data (‘clinical network’) • The pathology laboratories deliver structured files and reports (‘pathology network’) Thanks to expedited deliveries of data by the pathology network between January and September 2020, the Belgian Cancer Registry was able to make an estimation of the decline in the number of diagnoses by types of MLN. Since estimates were only based on pathology data and to prevent bias, all results are shown as a relative ratio between the new cancer diagnoses for incidence years 2020 and 2019. The ratios for the months January and February, both prior to the start of the COVID-19 pandemic, were expected to be around 100%. Decline = ratio -100%. Results: After a strong decline by 28% during the first wave (March-May 2020) when compared to March-May 2019, the total diagnosis of MLN reported by the pathology network stabilized around normal values compared to 2019 levels, leading to an incomplete recovery by end September 2020 (-12%). Variable effect by age group Although the 2 adult age groups, 20-79 vs 80+, exhibited the same reduction of 28% during the March-May period, a partial recovery was observed for the 20-79 age group (+4%) during the following June-September period while the older population showed a persistent reduction (-9%), leading to an overall decline of 16% for the 80+ compared to 10% for the 20-79 age group. Although subject to a low number of cases, there was no evidence of a decline in children and adolescents up to 19 years of age. Variable effect by MLN type Among B-cell MLN, the largest decrease by September was observed for mature B-cell leukemias (March-Sept: -28%; March-May: -43%). The decrease was smaller for plasma cell neoplasms (-18%; -34%), other indolent lymphomas (-14%; -40%) and Hodgkin lymphoma (-6%; -30%) while no evidence of decline for the more aggressive MLN (DLBCL and Burkitt lymphoma), except for 80+ (March-Sept: -13%). The strongest rebound in diagnosis was observed for mature T/NK cell lymphomas which completely recovered to above 2019 levels (March-May: -22%, June-Sept: +25%). Conclusion: This study with pathology data available until the end of September suggests a heterogeneous impact of the COVID19 crisis on the different types of MLN. The largest persistent declines are observed for the more indolent MLNs, while the effect was very limited for the high-grade B-cell lymphoid neoplasms, with exception of the older population. The research was funded by: Belgian Fondation Against Cancer Keywords: Cancer Health Disparities, Pathology and Classification of Lymphomas No conflicts of interests pertinent to the abstract.

Prevalence and incidence of anti-SARS-CoV-2 antibodies among healthcare workers in Belgian hospitals before vaccination: a prospective cohort study

ObjectivesTo describe prevalence and incidence of anti-SARS-CoV-2 antibodies among Belgian hospital healthcare workers (HCW) in April–December 2020.DesignProspective cohort study. Follow-up was originally planned until September and later extended.SettingMulticentre study, 17...

Positive screens for mental disorders among healthcare professionals during the first covid19 wave in Belgium

We examined the manifestation of major depressive disorder, generalized anxiety disorder, substance use disorder, post-traumatic stress disorder, and panic attacks among health care professionals during the first COVID-19 wave (n = 6409) by means of mental disorder screening instruments. Logistic regressions were used to gauge individual risk factors; population attributable risk proportions (PARP) were inferred to identify the most important risk factors at the societal level. Data were weighted to represent general profiles of Belgian health care professionals. Lifetime, pre-pandemic emotional problems and work-related factors during the first wave of COVID-19 were strongly associated (mean adjusted odds ratios of 3.79 and 1.47, respectively) with positive screens for current mental disorders (occurrence of 29.3%). Most prominently, the data suggest that disruptions of work-life balance account for more than a quarter of the observed mental health problems due to the combination of widespread occurrence and strong association.

Remdesivir for the Treatment of Hospitalised Patients with COVID-19 (DisCoVeRy): A Randomised, Controlled, Open-Label Trial

Remdesivir for the Treatment of Hospitalised Patients with COVID-19 (DisCoVeRy): A Randomised, Controlled, Open-Label Trial

Cost-effectiveness of adding Sativex\xae spray to spasticity care in Belgium: using bootstrapping instead of Monte Carlo simulation for probabilistic sensitivity analyses

BackgroundUncertainty in model-based cost-utility analyses is commonly assessed in a probabilistic sensitivity analysis. Model parameters are implemented as distributions and values are sampled from these distributions in a Monte Carlo simulation. Bootstrapping is an alternative method that requires fewer assumptions and incorporates correlations between model parameters.MethodsA Markov model-based cost–utility analysis comparing oromucosal spray containing delta-9-tetrahidrocannabinol + cannabidiol (Sativex®, nabiximols) plus standard care versus standard spasticity care alone in the management of multiple sclerosis spasticity was performed over a 5-year time horizon from the Belgian healthcare payer perspective. The probabilistic sensitivity analysis was implemented using a bootstrap approach to ensure that the correlations present in the source clinical trial data were incorporated in the uncertainty estimates.ResultsAdding Sativex® spray to standard care was found to dominate standard spasticity care alone, with cost savings of €6,068 and a quality-adjusted life year gain of 0.145 per patient over the 5-year analysis. The probability of dominance increased from 29% in the first year to 94% in the fifth year, with the probability of QALY gains in excess of 99% for all years considered.ConclusionsAdding Sativex® spray to spasticity care was found to dominate standard spasticity care alone in the Belgian healthcare setting. This study showed the use of bootstrapping techniques in a Markov model probabilistic sensitivity analysis instead of Monte Carlo simulations. Bootstrapping avoided the need to make distributional assumptions and allowed the incorporation of correlating structures present in the original clinical trial data in the uncertainty assessment.

Het traject van een patiënt met een hoofd- en halsmaligniteit in België

The pathway of a patient with a head and neck malignancy in Belgium This article describes the pathway of a patient with a head and neck malignancy from diagnosis to treatment. As this is the sixth most frequent malignancy, every physician has patient contacts in this population. Consecutively, the history taking, clinical examination and red flags are described, as well as the treatment which may consist of surgery, radiotherapy or systemic therapy or a combination of these. The indications, goal and complications of each of these therapies are discussed. The side effects and contra indications are highlighted. The innovative treatment and the recent addition of immunotherapy for head and neck tumors are discussed. Finally, the importance of support by a nurse specialized in oncological care is emphasized and the quality criteria implemented by the Belgian Health Care Knowledge Centre (KCE) are described.

De impact van de Covid-19-epidemie op het aandeel diagnoses van metastatische ziekte van de meest frequente kankers

The impact of the Covid-19 epidemic on the proportion of distant metastatic cancer diagnoses of the most frequent cancer types The Covid-19 epidemic had a tremendous impact on the Belgian health care system in March and April 2020 with non-urgent procedures and examinations being postponed and screening programs coming to a halt. This might have delayed cancer diagnosis. In this article the impact of the Covid-19 epidemic on the proportion of metastatic cancer diagnoses of the most frequent cancer types was examined. The data of the cancer registry of the Ziekenhuisnetwerk Antwerpen (ZNA) from March until August in the years 2018, 2019 and 2020 were retrospectively analysed. The studied cancer types were invasive breast cancer, colorectal cancer, lung cancer and prostate cancer. There is no relation between the time of diagnosis and the extent of disease. The ratio of metastatic and localised disease did not differ between the studied time periods. However, there is a reduction in the number of diagnosis for breast cancer, prostate cancer and lung cancer, compared with the same period in 2019. This reduction was most pronounced in prostate cancer with a relative reduction of 23%. For now, there does not seem to be a major impact of Covid-19 related restriction measures on the proportion of diagnosis of metastatic cancers in the defined registration period at Ziekenhuisnetwerk Antwerpen. However, further research is necessary to evaluate if the reduced number of diagnoses will lead to an increase in belated diagnoses.

Belgian rare diseases plan in clinical pathology: identification of key biochemical diagnostic tests and establishment of reference laboratories and financing conditions

BackgroundOne objective of the Belgian Rare Diseases plan is to improve patients’ management using phenotypic tests and, more specifically, the access to those tests by identifying the biochemical analyses used for rare diseases, developing new financing conditions and establishing reference laboratories.MethodsA feasibility study was performed from May 2015 until August 2016 in order to select the financeable biochemical analyses, and, among them, those that should be performed by reference laboratories. This selection was based on an inventory of analyses used for rare diseases and a survey addressed to the Belgian laboratories of clinical pathology (investigating the annual analytical costs, volumes, turnaround times and the tests unavailable in Belgium and outsourced abroad). A proposal of financeable analyses, financing modalities, reference laboratories’ scope and budget estimation was developed and submitted to the Belgian healthcare authorities. After its approval in December 2016, the implementation phase took place from January 2017 until December 2019.ResultsIn 2019, new reimbursement conditions have been published for 46 analyses and eighteen reference laboratories have been recognized. Collaborations have also been developed with 5 foreign laboratories in order to organize the outsourcing and financing of 9 analyses unavailable in Belgium.ConclusionsIn the context of clinical pathology and rare diseases, this initiative enabled to identify unreimbursed analyses and to meet the most crucial financial needs. It also contributed to improve patients’ management by establishing Belgian reference laboratories and foreign referral laboratories for highly-specific analyses and a permanent surveillance, quality and financing framework for those tests.

Anti-adhesion Gel versus No gel following Operative Hysteroscopy prior to Subsequent fertility Treatment or timed InterCourse (AGNOHSTIC), a randomised controlled trial: protocol.

STUDY QUESTIONSDoes the application of anti-adhesion gel, compared to no gel, following operative hysteroscopy to treat intrauterine pathology in women wishing to conceive increase the chance of conception leading to live birth?WHAT IS KNOWN ALREADYIntrauterine adhesions (IUAs) following operative hysteroscopy may impair reproductive success in women of reproductive age. Anti-adhesion barrier gels may decrease the occurrence of IUAs, but the evidence on their effectiveness to improve reproductive outcomes is sparse and of low quality.STUDY DESIGN, SIZE, DURATIONThis multicentre, parallel group, superiority, blinded and pragmatic randomised controlled trial is being carried out in seven participating centres in Belgium. Recruitment started in April 2019. Women will be randomly allocated to treatment with anti-adhesion gel (intervention group) or no gel (control group). Sterile ultrasound gel will be applied into the vagina as a mock-procedure in both treatment arms. The patient, fertility physician and gynaecologist performing the second-look hysteroscopy are unaware of the allocated treatment. Power analysis, based on a target improvement of 15% in conception leading to live birth using anti-adhesion gel, a power of 85%, a significance level of 5%, and a drop-out rate of 10%, yielded a number of 444 patients to be randomised. The baseline rate of conception leading to live birth in the control group is expected to be 45%.PARTICIPANTS/MATERIALS, SETTING, METHODSWomen of reproductive age (18–47 years), wishing to conceive (spontaneously or by fertility treatment) and scheduled for operative hysteroscopy to treat intrauterine pathology (endometrial polyps, myomas with uterine cavity deformation, uterine septa, IUAs or retained products of conception) are eligible for recruitment. Women may try to conceive from 3 to 6 weeks after receiving allocated treatment with follow-up ending at 30 weeks after treatment. If the woman fails to conceive within this timeframe, a second-look hysteroscopy will be scheduled within 2–6 weeks to check for IUAs. The primary endpoint is conception leading to live birth, measured at 30 weeks after randomisation. The secondary endpoints are time to conception, clinical pregnancy, miscarriage and ectopic pregnancy rates, measured at 30 weeks after receiving allocated treatment. The long-term follow-up starts when the patient is pregnant and she will be contacted every trimester.STUDY FUNDING/COMPETING INTEREST(S)This work is funded by the Belgian Healthcare Knowledge Centre (KCE). The anti-adhesion gel is supplied at no cost by Nordic Pharma and without conditions. Dr. Tomassetti reports grants and non-financial support from Merck SA, non-financial support from Ferring SA, personal fees and non-financial support from Gedeon-Richter, outside the submitted work. None of the other authors have a conflict of interest.