Ulcus cruris venosum: Was bringt die frühzeitige endovenöse Ablation bei venösen Ulzerationen?

<b>Importance:</b> One-year outcomes from the Early Venous Reflux Ablation (EVRA) randomized trial showed accelerated venous leg ulcer healing and greater ulcer-free time for participants who are treated with early endovenous ablation of lower extremity superficial reflux. <b>Objective:</b> To evaluate the clinical and cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with venous leg ulceration. <b>Design, Setting, and Participants:</b> Between October 24, 2013, and September 27, 2016, the EVRA randomized clinical trial enrolled 450 participants (450 legs) with venous leg ulceration of less than 6 months’ duration and superficial venous reflux. Initially, 6555 patients were assessed for eligibility, and 6105 were excluded for reasons including ulcer duration greater than 6 months, healed ulcer by the time of randomization, deep venous occlusive disease, and insufficient superficial venous reflux to warrant ablation therapy, among others. A total of 426 of 450 participants (94.7%) from the vascular surgery departments of 20 hospitals in the United Kingdom were included in the analysis for ulcer recurrence. Surgeons, participants, and follow-up assessors were not blinded to the treatment group. Data were analyzed from August 11 to November 4, 2019. <b>Interventions:</b> Patients were randomly assigned to receive compression therapy with early endovenous ablation within 2 weeks of randomization (early intervention, n = 224) or compression with deferred endovenous treatment of superficial venous reflux (deferred intervention, n = 226). Endovenous modality and strategy were left to the preference of the treating clinical team. <b>Main Outcomes and Measures:</b> The primary outcome for the extended phase was time to first ulcer recurrence. Secondary outcomes included ulcer recurrence rate and cost-effectiveness. <b>Results:</b> The early-intervention group consisted of 224 participants (mean [SD] age, 67.0 [15.5] years; 127 men [56.7%]; 206 White participants [92%]). The deferred-intervention group consisted of 226 participants (mean [SD] age, 68.9 [14.0] years; 120 men [53.1%]; 208 White participants [92%]). Of the 426 participants whose leg ulcer had healed, 121 (28.4%) experienced at least 1 recurrence during follow-up. There was no clear difference in time to first ulcer recurrence between the 2 groups (hazard ratio, 0.82; 95% CI, 0.57–1.17; P = .28). Ulcers recurred at a lower rate of 0.11 per person-year in the early-intervention group compared with 0.16 per person-year in the deferred-intervention group (incidence rate ratio, 0.658; 95% CI, 0.480–0.898; P = .003). Time to ulcer healing was shorter in the early-intervention group for primary ulcers (hazard ratio, 1.36; 95% CI, 1.12–1.64; P = .002). At 3 years, early intervention was 91.6% likely to be cost-effective at a willingness to pay of £20 000 ($26 283) per quality-adjusted life year and 90.8% likely at a threshold of £35 000 ($45 995) per quality-adjusted life year. <b>Conclusions and Relevance:</b> Early endovenous ablation of superficial venous reflux was highly likely to be cost-effective over a 3-year horizon compared with deferred intervention. Early intervention accelerated the healing of venous leg ulcers and reduced the overall incidence of ulcer recurrence. <b>Trial Registration:</b> ClinicalTrials.gov identifier: ISRCTN02335796.

Benefits, risks, and cost-effectiveness of COVID-19 self-tests from a consumer’s perspective

Background The aim of this study is to quantify the health benefits, risks, and cost-effectiveness of COVID-19 self-tests from a consumer’s perspective in Germany. Methods The analysis is based on a modelling approach using secondary data. The clinical endpoints considered in this analysis are avoided SARS-CoV-2 infections and secondary severe clinical events (death, intensive care unit (ICU) admission, and long COVID syndrome). The study determines the number of self-tests that need to be conducted under a 7-day incidence of 75 per 100,000 population to prevent one infection or severe clinical event. Furthermore, the study calculates the cost of testing per avoided clinical event and quality-adjusted life year (QALY) gained from a consumer perspective. Results Disregarding the rate of unreported COVID-19 cases, 4556 self-tests need to be conducted (over 12 years) in order to avoid one undesirable event (death, intensive care unit stay, or long COVID syndrome). Ninety percent of infections are not avoided among direct contacts but along the chain of infection. The costs per quality-adjusted life year gained from a consumer’s perspective are €5870. This ratio is particularly sensitive to the 7-day incidence, effective reproduction number, and the age of contacts. Conclusions The benefits of self-testing in the general population at a 7-day incidence rate of 75 per 100,000 appear to be minor. Nevertheless, cost-effectiveness may still be acceptable in the presence of higher-risk contacts given the low costs of self-test kits in Germany.

Cost-effectiveness of screening smokers and ex-smokers for lung cancer in the Netherlands in different age groups

Objective We aimed to assess the cost-effectiveness of screening smokers and ex-smokers for lung cancer in the Netherlands. Methods A Markov model was used to evaluate the health effects and costs of lung cancer screening from the healthcare perspective. The effects and costs of ten screening scenarios with different start and stop ages of screening were examined across a lifetime horizon in a cohort of 100,000 smokers and ex- smokers 50 years and older. Results The incremental cost-effectiveness ratios (ICERs) of screening smokers and ex-smokers aged 50–60 years, 50–70 years, and 50 years and older are below the cost-effectiveness threshold of € 20,000 per quality adjusted life year (QALY) gained. Screening 50–60-year-old smokers and ex-smokers was the most cost-effective scenario with an ICER of € 14,094 per QALY gained. However, screening smokers and ex-smokers 50 years and older yielded the highest QALYs and resulted in an ICER of € 16,594 per QALY, which is below the threshold of € 20,000 per QALY. All screening scenarios compared to no screening resulted in CERs between the € 14,000 and € 16,000 per QALY gained. The efficiency frontier showed that screening smokers and ex-smokers in the age groups 70 years and older, 60–70 years, 60 years and older are excluded by extended dominance by no screening, screening smokers and ex-smokers aged 50–60 years and 50–70 years. Conclusion This study showed that lung cancer screening is cost-effective in the Netherlands.

Additional offer of sigmoidoscopy in colorectal cancer screening in Germany: rationale and protocol of the decision-analytic modelling approach in the SIGMO study

IntroductionIn Germany, statutory insured persons are entitled to a stool test (faecal immunochemical test (FIT)) or colonoscopy for colorectal cancer (CRC) screening, depending on age and sex, yet participation rates are rather low. Sigmoidoscopy is a currently not available screening measure that has a strong evidence base for incidence and mortality reduction. Due to its distinct characteristics, it might be preferred by some, who now reject colonoscopy. The objective of this study is to estimate the economic consequences of the additional offer of sigmoidoscopy for CRC screening in Germany compared with the present screening practice while considering the preferences of the general population.Methods and analysisA decision-analytic modelling approach will be developed that compares the present CRC screening programme in Germany (FIT, colonoscopy) with a programme extended by sigmoidoscopy from a societal perspective. A decision tree and Markov model will be combined to assess both short-term and long-term effects, such as CRC and adenoma detection rates, the number of CRC cases, CRC mortality as well as complications. The incremental cost per quality-adjusted life year gained for each alternative will be calculated. The model will incorporate the general population’s preferences based on a discrete choice experiment. Further, input parameters will be taken from the literature, the German cancer registry and health insurance claims data.Ethics and disseminationEthical approval for the study was obtained from the Ethics Committee of Hannover Medical School (ID: 8671_BO_K_2019). The findings of the study will be published in peer-reviewed journals and presented at national and/or international conferences.Trial registration numberDRKS00019010.

Monetary valuation of a Quality-Adjusted Life Year (QALY) for depressive disorders among patients and non-patient respondents: A matched willingness to pay study

Background As estimated by the World Health Organization, depressive disorders will be the leading contributor to the Global Burden of Disease by 2030. In light of this fact, we designed a study whose aim was to investigate whether the value placed on health-related quality of life (HRQoL) for a depressive disorder is higher in patients diagnosed with a major depressive disorder (MDD) compared to non-patients in a matched sample. Method We collected data on willingness to pay (WTP) for a total of four health-gain scenarios, which were presented to 18 outpatients diagnosed with a MDD versus 18 matched non-patient respondents with no symptoms of depression. Matching characteristics included age, income, level of education, and type of health insurance. Respondents were presented with different HRQoL scenarios in which they could choose to pay money to regain their initial health state through various treatment options (e.g., inpatient treatment, electroconvulsive therapy). To test whether the probability of stating a positive WTP differed significantly between the two samples, Fisher’s exact test was used. Differences regarding stated WTP between the samples were investigated using the Mann-Whitney U-test. Results For most of the health scenarios, the probability of stating a positive WTP did not differ between the two samples. However, patient respondents declared WTP values up to 7.4 times higher than those stated by matched non-patient respondents. Conclusion Although the perceived necessity to pay for mental-HRQoL gains did not differ between respondents with MDD and respondents with no symptoms of depression, patient respondents stated higher values.

Cost-effectiveness analysis of COVID-19 vaccination in Poland

IntroductionTo assess the potential value of the Comirnaty COVID-19 vaccination in Poland.Material and methodsMarkov model with 1-week cycles was used to estimate patient events, direct medical costs, utilities and cost-effectiveness for one year with and without implementing the Comirnaty vaccine in Poland. The incremental cost per quality-adjusted life-year (QALY) gained vs. no vaccine was calculated for the general population as well as for selected age-groups.ResultsIn the base case analysis the incremental cost per QALY gained associated with vaccinating the whole population amounted 6,249 PLN. For individuals aged 60-69 and >80 vaccination proved to be less costly and more effective than no vaccination. The incremental cost per QALY gained when vaccinating individuals aged 40-49 and 30-39 amounted 28,135 PLN and 67,823 PLN, respectively. In the general population and in younger subpopulations the incremental cost-effectiveness ratio was most sensitive to the vaccine effectiveness, vaccine price and SARS-CoV-2 infection rates.ConclusionsWhen prioritization is required due to supply constraints, vaccination of elderly is justified as it allows to achieve highest number of QALY gained and generates savings to the health care system. Continual update of the model concerning vaccine real-life effectiveness and epidemic course is required to refine the prioritisation scheme in the future.

Cost-effectiveness of home non-invasive ventilation in COPD group GOLD D patients

Introduction. Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality, estimated to be the third most common cause of death by 2020. The natural evolution of the disease is characterized by frequent exacerbations, severe exacerbations evolving with respiratory acidosis. Introducing home non-invasive ventilation (NIV) in the management of COPD group GOLD (Global Initiative for Chronic Obstructive Lung Disease) D patients generates supplementary costs, but the decreasing of the number of severe exacerbations will decrease the costs of drug treatment and hospitalization. This balance can be verified through a careful study of cost-effectiveness through modern methods of assessing the costs and years of life gained in relation to quality of life. Material and method. This prospective study took place in the Emergency Department of the Bihor County Clinical Emergency Hospital, Oradea, between 01 October 2017 – 31 October2018, with a follow-up period of 2 years. We included 36 Group risk D COPD patients, presented with severe exacerbation that required NIV; the patients were divided into two study groups according to the treatment scheme after discharge (standard medication according to GOLD guidelines and long-term oxygen therapy - LTOT vs. LTOT + NIV). We follow-up at 2 years with the study group, and analyze the following: number of exacerbations (moderate and severe), number of hospitalizations, mortality rate in two years, average costs for the treatment of exacerbations and for stable COPD periods, quality adjusted life year (QALY). Results and discussions. From 36 enrolled, 10 patients benefited from home NIV. The number of exacerbations was significantly lower in the NIV group compared with the LTOT group (1.72±0.79 vs 3.54±1.18). The incremental cost-effectiveness ratio (ICER) showed a net gain of 31% from gross product (GDP) per capita (5,641.71 ± 1,737.0-euro vs 9,272.3 ± 3,681.9 euro) per quality adjusted life year (QALY) for each patient. Conclusions. Introduction home-NIV demonstrated clinical improvement and higher cost-effectiveness over LTOT alone in Class Risk D, COPD patients after discharge following a severe exacerbation. Keywords: chronic obstructive pulmonary disease, non-invasive ventilation, cost-effectiveness, quality adjusted life year,

PP451 Does NICE Reimburse Oncology Treatments Meeting End-Of-Life Criteria More Often Than Treatments That Do Not?

IntroductionThe National Institute of Health and Care Excellence (NICE) issued a supplementary advice in 2009 stating that treatments for patients with short life expectancies (<24 months) can exceed the cost-effectiveness threshold of GBP30,000 (EUR34,668) per additional quality-adjusted life-year (QALY), as long as the treatment is indicated for small patient populations and there is sufficient evidence that it extends life (≥ three months), compared with current National Health Service (NHS) treatments. This study investigated how often NICE reimburses treatments that meet end-of-life (EOL) criteria.MethodsHealth technology assessments (HTAs) conducted by NICE from 2009 to 2020 were reviewed for approved oncology drugs. Terminated appraisals were excluded. Data regarding EOL criteria in these submissions were then gathered. The HTA decisions were divided into the following categories: EOL criteria met; EOL criteria not met; and EOL criteria not applicable. A chi-square analysis was performed.ResultsA total of 316 reviews were assessed in the final sample, of which 71 percent (n = 223) of decisions were positive. Out of the positive decisions, 43 percent (n = 96), 25 percent (n = 55), and 32 percent (n = 72) of decisions were in the EOL criteria met, EOL criteria not met, and EOL criteria not applicable groups, respectively. The chi-square analysis showed a significant correlation between HTA decisions and EOL criteria (p = 0.0008). These results were consistent when the “EOL criteria not applicable” group was excluded (p = 0.001). When the analysis was performed between the “EOL criteria met” and “EOL criteria not met”, along with “EOL criteria not applicable” groups, it showed a possible correlation (p = 0.05).ConclusionsThis study showed that in oncology, NICE reimburses treatments that meet EOL criteria more often than treatments that attempt, but fail, to meet the EOL criteria.