Economic Evaluations of Screening Programs for Chronic Kidney Disease: A Systematic Review.

OBJECTIVES: The aim of this review is to appraise and assimilate evidence from studies that have reported on the cost-effectiveness of screening programs for chronic kidney disease (CKD). METHODS: The study protocol was registered on International Prospective Register of Systematic Reviews (PROSPERO). The final search was conducted on 18 January 2023 using 7 databases. Screening of articles, data extraction, and quality assessment was performed by 2 independent reviewers. The ISPOR-AMCP-NPC checklist was used to assess the credibility of the included studies. RESULTS: From 4948 retrieved studies, a final total of 20 studies were included in the qualitative synthesis. Studies found that screening in diabetic populations was cost-effective (n = 8, 57%) or even cost-saving (n = 6, 43%). Four studies (67%) found that screening in hypertensive populations was also cost-effective. For the general population, findings were inconsistent across studies in which many found screening to be cost-effective (n = 11, 69%), some cost-saving (n = 2, 12%), and others not cost-effective (n = 3, 19%). The most influential parameters identified were prevalence of CKD and cost of screening. CONCLUSIONS: Screening for CKD in patients with diabetes or hypertension is recommended from a cost-effectiveness point of view. For the general population, despite some inconsistent findings, the majority of studies demonstrated that screening in this population is cost-effective, depending mainly on the prevalence and the costs of screening. Healthcare decision makers need to consider the prevalence, stratification strategies, and advocate for lower screening costs to reduce the burden on healthcare budgets and to make screening even more favorable from the health-economic perspective.

Guiding Principles for Evaluating Vaccines in Joint Health Technology Assessment in the European Union: Preparing for the European Union's Regulation on Health Technology Assessment for Vaccines.

OBJECTIVES: The appraisal of vaccines in the European Union (EU) currently involves many different decision-making bodies and processes. The objective of this study was to help inform the development of standardized methodology and vaccine-specific processes for use in the EU Regulation on health technology assessment (HTA). METHODS: Literature reviews and expert consultation were conducted to identify current practices and gaps related to vaccine appraisals and to develop guiding principles for the joint clinical assessment of vaccines. RESULTS: We found that significant variation exists across the EU member states in the decision-making processes when clinically evaluating vaccines. Three guiding principles consisting of 13 recommendations were developed to help inform the development of decision-making frameworks for the joint clinical assessment of vaccines in the EU: (1) support the creation of appropriate terminology and measurements for clinical appraisals of vaccines; (2) develop inclusive, timely, and transparent vaccine appraisal processes to support stronger evidence generation for vaccine decision making and appraisal; and (3) improve the collection and interoperability of real-world data, including robust surveillance, to foster evidence generation and support the standardization of vaccine clinical appraisals. CONCLUSIONS: Given the significance of vaccines for public health, there is an urgency to develop standardized and vaccine-specific methodologies and processes for use in the EU joint HTA framework. The proposed guiding principles could support the effective implementation of the EU Regulation on HTA for vaccines and have the potential to ensure consistent, transparent, and timely access to new vaccines in the EU.

A Dutch cost-effectiveness analysis of fremanezumab versus best supportive care in patients with chronic migraine and inadequate response to prior preventive therapy.

BACKGROUND: Chronic migraine (CM) is the most severe and burdensome subtype of migraine. Fremanezumab is a monoclonal antibody that targets the calcitonin gene-related peptide pathway as a migraine preventive therapy. This study aimed to conduct a cost-effectiveness analysis of fremanezumab from a societal perspective in the Netherlands, using a Markov cohort simulation model. METHODS: The base-case cost-effectiveness analysis adhered to the Netherlands Authority guidelines. Fremanezumab was compared with best supportive care (BSC; acute migraine treatment only) in patients with CM and an inadequate response to topiramate or valproate and onabotulinumtoxinA (Dutch patient group [DPG]). A supportive analysis was conducted in the broader group of CM patients with prior inadequate response to 2-4 different classes of migraine preventive treatments. One-way sensitivity, probabilistic sensitivity, and scenario analyses were conducted. RESULTS: Over a lifetime horizon, fremanezumab is cost saving compared with BSC in the DPG (saving of €2514 per patient) and led to an increase of 1.45 quality-adjusted life-years (QALYs). In the broader supportive analysis, fremanezumab was cost effective compared with BSC, with an incremental cost-effectiveness ratio of €2547/QALY gained. Fremanezumab remained cost effective in all sensitivity and scenario analyses. CONCLUSION: In comparison to BSC, fremanezumab is cost saving in the DPG and cost effective in the broader population.

Societal costs of sepsis in the Netherlands.

BACKGROUND: Sepsis is a life-threatening syndrome characterized by acute loss of organ function due to infection. Sepsis survivors are at risk for long-term comorbidities, have a reduced Quality of Life (QoL), and are prone to increased long-term mortality. The societal impact of sepsis includes its disease burden and indirect economic costs. However, these societal costs of sepsis are not fully understood. This study assessed sepsis's disease-related and indirect economic costs in the Netherlands. METHODS: Sepsis prevalence, incidence, sepsis-related mortality, hospitalizations, life expectancy, QoL population norms, QoL reduction after sepsis, and healthcare use post-sepsis were obtained from previous literature and Statistics Netherlands. We used these data to estimate annual Quality-adjusted Life Years (QALYs), productivity loss, and increase in healthcare use post-sepsis. A sensitivity analysis was performed to analyze the burden and indirect economic costs of sepsis under alternative assumptions, resulting in a baseline, low, and high estimated burden. The results are presented as a baseline (low-high burden) estimate. RESULTS: The annual disease burden of sepsis is approximately 57,304 (24,398-96,244; low-high burden) QALYs. Of this, mortality accounts for 26,898 (23,166-31,577) QALYs, QoL decrease post-sepsis accounts for 30,406 (1232-64,667) QALYs. The indirect economic burden, attributed to lost productivity and increased healthcare expenditure, is estimated at €416.1 (147.1-610.7) million utilizing the friction cost approach and €3.1 (0.4-5.7) billion using the human capital method. Cumulatively, the combined disease and indirect economic burdens range from €3.8 billion (friction method) to €6.5 billion (human capital method) annually within the Netherlands. CONCLUSIONS: Sepsis and its complications pose a substantial disease and indirect economic burden to the Netherlands, with an indirect economic burden due to production loss that is potentially larger than the burden due to coronary heart disease or stroke. Our results emphasize the need for future studies to prevent sepsis, saving downstream costs and decreasing the economic burden.

Economic burden of pelvic sepsis after anastomotic leakage following rectal cancer surgery: A retrospective cost-of-illness analysis.

AIM: Anastomotic leakage following rectal cancer surgery remains a challenging complication, with a nonhealing rate of approximately 50% at 1 year. Pelvic sepsis may require tertiary treatment that encompasses additional admissions, extensive surgery and other types of interventions. The aim of this study is to analyse the financial burden of pelvic sepsis in a tertiary hospital. METHOD: From 2010 until 2020, all patients referred to a tertiary centre for pelvic sepsis after low anterior resection for rectal cancer were prospectively registered and retrospectively reviewed. The cost analysis adhered to Dutch National Healthcare Institute guidelines and covered hospital-imposed medical costs from salvage surgery to the last registered intervention, adjusted for inflation and priced in euros. RESULTS: This analysis included 126 patients, with an average total cost per patient of €31 131. Salvage surgery accounted for €21 326, with an additional €9805 for reinterventions and readmissions. Salvage surgery comprised nonrestorative surgery in 48% and restorative salvage surgery in the remaining cases. Length of hospital stay averaged 9.6 days on the general ward and 0.8 days in the intensive care unit. Common reinterventions included endoscopic vacuum sponge changes (n = 153), stoma closures (n = 59) and radiological abscess drainages (n = 51). Total costs did not differ significantly between nonrestorative surgery and restorative surgery (mean = €31 950 vs. €30 362, respectively; p = 0.893). CONCLUSION: Treating pelvic sepsis after rectal cancer resection in a tertiary hospital carries a substantial economic burden, averaging €31 131 per patient, and this work helps to quantify the potential economic impact of innovative care to reduce anastomotic leakage.

Vaccine hesitancy and equity: lessons learned from the past and how they affect the COVID-19 countermeasure in Indonesia.

INTRODUCTION: Indonesia has made progress in increasing vaccine coverage, but equitable access remains challenging, especially in remote areas. Despite including vaccines in the National Immunization Program (NIP), coverage has not met WHO and UNICEF targets, with childhood immunization decreasing during the COVID-19 pandemic. COVID-19 vaccination has also experienced hesitancy, slowing efforts to end the pandemic. SCOPE: This article addresses the issue of vaccine hesitancy and its impact on vaccination initiatives amidst the COVID-19 pandemic. This article utilizes the vaccine hesitancy framework to analyze previous outbreaks of vaccine-preventable diseases and their underlying causes, ultimately providing recommendations for addressing the current situation. The analysis considers the differences between the pre-pandemic circumstances and the present and considers the implementation of basic and advanced strategies. KEY FINDINGS AND CONCLUSION: Vaccine hesitancy is a significant challenge in the COVID-19 pandemic, and public health campaigns and community engagement efforts are needed to promote vaccine acceptance and uptake. Efforts to address vaccine hesitancy promote trust in healthcare systems and increase the likelihood of individuals seeking preventive health services. Vaccine hesitancy requires a comprehensive, culturally sensitive approach that considers local contexts and realities. Strategies should be tailored to specific cultural and societal contexts and monitored and evaluated.

A cost-minimization analysis of anti-VEGFs for the treatment of neovascular age-related macular degeneration in the Netherlands.

OBJECTIVE: Age-related macular degeneration (AMD) is the main cause of severe vision loss globally. Neovascular AMD (nAMD) is an advanced stage of AMD treated with anti-vascular endothelial growth factors (anti-VEGFs). Although anti-VEGF treatment is effective, the frequent intravitreal injections place a burden on patients, (in)formal caregivers, and clinics. This study assesses the health-economic impact of anti-VEGF agents with lower injection frequency that have the potential to reduce treatment burden and compares it to the standard of care. METHODS: We developed a cost-minimization model to evaluate the direct medical costs associated with first-line unilateral anti-VEGF treatment across a 3-year time horizon in the Netherlands. The analysis compared aflibercept 8 mg, aflibercept 2 mg, bevacizumab, faricimab, and ranibizumab. Our model adopted a treat-and-extend (T&E) regimen for aflibercept 2 mg, bevacizumab, and ranibizumab. For aflibercept 8 mg, a flexible regimen that was extendable up to 24 weeks was applied, while faricimab followed a flexible regimen that was extendable up to 16 weeks. Additionally, since list prices may vary from net prices, we calculated the break-even price for each anti-VEGF in comparison to bevacizumab, which is the recommended first-line treatment due to its low medication price. RESULTS: Based on list prices, aflibercept 8 mg led to the lowest treatment costs (€16,251 per patient over a 3-year time horizon), closely followed by bevacizumab (€17,616 per patient over a 3-year time horizon). Ranibizumab led to the highest per-patient costs (€31,746 over a 3-year time horizon). For bevacizumab, most costs were attributable to administration, while for the other anti-VEGFs, most were attributable to medication. Aflibercept 8 mg is cost-saving compared to bevacizumab at their medication prices at the time of writing. Aflibercept 2 mg, faricimab, and ranibizumab should be priced below €488, €591, and €75, respectively. To be cost-equal to bevacizumab with current list prices, anti-VEGFs should be administered with a maximum of 12.7 to 13.8 injections over a 3-year time horizon. CONCLUSION: According to the injection frequency observed in clinical trials, aflibercept 8 mg would be the anti-VEGF that generates the lowest per-patient healthcare costs for the treatment of nAMD in the Netherlands after a treatment period of three years. Our study indicates that anti-VEGF drugs with a lower injection frequency might provide a cost-saving solution to the increasing burden of anti-VEGF treatment on the healthcare system.

Culturally adapted training for community volunteers to improve their knowledge, attitude and practice regarding non-communicable diseases in Vietnam.

BACKGROUND: The burden of non-communicable diseases is becoming unmanageable by primary healthcare facilities in low- and middle-income countries. Community-based approaches are promising for supporting healthcare facilities. In Vietnam, community health volunteers are trained in providing health promotion and screening in a culturally adapted training. This study aims to assess the change in knowledge, attitude and practice regarding NCD prevention and management after a culturally adapted training, and the potential mechanisms leading to this change. METHODS: The Knowledge Attitude and Practice survey was assessed before and after an initial training, and before and after a refresher training (n = 37). We used a focus group discussion with community health volunteers (n = 8) to map potential mechanisms of the training and applying learned knowledge in practice. Data were collected in the districts Le Chan and An Duong of Hai Phong, Vietnam, in November 2021 and May 2022. RESULTS: We found that knowledge increased after training (mean = 5.54, 95%-confidence interval = 4.35 to 6.74), whereas attitude and practice did not improve. Next, knowledge decreased over time (m=-12.27;-14.40 to -10.11) and did not fully recover after a refresher training (m=-1.78;-3.22 to -0.35). As potential mechanisms for change, we identified the use of varying learning methods, enough breaks, efficient coordination of time located for theory and practice, handout materials, large group size and difficulty in applying a digital application for screening results. CONCLUSION: Culturally adapted trainings can improve knowledge among community health volunteers which is important for the support of primary healthcare in low- and middle-income countries. Using a digital screening application can be a barrier for the improvement of knowledge, attitude and practice and we suggest using an intergenerational or age-friendly approach, with the supervision of primary healthcare professionals. Future research on behavioral change should include additional components such as self-efficacy and interrelationships between individuals.

Impact of the 2008 economic crisis on the burden of hepatitis B and C diseases in Southern European countries.

BACKGROUND: The economic crisis that began in 2008 has severely affected Southern (Greece, Italy, Portugal, Spain) Western European (SWE) countries of Western Europe (WE) and may have affected ongoing efforts to eliminate viral hepatitis. This study was conducted to investigate the impact of the economic crisis on the burden of HBV and HCV disease. METHODS: Global Burden of Diseases 2019 data were used to analyse the rates of epidemiological metrics of HBV and HCV acute and chronic infections in SWE and WE. Time series modelling was performed to quantify the impact of healthcare expenditure on the time trend of HBV and HCV disease burden in 2000-2019. RESULTS: Declining trends in incidence and prevalence rates of acute HBV (aHBV) and chronic HBV were observed in SWE and WE, with the pace of decline being slower in the post-austerity period (2010-2019) and mortality due to HBV stabilised in SWE. Acute HCV (aHCV) metrics and chronic HCV incidence and mortality showed a stable trend in SWE and WE, whereas the prevalence of chronic HCV showed an oscillating trend, decreasing in WE in 2010-2019 (p < 0.001). Liver cancer due to both hepatitis infections showed a stagnant burden over time. An inverse association was observed between health expenditure and metrics of both acute and chronic HBV and HCV. CONCLUSIONS: Epidemiological metrics for HBV and HCV showed a slower pace of decline in the post-austerity period with better improvement for HBV, a stabilisation of mortality and a stagnant burden for liver cancer due to both hepatitis infections. The economic crisis of 2008 had a negative impact on the burden of hepatitis B and C. Elimination of HBV and HCV by 2030 will be a major challenge in the SWE countries.

Cost-utility analysis of early reconstruction surgery versus conservative treatment for anterior cruciate ligament injury in a lower-middle income country.

BACKGROUND: The ideal approach for treating anterior cruciate ligament (ACL) injury is still disputed. This study aimed to determine the more cost-effective strategy by comparing early ACL reconstruction (ACLR) surgery to conservative treatment (rehabilitation with optional delayed reconstruction) for ACL injury in a lower/middle-income country (LMIC), Indonesia. METHODS: A decision tree model was constructed for cost-utility analysis of early ACLR versus conservative treatment. The transition probabilities between states were obtained from the literature review. Utilities were measured by the EQ-5D-3 L from a prospective cohort study in a local hospital. The costs were obtained from a previous study that elaborated on the burden and cost of ACLR in Indonesia. Effectiveness was expressed in quality-adjusted life years gained (QALYs). Principal outcome measure was the incremental cost-effectiveness ratios (ICER). Willingness-to-pay was set at US$12,876 - three times the Indonesian GDP per capita in 2021 - the currently accepted standard in Indonesia as suggested by the World Health Organization Choosing Interventions that are Cost-Effective criterion (WHO-CHOICE). RESULTS: The early ACLR group showed an incremental gain of 0.05 QALYs over the conservative treatment group, with a higher overall cost to society of US$976. The ICER of ACLR surgery was US$19,524 per QALY, above the WTP threshold of US$12,876. The ICER was sensitive to cost of conservative treatment, cost of ACLR, and rate of cross-over to delayed ACLR numbers in the conservative treatment group. Using the WTP threshold of US$12,876, the probability of conservative treatment being preferred over early ACLR was 64%. CONCLUSIONS: Based on the current model, early ACLR surgery does not seem more cost-effective compared to conservative treatment for ACL injury patients in Indonesia. Because the result was sensitive to the rate of cross-over probabilities from the conservative treatment alone to delayed ACLR, a future study with a long-term perspective is needed to further elucidate its impact.

A situational and stakeholder analysis of health technology assessment in Zimbabwe.

OBJECTIVES: Systematic priority setting is necessary for achieving high-quality healthcare using limited resources in low- and middle-income countries. Health technology assessment (HTA) is a tool that can be used for systematic priority setting. The objective of this study was to conduct a stakeholder and situational analysis of HTA in Zimbabwe. METHODS: We identified and analyzed stakeholders using the International Decision Support Initiative checklist. The identified stakeholders were invited to an HTA workshop convened at the University of Zimbabwe. We used an existing HTA situational analysis questionnaire to ask for participants' views on the need, demand, and supply of HTA. A follow-up survey was done among representatives of stakeholder organizations that failed to attend the workshop. We reviewed two health policy documents relevant to the HTA. Qualitative data from the survey and document review were analyzed using thematic analysis. RESULTS: Forty-eight organizations were identified as stakeholders for HTA in Zimbabwe. A total of 41 respondents from these stakeholder organizations participated in the survey. Respondents highlighted that the HTA was needed for transparent decision making. The demand for HTA-related evidence was high except for the health economic and ethics dimensions, perhaps reflecting a lack of awareness. Ministry of Health was listed as a major supplier of HTA data. CONCLUSIONS: There is no formal HTA agency in the Zimbabwe healthcare system. Various institutions make decisions on prioritization, procurement, and coverage of health services. The activities undertaken by these organizations provide context for the institutionalization of HTA in Zimbabwe.

The economic impact of anastomotic leakage after colorectal surgery: a systematic review.

BACKGROUND: Anastomotic leakage (AL) remains a burdensome complication following colorectal surgery, with increased morbidity, oncological compromise, and mortality. AL may impose a substantial financial burden on hospitals and society due to extensive resource utilization. Estimated costs associated with AL are important when exploring preventive measures and treatment strategies. The purpose of this study was to systematically review the existing literature on (socio)economic costs associated with AL after colorectal surgery, appraise their quality, compare reported outcomes, and identify knowledge gaps. METHODS: Health economic evaluations reporting costs related to AL after colorectal surgery were identified through searching multiple online databases until June 2023. Pairs of reviewers independently evaluated the quality using an adapted version of the Consensus on Health Economic Criteria list. Extracted costs were converted to 2022 euros (€) and also adjusted for purchasing power disparities among countries. RESULTS: From 1980 unique abstracts, 59 full-text publications were assessed for eligibility, and 17 studies were included in the review. The incremental costs of AL after correcting for purchasing power disparity ranged from €2250 (+39.9%, Romania) to €83,633 (+ 513.1%, Brazil). Incremental costs were mainly driven by hospital (re)admission, intensive care stay, and reinterventions. Only one study estimated the economic societal burden of AL between €1.9 and €6.1 million. CONCLUSIONS: AL imposes a significant financial burden on hospitals and social care systems. The magnitude of costs varies greatly across countries and data on the societal burden and non-medical costs are scarce. Adherence to international reporting standards is essential to understand international disparities and to externally validate reported cost estimates.

Cost-effectiveness of finerenone in chronic kidney disease associated with type 2 diabetes in The Netherlands.

BACKGROUND: In the Netherlands, more than one million patients have type 2 diabetes (T2D), and approximately 36% of these patients have chronic kidney disease (CKD). Yearly medical costs related to T2D and CKD account for approximately €1.3 billion and €805 million, respectively. The FIDELIO-DKD trial showed that the addition of finerenone to the standard of care (SoC) lowers the risk of CKD progression and cardiovascular (CV) events in patients with CKD stages 2-4 associated with T2D. This study investigates the cost-effectiveness of adding finerenone to the SoC of patients with advanced CKD and T2D compared to SoC monotherapy. METHODS: The validated FINE-CKD model is a Markov cohort model which simulates the disease pathway of patients over a lifetime time horizon. The model was adapted to reflect the Dutch societal perspective. The model estimated the incremental costs, utilities, and incremental cost-effectiveness ratio (ICER). Sensitivity and scenario analyses were performed to assess the effect of parameter uncertainty on model robustness. RESULTS: When used in conjunction with SoC, finerenone extended time free of CV events and renal replacement therapy by respectively 0.30 and 0.31 life years compared to SoC alone, resulting in an extension of 0.20 quality-adjusted life years (QALYs). The reduction in renal and CV events led to a €6136 decrease in total lifetime costs per patient compared to SoC alone, establishing finerenone as a dominant treatment option. Finerenone in addition to SoC had a 83% probability of being dominant and a 93% probability of being cost-effective at a willingness-to-pay threshold of €20,000. CONCLUSION: By reducing the risk of CKD progression and CV events, finerenone saves costs to society while gaining QALYs in patients with T2D and advanced CKD in the Netherlands.

Comparison of different scoring systems for predicting in-hospital mortality for patients with Fournier gangrene.

PURPOSE: To compare different scoring systems for predicting in-hospital mortality in patients with Fournier gangrene (FG). METHODS: A comprehensive literature search was performed to find all scoring systems that have been proposed previously as a predictor for in-hospital mortality in patients with FG. Data of all patients with FG who were hospitalized in one of Indonesia's largest tertiary referral hospitals between 2012 and 2022 were used. The receiver operating characteristic (ROC) curve analysis was performed to evaluate the diagnostic performance of the scoring systems. RESULTS: Ten scoring systems were found, i.e., Fournier's Gangrene Severity Index (FGSI), Uludag FGSI, simplified FGSI, NUMUNE Fournier score (NFS), Laboratory Risk Indicator for Necrotizing Fasciitis, age-adjusted Charlson comorbidity index, sequential organ failure assessment (SOFA), quick SOFA, acute physiology and chronic health evaluation II, and surgery APGAR score (SAS). Of 164 FG patients included in the analyses, 26.4% died during hospitalization. All scoring systems except SAS could predict in-hospital mortality of patients with FG. Three scoring systems had areas under the ROC curve (AUROC) higher than 0.8, i.e., FGSI (AUROC 0.905, 95% confidence interval (CI) 0.860-0.950), SOFA (AUROC 0.830, 95% CI 0.815-0.921), and NFS (AUROC 0.823, 95% CI 0.739-0.906). Both FGSI and SOFA had sensitivity and NPV of 1.0, whereas NFS had a sensitivity of 0.74 and an NPV of 0.91. CONCLUSION: This study shows that FGSI and SOFA are the most reliable scoring systems to predict in-hospital mortality in FG, as indicated by the high AUROC and perfect sensitivity and NPV.

Reducing Hospital Capacity Needs for Seasonal Respiratory Infections: The Case of Switching to High-Dose Influenza Vaccine for Dutch Older Adults.

OBJECTIVES: Influenza is responsible for considerable health and economic burden every year. Especially older adults are vulnerable for influenza infection and its complications due to immunosenescence and often-underlying medical conditions. Recently, the innovative quadrivalent high-dose influenza vaccine (QIV-HD) has become available in Europe. Through its enhanced immunogenicity, QIV-HD offers improved protection for older adults against respiratory as well as cardiovascular complications. We estimated the potential impact-specifically in terms of hospital admissions and related costs-of a hypothetical past switch from QIV-Standard dose (SD) to QIV-HD in The Netherlands. METHODS: Estimates of hospitalizations for the older adults vaccinated with QIV-SD were derived from the seasons 2010/2011-2017/2018. Subsequently, the number of respiratory infections and cardiovascular complications of influenza were estimated for the year 2019/2020 for both QIV-SD and QIV-HD. To calculate the overall corresponding savings, costs for hospital complications, derived from literature, were used. RESULTS: When QIV-HD would have been used instead of QIV-SD during the season 2019/2020, an additional 220 hospitalizations would have been averted among older adults of 60 years and older in the Netherlands. This corresponds to savings of €1 219 779 (uncertainty interval: 1 089 813-1 348 549), of which 69% is attributable to cardiovascular-related hospitalizations. CONCLUSIONS: We demonstrate that a relevant improvement in influenza vaccination among older adults in The Netherlands can be achieved by switching from the current QIV-SD to QIV-HD. Not only comes a switch from QIV-SD to QIV-HD with a significant reduction in pressure on hospital capacity but also with notable cost savings.

The Effect of the Drug Life Cycle Price on Cost-Effectiveness: Case Studies Using Real-World Pricing Data.

OBJECTIVES: Cost-effectiveness analyses (CEAs) generally assume constant drug prices throughout the model time horizon, yet it is known that prices are not constant, often with price decreases near loss of exclusivity (LOE). This study explores the impact of using dynamic drug-specific prices on the incremental cost-effectiveness ratio (ICER) using selected reproduced case studies. METHODS: Case studies were selected following explicit criteria to reflect a variety of drug characteristics. For each drug, a published CEA model was identified, replicated, and modified with dynamic real-world pricing data, to compare ICERs based on constant drug prices with estimates obtained when including drug life cycle pricing. The impact of dynamic real-world pricing-inclusive LOE-was analyzed using a single patient cohort and multiple cohorts over time. RESULTS: Fluvastatin, alendronic acid + colecalciferol combination therapy, letrozole and clopidogrel were selected as case studies. Inclusion of real-world pricing data compared with applying constant prices reduced the ICER in a single-cohort setting up to 43%. In the multicohort analyses, further reductions of the ICERs were observed of up to 113%. The ICERs were sensitive to the period of drug usage relative to the models' time horizons, the relative proportions of drug costs in the overall treatment costs, and timing of LOE compared with the cost year of the original analysis. CONCLUSIONS: Assuming dynamic drug prices may lead to more representative ICER estimates. Future CEAs for drugs could account for predicted and disaggregated life cycle price developments based on retrospective data.

Psychometric properties of kidney disease quality of life-36 (KDQOL-36) in dialysis patients in Indonesia.

OBJECTIVE: The study aimed to evaluate the psychometric properties of KDQOL-36 Bahasa Indonesia in hemodialysis (HD) and continuous ambulatory peritoneal dialysis (CAPD) patients in Indonesia. METHODS: The psychometric analysis was conducted in three hospitals offering both HD and CAPD. The validity was assessed through structural, convergent, and known-group validity, while reliability was evaluated using internal consistency and test-retest reliability. RESULTS: The study involved 370 participants of which 71% received HD treatment. No floor and ceiling effects (< 10%) were identified. Confirmatory factor analysis supported a good model fit for both generic and kidney-specific domains, while exploratory factor analysis revealed three factors for kidney-specific domains and only three items with a loading factor below 0.4. Convergent validity showed positive correlations between kidney-specific domains, generic domains, and EQ-5D. The comparison of quality of life among subgroups based on dialysis type and whether or not patients had diabetes supported the hypotheses of known-group validity. Cronbach's alpha and omega values had demonstrated good internal consistency. Test-retest reliability indicated burden of kidney disease had good reliability, while other domains had moderate reliability. CONCLUSION: The study supports the validity and reliability of both generic and kidney-specific domains of KDQOL-36 Bahasa Indonesia to evaluate quality of life in patients with HD and CAPD in Indonesia. As health-related quality of life is a crucial predictor of patient outcomes, this report contributes new evidence about validity and reliability to recommend the use of KDQOL-36 Bahasa Indonesia in dialysis centers.

The Use of eHealth for Pharmacotherapy Management With Patients With Respiratory Disease, Cardiovascular Disease, or Diabetes: Scoping Review.

BACKGROUND: eHealth is increasingly considered an important tool for supporting pharmacotherapy management. OBJECTIVE: We aimed to assess the (1) use of eHealth in pharmacotherapy management with patients with asthma or chronic obstructive pulmonary disease (COPD), diabetes, or cardiovascular disease (CVD); (2) effectiveness of these interventions on pharmacotherapy management and clinical outcomes; and (3) key factors contributing to the success of eHealth interventions for pharmacotherapy management. METHODS: We conducted a scoping review following the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping review) statement. Databases searched included Embase, MEDLINE (PubMed), and Cochrane Library. Screening was conducted by 2 independent researchers. Eligible articles were randomized controlled trials and cohort studies assessing the effect of an eHealth intervention for pharmacotherapy management compared with usual care on pharmacotherapy management or clinical outcomes in patients with asthma or COPD, CVD, or diabetes. The interventions were categorized by the type of device, pharmacotherapy management, mode of delivery, features, and domains described in the conceptual model for eHealth by Shaw at al (Health in our Hands, Interacting for Health, Data Enabling Health). The effectiveness on pharmacotherapy management outcomes and patient- and clinician-reported clinical outcomes was analyzed per type of intervention categorized by number of domains and features to identify trends. RESULTS: Of 63 studies, 16 (25%), 31 (49%), 13 (21%), and 3 (5%) included patients with asthma or COPD, CVD, diabetes, or CVD and diabetes, respectively. Most (38/63, 60%) interventions targeted improving medication adherence, often combined for treatment plan optimization. Of the 16 asthma or COPD interventions, 6 aimed to improve inhaled medication use. The majority (48/63, 76%) of the studies provided an option for patient feedback. Most (20/63, 32%) eHealth interventions combined all 3 domains by Shaw et al, while 25% (16/63) combined Interacting for Health with Data Enabling Health. Two-thirds (42/63, 67%) of the studies showed a positive overall effect. Respectively, 48% (23/48), 57% (28/49), and 39% (12/31) reported a positive effect on pharmacotherapy management and clinician- and patient-reported clinical outcomes. Pharmacotherapy management and patient-reported clinical outcomes, but not clinician-reported clinical outcomes, were more often positive in interventions with ≥3 features. There was a trend toward more studies reporting a positive effect on all 3 outcomes with more domains by Shaw et al. Of the studies with interventions providing patient feedback, more showed a positive clinical outcome, compared with studies with interventions without feedback. This effect was not seen for pharmacotherapy management outcomes. CONCLUSIONS: There is a wide variety of eHealth interventions combining various domains and features to target pharmacotherapy management in asthma or COPD, CVD, and diabetes. Results suggest feedback is key for a positive effect on clinician-reported clinical outcomes. eHealth interventions become more impactful when combining domains.

A qualitative study on female executive pharmacists with convergent roles.

BACKGROUND: Although women's participation is relatively high in the pharmacist workforce, women remain underrepresented in executive positions. The rate of executive female pharmacists in diversified pharmaceutical areas, from education and research to politics, is recognized as being disproportionately low. OBJECTIVES: In this study, we aimed to explore female executive pharmacists' roles and identify reasons for their being underrepresented in such executive positions in Turkey. METHODS: Semistructured in-depth interviews were conducted from a feminist standpoint with female executive delegates working in the Grand National Assembly of Turkey, pharmacy chambers, and public pharmacy faculties. A thematic data analysis of transcriptions was conducted using MAXQDA 2020 software and was reported according to Consolidated Criteria for Reporting Qualitative Research. RESULTS: The researchers interviewed 19 participants. Three primary themes emerged: gender roles, being an executive, and being a pharmacist. Eight roles came to the surface: mother, child, wife, pharmacist, manager, homemaker, cook, and planner. Taking the responsibility for an executive position involves a continued and simultaneous performance of all other roles as well. CONCLUSION: In this context, female pharmacists' views on gender roles in relation to motherhood, inequalities, and their dedication to their profession came to the fore. This study can be considered as a starting point for studying the underlying causes of the limited representation of female pharmacists in executive positions.

A Genotype-Guided Strategy for Oral P2Y12 Inhibitors in Primary PCI.

BACKGROUND: It is unknown whether patients undergoing primary percutaneous coronary intervention (PCI) benefit from genotype-guided selection of oral P2Y12 inhibitors. METHODS: We conducted a randomized, open-label, assessor-blinded trial in which patients undergoing primary PCI with stent implantation were assigned in a 1:1 ratio to receive either a P2Y12 inhibitor on the basis of early CYP2C19 genetic testing (genotype-guided group) or standard treatment with either ticagrelor or prasugrel (standard-treatment group) for 12 months. In the genotype-guided group, carriers of CYP2C19*2 or CYP2C19*3 loss-of-function alleles received ticagrelor or prasugrel, and noncarriers received clopidogrel. The two primary outcomes were net adverse clinical events - defined as death from any cause, myocardial infarction, definite stent thrombosis, stroke, or major bleeding defined according to Platelet Inhibition and Patient Outcomes (PLATO) criteria - at 12 months (primary combined outcome; tested for noninferiority, with a noninferiority margin of 2 percentage points for the absolute difference) and PLATO major or minor bleeding at 12 months (primary bleeding outcome). RESULTS: For the primary analysis, 2488 patients were included: 1242 in the genotype-guided group and 1246 in the standard-treatment group. The primary combined outcome occurred in 63 patients (5.1%) in the genotype-guided group and in 73 patients (5.9%) in the standard-treatment group (absolute difference, -0.7 percentage points; 95% confidence interval [CI], -2.0 to 0.7; P<0.001 for noninferiority). The primary bleeding outcome occurred in 122 patients (9.8%) in the genotype-guided group and in 156 patients (12.5%) in the standard-treatment group (hazard ratio, 0.78; 95% CI, 0.61 to 0.98; P = 0.04). CONCLUSIONS: In patients undergoing primary PCI, a CYP2C19 genotype-guided strategy for selection of oral P2Y12 inhibitor therapy was noninferior to standard treatment with ticagrelor or prasugrel at 12 months with respect to thrombotic events and resulted in a lower incidence of bleeding. (Funded by the Netherlands Organization for Health Research and Development; POPular Genetics ClinicalTrials.gov number, NCT01761786; Netherlands Trial Register number, NL2872.).