Search

Multi-criteria decision analysis (MCDA) was proposed to surmount arbitrary clinical decisions in the field of biological therapies for psoriatic patients. At the same time, MCDA may further highlight the potential of bimekizumab for the treatment of moderate-to-severe psoriasis, compared to placebo, adalimumab, ustekinumab, secukinumab, and even ixekizumab and risankizumab. The EVIDEM framework was adapted to reflect relevant criteria for the assessment. Estimated values were obtained by means of an additive linear model combining weights and scores assigned by a multidisciplinary committee of 12 experts. Consistency and replicability were evaluated through an alternative weighting method and a re-test. Bimekizumab was assessed by the committee as an intervention with a positive value contribution for the treatment of moderate-to-severe psoriasis in comparison to any of the alternatives. The drug provides a substantial therapeutical benefits and improves the health results reported by the patients, as it combines a higher level of clearance, rapidity, and persistence with a similar safety and tolerability profile. Under a methodology with increasing use in the health field, bimekizumab was evaluated as a drug with a high added value for the treatment of moderate-to-severe psoriasis when compared to six different alternatives. [ABSTRACT FROM AUTHOR]

Psoriasis is a chronic, systemic inflammatory disease that affects the skin, with a high impact on patients' quality of life. The aim of this study was to identify and determine the relative importance of unmet needs in the management of moderate-to-severe psoriasis in Spain, from a multi-stakeholder perspective. A mixed method-approach was used to collect information, design a questionnaire and a discrete-choice exercise, and elicit the unmet needs through a multidisciplinary committee composed of 12 experts. A total of 65 unmet needs were identified and categorized into 4 areas: clinical, patient-related, decision-making process, and social. Decision-making process unmet needs were perceived as the most pressing ones, followed by social, clinical and patient-related. Individually, the need to incorporate outcomes that are important to the patients and to have treatments that achieve total clearance with a rapid onset of action and long-term persistence were the most important unmet needs. [ABSTRACT FROM AUTHOR]

Objectives: Our aim was to assess the value of nintedanib for non-idiopathic progressive fibrosing interstitial lung disease (non-IPF PF-ILD) and systemic sclerosis-associated ILD (SSc-ILD) in the Spanish context, using a multi-criteria decision analysis (MCDA). Methods: Following an adaptation of the Evidence and Value: Impact on DEcision Making (EVIDEM) MCDA methodology, the estimated value of nintedanib was obtained by means of an additive linear model that combined individual weights (100-points distribution) of criteria with the individual scoring of nintedanib in each criterion for every indication, assigned by a multidisciplinary committee of twelve clinicians, patients, pharmacists, and decision-makers. To assess the reproducibility, an alternative weighting method was applied, as well as a re-test of weights and scores at a different moment of time. Results: The experts committee recognized nintedanib as an intervention with a positive value contribution in comparison to placebo for the treatment of non-IPF PF-ILD (0.50 0.16, on a scale from 1 to 1) and SSc-ILD (0.40 0.12), diseases which were considered as very severe and with high unmet needs. The drug was perceived as a treatment that provides an added therapeutic benefit for patients (0.06–0.07), given its proven clinical efficacy (0.05–0.06), slight improvements in patient-reported outcomes (0.01–0.02), and similar safety profile than placebo (0.04–0.00), which will likely be positioned as a recommended therapy in the next clinical practice guidelines updates. Conclusions: Under this increasingly used methodology, nintedanib has shown to provide a positive value estimate for non-IPF PF-ILD and SSc-ILD when compared to placebo in Spain. [ABSTRACT FROM AUTHOR]

Introduction: Hereditary angioedema (HAE) is a rare genetic disease that impairs quality of life and could be life-threatening. The aim of this study was to apply a multicriteria decision analysis to assess the value of three long-term prophylactic (LTP) therapies for HAE in Spain. Methods: A multidisciplinary committee of 10 experts assessed the value of lanadelumab (subcutaneous use), C1-inhibitor (C1-INH; intravenous), and danazol (orally), using placebo as comparator. We followed the EVIDEM methodology that considers a set of 13 quantitative criteria. The overall estimated value of each intervention was obtained combining the weighting of each criterion with the scoring of each intervention in each criterion. We used two alternative weighting methods: hierarchical point allocation (HPA) and direct rating scale (DRS). A reevaluation of weightings and scores was performed. Results: Lanadelumab obtained higher mean scores than C1-INH and danazol in all criteria, except for the cost of the intervention and clinical practice guidelines. Under the HPA method, the estimated values were 0.51 (95% confidence interval [CI]: 0.44-0.58) for lanadelumab, 0.47 (95%CI: 0.41-0.53) for C1-INH, and 0.31 (95%CI: 0.24- 0.39) for danazol. Similar results were obtained with the DRS method: 0.51 (95%CI: 0.42-0.60), 0.47 (95%CI: 0.40-0.54), and 0.27 (95%CI: 0.18-0.37), respectively. The comparative cost of the intervention was the only criterion that contributed negatively to the values of lanadelumab and C1-INH. For danazol, four criteria contributed negatively, mainly comparative safety. Conclusion: Lanadelumab was assessed as a high-value intervention, better than C1-INH and substantially better than danazol for LTP treatment of HAE. [ABSTRACT FROM AUTHOR]

Objectives: Our aim was to assess the value of nintedanib for non-idiopathic progressive fibrosing interstitial lung disease (non-IPF PF-ILD) and systemic sclerosis-associated ILD (SSc-ILD) in the Spanish context, using a multi-criteria decision analysis (MCDA). Methods: Following an adaptation of the Evidence and Value: Impact on DEcision Making (EVIDEM) MCDA methodology, the estimated value of nintedanib was obtained by means of an additive linear model that combined individual weights (100-points distribution) of criteria with the individual scoring of nintedanib in each criterion for every indication, assigned by a multidisciplinary committee of twelve clinicians, patients, pharmacists, and decision-makers. To assess the reproducibility, an alternative weighting method was applied, as well as a re-test of weights and scores at a different moment of time. Results: The experts committee recognized nintedanib as an intervention with a positive value contribution in comparison to placebo for the treatment of non-IPF PF-ILD (0.50 ± 0.16, on a scale from −1 to 1) and SSc-ILD (0.40 ± 0.12), diseases which were considered as very severe and with high unmet needs. The drug was perceived as a treatment that provides an added therapeutic benefit for patients (0.06–0.07), given its proven clinical efficacy (0.05–0.06), slight improvements in patient-reported outcomes (0.01–0.02), and similar safety profile than placebo (−0.04–0.00), which will likely be positioned as a recommended therapy in the next clinical practice guidelines updates. Conclusions: Under this increasingly used methodology, nintedanib has shown to provide a positive value estimate for non-IPF PF-ILD and SSc-ILD when compared to placebo in Spain. [ABSTRACT FROM AUTHOR]

Abstract Background Although health is one of the main determinants of the welfare of societies, few studies have evaluated health related quality of life in representative samples of the population of a region or a country. Our aim is to describe the health-related quality of life of the inhabitants of two quite different Spanish regions (Canary Islands and Catalonia) and to compare the prevalence of health problems between age-sex groups. Methods We use data obtained from the 2006 Health Survey of Catalonia and the 2004 Canary Islands Health Survey. With an ordinal composite variable measuring HRQOL we identify the association of characteristics of individuals with self-reported quality of life and test for differences between the regions. Results The prevalence of problems in the five EQ-5 D dimensions increases with age and is generally higher for women than for men. The dimension with the highest prevalence of problems is "anxiety/depression", and there is noteworthy the extent of discomfort and pain among Canary Island women. Education, especially among the elderly, has an important effect on health-related quality of life. Conclusions There are substantial structural and compositional differences between the two regions. Regional context is a significant factor, independent of the compositional differences, and the effects of context are manifest above all in women. The findings show the importance of disease prevention and the need for improving the educational level of the population in order to reduce health inequalities.

Introduction: In March 2020, due to the pandemic caused by COVID-19, a pilot experience of pharmaceutical continuity of care received by hospital outpatients was launched in Cantabria, a Spanish autonomous community. Thanks to this experience, the medication was dispensed by the hospital pharmacy through the community pharmacy of the patient's choice. Our objective was to estimate the costs avoided by this practice during the months of April and May 2020. Methods: The analysis of the economic impact was carried out in terms of saved costs, from the hospital and from the social perspective. Savings associated with the avoided home delivery of medication and avoided labor productivity losses were calculated, as well as the time associated with avoided trips in monetary terms. Results: A total of 2,249 hospital-dispensed drugs were delivered through the community pharmacy in the analyzed period, with an average of 57.7 daily deliveries. The experience, which involved one hospital and 262 pharmacies of Cantabria, saved patients 93,305 km in trips to the hospital, associated with an average time saving of 1,374 hours. In terms of costs, the hospital saved on shipments by courier, estimated at €30,205, since it was the community pharmacy and the distribution warehouses that delivered the drugs. From a social perspective, this initiative saved €23,309 due to the trips (€8,907) and productivity losses (€14,402) that were avoided. Conclusions: This exceptional situation may be a good opportunity to improve the coordination between hospital pharmacies and community pharmacies in Spain, not only during the pandemic but also in the post-COVID-19 era. [ABSTRACT FROM AUTHOR]

Background and Objective: Multi-criteria decision analysis (MCDA) is a tool that systematically considers multiple factors relevant to health decision-making. The aim of this study was to use an MCDA to assess the value of dupilumab for severe atopic dermatitis compared with secukinumab for moderate to severe plaque psoriasis in Spain.Method: Following the EVIDEM (Evidence and Value: Impact on DEcision Making) methodology, the estimated value of both interventions was obtained by means of an additive linear model that combined the individual weighting (between 1 and 5) of each criterion with the individual scoring of each intervention in each criterion. Dupilumab was evaluated against placebo, while secukinumab was evaluated against placebo, etanercept and ustekinumab. A retest was performed to assess the reproducibility of weights, scores and value estimates.Results: The overall MCDA value estimate for dupilumab versus placebo was 0.51 ± 0.14. This value was higher than those obtained for secukinumab: 0.48 ± 0.15 versus placebo, 0.45 ± 0.15 versus etanercept and 0.39 ± 0.18 versus ustekinumab. The highest-value contribution was reported by the patients’ group, followed by the clinical professionals and the decision makers. A fundamental element that explained the difference in the scoring between pathologies was the availability of therapeutic alternatives. The retest confirmed the consistency and replicability of the analysis.Conclusions: Under this methodology, and assuming similar economic costs per patient for both treatments, the results indicated that the overall value estimated of dupilumab for severe atopic dermatitis was similar to, or slightly higher than, that of secukinumab for moderate to severe plaque psoriasis. [ABSTRACT FROM AUTHOR]

Background: It is well documented that obesity is strongly associated with mortality and morbidity, but less is known about its impact on functional status and health-related quality of life (HRQOL). The purpose of this study was to calculate the impact of the Body Mass Index (BMI) on the HRQOL of the Spanish adult population, with special emphasis on BMI ≥ 35.Methods: We used the Spanish National Health Survey (SNHS) 2011-2012 to assess the statistical association between HRQOL, measured through the EuroQol-5D-5L questionnaire, and the BMI. We conducted linear regression analysis for the EuroQol-5D-5L Visual Analogue Scale (VAS) and probit regressions for each of the five dimensions of the EuroQol-5D-5L.Results: Self-perceived problems in the five dimensions of the EuroQol-5D-5L increased along the BMI, especially in the mobility and pain/discomfort dimensions. Having a BMI ≥ 35 reduced HRQOL even in the absence of chronic diseases. After controlling for comorbidities, severe obesity decreased the VAS score by an average of 1.9 points and increased the probability of reporting any HRQOL problem in mobility (11.8%), self-care (2.2%), usual activities (4.3%) and pain/discomfort (7.4%). No association was found between obesity and mental problems. All the parameters analysed suggest that HRQOL in women and people aged 65 years and over was significantly worse than average.Conclusions: BMI is an explanatory factor of self-perceived quality of life. Obesity is associated with a worse HRQOL, especially in women and people aged over 64 years. These results may be useful for designing prevention or treatment health policies to target obesity among the Spanish population. [ABSTRACT FROM AUTHOR]

Background: Although health is one of the main determinants of the welfare of societies, few studies have evaluated health related quality of life in representative samples of the population of a region or a country. Our aim is to describe the health-related quality of life of the inhabitants of two quite different Spanish regions (Canary Islands and Catalonia) and to compare the prevalence of health problems between age-sex groups. Methods: We use data obtained from the 2006 Health Survey of Catalonia and the 2004 Canary Islands Health Survey. With an ordinal composite variable measuring HRQOL we identify the association of characteristics of individuals with self-reported quality of life and test for differences between the regions. Results: The prevalence of problems in the five EQ-5 D dimensions increases with age and is generally higher for women than for men. The dimension with the highest prevalence of problems is "anxiety/depression", and there is noteworthy the extent of discomfort and pain among Canary Island women. Education, especially among the elderly, has an important effect on health-related quality of life. Conclusions: There are substantial structural and compositional differences between the two regions. Regional context is a significant factor, independent of the compositional differences, and the effects of context are manifest above all in women. The findings show the importance of disease prevention and the need for improving the educational level of the population in order to reduce health inequalities. [ABSTRACT FROM AUTHOR]

Broad benefits of vaccination programs are well acknowledged but difficult to measure, especially when considering all vaccines included in a National Immunization Program (NIP). The aim was to conduct a cost-benefit analysis of the entire NIP in Spain, and an expanded NIP including four potential additional programs. A cost-benefit analysis was performed in Excel to assess the economic and health benefits (€) of vaccinating a single cohort of newborns over a lifetime horizon compared to no vaccination, from a societal perspective: firstly, according to the 2020 NIP in Spain (including 2021 recommendation for herpes zoster in 65-year-olds); and secondly, with an expanded NIP (adding rotavirus and meningococcal B in infants, and pertussis booster in adults aged >65 years and herpes zoster in all adults >50 years). The main inputs were taken from published literature and Spanish databases. Results were presented as a benefit-cost ratio (economic benefit per €1 invested). A cohort of 343,126 newborns were included in the analysis. The total investment needed to vaccinate the cohort throughout their lifetime, according to the 2020 NIP and the expanded NIP, was estimated at €168.5 million and €275.5 million, respectively. Potential economic benefits were €772.2 million and €803.0 million, respectively. The societal benefit-cost ratio was €4.58 and €2.91 per €1 invested, respectively. Even with the addition of new vaccination programs, the Spanish NIP yielded positive benefit-cost ratios from the societal perspective, demonstrating that NIPs spanning the full life course are an efficient public health measure.

Aims: Evaluate existing oncology value frameworks in terms of their methodology, structure, characteristics, and functionality using the example of enfortumab vedotin, an approved therapy for urothelial carcinoma., Methods: A search of PubMed, grey literature, and official websites of relevant international organizations was performed from January 2022 to March 2023., Results: Six frameworks were identified and analyzed, including the American Society of Clinical Oncology's assessment framework, European Society for Medical Oncology's Magnitude of Clinical Benefit Scale, the National Comprehensive Cancer Network's Evidence Blocks, Memorial Sloan Kettering Cancer Center's DrugAbacus, Institute for Clinical and Economic Review's assessment framework, and the Drug Assessment Framework. Comparisons across frameworks were challenging, owing to differing approaches, objectives, perspectives, methodology, and criteria. Based on the results of the EV-301 study (NCT03474107), the European Society for Medical Oncology's Magnitude of Clinical Benefit Scale assigned a score of 4 out of 5 to enfortumab vedotin administered after chemotherapy and immunotherapy. The National Comprehensive Cancer Network's Evidence Blocks enabled assessment of enfortumab vedotin compared with other treatments for locally advanced or metastatic urothelial carcinoma, resulting in the positioning of enfortumab vedotin as a preferred regimen after chemotherapy and immunotherapy., Conclusions: Application of value frameworks in oncology can contribute to informed value-based decision-making. However, comparisons across frameworks should be made with caution and limited to the same lines of treatment. Enfortumab vedotin may contribute to optimizing outcomes in patients previously treated with chemotherapy and immunotherapy for locally advanced or metastatic urothelial carcinoma.