A Review of Current Approaches to Evaluating and Reimbursing New Medicines in a Subset of OECD Countries.

OBJECTIVES: The aim of this study was to review the current evaluation and funding processes for new drugs in different developed countries, to provide a comparative framework with detailed, homogeneous, and up-to-date information. METHODS: Scientific publications, reports and websites were reviewed between July and December 2021 using PubMed, Google Scholar, and grey literature sources. The main items searched were actors and processes, including timelines, characteristics of clinical and economic evaluations, participation of stakeholders, elements of price and reimbursement decisions, cost-effectiveness thresholds and specific funds. The analysed 13 countries were Australia, Canada, England, France, Germany, Italy, Japan, the Netherlands, Portugal, Scotland, South Korea, Spain and Sweden. RESULTS: Eight countries perform the assessment process separated from the pricing decision. Countries measure each drug's added therapeutic value through multi-attribute value scales, algorithms, non-prescriptive lists of criteria, or quality-adjusted life years (QALYs). Health technology assessment (HTA) methodologies differ in their outcome measures, elicitation techniques, comparators, and perspectives. The criteria used for pricing and reimbursement include humanistic, clinical, and economic aspects. Only Scotland, England, the Netherlands, Canada and Portugal use explicit efficiency thresholds. Health care professionals participate in all assessment committees, and patients are becoming increasingly involved in most countries. The official time from marketing authorisation to the completion of the evaluation and pricing processes varied from 126 to 540 days. CONCLUSIONS: Most analysed countries show a trend towards value-based approaches that consider value for money to society, but also other economic, clinical, and humanistic criteria. Good practices included robustness, transparency, independence, and participation.

Optimising the management of patients with multiple myeloma in Spain: A measurement of the social return on investment.

OBJECTIVE: The aim of this study was to reach a consensus on a set of proposals to optimise the disease management of Multiple myeloma (MM) within the Spanish National Health System (SNHS) and to apply the Social Return on Investment (SROI) method to estimate their social impact. METHODS: A Multidisciplinary Working Team (MWT) including MM main stakeholders was organised. A survey was administered to gather information from patients regarding the impact of MM on different life domains. A forecast-type SROI analysis, with a 1-year timeframe, was applied. RESULTS: Fifteen proposals were selected, to optimise MM management, including actions for early diagnosis, psychological support, improvement of information for patients and quick access to palliative care, among others. The implementation of these proposals would benefit patients, their informal caregivers and the SNHS. The investment required would amount to 10.32 million euros with a social return of 43.31 million euros: 4.2 euros for each euro invested. According to the sensitivity analysis, this ratio could range from 3.38 to 5.20 euros from the worst to the best-case scenario. CONCLUSIONS: The current management of MM could be optimised by implementing a set of proposals that would most likely result in an overall positive social return.

A Social Return on Investment Analysis of Improving the Management of Chronic Obstructive Pulmonary Disease Within the Spanish National Healthcare System.

Purpose: To define a set of proposals that would improve the current management of chronic obstructive pulmonary disease (COPD) within the Spanish National Healthcare System (SNHS) from a comprehensive multidisciplinary perspective and to assess the impact of its implementation from clinical, healthcare, economic, and social perspectives. Patients and Methods: A group of 20 stakeholders related to COPD (healthcare professionals, patients, and informal caregivers, among others) participated in an online Delphi process to agree on a set of 15 proposals that would improve the current management of COPD within the SNHS in four areas: diagnosis, risk stratification, management of exacerbations, and management of stable COPD. A one-year forecast-type social return on investment (SROI) analysis was used to estimate the impact that implementing the set of proposals would have in relation to the investment required. A sensitivity analysis was used to test the strength of the model when varying assumption-based data-points. Results: The hypothetical implementation of the complete set of 15 proposals would require a €668 million investment and would generate a €2079 million social impact concerning savings for the SNHS and quality of life improvements for patients and their informal caregivers, among others. Accordingly, for every euro invested in the set of proposals, a social return of €3.11 would be generated (€2.71 in the worst-case scenario and €3.62 in the best-case scenario) of both tangible (32.56%) and intangible nature (67.44%). Conclusion: Altogether, implementing this set of 15 proposals would generate a positive social impact, threefold the required investment. The results may inform decisions relative to healthcare policy and practice regarding COPD management within the SNHS, further contributing to reduce the large burden of COPD.

Assessing the value contribution of bimekizumab for the treatment of moderate-to-severe psoriasis using a multidisciplinary reflective multi-criteria decision analysis.

BACKGROUND: 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. RESEARCH DESIGN AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

The economic burden of pulmonary arterial hypertension in Spain.

BACKGROUND: Pulmonary Arterial Hypertension (PAH) is a rare, debilitating, and potentially fatal disease. This study aims to quantify the economic burden of PAH in Spain. METHODS: The study was conducted from a societal perspective, including direct and indirect costs associated with incident and prevalent patients. Average annual costs per patient were estimated by multiplying the number of resources consumed by their unit cost, differentiating the functional class (FC) of the patient. Total annual costs per FC were also calculated, taking the 2020 prevalence and incidence ranges into account. An expert committee validated the information on resource consumption and provided primary information on pharmacological consumption. Unit costs were estimated using official tariffs and salaries in Spain. A deterministic sensitivity analysis was conducted to test the uncertainty of the model. RESULTS: The average annual total cost was estimated at €98,839 per prevalent patient (FC I-II: €65,233; FC III: €103,736; FC IV: €208,821), being €42,110 for incident patients (FC I-II: €25,666; FC III: €44,667; FC IV: €95,188). The total annual cost of PAH in Spain, taking into account a prevalence between 16.0 and 25.9 cases per million adult inhabitants (FC I-II 31.8%; FC III 61.3%; FC IV 6.9%) and an incidence of 3.7, was estimated at €67,891,405 to €106,131,626, depending on the prevalence considered. Direct healthcare costs accounted for 64% of the total cost, followed by indirect costs (24%), and direct non-healthcare costs (12%). The total costs associated with patients in FC I-II ranged between €14,161,651 and €22,193,954, while for patients in FC III costs ranged between €43,763,019 and €68,391,651, and for patients in FC IV between €9,966,735 and €15,546,021. In global terms, patients with the worst functional status (FC IV) account for only 6.9% of the adults suffering from PAH in Spain, but are responsible for 14.7% of the total costs. CONCLUSIONS: PAH places a considerable economic burden on patients and their families, the healthcare system, and society as a whole. Efforts must be made to improve the health and management of these patients since the early stages of the disease.

The impact of improving haemophilia A management within the Spanish National Healthcare System: a social return on investment analysis.

BACKGROUND: Haemophilia A (HA) has been associated with poor health-related quality of life and a large economic burden, accentuated by severity, arthropathy, and inhibitors. To meet global standards of care, the management of HA should align with the principles of care outlined by the World Federation of Haemophilia. The aims of the present study were to establish a set of proposals to improve HA management within the Spanish National Health System (SNHS) and to estimate the impact its hypothetical implementation would generate from a clinical, healthcare, economic, and social perspective. METHODS: A multidisciplinary group of experts agreed on a set of 15 proposals to improve HA management within the SNHS. Thereafter, a forecast-type Social Return on Investment analysis was carried out to estimate the impact of implementing this set of proposals within the SNHS over a one-year timeframe, in relation to the required investment. RESULTS: This study estimated that the implementation of the complete set of 15 proposals would require a total investment of 2.34 M€ and have a total impact of 14.60 M€. Accordingly, every euro invested in the complete set of 15 proposals would yield a social return of €6.23 (€3.37 in the worst-case scenario and €9.69 in the best-case scenario) of both tangible and intangible nature in similar proportions (45.71 and 54.29%, respectively). CONCLUSIONS: These results can be used to inform policy and practice such that interventions that may potentially improve current public health challenges associated with the management of HA may be implemented.

A multicriteria decision analysis (MCDA) applied to three long-term prophylactic treatments for hereditary angioedema in Spain.

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.

Social economic costs of ankylosing spondylitis in Spain.

OBJECTIVES: Ankylosing spondylitis (AS) is a disease associated with a high number of comorbidities, chronic pain, functional disability, and resource consumption. The aim of this study was to estimate the burden of AS in Spain. METHODS: A questionnaire, designed for the development of the "Atlas of Axial Spondyloarthritis in Spain 2017" cross-sectional study, was distributed to patients in 2016. This questionnaire was used to collect relevant sociodemographic and clinical information on patients with AS, as well as to identify resource consumption and patient work productivity losses related to AS within the previous 12 months of survey completion. Subsequently, direct costs were estimated with the bottom-up method and work productivity losses with the human capital method. Economic burden was estimated by subgroups, taking into account the degree of disease activity and the psychological status. RESULTS: The study sample comprised 578 patients with AS: mean age was 46.0±11.0 years, 52.9% were males, and 35.8% had a university-level education. Mean disease duration and diagnostic delay were 13.4±11.3 and 8.4±7.6 years, respectively, and mean Bath Ankylosing Spondylitis Disease Activity Index was 5.4±2.1. The estimated median annual cost per patient with AS was 5,402.4, with an average annual cost per patient of 11,462.3 euros, of which 61.1% (6,999.8 euros) were attributed to direct health care costs, 5.3% (611.3 euros) to direct non-health care costs, and 33.6% (3,851.2 euros) to work productivity losses. CONCLUSIONS: AS poses a significant burden for the Spanish National Health System and society.

The Cost of Postoperative Complications and Economic Validation of the Comprehensive Complication Index: Prospective Study.

OBJECTIVE: To validate the Comprehensive Complication Index (CCI) via an assessment of its relation to postoperative costs. BACKGROUND: The CCI summarizes all the postoperative complications graded by the Clavien-Dindo classification (CDC) on a numerical scale. Its relation to hospital costs has not been validated to date. METHODS: Prospective observational cohort study, including all patients undergoing surgery at a general surgery service during the 1-year study period. All complications graded with the CDC and CCI and related to the initial admission, or until discharge if the patient was readmitted within 90 days of surgery, were included. The surgeries were classified according to their Operative Severity Score (OSS) and in 4 groups of homogeneous surgeries. All postoperative costs were recorded. RESULTS: In all, 1850 patients were included, of whom 513 presented complications (27.7%). The CDC and the CCI were moderately to strongly correlated with overall postoperative costs (OPCs) in all OSS groups (rs = 0.444-0.810 vs 0.445-0.820; P < 0.001), homogeneous surgeries (rs = 0.364-0.802 vs 0.364-0.813; P < 0.001), prolongation of postoperative stay (rs = 0.802 vs 0.830; P < 0.001), and initial operating room costs (rs = 0.448 vs 0.451; P < 0.001). This correlation was higher in emergency surgery. With higher CDC grades, the OPC tended to increase an upward trend. In the multivariate analysis, CDC, CCI, age, and duration of surgery were all associated with OPC (P < 0.001). CONCLUSIONS: In our environment, the CCI presented associations with OPC. This demonstration of its economic validity enhances its clinical validity.

Social value of a set of proposals for the ideal approach of multiple sclerosis within the Spanish National Health System: a social return on investment study.

BACKGROUND: Multiple Sclerosis (MS) is a chronic inflammatory, demyelinating and neurodegenerative disease that in many cases produces disability, having a high impact in patients' lives, reducing significantly their quality of life. The aim of this study was to agree on a set of proposals to improve the current management of MS within the Spanish National Health System (SNHS) and apply the Social Return on Investment (SROI) method to measure the potential social impact these proposals would create. METHODS: A Multidisciplinary Working Team of nine experts, with representation from the main stakeholders regarding MS, was set up to agree on a set of proposals to improve the management of MS. A forecast SROI analysis was carried out, with a one-year timeframe. Data sources included an expert consultation, a narrative literature review and a survey to 532 MS patients. We estimated the required investment of a hypothetical implementation, as well as the potential social value that it could create. We calculated outcomes in monetary units and we measured intangible outcomes through financial proxies. RESULTS: The proposed ideal approach revealed that there are still unmet needs related to MS that can be addressed within the SNHS. Investment would amount to 148 million € and social return to 272 million €, so each euro invested could yield almost €2 of social return. CONCLUSIONS: This study could guide health interventions, resulting in money savings for the SNHS and increases in patients' quality of life.

The social return on investment of a new approach to heart failure in the Spanish National Health System.

AIMS: We aim to agree on a set of proposals to improve the current management of heart failure (HF) within the Spanish National Health System (SNHS) and apply the social return on investment (SROI) method to measure the social impact that these proposals would generate. METHODS AND RESULTS: A multidisciplinary working team of 16 experts was set up, with representation from the main stakeholders regarding HF: medical specialists (cardiologists, internal medicine physicians, general practitioners, and geriatric physicians), nursing professionals, health management professionals, patients, and informal caregivers. This team established a set of proposals to improve the management of HF according to the main areas of HF care: emergency and hospitalization, primary care, cardiology, and internal medicine. A forecast-type SROI method, with a 1-year time frame, was applied to measure the social impact resulting from the implementation of these proposals. The required investment and social return were estimated and summarized into a ratio indicating how much social return could be generated for each euro invested. Intangible returns were included and quantified through financial proxies. The approach to improve the management of HF consisted of 28 proposals, including the implementation of a case management nurse network, standardization of operational protocols, psychological support, availability of echocardiography machines at emergency departments, stationary units and primary care, early specialist visits after hospital discharge, and cardiac rehabilitation units, among others. These proposals would benefit not only patients and their informal caregivers but also the SNHS. Regarding patients, proposals would increase their autonomy in everyday activities, decrease anxiety, increase psychological and physical well-being, improve pharmacological adherence and self-care, enhance understanding of the disease, delay disease progression, expedite medical assessment, and prevent the decrease in work productivity associated with HF management. Regarding informal caregivers, proposals would increase their quality of life; improve their social, economic, and emotional well-being; and reduce their care burden. The SNHS would benefit from shorter stays of HF patients at intensive care units and reduction of hospitalizations and admissions to emergency departments. The investment needed to implement these proposals would amount to €548m and yield a social return of €1932m, that is, €3.52 for each euro invested. CONCLUSIONS: The current management of HF could be improved by a set of proposals that resulted in an overall positive social return, varying between areas of analysis. This may guide the allocation of healthcare resources and improve the quality of life of patients with HF.

The Economic Influence of Breastfeeding on the Health Cost of Newborns.

BACKGROUND: Breastfeeding provides health benefits for women and newborns. However, few studies have explored how these health benefits translate into economic savings. RESEARCH AIM: This study aimed to estimate the healthcare costs savings generated by exclusive breastfeeding for healthy newborns. METHODS: We designed a longitudinal two-group observational study that included healthy women and newborns ( N = 236) in Toledo, Spain. Over the first 6-months of the infants' lives, we reviewed their clinical histories to determine their consumption of healthcare resources and the type of nutrition provided. The sample was categorized into two groups: exclusive breastfeeding ( n = 46) and non-exclusive breastfeeding for 6 months ( n = 190). Two-part regression models were applied to determine whether there were differences in healthcare costs between the groups. RESULTS: The average age of the women was 32 ( SD: 5.3). The average birth weight of the newborns was 3.3 kg. ( SD: 0.38). At 6 months, 19.5% ( n = 46) of the women breastfed exclusively, 28.4% ( n = 67) combined breastfeeding with formula, and 45.8% ( n = 108) used formula only. Healthcare costs during follow-up reached €785.58 (44% for specialized care, 42% for primary care, 9.8% for medical emergencies, 3% for medications and approximately 1% for medical tests). The statistical analysis estimated a lower healthcare cost of between €454.40 and €503.50 for exclusively breastfed newborns. CONCLUSION: Breastfeeding generated savings in healthcare costs; therefore, it could be a cost-efficient option compared with alternatives. Researchers who evaluate the efficiency of strategies that promote breastfeeding can contribute to the sustainability of health services.

The economic burden of disease of epithelial ovarian cancer in Spain: the OvarCost study.

OBJECTIVE: To assess the economic burden of epithelial ovarian cancer (EOC) in incident patients and the burden by disease stage in Spain. METHODS: We developed a Markov model from a social perspective simulating the natural history of EOC and its four stages, with a 10-year time horizon, 3-week cycles, 3% discount rate, and 2016 euros. Healthcare resource utilization and costs were estimated by disease stage. Direct healthcare costs (DHC) included early screening, genetic counselling, medical visits, diagnostic tests, surgery, chemotherapy, hospitalizations, emergency services, and palliative care. Direct non-healthcare costs (DNHC) included formal and informal care. Indirect costs (IC) included labour productivity losses due to temporary and permanent leaves, and premature death. Epidemiology data and resource use were taken from the literature and validated for Spain by the OvarCost group using a Delphi method. RESULTS: The total burden of EOC over 10 years was 3102 mill euros: 15.1% in stage I, 3.9% in stage II, 41.0% in stage III, and 40.2% in stage IV. Annual average cost/patient was €24,111 and it was €8,641; €14,184; €33,858, and €42,547 in stages I-IV, respectively. Of total costs, 71.2% were due to DHC, 24.7% to DNHC, and 4.1% to IC. CONCLUSIONS: EOC imposes a significant economic burden on the national healthcare system and society in Spain. Investment in better early diagnosis techniques might increase survival and patients' quality of life. This would likely reduce costs derived from late stages, consequently leading to a substantial reduction of the economic burden associated with EOC.

Atlas of axial spondyloarthritis in Spain 2017: Study design and population.

OBJECTIVE: Atlas of Axial Spondyloarthritis in Spain 2017 aims to better understand the reality of the patients suffering from this disease from an integrated approach. METHODS: The Atlas 2017 based its results on an extensive cross-sectional patient survey conducted in Spain (2016), validated by a multidisciplinary group of experts on spondyloarthritis. RESULTS: Data from 680 patients with axSpA were obtained, most of them suffered from AS, were HLA-B27 positive, older than 45 years, and live as part of a couple. A large percentage had university studies, were disabled and members of a patient association. Patients reported a diagnostic delay of 8.5 years, high disease activity (BASDAI 5.5±2.2), moderate-important stiffness (61.0%), medium-high functional limitation (74.9%), and psychological distress (GHQ 5.7±4.5). A total of 54.7% reported taking NSAIDs, 28.4% DMARDs, 36.3% biological therapy and 32.2% were not receiving pharmacological treatment. CONCLUSIONS: The Atlas survey data reveals still a long diagnostic delay, high disease activity, psychological distress, while an important proportion could be undertreated.

Multi-Indication Pricing: Nice in Theory but Can it Work in Practice?

For medicines with different valued indications (uses), multi-indication pricing implies charging different prices for different uses. In this article, we assess how multi-indication pricing could help achieve overall strategic objectives of pricing controls, summarise its advantages and disadvantages (vs. uniform pricing) and estimate the hypothetical impact on prices of moving towards multi-indication pricing for specific oncologic medicines in Spain. International experience shows that multi-indication pricing can be implemented in real practice, and indeed a few initiatives are currently in use, albeit mostly applied indirectly through confidential pricing agreements that offer a way to discriminate prices across countries without altering list prices. However, some more sophisticated systems are in place in Italy, and more recently in Spain, where the objective is to monitor usage per patient/indication, and ultimately pay for outcomes. Based on the existing experience, we also outline six conditions required for multi-indication pricing. Multi-indication pricing is a useful tool to determine the relative prices of a drug for multiple (different-valued) indications, but by itself will not offer the 'solution' to what the absolute price should be. That will be driven, among other things, by cost-effectiveness thresholds, if they exist. Overall, we argue multi-indication pricing is nice in theory and it could work in practice, although changes in the manner in which medicines are priced, procured and monitored in clinical practice need to be applied.

Social economic costs of COPD in Extremadura (Spain): an observational study.

Purpose: COPD has been associated with a high number of comorbidities and a relatively high level of health care resource utilization. This study aimed to estimate the social economic impact of COPD in the autonomous community of Extremadura (Spain) in 2015. Patients and methods: This is a retrospective observational study carried out using a representative sample of patients diagnosed with COPD in Extremadura. Sociodemographic data, data on health care resource utilization, formal and informal care received by the patients, and loss of labor productivity in the last 12 months were collected through an electronic data collection platform. Direct health care costs were estimated using the bottom-up approach, costs of informal care were assessed using the substitution method, and labor productivity losses were calculated using the human capital method. Results: A sample of 386 patients was obtained (mean age: 71.8±10.3 years, males: 76.2%). The results show an average annual cost per patient of 3,077 euros. Direct health care costs represented 43.8% (1,645 euros), direct non-health care costs amounted to 38.3% (1,440 euros), and labor productivity losses represented 17.9% (672 euros) of the average annual cost. The total annual cost of patients with COPD in Extremadura reached 36.2 million euros in 2015. Conclusion: COPD poses a significant burden for the health care system and the society of Extremadura. The implementation of preventive and control measures could result in a substantial reduction in the economic impact.

Determining the Value of Two Biologic Drugs for Chronic Inflammatory Skin Diseases: Results of a Multi-Criteria Decision Analysis.

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.

The Impact of Severe Obesity on Healthcare Resource Utilisation in Spain.

BACKGROUND: Obesity is not only a health problem but also a source of increased monetary expenditures. The objectives of this study were to analyse the use of healthcare resources in the Spanish adult population with class II obesity and above (BMI ≥35 kg/m2) and to compare it with other BMI groups. METHOD: We used the Spanish National Health Survey, a longitudinal population-based survey (n = 18,682), to analyse healthcare resource utilisation by BMI groups. Adjusted and unadjusted logistic regression models were used to calculate odds ratios (OR) for healthcare use among class II and over obese subjects versus normal BMI. RESULTS: Persons with BMI ≥35 are more likely to attend general practitioner (GP)'s consultations (17%), to visit the emergency department (26%), to consume medications (36%), to be hospitalised (49%), to require nursing consultations (61%) and to require psychology consultations (83%). The proportion of obese people receiving home visits is 2.6 times higher than among normal BMI. After controlling for sex and age groups, people with severe obesity (BMI ≥35 kg/m2) were more prone to requiring home care visits (OR 2.3; CI [1.3; 4.2]), GP visits (OR 2.1; CI [1.5; 3.0]), psychologist visits (OR 1.96; CI [1.3; 2.99]), emergency service visits (OR 1.5; CI [1.2; 1.8]), nurse visits (OR 1.46; CI [1.2; 1.9]) and hospitalisations (OR 1.43; CI [1.1; 1.9]) and after also adjusting for relevant comorbidities like hypertension, diabetes and cardiovascular diseases: GP visits (OR 1.85; CI [1.3; 2.7]), psychologist visits (OR 1.8; CI [1.2; 2.7]), specialised care visits (OR 0.92; CI [0.7; 1.2]) and physiotherapist visits (OR 0.7; CI [0.5; 1.0]). CONCLUSIONS: Severe obesity significantly increases healthcare resource utilisation in Spain. The results shed light on the real magnitude of the burden of obesity in Spain.

Cost of vitamin K antagonist anticoagulant treatment in patients with metallic prosthetic valve in mitral position.

BACKGROUND: The initiation of oral anticoagulation therapy after valve replacement surgery requires strict monitoring because these patients are at high risk for the development of thrombotic complications and present an increased risk of bleeding. OBJECTIVES: The aim of this study was to examine the total healthcare costs of oral anticoagulant treatment with vitamin K antagonists in patients with metallic prosthetic valves in the mitral position. METHODS: Data from clinical records were used in the study including international normalized ratio results, number of medical visits, type of anticoagulant, use of rescue medication and hospital admissions from related complications. The drug cost was calculated based on the official Spanish Ministry of Health price list. Monitoring expenses were included in the cost of the medical supplies used in the procedures. Hospitalization costs were calculated using the diagnosis-related group price for each case. RESULTS: We collected data from 151 patients receiving oral anticoagulation therapy with vitamin K antagonist who were diagnosed with mitral prosthesis (n = 90), mitro-aortic prosthesis (n = 57), and mitral and tricuspid prosthesis (n = 4). The total direct healthcare cost was €15302.59, with a mean total cost per patient per year of €1558.15 (±2774.58) consisting of 44.38 (±42.30) for drug cost, €71.41 (±21.43) for international normalized ratio monitoring, €429.52 (±126.87) for medical visits, €26.31 (±28.38) for rescue medication and €986.53 (±2735.68) for related complications. CONCLUSION: Most direct healthcare costs associated with the sampled patients arose from the specialist-care monitoring required for treatment. Good monitoring is inversely related to direct healthcare costs.

Cost-utility analysis of certolizumab pegol versus alternative tumour necrosis factor inhibitors available for the treatment of moderate-to-severe active rheumatoid arthritis in Spain.

BACKGROUND: Certolizumab pegol, a PEGylated tumour necrosis factor (TNF)-inhibitor, improves the clinical signs and symptoms of rheumatoid arthritis (RA) when used in combination with methotrexate or as monotherapy. This study evaluatedthe cost-utility of certolizumab pegol versusTNF-inhibitors plus methotrexate in the treatment of moderate-to-severe RA in Spain. METHODS: A Markov cohort health state transition model was developed to evaluate the cost-utility (costs and quality-adjusted life years [QALYs]) of certolizumab pegol versus other TNF-inhibitors licensed in Spain in 2009. Efficacy was measured using the American College of Rheumatology (ACR) responses at 6 months, based on adjusted indirect comparisons from published clinical trials. Utilities were derived from EQ-5D data from certolizumab pegol RA clinical trials. Clinical history and resource use data came from published literature. Unit costs were taken from Spanish databases or published data (cost year 2009). Base case analyses were conducted from the payer perspective, with a lifetime horizon, 3.5 % annual discounting rates for costs and outcomes, and 3 % inflation rate for 2009 onwards. One-way sensitivity analyses were conducted. RESULTS: The average lifetime costs for certolizumab pegol, etanercept, adalimumab (every 2 weeks and weekly) and infliximab (3 mg/kg and 5 mg/kg) in combination with methotrexate were €140,971, €141,197, €139,148, €164,741, €136,961 and €152,561, respectively. The QALYs gained were 6.578, 6.462, 6.430 (for both adalimumab doses), 6.430, and 6.318 (for both infliximab doses), respectively. At a €30,000/QALY willingness-to-pay threshold, certolizumab pegol plus methotrexate dominated adalimumab weekly, etanercept, and infliximab 5 mg/kg, and was cost-effective versus adalimumab every 2 weeks and infliximab 3 mg/kg (all with methotrexate), with estimated ICERs of €12,346/QALY and €15,414/QALY, respectively. Certolizumab pegol monotherapy was more cost-effective versus adalimumab, and less expensive with similar health gains versus etanercept (6.416 QALYs vs 6.492). Univariate analysis showed ICERs to be sensitive to changes in time horizon, ACR response time point, baseline Heath Assessment Questionnaire (HAQ) score, and rate of HAQ-disability index deterioration after discontinuing treatment. CONCLUSIONS: This analysis shows that certolizumab pegol is cost-effective compared with other TNF-inhibitors recommended in Spain for the treatment of RA.