Capturing the Value of Vaccination within Health Technology Assessment and Health Economics-Practical Considerations for Expanding Valuation by Including Key Concepts.

Following the development of a value of vaccination (VoV) framework for health technology assessment/cost-effectiveness analysis (HTA/CEA), and identification of three vaccination benefits for near-term inclusion in HTA/CEA, this final paper provides decision makers with methods and examples to consider benefits of health systems strengthening (HSS), equity, and macroeconomic gains. Expert working groups, targeted literature reviews, and case studies were used. Opportunity cost methods were applied for HSS benefits of rotavirus vaccination. Vaccination, with HSS benefits included, reduced the incremental cost-effectiveness ratio (ICER) by 1.4-50.5% (to GBP 11,552-GBP 23,016) depending on alternative conditions considered. Distributional CEA was applied for health equity benefits of meningococcal vaccination. Nearly 80% of prevented cases were among the three most deprived groups. Vaccination, with equity benefits included, reduced the ICER by 22-56% (to GBP 7014-GBP 12,460), depending on equity parameters. Macroeconomic models may inform HTA deliberative processes (e.g., disease impact on the labour force and the wider economy), or macroeconomic outcomes may be assessed for individuals in CEAs (e.g., impact on non-health consumption, leisure time, and income). These case studies show how to assess broader vaccination benefits in current HTA/CEA, providing decision makers with more accurate and complete VoV assessments. More work is needed to refine inputs and methods, especially for macroeconomic gains.

Approach to patients with diabetes and obesity in primary care.

AIMS: The aim of this study is to analyse the effect of pharmacological and non-pharmacological treatment on weight control in patients with diabetes and obesity. DESIGN: Epidemiological, descriptive, cross-sectional study. SITE: Primary care. In 11 health centres in Málaga and Cádiz during April and October 2022. PARTICIPANTS: 281 patients over 18 years old with type 2 diabetes and obesity are included. MAIN MEASUREMENTS: Socio-demographics, clinical, treatment and lifestyle habits variables were obtained from medical records and personal interview. Descriptive statistics were obtained for continuous variables. Statistical tests were performed based on the nature of the variables. RESULTS: Variables like marital status, level of education and occupation, and smoking habit, shows differences regarding the sex (p<0.05). 82.3% of those who received education lost weight, compared to 67.5% of lost weight who received no health education (p=0.004). GLP1 and SGLT2 were more commonly prescribed for women (p=0.048), and SGLT2 more commonly prescribed for men (p=0.047). Patients taking GLP1, SGLT2 or both, regardless of sex, weight loss during the study period was -3.1kg (SE: 0.60), while the loss of those who took other medications was -1.33kg (SE: 0.62). The mean difference was 1.75kg (p=0.046). CONCLUSIONS: In terms of weight loss, obese diabetics who took GLP1, SGLT2 or both were 2.5 times more likely to lose weight than those who did not. Healthy lifestyle choices are key to weight loss in obese diabetic patients.

Study Protocol on Social Return on Investment (SROI) Project of the Surgical Waiting List Management System.

In Andalusia, the right to maximum waiting times for healthcare clashes with the available supply, leading to an increase in demand in the form of waiting lists. To address this situation, the activity of private centers has been created for certain diagnostic tests. The Social Return on Investment (SROI) model evaluates an intervention from an economic and stakeholder perspective. However, there are no studies on the suitability of waiting lists using SROI, which is why it is intended to be studied as a decision-making tool for the clinical and healthcare management of waiting lists. This research protocol is designed to determine the quality of life gained, with the EuroQol-5D-5L questionnaire, and its social assessment, with the specific survey of the SROI method, and, thus, analyze the social return on investment and determine the suitability of the intervention (diagnostic endoscopy activity arranged in a contracted center). After the study, we will know the economic (cost in public health centers and the incremental cost of extraordinary health resources), social (quality of life with health), and environmental scenarios of the concerted activity intervention in order to adjust waiting list times.

Benefit-risk assessment of sonidegib and vismodegib in the treatment of locally advanced basal cell carcinoma.

Background: Sonidegib and vismodegib are Hedgehog pathway inhibitors (HhIs) that play a relevant role in the management of locally advanced basal cell carcinoma (laBCC). This study compared the efficacy and safety of both HhIs based on their available data using effect size measures such as number needed to treat (NNT), number needed to harm (NNH), and likelihood to be helped or harmed (LHH). Methods: We reviewed data from pivotal trials of sonidegib (BOLT) and vismodegib (ERIVANCE). The NNT for sonidegib and vismodegib was calculated from objective response rate (ORR) values. The NNH was calculated from data relating to treatment discontinuation due to adverse events (AEs) and incidence of AEs. The LHH was calculated as the ratio between the corresponding NNH and NNT. Results: For sonidegib (200 mg), the NNT for ORR at 18 months was 1.65 (95% CI 1.35-2.01) whilst that for vismodegib (150 mg) at 21 months was 2.10 (95% CI 1.65-2.82). The NNH related to treatment discontinuation due to AEs was 1.9 (95% CI 1.6-2.5) for sonidegib and 1.8 (95% CI 1.4-2.2) for vismodegib. The LHH for sonidegib and vismodegib related to treatment discontinuation due to AEs was 1.14 and 0.84, respectively, whilst the LHH according to AEs of grade ≥3 was 1.41 for sonidegib and 0.85 for vismodegib. Conclusions: Sonidegib showed a better benefit-risk ratio compared to vismodegib, being more likely to achieve therapeutic response than to AEs leading to discontinuation. These results should be confirmed in clinical practice and/or in a direct comparison study.

Capturing the value of vaccination within health technology assessment and health economics: Literature review and novel conceptual framework.

BACKGROUND: Vaccination provides significant health gains to individuals and society and can potentially improve health equity, healthcare systems and national economies. Policy decisions, however, are rarely informed by comprehensive economic evaluations (EE) including vaccination's wide-ranging value. The objective of this analysis was to focus on health technology assessment systems to identify relevant value concepts in order to improve current EE of non-pandemic vaccines. METHODS: Following a literature review, a novel Value of Vaccination (VoV) framework was developed with experts in vaccine EE from developed countries with established health technology assessment systems. RESULTS: Forty-four studies presenting value frameworks or concepts applicable to vaccination were included. Eighteen unique value concepts relevant to EE were identified and defined. These were categorised within the VoV framework using three dimensions, moving from a narrow payer perspective to a more expansive and societal perspective. The dimensions were: (I) conventional payer perspective concepts (e.g., health gains in vaccinees, direct medical costs); (II) conventional societal perspective concepts (e.g., indirect health/economic gains to caregivers/households, productivity in vaccinees); and (III) novel societal concepts (e.g., financial risk protection, peace of mind, societal health gains, healthcare systems security, political stability, social equity and macroeconomic gains). While good quality evidence and methods are available to support concepts in Dimensions I and II, further work is needed to generate the required evidence for vaccination impact on Dimension III concepts. CONCLUSIONS: The devastating effect on nations of the COVID-19 pandemic has helped to highlight the potential far-reaching benefits that many vaccination programmes can offer. This VoV framework is particularly relevant to policy decisions considering EE, and the potential future expansion of non-pandemic vaccination value considerations. The framework helps to understand and compare current value considerations across countries and payer versus societal perspectives. It provides decision-makers with a transparent and logical path to broaden consideration of VoV in EE.

Capturing the value of vaccination within health technology assessment and health economics: Country analysis and priority value concepts.

BACKGROUND: A value of vaccination framework for economic evaluation (EE) identified unique value concepts for the broad benefits vaccination provides to individuals, society, healthcare systems and national economies. The objectives of this paper were to work with experts in developed countries to objectively identify three priority concepts to extend current EE. METHODS: The previously developed classification of value concepts in vaccination distinguished 18 concepts, categorised as conventional payer and societal perspective concepts and novel broader societal concepts. Their inclusion in current EE guidelines was assessed. Experts identified eight criteria relevant to decision-making and measurement feasibility, which were weighted and used to score each concept. The relative ranking of concepts by importance and the gaps in guidelines were used to identify three priority concepts on which to focus immediate efforts to extend EE. RESULTS: The EE guidelines review highlighted differences across countries and between guidelines and practice. Conventional payer perspective concepts (e.g., individual and societal health gains and medical costs) were generally included, while gaps were evident for conventional societal perspective concepts (e.g., family/caregiver health and economic gains). Few novel broader societal benefits were considered, and only in ad hoc cases. The top-three concepts for near-term consideration: macroeconomic gains (e.g., benefiting the economy, tourism), social equity and ethics (e.g., equal distribution of health outcomes, reduced health/financial equity gaps) and health systems strengthening, resilience and security (e.g., efficiency gains, reduced disruption, increased capacity). CONCLUSIONS: Gaps, inconsistencies and limited assessment of vaccination value in EE can lead to differences in policy and vaccination access. The three priority concepts identified provide a feasible approach for capturing VoV more broadly in the near-term. Robust methods for measuring and valuing these concepts in future assessments will help strengthen the evidence used to inform decisions, improving access to vaccines that are demonstrably good value for money from society's point of view.

Cross-cultural adaptation and psychometric validation of a Spanish version of the revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire.

OBJECTIVES: Successful deprescribing depends largely on factors related to the patient. The revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire was developed with the objective of evaluating the beliefs and attitudes of older adults and caregivers towards deprescribing. The present study was designed to validate a Spanish version of the rPATD questionnaire, both the versions for older adults and for caregivers, through a qualitative validation phase and the analysis of its psychometric properties. DESIGN: Cross-sectional validation study. SETTING: Primary care settings in Málaga (Spain). PARTICIPANTS: A sample of 120 subjects (60 patients with polypharmacy and 60 caregivers of patients with polypharmacy) were enrolled in the study. MAIN OUTCOME MEASURES: In the qualitative validation stage, the rPATD questionnaire was translated/back-translated and subjected to a cross-cultural adaptation to evaluate its face validity and feasibility. Next, its psychometric properties were assessed. Confirmatory factor analysis was used to evaluate construct validity. Internal consistency was determined using Cronbach's alpha test. Criterion validity through pre-established hypotheses from the Beliefs about Medicines Questionnaire (BMQ) Specific-Concerns Scale, and test-retest reliability were analysed. RESULTS: Confirmatory factor analysis verified the four-factor structure of the original rPATD questionnaire, with items loading into four factors: involvement, burden, appropriateness and concerns about stopping. The Cronbach's alpha coefficient of the factors ranged from 0.683 to 0.879. The burden, appropriateness and concerns about stopping factors were significantly correlated with the BMQ Specific-Concerns Score, except for the concerns about stopping factor in the older adults' version. The consistency of the items between administration times (test-retest reliability) showed weighted Cohen's kappa values ranging from moderate (>0.4) to very good (>0.8). CONCLUSIONS: The Spanish version of the rPATD questionnaire is a feasible, valid and reliable instrument to evaluate attitudes towards deprescribing in Spanish-speaking patients and caregivers.

Cost of illness of invasive meningococcal disease caused by serogroup B Neisseria meningitidis in Spain.

INTRODUCTION: Invasive meningococcal disease (IMD) is a severe infectious disease, mainly affecting children under 5 years, associated with long-term physical, neurological and psychological sequelae. In Spain, most IMD cases are caused by meningococcal serogroup B (MenB). This study estimates its economic burden from a societal perspective in Spain. METHODS: A previously published bottom-up, model-based incidence costing approach by Scholz et al. (2019) to estimate the economic burden of MenB in Germany was adapted to the Spanish setting. Diagnosis and age-related costs for a hypothetical Spanish cohort were calculated over a lifetime horizon. Official Spanish databases, literature and expert opinion were used as data sources. The costs were updated to 2019 prices, and a 3% discount rate was applied. Direct costs related to the acute IMD phase, long-term sequelae, rehabilitation and public health response were considered. Indirect costs included productivity losses and premature mortality and were calculated using the human-capital approach (HCA) and friction-cost approach (FCA). Deterministic and probabilistic sensitivity analyses were also performed. RESULT: At base-case, the total cost for a cohort of 142 patients (2017-2018 period) was €4.74 million (€33,484/case) using the FCA and €13.14 million (€92,768/case) using the HCA. Direct costs amounted to €4.65 million (€32,765/case). Sequelae costs represented 62.46% of the total cost using the FCA and 77.63% using the HCA. Deterministic sensitivity analysis showed that variation of ± 20% in the input parameter values (population, epidemiology, productivity, costs) had the greatest influence on the base-case results, and the probabilistic sensitivity analysis showed the probability of fitting base-case estimates was > 99%, both for FCA and HCA. DISCUSSION: MenB IMD is an uncommon but severe disease, with a high economic burden for Spanish society. The elevated costs per IMD case reflect its severity in each patient suffering this disease, especially due to the development of sequelae.

Impact of Covid-19 containment on community pharmaceutical spending in Andalusia - Spain.

BACKGROUND: In the field of health, the year 2020 will be remembered for testing (stressing) all health institutions and their forms of management (centralised and decentralised). The everyday activity of primary and hospital care was significantly altered by the introduction of telephone consultations, which reduce the number of visits to health centres or hospitals and are still relevant today in the face of successive waves of the pandemic. OBJECTIVE: To analyse whether population confinement due to the COVID-19 pandemic had an impact on the dispensing of medications in community pharmacies and the associated spending during the period March-July 2020 in Andalusia (Spain). METHODS: A time series analysis applying econometric model analysis techniques to confirm or rule out whether the lockdown caused by the COVID-19 pandemic had an impact on the dispensing of medications by community pharmacies and the associated expenditures. The variables used were the number of medication containers dispensed by community pharmacies (charged to the public funds of the Spanish National Health System) and the expenditure on prescription drugs, both in relation to the population. The analysis was performed within the region of Andalusia, which has 8,464,441 inhabitants. RESULTS: The data obtained from the time series confirmed that there were no significant differences during the studied period between the number of medication containers actually dispensed and the number that would have been expected to be dispensed according to the trend in this variable for the sample period. The expenditure results followed the same pattern. CONCLUSIONS: The health crisis produced by the COVID-19 lockdown had no impact on medication consumption in Andalusia.

[Validation into Spanish of the revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire to assess patients' attitudes towards deprescribing. Research protocol]. / Validación al castellano del cuestionario revised Patients' Attitudes Towards Deprescribing (rPATD) para evaluar las actitudes de los pacientes hacia la deprescripción. Protocolo de investigación.

INTRODUCTION AND OBJECTIVE: Polypharmacy has become a priority public health problem in developed countries. In response to its approach, deprescription stands out. Its success will depend largely on the attitudes and beliefs of patients towards the number of drugs they are taking and their willingness to initiate a process of deprescription. To explore these factors, researchers have developed the revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire, originally in English. The objective of this study is the validation into Spanish of rPATD questionnaire, both older adults and caregivers versions. MATERIAL AND METHODS: A first qualitative validation phase and a second phase of analysis of its psychometric characteristics will be carried out through an observational descriptive study of validation of a measurement instrument. One hundred and twenty subjects (polymedicated older adults and caregivers) from three health centers will be selected by consecutive sampling. The questionnaire will be provided and clinical and sociodemographic data will be collected. Feasibility, reliability (through internal consistency and intraobserver reliability) and validity (apparent, construct and criterion) of the questionnaire will be evaluated. EXPECTED RESULTS: It is expected to obtain a questionnaire that will serve as a tool for the clinician to identify patients with a favorable predisposition to deprescription and that will allow to contribute the patient's perspective to this process. CONCLUSION: The use of the rPATD questionnaire, alone or integrated into other more complex interventions, may lead to an improvement in the quality of care for the polymedicated patients.

Medicines use review service in community pharmacies in Spain: REVISA project.

Background Community pharmacy services play an important role in controlling some factors related to medicine use and patients can benefit from these services to improve the adherence and knowledge of their medications, besides to reduce medicine-related problems. Objective The aim of the REVISA project is to carry out a study on preliminary implementation of the medicines use review service in Spanish community pharmacies. Setting Sixty-four community pharmacies from all regions of Spain. Method A preliminary implementation, cross-sectional multicentre study was conducted using a convenience sample of voluntary community pharmacies. A structured interview enabled to pharmacists to obtain a better understanding of patient's medicines use. Main outcome measure Medicines use review-related time and cost, satisfaction and willingness to pay. Results A total of 495 patients were enrolled. The mean age of the patients was 66.1 years, with the majority females (56.4%) and a mean consumption of 5.7 medicines. A total of 2811 medicines were evaluated and 550 referral recommendations were made (29.8% to Primary Care). The mean time employed by the pharmacists in the medicines use review service was 52.8 min (medicines use review-related cost of €17.27). Most patients expressed a high level of satisfaction with this service (98.5%) and a willingness to pay for it (84%). Conclusion Medicines use review service in community pharmacies in Spain can be delivered, that it appears to be acceptable to patients and that most patients said they would be willing to pay for it. This service may offer an opportunity to promote inter-professional collaboration between pharmacists and general practitioners.

Value-Based Healthcare in Ostomies.

In order to achieve significant improvements in quality, cost, and accessibility (the health "iron triangle"), innovation in organizational and service delivery models is necessary to increase the value of healthcare. The aim of this study is to evaluate the efficiency of a model of organizational innovation based on advanced practice nurse in the care of people with ostomies (APN-O) versus usual care. An observational, exploratory, analytical, prospective study with a six-month follow-up was carried out at 12 hospitals that implemented this model in Andalusia. A total of 75 patients who had undergone a digestive elimination ostomy and/or a urinary ostomy were followed for six months. Clinical outcomes, healthcare resources, health-related quality of life, and willingness to pay (WTP) were analyzed. The economic evaluation was conducted from a societal perspective, including healthcare costs and indirect costs. The cost difference between the two models was €136.99 and the quality-adjusted life year (QALY) gained was 0.05965 (€2297 per QALY gained). At six months, the mean of WTP was €69 per APN-O consultation. This model contributes to increasing the value-based healthcare in ostomies. Results of this study suggested that APN-O is an effective patient management model for improving their health status and is highly efficient.

Long term COST-minimization analysis of robot-assisted hysterectomy versus conventional laparoscopic hysterectomy.

BACKGROUND: The aim of this study is to carry out the economic evaluation, in term of a cost-minimization analysis that considers healthcare costs and indirect costs, of robot-assisted hysterectomy (RAH) compared with conventional laparoscopic hysterectomy (CLH) in female adults scheduled for total laparoscopic hysterectomy for benign conditions. METHODS: Cost-minimization analysis based on an analytic observational study of prospective cohorts with a five-year time horizon. Eligible participants were all female adults scheduled for total laparoscopic hysterectomy for benign conditions at tertiary hospital. The economic evaluation was conducted from a Spanish National Health Service and societal perspective, including healthcare costs and indirect costs. The costs are expressed in Euros from the year 2015. RESULTS: One hundred sixty nine patients were analyzed, 68 in the RAH group and 101 in the CLH group. Average cost for the RAH group was €8982.42 compared to €8015.14 for the CLH group (incremental cost €967.27; p = 0.054). Healthcare cost is the most important component of total cost and represents 86.4% for the RAH group and 82.3% for the CLH group. The difference of €1169 (p = 0.01) in the average healthcare cost is mainly due to the cost of purchasing and maintaining the equipment (difference of €1206.39 in favor of RAH; p < 0.005). With regard to indirect costs, for patients in the RAH group the costs associated with loss of productivity were lower (difference of €203.42; p = 0.17), while the cost of trips to the hospital was higher (difference of €1.98; p = 0.66) in respect to CLH. CONCLUSIONS: Our findings reveal similar effectiveness between RAH and CLH, although CLH is the more efficient option from the point of view of an economic analysis based on cost-minimization.

[Crisis, Public Spending on Health and Policy]. / Modelos de gestión según el proveedor y sus efectos en la dinámica de los equipos de atención primaria en Cataluña.

OBJECTIVE: The Spanish economic crisis began in 2008 and according to the Ministry of Economy, Industry and Compe- titiveness it concluded in 2014. During the crisis the main macroeconomic indicators had an adverse evolution and the effects have lasted for more than six years to the present. Aim: To assess the influence on public spending (health and pharmaceutical) that the governing policies have had and the time of crisis suffered. METHODS: Public expenditure per inhabitant (health and pharmaceutical) is compared according to the study period (pre, crisis and post), the political ideology of the ruling party (conservative/ progressive) and each autonomous community in reference to GDP per inhabitant in each of they respect the national average (poor, average or rich) according to the quartiles. The sources of the data have been the National Statistics Institute (GDP and inhabitants of each Autonomous Community and study period) and the Ministry of Health, Social Services and Equality (public health and pharmaceutical expenditure). The statistical procedures (SPSS v24) included descriptive and inferential analysis for public healthcare and pharmaceutical expenditure according to the period of study and ideology. There was also a regression fit to know the relative importance of predictor varibles. RESULTS: During the crisis period there were differences in public health expenditure per inhabitant in the different types of Autonomous Communities (poor / medium / rich) and according to political ideology (p <0.05). Public pharmaceutical expenditure was € 327 / inhab (pre-crisis) to € 366 / inhabitant in the final period of the study. There were statistically significant differences in pharmaceutical expenditure according to the different types of CCAA. Likewise, differences were found in per capita pharmaceutical expenditure between the Autonomous Communities run by conservatives and type of Autonomous Communities throughout the study period. CONCLUSIONS: The community pharmaceutical expenditure per capita has decreased by more than 13% since 2006 until 2017, while the hospital pharmaceutical expenditure has increased by more than 84%. Rich regions invest more in the health care costs and the poor more than drugs.

OBJETIVO: La crisis económica española se inició en el año 2008 y según el Ministerio de Economía, Industria y Compe- titividad concluyó en el año 2014. Durante la crisis los principa- les indicadores macro-económicos tuvieron una evolución adversa y los efectos se han prolongado durante más de seis años hasta la actualidad. El objetivo de este trabajo fue valorar la influencia en el gasto público (sanitario y farmacéutico) que han tenido las políticas gobernantes y el tiempo de crisis sufrido. METODOS: Se compara el gasto público por habitante (sanitario y farmacéutico) según el período de estudio (pre, crisis y post), la ideología política del partido gobernante (conservador/ progresista) y cada comunidad autónoma en referencia al PIB por habitante en cada una de ellas respecto de la media nacional (pobres, en la media o ricas) según los cuartiles. Las fuentes de los datos han sido el INE (PIB y habitantes de cada CCAA y periodo de estudio) y del Ministerio de Sanidad, Servicios Sociales e Igualdad (gasto público sanitario y farmacéutico). El examen estadístico (SPSS 24) incluyó análisis descriptivo e inferencial del gasto sanitario y farmacéutico publico según el período de estudio e ideología, también se realizó un ajuste de regresión para conocer la importancia relativa de las variables predictoras. RESULTADOS: Durante el período de crisis hubo diferencias en el gasto sanitario público por habitante en los distintos tipos de CCAA (pobres/medias/ricas) y según ideología política gobernante (p <0,05). El gasto farmacéutico público pasó de 327 €/hab (pre-crisis) a 366 €/hab en el período final del estudio. Hubo diferencias estadísticamente significativas en el gasto farmacéutico según los distintos tipos de CCAA. De igual forma se encontraron diferencias en el gasto farmacéutico por habitante entre las CCAA regentadas por conservadores y tipo de CCAA a lo largo de todo el período de estudio. CONCLUSIONES: El gasto farmacéutico comunitario por habitante ha disminuido en más del 13% desde 2006 hasta 2017, mientras que el gasto farmacéutico hospitalario se ha incrementado en más del 84%. Las CCAA ricas invierten más en gasto sanitario y las pobres más de medicamentos.

Efficacy of the Treatments Used in Multiple Sclerosis: From Meta-analysis to Number Needed to Treat.

The aim of this study was to analyze the efficacy of drugs used in relapsing-remitting multiple sclerosis, first- and second-line drugs, using the number needed to treat (NNT) as a measure of efficacy. METHODS: Data from randomized clinical trials were analyzed for 3 categories of clinical efficacy outcomes: relapse, change in Expanded Disability Status Scale, and number of new lesions in magnetic resonance imaging. Meta-analysis results are expressed as odds ratios. RESULTS: The global odds ratio was 0.41 (95% confidence interval [CI], 0.34-0.49). For analyzed clinical outcomes, the odds ratio was less for second-line drugs (odds ratio, 2.0). For all studied clinical conditions, in the control group, 47 of 100 patients do not get benefits, compared with 25 (95% CI, 18-32 patients) of 100 for the active treatment group. The NNT was 5 patients (95% CI, 4-7 patients). For the proportion of patients free of relapses, in the control group, 56 of 100 patients had a relapse at 2 years, compared with 37 of 100 patients in the treatment group, with an NNT of 6 patients (95% CI, 5-8 patients). CONCLUSIONS: Active treatments produced statistically significant improvements compared with placebo.

Cost-effectiveness analysis of antipsychotics in reducing schizophrenia relapses.

BACKGROUND: Schizophrenia is a severe form of mental illness which is associated with significant and long-lasting health, social and financial burdens.The aim of this project is to assess the efficiency of the antipsychotics used in Spain in reducing schizophrenia relapses under the Spanish Health System perspective. MATERIAL AND METHODS: A decision-analytic model was developed to explore the relative cost-effectiveness of five antipsychotic medications, amisulpride, aripiprazole, olanzapine, paliperidone Extended-Release (ER) and risperidone, compared to haloperidol, over a 1-year treatment period among people living in Spain with schizophrenia. The transition probabilities for assessed therapies were obtained from the systemic review and meta-analysis performed by National Institute for Health and Clinical Excellence (NICE). RESULTS: Paliperidone ER was the option that yielded more quality-adjusted life years (QALYs) gained per patient (0.7573). In addition, paliperidone ER was the least costly strategy (€3,062), followed by risperidone (€3,194), haloperidol (€3,322), olanzapine (€3,893), amisulpride (€4,247) and aripiprazole (€4,712).In the incremental cost-effectiveness (ICE) analysis of the assessed antipsychotics compared to haloperidol, paliperidone ER and risperidone were dominant options. ICE ratios for other medications were €23,621/QALY gained, €91,584/QALY gained and €94,558/QALY gained for olanzapine, amisulpride and aripiprazole, respectively. Deterministic sensitivity analysis showed that risperidone is always dominant when compared to haloperidol. Paliperidone ER is also dominant apart from the exception of the scenario with a 20% decrease in the probability of relapses. CONCLUSIONS: Our findings may be of interest to clinicians and others interested in outcomes and cost of mental health services among patients with schizophrenia.Paliperidone ER and risperidone were shown to be dominant therapies compared to haloperidol in Spain. It is worthwhile to highlight that schizophrenia is a highly incapacitating disease and choosing the most appropriate drug and formulation for a particular patient is crucial.The availability of more accurate local epidemiological data on schizophrenia would allow a better adaptation of the model avoiding some of the assumptions taken in our work. Future research could be focused on this.

Cost-utility and budget impact analysis of primary prevention with alendronate of osteoporotic hip fractures in Catalonia.

OBJECTIVES: To determine whether primary drug prevention of osteoporotic hip fracture is a useful measure in Catalonia and what would be their budgetary impact. MATERIAL AND METHODS: We performed a cost-utility social perspective study with a time horizon of 10 to 20 years. Univariate sensitivity analysis was performed. Doing nothing is compared with an intervention that includes screening for osteoporosis in women> 64 years and in those diagnosed and who received treatment with generic alendronate for 10 years. Decision trees are developed for groups of 65-69, 70-74 and 75-79. HF data is from 2009 hospital discharges .Costs are derived from fees paid by public insurance. RESULTS: In 2009 there were 9262 HF. The direct cost was € 55 million (€ 5,943.4/patient). The total cost was € 227 million for 10 years. The intervention dominates in all age groups in a 20 year perspective. In any horizon and age group, the different scenario puts the value per QALY below or within the proposed values for Spain. The budgetary impact is estimated at € 8.9 million which increased by 31% the actual direct cost, and 0.5% of the public pharmacy budget. Considering the total costs and the prospect of 20 years, annual savings of 7.4 million € were seen. CONCLUSIONS: The prevention of HF with alendronate in osteoporotic women>64 years is cost-useful in the long term (20 years) with a low budgetary impact in the 75-79 year group.

[A comparison of leflunomide and subcutaneous methotrexate in the treatment of rheumatoid arthritis: an approximation based on the number needed to treat]. / Comparación de leflunomida y metotrexato subcutáneo en el tratamiento de la artritis reumatoide: una aproximación basada en el número de pacientes que es necesario tratar.

OBJECTIVE: To compare, in the Spanish setting, two drugs for adults with rheumatoid artritis (RA): leflunomide and subcutaneous methotrexate (SC). The high price of methotrexate SC compared with traditional presentations of methotrexate justifies conducting an economic evaluation comparing it with leflunomide. METHODS: The analysis considered the annual costs of the drugs and their effectiveness, measured with a Number Needed to Treat (NNT) approach, considering both the ACR20 and ACR50 criteria for effectiveness. Data about efficacy and dosage were derived from the clinical trial US310, a randomized, doble-blinded controlled trial, which compared efficacy and safety of leflunomide (20mg/daily) vs placebo vs methotrexate (7.5-15mg/weekly) in 482 patients with active RA. Data about use of medical resources for drug monitoring (visits to rheumatologists and diagnostic procedures) were derived from the manufacturers' summary of product characteristics. Direct costs (drugs and monitoring) were obtained from two Spanish databases. The analysis has been performed under the Spanish National Health System perspective. RESULTS: Using the ACR20 criteria, the NNT with leflunomide and methotrexate are 4 (95% CI, 2.56-7.71) and 5 (95% CI, 3.03-14.3) respectively. Using the ACR50 criteria, NNT are 4 (95% CI, 2.72-6.54) and 7 (95% CI, 4.03-19.3). In the case of leflunomide, annual treatment costs per patient-year equals 1,793.30€; in the case of methotrexate total treatment costs amounts to 2,149.20€. CONCLUSIONS: Combining these results the cost of a controlled patient according to ACR20 would amount 7,173€ for leflunomide and 10,746€ for methotrexate SC. Results considering ACR50 are 7,173€ and 15,044€ for leflunomide and methotrexate respectively.

Randomised controlled study in the primary healthcare sector to investigate the effectiveness and safety of auriculotherapy for the treatment of uncomplicated chronic rachialgia: a study protocol.

BACKGROUND: Uncomplicated chronic rachialgia is a highly prevalent complaint, and one for which therapeutic results are contradictory. The aim of the present study is to evaluate the effectiveness and safety of treatment with auriculopressure, in the primary healthcare sector, carried out by trained healthcare professionals via a 30-hour course. METHODS/DESIGN: The design consists of a multi-centre randomized controlled trial, with placebo, with two parallel groups, and including an economic evaluation. Patients with chronic uncomplicated rachialgia, whose GP is considering referral for auriculopressure sensory stimulation, are eligible for inclusion. Sampling will be by consecutive selection, and randomised allocation to one of the two study arms will be determined using a centralised method, following a 1:1 plan (true auriculopressure; placebo auriculopressure). The implants (true and placebo) will be replaced once weekly, and the treatment will have a duration of 8 weeks. The primary outcome measure will be the change in pain intensity, measured on a visual analogue scale (VAS) of 100 mm, at 9 weeks after beginning the treatment. A follow up study will be performed at 6 months after beginning treatment. An assessment will also be made of the changes measured in the Spanish version of the McGill Pain Questionnaire, of the changes in the Lattinen test, and of the changes in quality of life (SF-12). Also planned is an analysis of cost-effectiveness and also, if necessary, a cost-benefit analysis. DISCUSSION: This study will contribute to developing evidence on the use of auriculotherapy using Semen vaccariae [wang bu liu xing] for the treatment of uncomplicated chronic rachialgia. TRIAL REGISTRATION: Current Controlled Trials ISRCTN01897462.