Economic assessment of abemaciclib for the adjuvant treatment of luminal HER2- breast cancer from the perspective of the Spanish health system.

INTRODUCTION: Abemaciclib is an oral inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). Data from the clinical trial monarchE (2023) showed improved survival from invasive disease. The aim of the present article was to conduct an economic assessment of adjuvant treatment with abemaciclib in women with luminal, HER2- and node-positive breast cancer. METHODS: A Markov model was constructed with four mutually exclusive health states (disease-free, local recurrence, distal recurrence and death). Analyses were based on the clinical trial monarchE which compared an intervention group (abemaciclib + hormone therapy [HT]) with HT alone. The effectiveness measure used was quality-adjusted life years (QALY), with unit costs and utilities being obtained from existing literature. The incremental cost-utility ratio (ICUR) was used to compare the two treatment strategies. RESULTS: Total costs were €98,765 and €17,935 for the abemaciclib plus HT group and the HT alone group, respectively. The health outcome was 10.076QALY for the intervention group and 9.495QALY for the control group, with the ICUR being€139,173/QALY. CONCLUSION: Despite the significant gains of abemaciclib as adjuvant treatment in terms of progression-free survival, this treatment is not cost-effective for the Spanish National Health System at published prices. It may be cost-effective with an appropriate discount on the official price.

Urban environment and health: a cross-sectional multiregional project based on population health surveys in Spain (DAS-EP project) - study protocol.

INTRODUCTION: The European Environment Agency estimates that 75% of the European population lives in cities. Despite the many advantages of city life, the risks and challenges to health arising from urbanisation need to be addressed in order to tackle the growing burden of disease and health inequalities in cities. This study, Urban environment and health: a cross-sectional multiregional project based on population health surveys in Spain (DAS-EP project), aims to investigate the complex association between the urban environmental exposures (UrbEEs) and health. METHODS AND ANALYSIS: DAS-EP is a Spanish multiregional cross-sectional project that combines population health surveys (PHS) and geographical information systems (GIS) allowing to collect rich individual-level data from 17 000 adult citizens participating in the PHS conducted in the autonomous regions of the Basque Country, Andalusia, and the Valencian Community, and the city of Barcelona in the years 2021-2023. This study focuses on the population living in cities or metropolitan areas with more than 100 000 inhabitants. UrbEEs are described by objective estimates at participants' home addresses by GIS, and subjective indicators present in PHS. The health outcomes included in the PHS and selected for this study are self-perceived health (general and mental), prevalence of chronic mental disorders, health-related quality of life, consumption of medication for common mental disorders and sleep quality. We aim to further understand the direct and indirect effects between UrbEEs and health, as well as to estimate the impact at the population level, taking respondents' sociodemographic and socioeconomic characteristics, and lifestyle into consideration. ETHICS AND DISSEMINATION: The study was approved by the regional Research Ethics Committee of the Basque Country (Ethics Committee for Research Involving Medicinal Products in the Basque Country; PI2022138), Andalusia (Biomedical Research Ethics Committee of the Province of Granada; 2078-N-22), Barcelona (CEIC-PSMar; 2022/10667) and the Valencian Community (Ethics Committee for Clinical Research of the Directorate General of Public Health and Center for Advanced Research in Public Health; 20221125/04). The results will be communicated to the general population, health professionals, and institutions through conferences, reports and scientific articles.

The cost-effectiveness of a uniform versus age-based threshold for one-off screening for prevention of cardiovascular disease.

The objective of this article was to assess the cost-effectiveness of screening strategies for cardiovascular diseases (CVD). A decision analytic model was constructed to estimate the costs and benefits of one-off screening strategies differentiated by screening age, sex and the threshold for initiating statin therapy ("uniform" or "age-adjusted") from the Spanish NHS perspective. The age-adjusted thresholds were configured so that the same number of people at high risk would be treated as under the uniform threshold. Health benefit was measured in quality-adjusted life years (QALY). Transition rates were estimated from the European Prospective Investigation into Cancer and Nutrition (EPIC-CVD), a large multicentre nested case-cohort study with 12 years of follow-up. Unit costs of primary care, hospitalizations and CVD care were taken from the Spanish health system. Univariate and probabilistic sensitivity analyses were employed. The comparator was no systematic screening program. The base case model showed that the most efficient one-off strategy is to screen both men and women at 40 years old using a uniform risk threshold for initiating statin treatment (Incremental Cost-Effectiveness Ratio of €3,274/QALY and €6,085/QALY for men and women, respectively). Re-allocating statin treatment towards younger individuals at high risk for their age and sex would not offset the benefit obtained using those same resources to treat older individuals. Results are sensitive to assumptions about CVD incidence rates. To conclude, one-off screening for CVD using a uniform risk threshold appears cost-effective compared with no systematic screening. These results should be evaluated in clinical studies.

Challenges for Economic Evaluations of Advanced Therapy Medicinal Products: A Systematic Review.

OBJECTIVES: Advanced therapy medicinal products (ATMPs) are drugs for human use for the treatment of chronic, degenerative, or life-threatening diseases that are based on genes, tissues, or cells. This article aimed to identify and critically review published economic analyses of ATMPs. METHODS: A systematic review of economic analyses of ATMPs was undertaken. Study characteristics, design, sources of data, resources and unit costs, modeling and extrapolation methods, study results, and sensitivity analyses were assessed. RESULTS: A total of 46 economic analyses of ATMP (from 45 articles) were included; 4 were cell therapy medicinal products, 33 gene therapy medicinal products, and 9 tissue-engineered products. 30 therapies had commercial marketing approval; 39 studies were cost-utility analysis, 5 were cost-effectiveness analysis, and 2 were cost only studies. Four studies predicted that the ATMP offered a step change in the management of the condition and 10 studies estimated that the ATMP would offer a lower mean cost. CONCLUSIONS: Comparison with historical controls, pooling of data, and use of techniques such as mixture cure fraction models should be used cautiously. Sensitivity analyses should be used across a plausible range of prices. Clinical studies need to be designed to align with health technology assessment requirements, including generic quality of life, and payers should aim for clarity of criteria. Regulators and national payers should aim for compatibility of registers to allow interchange of data. Given the increasing reliance on industry-funded economic analyses, careful critical review is recommended.

Development of the European Healthcare and Social Cost Database (EU HCSCD) for use in economic evaluation of healthcare programs.

INTRODUCTION: Costs are one of the critical factors for the transferability of the results in health technology assessment and economic evaluation. The objective is to develop a cost database at the European level to facilitate cross-border cost comparisons in different settings and explains the factors that lead to differences in healthcare costs in different countries, taking into account the differences between health systems and other factors. METHODOLOGY: The core of the database is compounded of three main categories (primary resources, composite goods and services, and complex processes and interventions) organized into 13 subcategories. A number of elements providing as detailed information of unit cost as possible were identified in order to mitigate the problem of comparability. Consortium partners validated both the database structure and selected costing items. RESULTS: Twenty-seven costing items included in the EU HCSCD resulted in 1450 unit costs when taking into account all item subtypes and countries. Cross-country differences in costs are driven by the type of resources included in the costing items (e.g., overhead costs in case of complex processes and interventions) or by the variety of existing brands and/or models and the type of unit value in most of the primary resources. CONCLUSION: The EU HCSCD is the only public unit healthcare and social cost database at European level that gather data on unit costs and explains differences in costs across countries. Its maintenance and regular data updating will enable establishing specific systems for generating and recording information that will meet many of its current limitations.

Costing methodologies in European economic evaluation guidelines: commonalities and divergences.

From both the methodological point of view and standardization of methodology, little attention has been paid to the estimation of direct costs in evaluation of healthcare technologies. The objective is to revise the recommendations on direct costs provided in European economic evaluation guidelines and to identify the commonalities and divergences among them. To achieve this, a comprehensive search through several online databases was performed resulting in 41 documents from 26 European countries, be they economic evaluation guidelines or costing guidelines. The results show a large disparity in methodologies used in estimation of direct costs to be included in economic evaluations of health technologies recommended by European countries. A lack of standardization of cost estimation methodologies influences arbitrariness in selecting costs of resources included in economic evaluations of medicinal products or any other technologies and, therefore, in decision making process necessary to introduce new technology. In addition, this heterogeneity poses a major challenge for identifying factors that could affect the variability of unit costs across countries.

Child Care Center Hand Hygiene Programs' Cost-Effectiveness in Preventing Respiratory Infections.

BACKGROUND: We previously demonstrated that a hand hygiene program, including hand sanitizer and educational measures, for day care center (DCC) staff, children, and parents was more effective than a soap-and-water program, with initial observation, in preventing respiratory infections (RIs) in children attending DCCs. We analyzed the cost-effectiveness of these programs in preventing RIs. METHODS: A cluster, randomized, controlled and open study of 911 children aged 0 to 3 years, attending 24 DCCs in Almeria. Two intervention groups of DCC-families performed educational measures and hand hygiene, one with soap-and-water (SWG) and another with hand sanitizer (HSG). The control group (CG) followed usual hand-washing procedures. RI episodes, including symptoms, treatments, medical contacts, complementary analyses, and DCC absenteeism days, were reported by parents. A Bayesian cost-effectiveness model was developed. RESULTS: There were 5201 RI episodes registered. The adjusted mean societal costs of RIs per child per study period were CG: €522.25 (95% confidence interval [CI]: 437.10 to 622.46); HSG: €374.53 (95% CI: 314.90 to 443.07); SWG: €494.51 (95% CI: 419.21 to 585.27). The indirect costs constituted between 35.7% to 43.6% of the total costs. Children belonging to the HSG had an average of 1.39 fewer RI episodes than the CG and 0.93 less than the SWG. It represents a saving of societal cost mean per child per study period of €147.72 and €119.15, respectively. The HSG intervention was dominant versus SWG and CG. CONCLUSIONS: Hand hygiene programs that include hand sanitizer and educational measures for DCC staff, children, and parents are more effective and cost less than a program with soap and water and initial observation in children attending DCCs.

A cost utility analysis alongside a cluster-randomised trial evaluating a minor ailment service compared to usual care in community pharmacy.

BACKGROUND: Minor ailments are "self-limiting conditions which may be diagnosed and managed without a medical intervention". A cluster randomised controlled trial (cRCT) was designed to evaluate the clinical, humanistic and economic outcomes of a Minor Ailment Service (MAS) in community pharmacy (CP) compared with usual care (UC). METHODS: The cRCT was conducted for 6 months from December 2017. The pharmacist-patient intervention consisted of a standardised face-to-face consultation on a web-based program using co-developed protocols, pharmacists' training, practice change facilitators and patients' educational material. Patients requesting a non-prescription medication (direct product request) or presenting minor ailments received MAS or UC and were followed-up by telephone 10-days after the consultation. The primary economic outcomes were incremental cost-utility ratio (ICUR) of the service and health related quality of life (HRQoL). Total costs included health system, CPs and patient direct costs: health professionals' consultation time, medication costs, pharmacists' training costs, investment of the pharmacy and consultation costs within the 10 days following the initial consultation. The HRQoL was obtained using the EuroQoL 5D-5L at the time of the consultation and at 10-days follow up. A sensitivity analysis was carried out using bootstrapping. There were two sub-group analyses undertaken, for symptom presentation and direct product requests, to evaluate possible differences. RESULTS: A total of 808 patients (323 MAS and 485 UC) were recruited in 27 CPs with 42 pharmacists (20 MAS and 22 UC). 64.7% (n = 523) of patients responded to follow-up after their consultation in CP. MAS patients gained an additional 0.0003 QALYs (p = 0.053). When considering only MAS patients presenting with symptoms, the ICUR was 24,733€/QALY with a 47.4% probability of cost-effectiveness (willingness to pay of 25,000€/QALY). Although when considering patients presenting for a direct product request, MAS was the dominant strategy with a 93.69% probability of cost-effectiveness. CONCLUSIONS: Expanding community pharmacists' scope through MAS may benefit health systems. To be fully cost effective, MAS should not only include consultations arising from symptom presentation but also include an oversight of self-selected products by patients. MAS increase patient safety through the appropriate use of non-prescription medication and through the direct referral of patients to GP. TRIAL REGISTRATION: ISRCTN, ISRCTN17235323 . Registered 07/05/2021 - Retrospectively registered.

Cost-Utility Analysis of a Medication Adherence Management Service Alongside a Cluster Randomized Control Trial in Community Pharmacy.

BACKGROUND: It is necessary to determine the cost utility of adherence interventions in chronic diseases due to humanistic and economic burden of non-adherence. PURPOSE: To evaluate, alongside a cluster-randomized controlled trial, the cost-utility of a pharmacist-led medication adherence management service (MAMS) compared with usual care in community pharmacies. MATERIALS AND METHODS: The trial was conducted over six months. Patients with treatments for hypertension, asthma or chronic obstructive pulmonary disease (COPD) were included. Patients in the intervention group (IG) received a MAMS based on a brief complex intervention, whilst patients in the control group (CG) received usual care. The cost-utility analysis adopted a health system perspective. Costs related to medications, healthcare resources and adherence intervention were included. The effectiveness was estimated as quality-adjusted life years (QALYs), using a multiple imputation missing data model. The incremental cost-utility ratio (ICUR) was calculated on the total sample of patients. RESULTS: A total of 1186 patients were enrolled (IG: 633; CG: 553). The total intervention cost was estimated to be €27.33 ± 0.43 per patient for six months. There was no statistically significant difference in total cost of medications and healthcare resources per patient between IG and CG. The values of EQ-5D-5L at 6 months were significantly higher in the IG [IG: 0.881 ± 0.005 vs CG: 0.833 ± 0.006; p = 0.000]. In the base case, the service was more expensive and more effective than usual care, resulting in an ICUR of €1,494.82/QALY. In the complete case, the service resulted in an ICUR of €2,086.30/QALY, positioned between the north-east and south-east quadrants of the cost-utility plane. Using a threshold value of €20,000/QALY gained, there is a 99% probability that the intervention is cost-effective. CONCLUSION: The medication adherence management service resulted in an improvement in the quality of life of the population with chronic disease, with similar costs compared to usual care. The service is cost-effective.

Cost transferability problems in economic evaluation as a framework for an European health care and social costs database.

This article presents part of the work within Work Package 3 (WP3) of Impact HTA (Improved methods and actionable tools for enhancing HTA), a H2020 EU-funded research project, intended to enhance and promote collaboration in HTA across EU MS. Amongst other objectives, and in close collaboration with WP4, WP3 addressed setting up a multi-country unit-cost database: the European health care and social costs database (EU HCSCD). The purpose of the database is to facilitate the transference of healthcare economic evaluation analyses across countries, jurisdictions and settings. WP3 concentrates on healthcare costs; WP4 on social costs. This paper discusses the state of the art on this topic, building an appropriate conceptual and theoretical framework for Database development. We conducted a broad, but not systematic, literature and gray-literature review (LR), identifying existing practices and problems, and their implications, described in the Results section. We discuss practical implications and draw important conclusions behind the construction, and future evolution, of this database.

A general framework for classifying costing methods for economic evaluation of health care.

According to the most traditional economic evaluation manuals, all "relevant" costs should be included in the economic analysis, taking into account factors such as the patient population, setting, location, year, perspective and time horizon. However, cost information may be designed for other purposes. Health care organisations may lack sophisticated accounting systems and consequently, health economists may be unfamiliar with cost accounting terminology, which may lead to discrepancy in terms used in the economic evaluation literature and management accountancy. This paper identifies new tendencies in costing methodologies in health care and critically comments on each included article. For better clarification of terminology, a pragmatic glossary of terms is proposed. A scoping review of English and Spanish language literature (2005-2018) was conducted to identify new tendencies in costing methodologies in health care. The databases PubMed, Scopus and EconLit were searched. A total of 21 studies were included yielding 43 costing analysis. The most common analysis was top-down micro-costing (49%), followed by top-down gross-costing (37%) and bottom-up micro-costing (14%). Resource data were collected prospectively in 12 top-down studies (32%). Hospital database was the most common way of collection of resource data (44%) in top-down gross-costing studies. In top-down micro-costing studies, the most resource use data collection was the combination of several methods (38%). In general, substantial inconsistencies in the costing methods were found. The convergence of top-down and bottom-up methods may be an important topic in the next decades.

Economic evaluation and budgetary burden of mepolizumab in severe refractory eosinophilic asthma.

OBJECTIVE: Mepolizumab is indicated as an additional treatment of severe refractory eosinophilic asthma. The observed differences in  population subgroups according to plasma eosinophil count, the  existence of patients with high levels of immunoglobulin E who are  candidates of omalizumab and mepolizumab, as well as mepolizumab's  economic impact, lead to make efficient economic studies for clinical  decision making. The aim was to analyze mepolizumab's cost-efficacy  and budget impact. METHOD: Cost comparison and the use of mepolizumab's budgetary  impact was performed, from the Spanish National Health System's  perspective. Among the assessed alternatives, inhaled systemic  corticosteroids, plus long acting beta agonist (ß2) and/or oral systemic  corticosteroids in patients with non immunoglobulin E-mediated severe  allergic asthma, and said treatment along with omalizumab in patients  with immunoglobulin E mediated eosinophilic allergic asthma were  included. Its efficacy was evaluated through avoided clinically relevant  exacerbations. The direct costs associated with exacerbation were  assessed. RESULTS: Mepolizumab's long run average incremental cost regarding omalizumab's is 797 euros per patient a year. Considering  omalizumab's alternative discounted price, including mepolizumab for  patients with immunoglobulin E mediated eosinophilic allergic asthma  would increase public spending from 2.3 to 4.6 million euros. Given  omalizumab's notified price, the gradual introduction of mepolizumab in  the Spanish National Health System would save 3.6 million euros in  three years. For non immunoglobulin E-mediated severe asthma  patients, the avoided cost/exacerbation by introducing mepolizumab is  15,085 euros, assuming a gradual market penetration of mepolizumab. In patients with ≥ 500 eosinophils/µL, this cost decreases to 7,767  euros per avoided exacerbation with a budgetary impact of 183.2 million  euros in three years with a progressive penetration of mepolizumab. CONCLUSIONS: The cost comparison between mepolizumab and  omalizumab in immunoglobulin E mediated eosinophilic asthma patients  suggests a use of the lower cost drug, promoting price competition.  Additionally, prioritizing its use among non immunoglobulin E-mediated  severe refractory eosinophilic asthma patients and ≥ 500 eosinophils/µL  plasma level patients, would improve its efficiency as well as  reducing its budgetary impact.

Objetivo: Mepolizumab está indicado como tratamiento adicional del asma eosinofílica refractaria grave. Las diferencias observadas en  subgrupos poblacionales según recuento eosinofílico plasmático,  existencia de pacientes con altos niveles de inmunoglobulina E  candidatos a omalizumab y mepolizumab, e impacto económico de  mepolizumab obligan a realizar estudios económicos para tomar  decisiones clínicas eficientes. El objetivo fue realizar un análisis de  coste/eficacia e impacto presupuestario de mepolizumab.Método: Se realizó la comparación de costes e impacto presupuestario del uso de mepolizumab desde la perspectiva del  Sistema Nacional de Salud. Las alternativas valoradas fueron  corticosteroides sistémicos inhalados + agonista ß2 de larga duración  y/o corticosteroides sistémicos orales en pacientes con asma alérgica  grave no mediada por inmunoglobulina E, y este tratamiento junto a  omalizumab en pacientes con asma eosinofílica alérgica mediada por  inmunoglobulina E. La eficacia se evaluó mediante exacerbaciones  clínicamente relevantes evitadas. Se valoraron los costes directos  asociados a exacerbación.Resultados: El coste incremental medio de mepolizumab respecto a omalizumab es de 797 euros por paciente y año. Considerando precio alternativo con descuento de omalizumab, incluir mepolizumab  para pacientes con asma eosinofílica alérgica y mediada por  inmunoglobulina E supondría incrementar el gasto público de 2,3 a 4,6  millones de euros. Teniendo en cuenta el precio notificado de  omalizumab, la introducción gradual de mepolizumab en el Sistema  Nacional de Salud supondría ahorrar 3,6 millones de euros en tres años.  Para pacientes con asma grave no mediada por inmunoglobulina  E, el coste/exacerbación evitada al añadir mepolizumab es de 15.085  euros, con un impacto presupuestario en tres años de 578,4 millones de  euros, asumiendo una penetración progresiva de mepolizumab en el  mercado. En los pacientes con ≥ 500 eosinófilos/µl, este coste  disminuye a 7.767 euros por exacerbación evitada, con un impacto  presupuestario de 183,2 millones de euros en tres años con penetración  progresiva de mepolizumab.Conclusiones: La comparación de costes entre mepolizumab y  omalizumab en pacientes con asma eosinofílica mediada por  inmunoglobulina E señala como razonable utilizar el fármaco de menor  coste, promoviendo competencia de precios. Asimismo, priorizar su uso  en pacientes con asma eosinofílica refractaria grave no mediada por  inmunoglobulina E y niveles plasmáticos ≥ 500 eosinófilos/µl permitiría  mejorar la eficiencia y disminuir el impacto presupuestario.

Determinants of Burden and Satisfaction in Informal Caregivers: Two Sides of the Same Coin? The CUIDAR-SE Study.

The aim of this study conducted in Spain was to analyze and compare burden, severe burden, and satisfaction among informal caregivers in relation to health-related quality of life (HRQoL), type and duration of caregiving, perceived social support, and use of social and health care services. We performed multivariate analyses to identify variables associated with caregiver burden, severe burden, and satisfaction with caregiving, stratified by gender. The results showed that secondary or third-level education, performance of ungratifying tasks, negative coping with caregiving, and more years providing care were associated with greater burden. Variables with protective effect were better perceived health of the person being cared for, better caregiver HRQoL, and high perceived social support. Women were 75% more likely to experience severe burden compared with male caregivers. Burden was reduced by high perceived social support in the case of women and by high caregiver HRQoL in the case of men. The main determinant of caregiving satisfaction for both men and women was perceived social support (OR = 3.11 and OR = 6.64). This study shows the need for interventions that promote gender equality and social support as a means of relieving burden and severe burden and improving satisfaction in both male and female caregivers.

Cost-effectiveness of lenalidomide maintenance in patients with multiple myeloma who have undergone autologous transplant of hematopoietic progenitor cells.

The objective of this article is to analyze the ratio of cost-effectiveness and budgetary impact of lenalidomide treatment in patients with multiple myeloma who have undergone autologous transplant in Spain. The analyses were based on clinical trials CALGB 100104 and IFM 2005-02, from the perspective of the National Health System. The alternatives compared were the treatment with lenalidomide against maintenance without treatment (MwT). Efficiency measures used were years of life gained (YGs) and quality-adjusted life years (QALYs). According to the CALGB 100104 trial data, the average health costs of patients who were treated with lenalidomide for 120 months was €836,534.31 and without treatment was €528,963.63. The effectiveness of the lenalidomide group was 7.59YGs (5.72 QALY) against 6.58 of MwT (4.61 QALY). The incremental cost-utility ratio (ICUR) was €277,456.72/QALY and the incremental cost-effectiveness ratio was €303,191.05/YGs. From the analysis, the IFM2005-02 trial obtained 5.13 QALY in the lenalidomide group against the 4.98 QALY in the MwT group, with an ICUR of €1,502,780.55/QALY. In terms of budgetary impact, a range between 799 and 1452 patients susceptible to receive treatment with lenalidomide was assumed in Spain. In conclusion, the results show a high ICUR and budgetary impact, which adds uncertainty about the maximum prudent duration of the treatment.

The economic value of time of informal care and its determinants (The CUIDARSE Study).

OBJECTIVE: The main aims of this paper are to analyse the monetary value of informal care time using different techniques and to identify significant variables associated with the number of caregiving hours. DATA AND METHODS: A multicentre study in two Spanish regions in adult caregivers was conducted. A total sample of 604 people was available. A multivariate analysis was performed to identify the variables associated with the number of hours of caregiving time. In the monetary valuation of informal care provided, three approaches were used: replacement cost method, opportunity cost and contingent valuation (willingness to pay and willingness to accept). RESULTS: The main determinants of the amount of time of informal care provided were age, gender, the level of care receiver´s dependence and the professional care services received (at home and out of home). The value estimated for informal care time ranges from EUROS 80,247 (replacement cost method) to EUROS 14,325 (willingness to pay), with intermediate values of EUROS 27,140 and EUROS 29,343 (opportunity cost and willingness to accept, respectively). Several sensitivity analyses were performed over the base cases, confirming the previous results. CONCLUSIONS: Time of informal care represents a great social value, regardless of the applied technique. However, the results can differ strongly depending on the technique chosen. Therefore, the choice of technique of valuation is not neutral. Among the determinants of informal care time, the professional care received at home has a complementary character to informal care, while the formal care outside the home has a substitute character.

HTA and decision-making processes in Central, Eastern and South Eastern Europe: Results from a survey.

OBJECTIVE: To gain knowledge and insights on health technology assessment (HTA) and decision-making processes in Central, Eastern and South Eastern Europe (CESEE) countries. METHODS: A cross-sectional study was performed. Based on the literature, a questionnaire was developed in a multi-stage process. The questionnaire was arranged according to 5 broad domains: (i) introduction/country settings; (ii) use of HTA in the country; (iii) decision-making process; (iv) implementation of decisions; and (v) HTA and decision-making: future challenges. Potential survey respondents were identified through literature review-with a total of 118 contacts from the 24 CESEE countries. From March to July 2014, the survey was administered via e-mail. RESULTS: A total of 22 questionnaires were received generating an 18.6% response rate, including 4 responses indicating that their institutions had no involvement in HTA. Most of the CESEE countries have entities under government mandates with advisory functions and different responsibilities for decision-making, but mainly in charge of the reimbursement and pricing of medicines. Other areas where discrepancies across countries were found include criteria for selecting technologies to be assessed, stakeholder involvement, evidence requirements, use of economic evaluation, and timeliness of HTA. CONCLUSIONS: A number of CESEE countries have created formal decision-making processes for which HTA is used. However, there is a high level of heterogeneity related to the degree of development of HTA structures, and the methods and processes followed. Further studies focusing on the countries from which information is scarcer and on the HTA of health technologies other than medicines are warranted. CLASSIFICATION: Reviews/comparative analyses.

Cost-effectiveness of a primary care-based exercise intervention in perimenopausal women. The FLAMENCO Project.

OBJECTIVE: Adequate physical activity levels and a healthy lifestyle may prevent all kinds of non-communicable diseases, promote well-being and reduce health-care costs among perimenopausal women. This study assessed an exercise programme for perimenopausal women. METHOD: A total of 150 women (aged 45-64 years) not engaged in regular physical activity were randomly assigned to either a 16 week exercise intervention or to the control group. The study was conducted from the perspective of the National Health System. Health outcomes were quality-adjusted life years (QALYs), measured by the EuroQol-5D-5L questionnaire. The total direct costs of the programme were the costs of visits to primary care, specialty care, emergency, medicines, instructor cost and infrastructure cost. The results were expressed as the incremental cost-effectiveness ratio. Sensitivity analysis was undertaken to test the robustness of the analysis. RESULTS: Mean QALYs over 16 weeks were.228 in the control group and.230 in the intervention group (mean difference: .002; 95% confidence interval [95%CI]: -0.005 to 0.009). Improvements from baseline were greater in the intervention group in all dimensions of the EuroQol-5D-5L but not statistically significant. The total costs at the end of the intervention were 160.38 € in the control group and 167.80 € in the intervention group (mean difference: 7.42 €; 95%CI: -47 to 62). The exercise programme had an incremental cost-effectiveness ratio of 4,686 €/QALY. CONCLUSIONS: The programme could be considered cost-effective, although the overall difference in health benefits and costs was very modest. Longer term follow-up is needed.

Health technology assessment process of a cardiovascular medical device in four different settings.

AIM: Health technology assessment (HTA) is a tool to help the decision-making process. The aim is to describe methods and processes used in the reimbursement decision making for drug-eluting stents (DES) in four different settings. METHODS: DES as a technology under study was selected according to different criteria, all of them agreed by a working group. A survey of key informants was designed. RESULTS: DES was evaluated following well-structured HTA processes. Nonetheless, scope for improvement was observed in relation to the data considered for the final decision, the transparency and inclusiveness of the process as well as in the methods employed. CONCLUSION: An attempt to describe the HTA processes of a well-known medical device.