Revisión sistemática y coste efectividad del tratamiento con abobotulinumtoxinA Para la espasticidad post-ictus en comparación con fisioterapia / Systematic review and cost-effectiveness analysis of the treatment of post-stroke spasticity with abobotulinumtoxinA compared to physiotherapy

Objective Post-stroke spasticity (PSS) is a common complication in stroke survivors, causing severe burden to patients living with it. The aim of this review was to conduct a cost-effectiveness analysis (CEA) of the treatment of post-stroke spasticity, in adults, with abobotulinumtoxinA compared to the best supportive care, based on results from a systematic literature review. Given that abobotulinumtoxinA (aboBoNT-A) is always accompanied by the best supportive care treatment, the CEA compared aboBoNT-A plus the best supportive care with the best supportive care alone. Methods A systematic literature review in EMBASE (including Medline and PubMed), Scopus, and other sources (Google Scholar) was conducted. Articles of all types, providing information on the costs and/or effectiveness measures for the current treatments of PSS in adults were included. The synthesis of information from the review provided the parameters for the design of a cost-effectiveness analysis of the mentioned treatment of interest. The societal perspective was compared to a perspective where only direct costs were observed. Results In total, 532 abstracts were screened. Full information was revised from 40 papers and 13 of these were selected as core papers for full data extraction. Data from the core publications formed the basis for the development of a cost-effectiveness model. In all the included papers physiotherapy was the best supportive care treatment (SoC)... (AU)

Antecedentes La espasticidad post-ictus es una enfermedad común que afecta a los adultos y causa una carga grave a los pacientes que la padecen. El objetivo de la revisión fue realizar un análisis coste-efectividad (ACE) del tratamiento de la espasticidad post-ictus, en adultos, con abobotulinumtoxinA (aboBoNT-A) en comparación con el tratamiento convencional, basado en los resultados de una revisión sistemática de la literatura. Dado que este tratamiento se proporciona siempre al mismo tiempo que el tratamiento convencional, el ACE se realizó del tratamiento aboBoNT-A con el tratamiento convencional, en comparación con recibir únicamente el tratamiento convencional. Métodos Se realizó una revisión sistemática de la literatura en EMBASE (incluyendo Medline y Pubmed), Scopus y otras fuentes (Google Scholar). Se incluyeron artículos de todo tipo que proporcionaran información sobre los costes y/o las medidas de efectividad de los tratamientos actuales del PSS en adultos. La síntesis de la información de la revisión proporcionó los parámetros para el diseño de un análisis coste-efectividad del mencionado tratamiento de interés. Se comparó la perspectiva social con una perspectiva donde solo se observaron los costes directos del tratamiento. Resultados Se revisaron un total de 532 resúmenes. Se revisó la información completa de 40 artículos y se seleccionaron 13 artículos para la extracción completa de datos. La información de estos documentos se sintetizó y utilizó para desarrollar un modelo de coste-efectividad. En todos los artículos incluidos se identificó el tratamiento con fisioterapia como el tratamiento convencional principal... (AU)

Systematic review and cost-effectiveness analysis of the treatment of post-stroke spasticity with abobotulinumtoxinA compared to physiotherapy. / [Artículo traducido] Revisión sistemática y coste-efectividad del tratamiento con abobotulinumtoxinA para la espasticidad postictus en comparación con la fisioterapia.

OBJECTIVE: Post-stroke spasticity is a common complication in stroke survivors, causing severe burden to patients living with it. The aim of this review was to conduct a cost-effectiveness analysis (CEA) of the treatment of post-stroke spasticity, in adults, with abobotulinumtoxinA compared to the best supportive care, based on results from a systematic literature review. Given that abobotulinumtoxinA (aboBoNT-A) is always accompanied by the best supportive care treatment, the CEA compared aboBoNT-A plus the best supportive care with the best supportive care alone. METHODS: A systematic literature review in EMBASE (including Medline and PubMed), Scopus, and other sources (Google Scholar) was conducted. Articles of all types, providing information on the costs and/or effectiveness measures for the current treatments of post-stroke spasticity in adults were included. The synthesis of information from the review provided the parameters for the design of a CEA of the mentioned treatment of interest. The societal perspective was compared to a perspective where only direct costs were observed. RESULTS: In total, 532 abstracts were screened. Full information was revised from 40 papers and 13 of these were selected as core papers for full data extraction. Data from the core publications formed the basis for the development of a cost-effectiveness model. In all the included papers physiotherapy was the best supportive care treatment. The cost-effectiveness analysis showed that even in the most conservative scenario, assuming the worst case scenario, the probability of a cost per quality-adjusted life-year (QALY) gained below €40,000, for aboBoNT-A together with physiotherapy is above 0.8, and with certainty below €50,000/QALY when either a direct costs, or a societal perspective was taken. On average, the probabilistic model obtains a negative mean incremental cost-effectiveness ratio of around -15,000 €/QALY. CONCLUSION: The cost-effectiveness analyses show that aboBoNT-A together with physiotherapy would be a cost-effective treatment compared with physiotherapy alone, independently of the perspective considered.

Systematic review and cost-effectiveness analysis of the treatment of post-stroke spasticity with abobotulinumtoxinA compared to physiotherapy.

OBJECTIVE: Post-stroke spasticity (PSS) is a common complication in stroke survivors, causing severe burden to patients living with it. The aim of this review was to conduct a cost-effectiveness analysis (CEA) of the treatment of post-stroke spasticity, in adults, with abobotulinumtoxinA compared to the best supportive care, based on results from a systematic literature review. Given that abobotulinumtoxinA (aboBoNT-A) is always accompanied by the best supportive care treatment, the CEA compared aboBoNT-A plus the best supportive care with the best supportive care alone. METHODS: A systematic literature review in EMBASE (including Medline and PubMed), Scopus, and other sources (Google Scholar) was conducted. Articles of all types, providing information on the costs and/or effectiveness measures for the current treatments of PSS in adults were included. The synthesis of information from the review provided the parameters for the design of a cost-effectiveness analysis of the mentioned treatment of interest. The societal perspective was compared to a perspective where only direct costs were observed. RESULTS: In total, 532 abstracts were screened. Full information was revised from 40 papers and 13 of these were selected as core papers for full data extraction. Data from the core publications formed the basis for the development of a cost-effectiveness model. In all the included papers physiotherapy was the best supportive care treatment (SoC). The cost-effectiveness analysis showed that even in the most conservative scenario, assuming the worst case scenario, the probability of a cost per quality-adjusted life-year (QALY) gained below €40,000, for aboBoNT-A together with physiotherapy is above 0.8, and with certainty below €50,000/QALY when either a direct costs, or a societal perspective was taken. On average, the probabilistic model obtains a negative mean incremental cost-effectiveness ratio of around -15,000 €/QALY. CONCLUSION: The cost-effectiveness analyses show that aboBoNT-A together with physiotherapy would be a cost-effective treatment compared with physiotherapy alone, independently of the perspective considered.

The association of chronic neck pain, low back pain, and migraine with absenteeism due to health problems in Spanish workers.

STUDY DESIGN: Cross-sectional. OBJECTIVE: To examine whether 3 types of chronic pain are associated with absenteeism and with the number of days absent from work in the general population of Spain. SUMMARY OF BACKGROUND DATA: Chronic pain has been associated with absenteeism, but most of the evidence is based on unadjusted analyses and on specific professional categories. METHODS: A cross-sectional analysis was performed on the basis of data of 8283 Spanish workers. Chronic pain was ascertained from self-reported information on frequent symptoms of pain in the low back and neck and/or migraine in the last 12 months. Absenteeism was defined as missing at least 1 day from work because of health problems. Multivariate regression models were adjusted for the main confounders. RESULTS: Health-related absenteeism was reported by 27.8% of subjects. The prevalence of chronic pain was reported to be 12.3% in the neck, 14.1% in the low back, and 10.3% migraine. In adjusted analyses, absenteeism was associated with chronic neck pain (odds ratio: 1.20; 95% confidence interval [CI], 1.02-1.40), low back pain (odds ratio: 1.22; 95% CI, 1.06-1.42), and migraine (odds ratio: 1.22; 95% CI, 1.04-1.44). These associations were strongest in younger (18-34 yr) rather than in older workers. Furthermore, those who reported frequent pain in the neck and low back were 44% more likely to be absent for more than 30 days in the past year than those who did not report these symptoms. CONCLUSION: Spanish workers with chronic pain were more likely to be absent from work and to stay absent from work for longer. These associations are independent of sociodemographic characteristics, occupation, lifestyle, health status, and analgesics use. LEVEL OF EVIDENCE: N/A.

Systematic review of economic evaluation analyses of available vaccines in Spain from 1990 to 2012.

OBJECTIVE: The objective of this survey was to describe the evolution of economic evaluation studies on vaccines available in Spain. METHODS: We conducted a systematic review of the economic evaluations published by Spanish researchers in major bibliographic databases available online from 1990 to 2012. For all references identified, we limited them to full economic evaluation carried out in Spanish vaccine programs. The following variables were analyzed: type of study, year of publication, vaccine evaluated, the herd immunity and the main methodological aspects proposed by international guidelines. The type of vaccines studied were Hepatitis A and B, Rotavirus, Influenza, Varicella, Tetanus, Measles, Human papillomavirus, Streptococcus pneumoniae infection and Neisseria meningitides serogroup C infection. RESULTS: A total of 34 references was included in the study. The number of economic evaluations has been increasing over the years by 86%. For many of the vaccines there were no economic evaluations, while others such as the vaccine against S. pneumoniae infection took up most of the studies. The non-vaccinated comparison was the most used strategy. The cost-effectiveness model was selected in 60% of cases. The most common health outcome was "cost per case prevented" and in 82% of the studies did not consider herd immunity. The results showed a cost-effectiveness ratio which was below breakeven. CONCLUSIONS: It is clear that the existence of a huge gap in this kind of work compared to other countries. Although the quality of the work discussed here was significant, we found many areas which could be improved. The reviewed literature exposed the great benefit of vaccination for society by analysing the health outcomes achieved for decades since its implementation. However, the evidence on the efficiency and effectiveness vaccination is not very high, and there are few studies about economic evaluation.

Analysis of economic evaluations of pharmacological cancer treatments in Spain between 1990 and 2010.

Economic evaluation of pharmacological cancer treatment is a critical clinical problem currently under consideration worldwide. We have analysed their main characteristics in Spain between 1990 and 2010 following a systematic review of the 29 complete economic analyses published. The pathology most frequently evaluated was non-small cell lung cancer (31 %). Cost-effectiveness analyses (69 %) were the most frequent analyses. A wide range of incremental cost-effectiveness values (295-160,667 € /QALY) has been reported, and mostly are developed from the perspective of the National Health System (65.5 %). However, none of the studies estimated the indirect costs. The major conclusion is that the absence of regulations concerning the application of the efficiency criterion in decision-making on the subject of price and financing and, most importantly, the fact that these are not included in Spanish hospitals forms make it difficult to analyse the real impact of economic evaluations of cancer treatments on such decisions.

Prospective one-year cost-of-illness study in a cohort of patients with dementia of Alzheimer's disease type in Spain: the ECO study.

In this study, we analyzed the economic impact of one-year healthcare and non-healthcare resources utilization by patients with dementia of Alzheimer's disease (AD) under usual medical practice in Spain. A one-year, prospective, naturalistic, multicenter cohort study was designed to recruit patients with mild, moderate to severe, and severe AD according to Clinical Dementia Rating scale: the ECO study. Healthcare resources (medical visits, drugs and concomitant treatments, complementary and diagnostic tests, institutionalization and use of home-nursing facilities) and non-healthcare resources (inventory materials, consumables, professional and non-professional caregivers' time for care and supervision) were recorded and valued at 2006 prices. A total of 560 patients with possible/probable AD by DSM-IV-NINCDS-ADRDA criteria were included in the study: 68% women, 77 +/- 6 years old, 29% treatment naïve. Monthly average cost per patient was 1,425.73 euro, and increased 10.08% at the end of the study (baseline monthly cost; 1,316.22 euro). Non-healthcare costs 1059.00 euro, 74.30% of total cost) decreased 4.30 euro/month (0.40%) at the end of the year, while healthcare costs, which presented a total average of 366.66 euro, grew by 136.94 euro in the period (54.06%), mainly due to cost of drugs, nursing home utilization, and institutionalization. The 87.26% of the overall cost (1,244.22 euro) was not financed by National Health Service (NHS), and the majority of this cost corresponded to caregiver-associated cost. The caregiver's total burden represented 70.86% of the overall cost-of-illness. In conclusion, monthly overall mean cost of dementia of AD type was high in Spain (1,412.73 euro). Almost 88% of the cost-of-illness is funded by the patient's own family, adding a financial burden to the suffering of these families.

N-3 fatty acids, cancer and cachexia: a systematic review of the literature.

Use of n-3 fatty acids (FA) has been reported to be beneficial for cancer patients. We performed a systematic review of the literature in order to issue recommendations on the clinical use of n-3 FA in the cancer setting. A systematic search was performed in MEDLINE, EMBASE, Cochrane and Healthstar databases. We selected clinical trials or prospective observational studies including patients with cancer and life expectancy >2 months, in which enteral supplements with n-3 FA were administered. Parameters evaluated individually were clinical (nutritional status, tolerance, survival and hospital stays), biochemical (inflammatory mediators), and functional (functional status, appetite and quality of life (QoL)). Seventeen studies met the inclusion criteria; eight were of high quality. The panel of experts established the following evidence: (1) oral supplements with n-3 FA benefit patients with advanced cancer and weight loss, and are indicated in tumours of the upper digestive tract and pancreas; (2) the advantages observed were: increased weight and appetite, improved QoL, and reduced post-surgical morbidity; (3) there is no defined pattern for combining different n-3 FA, and it is recommended to administer > 1.5 g/day; and (4) better tolerance is obtained administering low-fat formulas for a period of at least 8 weeks. All the evidences were grade B but for 'length of treatment' and 'advantage of survival' it was grade C. Our findings suggest that administration of n-3 FA (EPA and DHA) in doses of at least 1.5 g/day for a prolonged period of time to patients with advanced cancer is associated with an improvement in clinical, biological and QoL parameters.

Discussion point: should governments buy drug patents?

Between just 1995 and 2003, the number of new chemical entities fell from 45 to 25, while the costs increased by two and a half times in the same period. Firms in the USA accounted for more than half of biotech drugs from 1982 to 2003. European firms are losing competitiveness. In this hostile environment for investment in pharmaceutical R&D, providing quick access to market for real innovations is the main challenge for regulatory agencies. More initiatives, more entrepreneurial spirit and easier work regulation are needed to facilitate the growth of firms in this field, especially in emerging economies like the Spanish. A new open source model proposes the use of pre-competitive public platforms formed by young and qualified human capital carrying out research in areas not sufficiently attractive for private initiatives, followed by the introduction of pharmaceutical companies to carry out the clinical research. The last step would be fast and effective approval by assessment agencies. Governments should, therefore, facilitate the regulation of socially effective innovations, bringing in manufacturers to take part in the post-clinical trial period after entering the market. The gathering of incentives between regulatory agencies and pharmaceutical industry must be approached through innovation and authorization stimulating systems.

Indirect costs in ambulatory patients with HIV/AIDS in Spain: a pilot study.

OBJECTIVE: To estimate indirect costs in Spanish ambulatory patients with HIV/AIDS and to identify changes in employment status and their current QOL. METHOD: Information was obtained through 32 interviews/enquiries carried out with ambulatory patients receiving medical attention at Gregorio Marañón and Puerta de Hierro hospitals in Madrid, Spain. The study variables included information on sociodemographics, economics, and clinical and QOL (EuroQol instrument; EQ-5D) parameters of these patients. RESULTS: Our main result showed the existence of high indirect costs (lost income and lost wages; 2002 values) at the individual level. We identified a strong effect in terms of income loss (the annual loss of income ranged between Euro 5271 and Euro 6150 per patient) and lost wages (the annual loss of wages ranged between Euro 7537 and Euro 8793 per patient). We also observed a strong impact on household income (the annual loss of household income ranged between Euro 6693 and Euro 7813). There was a great variability in these costs among the patients depending on their QOL, gender and education. We detected a statistically significant and positive correlation between QOL and having a job. CONCLUSIONS: We observed a high level of QOL among the patients, which reflects the potential benefits of pharmacological treatment. We found that the better the QOL, the higher the probability of being employed. However, indirect costs were high among patients despite their good QOL.

Clinical evidence for enteral nutritional support with glutamine: a systematic review.

OBJECTIVE: The purpose of this systematic review was to locate and assess the quality of scientific evidence to establish a graded recommendation based on the effectiveness of glutamine-enriched enteral nutrition in different medical and surgical conditions. We were concerned with the following topics: 1) benefits of enteral administration of glutamine in different pathologic conditions, and 2) dose, duration, and time of initiation of glutamine-enriched diets. METHODS: The sources consulted for the search were MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Healthstar and HSTAT. Ninety-one studies were assessed; after a methodologic review (primary review), only 16 studies met the inclusion criteria for analysis by a group of experts (secondary review). The coordinators supervised all data, and a final consensus was reached among the coordinators, experts, and methodologists. RESULTS AND CONCLUSIONS: Glutamine-enriched diets showed good overall tolerance, improvement of immunologic aspects in multiple trauma patients, cost reduction in critically ill patients, and improvement of mucositis in post-chemotherapy patients (grade B recommendations). The doses given and the duration of therapy varied widely depending on the pathologic condition. Intake of 20 to 30 g/d, early initiation of diet, and maintenance for 5 d or longer are recommended (grade C recommendations).