Does the inclusion of societal costs change the economic evaluations recommendations? A systematic review for multiple sclerosis disease.

BACKGROUND: Multiple sclerosis imposes a heavy burden on the person who suffers from it and on the relatives, due to the caregiving load involved. The objective was to analyse whether the inclusion of social costs in economic evaluations of multiple sclerosis-related interventions changed results and/or conclusions. METHODS: A systematic review was launched using Medline and the Cost-Effectiveness Analysis Registry of Tufts University (2000-2019). Included studies should: (1) be an original study published in a scientific journal, (2) be an economic evaluation of any multiple sclerosis-related intervention, (3) include productivity losses and/or informal care costs (social costs), (4) be written in English, (5) use quality-adjusted life years as outcome, and (6) separate the results according to the perspective applied. RESULTS: Twenty-nine articles were selected, resulting in 67 economic evaluation estimations. Social costs were included in 47% of the studies. Productivity losses were assessed in 90% of the estimations (the human capital approach was the most frequently used method), whereas informal care costs were included in nearly two-thirds of the estimations (applying the opportunity and the replacement-cost methods equally). The inclusion of social costs modified the figures for incremental costs in 15 estimations, leading to a change in the conclusions in 10 estimations, 6 of them changing from not recommended from the healthcare perspective to implemented from the societal perspective. The inclusion of social costs also altered the results from cost-effective to dominant in five additional estimations. CONCLUSIONS: The inclusion of social costs affected the results/conclusions in multiple sclerosis-related interventions, helping to identify the most appropriate interventions for reducing its economic burden from a broader perspective.

Economic burden and health-related quality of life in tenosynovial giant-cell tumour patients in Europe: an observational disease registry.

BACKGROUND: Tenosynovial Giant-Cell Tumour (TGCT) is a benign clonal neoplastic proliferation arising from the synovium, causing a variety of symptoms and often requiring repetitive surgery. This study aims to define the economic burden-from a societal perspective-associated with TGCT patients and their health-related quality of life (HRQOL) in six European countries. METHODS: This article analyses data from a multinational, multicentre, prospective observational registry, the TGCT Observational Platform Project (TOPP), involving hospitals and tertiary sarcoma centres from six European countries (Austria, France, Germany, Italy, the Netherlands, and Spain). It includes information on TGCT patients' health-related quality of life and healthcare and non-healthcare resources used at baseline (the 12-month period prior to the patients entering the registry) and after 12 months of follow-up. RESULTS: 146 TGCT patients enrolled for the study, of which 137 fulfilled the inclusion criteria. Their mean age was 44.5 years, and 62% were female. The annual average total costs associated with TGCT were €4866 at baseline and €5160 at the 12-month follow-up visit. The annual average healthcare costs associated with TGCT were €4620 at baseline, of which 67% and 18% corresponded to surgery and medical visits, respectively. At the 12-month follow-up, the mean healthcare costs amounted to €5094, with surgery representing 70% of total costs. Loss of productivity represented, on average, 5% of the total cost at baseline and 1.3% at follow-up. The most-affected HRQOL dimensions, measured with the EQ-5D-5L instrument, were pain or discomfort, mobility, and the performance of usual activities, both at baseline and at the follow-up visit. Regarding HRQOL, patients declared a mean index score of 0.75 at baseline and 0.76 at the 12-month follow-up. CONCLUSION: The results suggest that TGCT places a heavy burden on its sufferers, which increases after one year of follow-up, mainly due to the healthcare resources required-in particular, surgical procedures. As a result, this condition has a high economic impact on healthcare budgets, while the HRQOL of TGCT patients substantially deteriorates over time.

How relevant are social costs in economic evaluations? The case of Alzheimer's disease.

BACKGROUND: The main objective of this study was to analyse how the inclusion (exclusion) of social costs can alter the results and conclusions of economic evaluations in the field of Alzheimer's disease interventions. METHODS: We designed a systematic review that included economic evaluations in Alzheimer's disease. The search strategy was launched in 2000 and ran until November 2018. The inclusion criteria were: being an original study published in a scientific journal, being an economic evaluation of any intervention related to Alzheimer's disease, including social costs (informal care costs and/or productivity losses), being written in English, using QALYs as an outcome for the incremental cost-utility analysis, and separating the results according to the perspective applied. RESULTS: It was finally included 27 studies and 55 economic evaluations. Around 11% of economic evaluations changed their main conclusions. More precisely, three of them concluded that the new intervention became cost-effective when the societal perspective was considered, whereas when using just the health care payer perspective, the new intervention did not result in a cost-utility ratio below the threshold considered. Nevertheless, the inclusion of social cost can also influence the results, as 37% of the economic evaluations included became the dominant strategy after including social costs when they were already cost-effective in the health care perspective. CONCLUSIONS: Social costs can substantially modify the results of the economic evaluations. Therefore, taking into account social costs in diseases such as Alzheimer's can be a key element in making decisions about public financing and pricing of health interventions.

Social/economic costs and health-related quality of life in patients with juvenile idiopathic arthritis in Europe.

OBJECTIVE: The aim of this study was to determine the economic burden from a societal perspective and the health-related quality of life (HRQOL) of patients with juvenile idiopathic arthritis (JIA) in Europe. METHODS: We conducted a cross-sectional study of patients with JIA from Germany, Italy, Spain, France, the United Kingdom, Bulgaria, and Sweden. Data on demographic characteristics, healthcare resource utilization, informal care, labor productivity losses, and HRQOL were collected from the questionnaires completed by patients or their caregivers. HRQOL was measured with the EuroQol 5-domain (EQ-5D-5L) questionnaire. RESULTS: A total of 162 patients (67 Germany, 34 Sweden, 33 Italy, 23 United Kingdom, 4 France, and 1 Bulgaria) completed the questionnaire. Excluding Bulgarian results, due to small sample size, country-specific annual health care costs ranged from €18,913 to €36,396 (reference year: 2012). Estimated direct healthcare costs ranged from €11,068 to €22,138; direct non-healthcare costs ranged from €7837 to €14,155 and labor productivity losses ranged from €0 to €8715. Costs are also shown to differ between children and adults. The mean EQ-5D index score for JIA patients was estimated at between 0.44 and 0.88, and the mean EQ-5D visual analogue scale score was estimated at between 62 and 79. CONCLUSIONS: JIA patients incur considerable societal costs and experience substantial deterioration in HRQOL in some countries. Compared with previous studies, our results show a remarkable increase in annual healthcare costs for JIA patients. Reasons for the increase are the inclusion of non-professional caregiver costs, a wider use of biologics, and longer hospital stays.

Economic evaluation in chronic pain: a systematic review and de novo flexible economic model.

There is unmet need in patients suffering from chronic pain, yet innovation may be impeded by the difficulty of justifying economic value in a field beset by data limitations and methodological variability. A systematic review was conducted to identify and summarise the key areas of variability and limitations in modelling approaches in the economic evaluation of treatments for chronic pain. The results of the literature review were then used to support the development of a fully flexible open-source economic model structure, designed to test structural and data assumptions and act as a reference for future modelling practice. The key model design themes identified from the systematic review included: time horizon; titration and stabilisation; number of treatment lines; choice/ordering of treatment; and the impact of parameter uncertainty (given reliance on expert opinion). Exploratory analyses using the model to compare a hypothetical novel therapy versus morphine as first-line treatments showed cost-effectiveness results to be sensitive to structural and data assumptions. Assumptions about the treatment pathway and choice of time horizon were key model drivers. Our results suggest structural model design and data assumptions may have driven previous cost-effectiveness results and ultimately decisions based on economic value. We therefore conclude that it is vital that future economic models in chronic pain are designed to be fully transparent and hope our open-source code is useful in order to aspire to a common approach to modelling pain that includes robust sensitivity analyses to test structural and parameter uncertainty.

The societal costs of intracerebral hemorrhage in Spain.

This study estimates the lifetime societal costs associated with incident intracerebral hemorrhage (ICH) in Spain. An epidemiological model of ICH incidence, survival and morbidity was developed using retrospective data from 28 hospitals in Andalusia and published data identified in a systematic literature review. Data on resource utilization and costs were obtained from five hospitals in the Canary Islands, whereas cost of outpatient care, informal care and lost productivity were obtained from standardized questionnaires completed by survivors of ICH. The lifetime societal costs of incident ICH in Spain is estimated at 46,193 euros per patient. Direct medical costs accounted for 32.7% of lifetime costs, whilst 67.3% were related to indirect costs. One-third of direct medical costs over the first year were attributable to follow-up care, including rehabilitation. Indirect costs were dominated by costs of informal care (71.2%). The aggregated lifetime societal costs for the estimated 12,534 Spanish patients with a first-ever ICH in 2004 was 579 million euros. ICH implies substantial costs to society primarily due to formal and informal follow-up care and support needed after hospital discharge. Interventions that offer survival benefits without improving patients' functional status are likely to further increase the societal costs of ICH.

Impact on health-related quality of life and perceived burden of informal caregivers of individuals with Alzheimer's disease.

This study assessed the impact on health-related quality of life (HRQL) and the perceived burden of informal caregivers of individuals with Alzheimer's disease (AD) on the Canary Islands (Spain). We utilized a multicenter, cross-sectional design, based on questionnaire responses of 237 informal caregivers of AD patients. Patients were classified according to the degree of severity utilizing the Clinical Dementia Rating Scale. Sociodemographic, HRQL (EQ-5D) and functional dependency data were gathered together with the degree of caregiver burden. Caregivers had a higher frequency of problems than did the general population for every EQ-5D dimension. Caregivers' HRQL was inversely associated with the subject dependency level and caregiver age. HRQL was higher for more educated caregivers. Variables with a negative and/or significant effect on caregivers' HRQL were high feelings of burden, more committed time to care, and older age. The caregiver burden quantified by the Zarit scale showed 83.3% of caregivers with a high level of burden.

[Socio-economic costs of mental health in the Canary Islands, Spain, in 2002]. / Costes socioeconómicos de las enfermedades mentales en las Islas Canarias en 2002.

OBJECTIVE: To evaluate the economic impact in terms of direct and indirect costs of the mental health in Canary Islands (Spain) in 2002. DESIGN: The cost-of-illness method was used. Direct and indirect costs were estimated using prevalence cost, i.e., the costs produced in 2002. The human capital theory approach has been used. SETTING: Canary Islands, Spain, including primary health care and inpatient care. PARTICIPANTS: Mental health patients. MAIN MEASUREMENTS: Direct health costs (inpatients, ambulatory care, primary health care, and drugs). Indirect costs (premature death, short-term illness, and permanent disability). RESULTS: The total costs of mental health were 189.59 million euros. The direct health costs were 81.67 million euros, constituting 43% of the total costs and 5.2% of the total public health care budget in this region. The indirect costs of mental health were 107.92 million euros, representing 57% of the total costs. CONCLUSIONS: Although this study adopts a conservative approach, the high socio-economic cost of the mental health helps us to define better the dimension of the problem to establish priorities besides opening a way towards cost-effectiveness studies that allow a more transparent debate on this topic.

Bone mineral density referral for dual-energy X-ray absorptiometry using quantitative ultrasound as a prescreening tool in postmenopausal women from the general population: a cost-effectiveness analysis.

The aim of our study was to assess, from the perspective of the National Health Services in Spain, the cost-effectiveness of quantitative ultrasound (QUS) as a prescreen referral method for bone mineral density (BMD) assessment by dual-energy X-ray absorptiometry (DXA) in postmenopausal women of the general population. Using femoral neck DXA and heel QUS. We evaluated 267 consecutive postmenopausal women 65 years and older and attending primary care physician offices for any medical reason. Subjects were classified as osteoporotic or nonosteoporotic (normal or osteopenic) using the WHO definition for DXA. Effectiveness was assessed in terms of the sensitivity and specificity of the referral decisions based on the QUS measurement. Local costs were estimated from health services and actual resource used. Cost-effectiveness was evaluated in terms of the expected cost per true positive osteoporotic case detected. Baseline prevalence of osteoporosis evaluated by DXA was 55.8%. The sensitivity and specificity for the diagnosis of osteoporosis by QUS using the optimal cutoff thresholds for the estimated heel BMD T-score were 97% and 94%, respectively. The average cost per osteoporotic case detected based on DXA measurement alone was 23.85 euros. The average cost per osteoporotic case detected using QUS as a prescreen was 22.00 euros. The incremental cost-effectiveness of DXA versus QUS was 114.00 euros per true positive case detected. Our results suggest that screening for osteoporosis with QUS while applying strict cufoff values in postmenopausal women of the general population is not substantially more cost-effective than DXA alone for the diagnosis of osteoporosis. However, the screening strategy with QUS may be an option in those circumstances where the diagnosis of osteoporosis is deficient because of the difficulty in accessing DXA equipment.

Preoperative assessment.

Although anaesthetic and surgical procedures should be individualised for every patient, in practice many preoperative protocols and routines are used generally. In this article, we aim to emphasise: why preoperative assessment is important; how it should be done, and by whom; what can be expected; and the importance of test selection based on patients' needs and on scientific evidence of effectiveness. We outline the roles of preoperative medical assessment in otherwise healthy patients. Clinical history, preoperative questionnaires, physical examination, routine tests, individual risk-assessment, and fasting policies are investigated by review of published work. Cost of routine preoperative assessment, the anaesthetist's legal responsibility, and patients'views in the preoperative process are also considered. A thorough clinical preoperative assessment of the patient is more important than routine preoperative tests, which should be requested only when justified by clinical indications. Moreover, this practice eliminates unnecessary cost without compromising the safety and quality of care. Education and training of medical doctors should be more scientifically guided, emphasising the relevance of effectiveness, and cost-effectiveness in clinical decision-making and complemented by audit.

[Socioeconomic costs of cardiovascular disease and cancer in the Canary Islands (Spain) in 1998]. / Los costes socioeconómicos de las enfermedades cardiovasculares y del cáncer en las Islas Canarias en 1998.

OBJECTIVE: To evaluate the economic impact in terms of direct and indirect costs of the cardiovascular disease and cancer in the Canary Islands in 1998. METHODS: The cost-of-illness method was used. Direct and indirect costs were estimated using prevalence costs, i.e., the costs produced in 1998. Direct costs were divided into hospitalization costs, outpatient costs, primary health care costs, and drug costs while indirect costs were obtained through transformation of physical units into monetary units using the approach of human capital theory and the friction cost method. RESULTS: The total costs of cardiovascular disease and cancer were 246.11 and 193.72 million euros respectively. The direct costs of the two diseases were 134.44 and 58.04 million euros respectively, representing 55% and 30% of total costs and 16% of total health care expenditure in this region. The indirect costs of these two diseases were 111.68 and 135.68 million euros respectively, representing 45% and 70% of total costs. Use of the friction cost method revealed that indirect costs decreased by 88% for cardiovascular disease and those for cancer decreased by 77%. CONCLUSIONS: Although this study adopts a conservative approach by omitting costs associated with pain and suffering, permanent disability, and those of at-home care provided by the family, the annual socioeconomic cost of cardiovascular disease and cancer in the Canary Islands was high, amounting to 440 million euros.

[Cost analysis and potential savings related to the use of preoperative tests in the hospitals of the Canary Islands [Spain]]. / Análisis de costes y ahorros potenciales relacionados con la utilización de pruebas preoperatorias en los hospitales de Canarias.

OBJECTIVE: To estimate the potential cost savings that might take place in the Canary Islands Health Service (CHS) through the appropriate scientific use of preoperative tests, using information obtained from five public university hospitals. METHODS: A questionnaire was completed by 55 anesthesiologists, representing 60% of the total in the CHS. The questionnaire paid special attention to the most frequently used preoperative tests: chest radiograph, electrocardiogram, laboratory tests, and spirometry. The mean unit costs for the various preoperative tests were obtained from the two hospitals participating in the study. To calculate the potential cost savings derived from the appropriate use of preoperative tests, several scenarios were considered. These were characterized by different hypotheses or degrees of fulfillment of a protocol based on scientific knowledge and considered as the gold standard. RESULTS: In the ideal scenario in which the recommended scientific protocol was fulfilled in 100% of the 16 179 patients with an American Society of Anesthesiologists (ASA) grade of I-II, the economic impact would be notable, since it would free sensitive resources that could be used for other health programs. These figures could amount to approximately 1.02 million euros, without considering the cost of preoperative hospital stay. This figure could increase by up to approximately 2.13 million euros if one day of preoperative hospital stay were included and by up to 3.24 million euros if two days of preoperative hospital stay were included. CONCLUSIONS: The recent literature review and the results of the questionnaire applied in the CHS indicate that preoperative tests are of greatest benefit to patients and to society if their use is guided by scientific knowledge. In addition, resources can be freed by better selection and utilization of preoperative tests.

[The social and economic cost of diabetes mellitus]. / Los costes socioeconómicos de la diabetes mellitus.

OBJECTIVE: To evaluate the economic impact in terms of the direct costs (health care costs) and the indirect costs (effects on production caused by mortality and morbidity) of diabetes mellitus (DM) in the Canary Islands (Spain) during 1998. DESIGN: The approach used was to study the cost of the disease through looking only at people in the productive sphere (human capital). Direct and indirect costs were calculated by using costs of prevalence, i.e. the costs caused during 1998. SETTING: Direct costs were broken down into hospital care, primary care, out-patient consultations, drugs and further tests; indirect costs, into premature mortality and time off work. Measurements and main results. The total cost of DM amounted to 6468.76 million pesetas (38.88 millio ), or the equivalent of 126 168 pesetas (758.28 ) a year for each known diabetic patient. Total direct cost of DM was 4011.51 million pesetas (24.11 million ), which amounts to 2.13% of health expenditure in the Canaries; or the equivalent of 78 240 pesetas (470.23 ) a year for each known diabetic patient. Direct cost of health care was 62% of the total cost. Total indirect cost was 2457.25 million pesetas (14.77 million ), 38% of the total cost. CONCLUSIONS: Despite the conservatism of the approach, in that the study omitted costs linked to pain and suffering, permanent disability or home care by family members, the high social and economic cost of DM patients calls for cost-effectiveness studies that would permit a more transparent debate on this question.

Pharmaceutical expenditure in Spain: cost and control.

In recent years, the Spanish government has been battling to keep pharmaceutical expenditures under control. Its measures include control of prices, introduction of a "negative list" of drugs no longer reimbursed, increased cost-sharing, and introduction of overall budgets for pharmaceutical expenditures. Although the average prices of old pharmaceutical products declined by 39 percent over the last 15 years and consumption in value increased by only 10 percent, real pharmaceutical expenditures in Spain increased by 264 percent over that period. The main reason for the continuing rise in these expenditures and the failure of cost-containment measures is the introduction of new, more expensive drugs, which often fail to offer any real therapeutic advantages over products already on the market. This situation is exacerbated by a lack of effective demand-side measures such as budgets for doctors and lack of a generics market.

[Health crisis or crisis of medicine?]. / Crisis de la sanidad o crisis de la medicina?

The paper compares the existence of a crisis of medicine (characterised by a lack of assessment mechanisms of the medical treatment outcomes and their health alternatives) with a health crisis (characterised by the existence of health's determinants outside the health service area and the increase in the health demand) and the need to search for adequate solutions in order to solve them. We approach the problem from different standpoints. First, we search for ideas in the free market. Second, we propose several considerations on the "Health Maintenance Organisation" (HMOs) in the USA as well as on their limitations. Third, we study the radical proposals of change in Spain, Holland and the United Kingdom with the problems that competition can bring about, emphasizing the current difficulties in the British reforms and the lessons to consider from the Spanish case. Finally, the author concludes by pointing out the need for a more efficient use of resources and a better choice of priorities in Health.