| 1. |
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| 2. |
- Doria, Andrea, et al.
(författare)
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Annual direct medical cost of active systemic lupus erythematosus in five European countries
- 2014
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Ingår i: Annals of the Rheumatic Diseases. - : BMJ. - 1468-2060 .- 0003-4967. ; 73:1, s. 154-160
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Tidskriftsartikel (refereegranskat)abstract
- Objectives To evaluate the annual direct medical cost of managing adult systemic lupus erythematosus (SLE) patients with active autoantibody positive disease in Europe. Methods A 2-year, retrospective, multicentre, observational study was conducted in five countries (France, Germany, Italy, Spain and the UK). Data included patients' characteristics, disease activity and severity, flare assessments and health resource use (eg, laboratory tests, medications, specialist visits and hospitalisations). Costs were assessed from the public payers' perspective. Cost predictors were estimated by multivariate regression models. Results Thirty-one centres enrolled 427 consecutive eligible patients stratified equally by disease severity. At baseline, mean (SD) age was 44.5 (13.8) years, 90.5% were women and mean (SD) SLE duration was 10.7 (8.0) years. The SELENA-SLEDAI (11.2 vs 5.3) and SLICC/ACR index (1.0 vs 0.7) scores were higher in severe patients. Over the study period, patients experienced on average 1.02 (0.71) flares/year. The mean annual direct medical cost was higher in severe compared to non-severe patients (Euro4748 vs Euro2650, p<0.001). Medication costs were Euro2518 in severe versus Euro1251 in non-severe patients (p<0.001). Medications represented 53% and 47% of the total cost for severe and non-severe patients, respectively, primarily due to immunosuppressants and biologics. Flares, especially severe flares, were identified as the major cost predictor, with each flare increasing the annual total cost by about Euro1002 (p<0.001). Conclusions The annual direct medical cost of SLE patients in Europe is related to disease severity and flares. Medical treatments were the main cost drivers. Severe flares and major organ involvement were identified as important cost predictors.
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| 3. |
- Dusankova, J. Blahova, et al.
(författare)
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Cost of multiple sclerosis in the Czech Republic: The COMS study
- 2012
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Ingår i: Multiple Sclerosis Journal. - : SAGE Publications. - 1477-0970 .- 1352-4585. ; 18:5, s. 662-668
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Tidskriftsartikel (refereegranskat)abstract
- Background: Information about cost of multiple sclerosis (MS) is available from a number of European countries, but no data from the Czech Republic have been published so far. Objective: The objective of this study was to establish the cost of MS in the Czech Republic, overall and by level of disease severity. Methods: Data on demographics, disease history, resource consumption and production losses were collected from 909 patients recruited in 7 MS centres in the Czech Republic. Annual costs were estimated in the societal perspective, using 2007 unit costs. To evaluate the relationship between disability and costs, patients were stratified into those with mild (67%), moderate (27%) and severe (10%) disability using the Expanded Disability Status Scale. Results: Mean total annual costs per patient were (sic)12,272, of which 51% were direct medical costs, 4% direct non-medical costs and 45% indirect costs. The average annual costs in patients with mild, moderate and severe disability amounted to (sic)9905, (sic)14,064 and (sic)22,880, respectively. Conclusion: The total costs of MS in the Czech Republic are estimated at (sic)208.6 million per year. Consistent with other studies, the costs increase significantly with the severity of MS.
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| 4. |
- Gustavsson, Anders, et al.
(författare)
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Corrigendum to “Cost of disorders of the brain in Europe 2010” [Eur. Neuropsychopharmacol. 21 (2011) 718–779]
- 2012
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Ingår i: European Neuropsychopharmacology. - : Elsevier BV. - 0924-977X .- 1873-7862. ; 22:3, s. 237-238
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Tidskriftsartikel (refereegranskat)abstract
- The spectrum of disorders of the brain is large, covering hundreds of disorders that are listed in either the mental or neurological disorder chapters of the established international diagnostic classification systems. These disorders have a high prevalence as well as short- and long-term impairments and disabilities. Therefore they are an emotional, financial and social burden to the patients, their families and their social network. In a 2005 landmark study, we estimated for the first time the annual cost of 12 major groups of disorders of the brain in Europe and gave a conservative estimate of €386 billion for the year 2004. This estimate was limited in scope and conservative due to the lack of sufficiently comprehensive epidemiological and/or economic data on several important diagnostic groups. We are now in a position to substantially improve and revise the 2004 estimates. In the present report we cover 19 major groups of disorders, 7 more than previously, of an increased range of age groups and more cost items. We therefore present much improved cost estimates. Our revised estimates also now include the new EU member states, and hence a population of 514 million people.
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| 5. |
- Gustavsson, Anders, et al.
(författare)
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Cost of disorders of the brain in Europe 2010.
- 2011
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Ingår i: European Neuropsychopharmacology. - Amsterdam : Elsevier BV. - 0924-977X .- 1873-7862. ; 21:10, s. 718-79
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: The spectrum of disorders of the brain is large, covering hundreds of disorders that are listed in either the mental or neurological disorder chapters of the established international diagnostic classification systems. These disorders have a high prevalence as well as short- and long-term impairments and disabilities. Therefore they are an emotional, financial and social burden to the patients, their families and their social network. In a 2005 landmark study, we estimated for the first time the annual cost of 12 major groups of disorders of the brain in Europe and gave a conservative estimate of €386 billion for the year 2004. This estimate was limited in scope and conservative due to the lack of sufficiently comprehensive epidemiological and/or economic data on several important diagnostic groups. We are now in a position to substantially improve and revise the 2004 estimates. In the present report we cover 19 major groups of disorders, 7 more than previously, of an increased range of age groups and more cost items. We therefore present much improved cost estimates. Our revised estimates also now include the new EU member states, and hence a population of 514 million people.AIMS: To estimate the number of persons with defined disorders of the brain in Europe in 2010, the total cost per person related to each disease in terms of direct and indirect costs, and an estimate of the total cost per disorder and country.METHODS: The best available estimates of the prevalence and cost per person for 19 groups of disorders of the brain (covering well over 100 specific disorders) were identified via a systematic review of the published literature. Together with the twelve disorders included in 2004, the following range of mental and neurologic groups of disorders is covered: addictive disorders, affective disorders, anxiety disorders, brain tumor, childhood and adolescent disorders (developmental disorders), dementia, eating disorders, epilepsy, mental retardation, migraine, multiple sclerosis, neuromuscular disorders, Parkinson's disease, personality disorders, psychotic disorders, sleep disorders, somatoform disorders, stroke, and traumatic brain injury. Epidemiologic panels were charged to complete the literature review for each disorder in order to estimate the 12-month prevalence, and health economic panels were charged to estimate best cost-estimates. A cost model was developed to combine the epidemiologic and economic data and estimate the total cost of each disorder in each of 30 European countries (EU27+Iceland, Norway and Switzerland). The cost model was populated with national statistics from Eurostat to adjust all costs to 2010 values, converting all local currencies to Euro, imputing costs for countries where no data were available, and aggregating country estimates to purchasing power parity adjusted estimates for the total cost of disorders of the brain in Europe 2010.RESULTS: The total cost of disorders of the brain was estimated at €798 billion in 2010. Direct costs constitute the majority of costs (37% direct healthcare costs and 23% direct non-medical costs) whereas the remaining 40% were indirect costs associated with patients' production losses. On average, the estimated cost per person with a disorder of the brain in Europe ranged between €285 for headache and €30,000 for neuromuscular disorders. The European per capita cost of disorders of the brain was €1550 on average but varied by country. The cost (in billion €PPP 2010) of the disorders of the brain included in this study was as follows: addiction: €65.7; anxiety disorders: €74.4; brain tumor: €5.2; child/adolescent disorders: €21.3; dementia: €105.2; eating disorders: €0.8; epilepsy: €13.8; headache: €43.5; mental retardation: €43.3; mood disorders: €113.4; multiple sclerosis: €14.6; neuromuscular disorders: €7.7; Parkinson's disease: €13.9; personality disorders: €27.3; psychotic disorders: €93.9; sleep disorders: €35.4; somatoform disorder: €21.2; stroke: €64.1; traumatic brain injury: €33.0. It should be noted that the revised estimate of those disorders included in the previous 2004 report constituted €477 billion, by and large confirming our previous study results after considering the inflation and population increase since 2004. Further, our results were consistent with administrative data on the health care expenditure in Europe, and comparable to previous studies on the cost of specific disorders in Europe. Our estimates were lower than comparable estimates from the US.DISCUSSION: This study was based on the best currently available data in Europe and our model enabled extrapolation to countries where no data could be found. Still, the scarcity of data is an important source of uncertainty in our estimates and may imply over- or underestimations in some disorders and countries. Even though this review included many disorders, diagnoses, age groups and cost items that were omitted in 2004, there are still remaining disorders that could not be included due to limitations in the available data. We therefore consider our estimate of the total cost of the disorders of the brain in Europe to be conservative. In terms of the health economic burden outlined in this report, disorders of the brain likely constitute the number one economic challenge for European health care, now and in the future. Data presented in this report should be considered by all stakeholder groups, including policy makers, industry and patient advocacy groups, to reconsider the current science, research and public health agenda and define a coordinated plan of action of various levels to address the associated challenges.RECOMMENDATIONS: Political action is required in light of the present high cost of disorders of the brain. Funding of brain research must be increased; care for patients with brain disorders as well as teaching at medical schools and other health related educations must be quantitatively and qualitatively improved, including psychological treatments. The current move of the pharmaceutical industry away from brain related indications must be halted and reversed. Continued research into the cost of the many disorders not included in the present study is warranted. It is essential that not only the EU but also the national governments forcefully support these initiatives.
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| 6. |
- Jönsson, Bengt, et al.
(författare)
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Patient access to rheumatoid arthritis treatments
- 2008
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Ingår i: European Journal of Health Economics. - : Springer Science and Business Media LLC. - 1618-7601 .- 1618-7598. ; 8:Suppl. 2, s. 33-34
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)
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| 7. |
- Jönsson, B, et al.
(författare)
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The burden of rheumatoid arthritis and access to treatment: uptake of new therapies
- 2008
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Ingår i: European Journal of Health Economics. - : Springer Science and Business Media LLC. - 1618-7601 .- 1618-7598. ; 8:Suppl. 2, s. 61-86
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Tidskriftsartikel (refereegranskat)abstract
- This paper presents data on international differences in use of TNF inhibitors. It is part of a study on burden and cost of RA, access to new therapies and the role of HTA in determining access and cost-effectiveness. United States has the fastest most extensive use of the new drugs, about three times the average in the western European countries and Canada. Eastern and central European countries as well as Australia, South Africa and Turkey lag far behind. However, some smaller European countries, most notably Norway and Sweden have use of the new drugs not far behind the United States. While the income level of the country, and thus the health care expenditures per capita is a major factor for determining use in low and middle income countries, there are still considerable differences among countries with similar high total health care expenditures. Differences in prices are considerable between the US and Europe due to the changes in exchange rates between the US dollar and the Euro, but high and low use is not systematically related to differences in price.
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| 8. |
- Kobelt, Gisela, et al.
(författare)
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Comparison of the cost-effectiveness of infliximab in the treatment of ankylosing spondylitis in the United Kingdom based on two different clinical trials
- 2007
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Ingår i: International Journal of Technology Assessment in Health Care. - 1471-6348 .- 0266-4623. ; 23:3, s. 368-375
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: To compare the cost-effectiveness of the treatment of ankylosing spondylitis (AS) with infliximab in the United Kingdom over lifetime estimated from two different clinical trials and adjusted for clinical practice guidelines. Methods: A cost-effectiveness model was developed to incorporate clinical, epidemiological, and economic data and allow extrapolation of trial results and incorporation of long-term treatment. Assumptions regarding treatment beyond the trials were based on open extensions from the trials and treatment guidelines by the British Society for Rheumatology. Results are presented for both the societal perspective and the perspective of the National Health Service (UK pound, discounted 3.5 percent). Results: Under the assumption that disease activity would be controlled and functional capacity would remain stable while on drug, treatment with infliximab (5 mg/kg every 6 weeks) dominates standard treatment in the societal perspective. In the National Health Service perspective, the cost per quality-adjusted life-year (QALY) gained over lifetime was 28,300 pound and 26,800 pound for the two trials. If functional capacity were to deteriorate at half the rate of untreated patients, the cost per QALY gained would be 35,300 pound and 34,11 pound 00, respectively. The results are sensitive to the dosing regimen adopted, the discontinuation rate, and assumptions concerning disease progression while on treatment. Conclusions: The two clinical trials yield the same cost-effectiveness results and the cost per QALY gained with treatment was found to be in the acceptable range.
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| 9. |
- Kobelt, Gisela, et al.
(författare)
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Cost-effectiveness of etanercept treatment in early active rheumatoid arthritis followed by dose adjustment.
- 2011
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Ingår i: International Journal of Technology Assessment in Health Care. - 1471-6348. ; 27:3, s. 193-200
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: To explore the cost-effectiveness of early biologic treatment, followed by dose-reduction in the case of remission, of active rheumatoid arthritis (RA), compared with standard treatment with methotrexate (MTX) in Sweden.Methods: Effectiveness (function, disease activity, erosions) in early RA for both alternatives was taken from a clinical trial comparing etanercept (ETA) combined with MTX to MTX alone. Patients discontinuing treatment can switch to another or their first biologic treatment. For patients in remission (Disease Activity Score [DAS28] < 2.6), ETA is reduced to half the dose. Return to full dose occurs when DAS28 reaches ≥ 3.2 again. Costs and utilities by level of functional capacity from an observational study are used. The model is analyzed as a micro-simulation and results are presented from the societal perspective for Sweden, for 10 years; costs (€2008) and effects are discounted at 3 percent. Sensitivity analysis was performed for the perspective, the time horizon, switching, and dose-reduction.Results: The main analysis conservatively assumes 50 percent switching at discontinuation. The cost per quality-adjusted life-year (QALY) gained with early ETA/MTX treatment is €13,500 (societal perspective, incremental cost of €15,500 and incremental QALYs of 1.15). With 75 percent switching, the cost per QALY gained was €10,400. Over 20 years, the cost per QALY gained was €8,200. Results were further sensitive to the time patients remained on half dose and the perspective.Conclusions and Policy Implications: This study combines clinical trial and clinical practice data to explore cost-effective treatment scenarios in early RA, including the use of biologics. Our results indicate that a situation where a considerable proportion of patients achieve remission, dose-adjustments will increase the cost-effectiveness of treatment.
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| 10. |
- Kobelt, Gisela, et al.
(författare)
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Costs and outcomes for patients with rheumatoid arthritis treated with biological drugs in Sweden: a model based on registry data
- 2009
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Ingår i: Scandinavian Journal of Rheumatology. - : Informa UK Limited. - 1502-7732 .- 0300-9742. ; 38:6, s. 409-418
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To design an economic model describing the costs and outcomes for patients treated with tumour necrosis factor alpha ( TNF alpha) inhibitors for rheumatoid arthritis ( RA) in current clinical practice in Sweden, to be used as a tool to estimate cost- effectiveness of the next generation of treatments. Methods: The model was constructed as a discrete event simulation ( DES) model analysed at patient level. It contains treatment and outcome data for 1903 patients followed in the RA registry for biological drugs in southern Sweden between 1999 and 2007 [ the Southern Swedish Arthritis Treatment Group ( SSATG) Register]. Resource consumption was based on a survey of 1027 patients in the same region. Costs and quality- adjusted life years ( QALYs) are presented for 10 ( 5) years, for patients with the mean characteristics at treatment start in SSATG [ Health Assessment Questionnaire ( HAQ) score 1.33, disease duration 12.1 years, age 55 years], but also for patients with more or less severe disease. Cost and outcomes ( QALYs) are discounted with 3%. Results: The 10- year costs in the base case amount to USD336 000 ( SD USD 64 000) or EUR 223 000, with a total of 4.4 QALYs. Over 5 years, the costs amount to USD 208 000 or EUR 138 000 and QALYs to 2.5. The results were most sensitive to HAQ level at treatment start, but also to underlying disease progression, age, and disease duration. Starting treatment at a lower HAQ level ( 0.85) reduces costs by 10% and increases QALYs by 20%. Conclusion: This analysis is based on the longest available follow- up for patients treated with TNF alpha inhibitors and provides an opportunity to explore treatment strategies when new therapies become available using actual clinical practice data.
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| 11. |
- Kobelt, Gisela, et al.
(författare)
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Costs and quality of life of patients with multiple sclerosis in Europe
- 2006
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Ingår i: Journal of Neurology, Neurosurgery and Psychiatry. - : BMJ. - 1468-330X .- 0022-3050. ; 77:8, s. 918-926
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To assess overall resource consumption, work capacity and quality of life of patients with multiple sclerosis in nine European countries. Methods: Information on resource consumption related to multiple sclerosis, informal care by relatives, productivity losses and overall quality of life (utility) was collected with a standardised pre-tested questionnaire from 13186 patients enrolled in national multiple sclerosis societies or followed up in neurology clinics. Information on disease included disease duration, self-assessed disease severity and relapses. Mean annual costs per patient (Euro, 2005) were estimated from the societal perspective. Results: The mean age ranged from 45.1 to 53.4 years, and all levels of disease severity were represented. Between 16% and 29% of patients reported experiencing a relapse in the 3 months preceding data collection. The proportion of patients in early retirement because of multiple sclerosis ranged from 33% to 45%. The use of direct medical resources (eg, hospitalisation, consultations and drugs) varied considerably across countries, whereas the use of non-medical resources (eg, walking sticks, wheel chairs, modifications to house and car) and services (eg, home care and transportation) was comparable. Informal care use was highly correlated with disease severity, but was further influenced by healthcare systems and family structure. All types of costs increased with worsening disease. The total mean annual costs per patient (adjusted for gross domestic product purchasing power) were estimated at Euro 18000 for mild disease (Expanded Disability Status Scale (EDSS) < 4.0), Euro 36500 for moderate disease (EDSS 4.0-6.5) and Euro 62000 for severe disease (EDSS > 7.0). Utility was similar across countries at around 0.70 for a patient with an EDSS of 2.0 and around 0.45 for a patient with an EDSS of 6.5. Intangible costs were estimated at around Euro 13000 per patient.
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| 12. |
- Kobelt, Gisela, et al.
(författare)
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Disease status, costs and quality of life of patients with rheumatoid arthritis in France: The ECO-PR Study.
- 2008
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Ingår i: Joint Bone Spine. - : Elsevier BV. - 1778-7254 .- 1297-319X. ; May 1, s. 408-415
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To investigate resource consumption and quality of life (utility) in a sample of patients covering the full spectrum of the disease, modalities of patient management and geographic areas. METHODS: Information on demographics, disease parameters, work capacity and resource consumption (in the past 1, 3 or 12months depending on the resource) was collected in an anonymous mail survey from all members of a national patient association (ANDAR). Results are presented for the sample and by level of functional capacity, in euro2005. RESULTS: 1487 patients were included in the analysis (response rate 49%). Mean age was 62.7years and 83.5% of respondents were female. Mean disease duration was 18years; mean HAQ was 1.42; fatigue and pain ranked 5.6 and 4.8 on a scale between 0 and 10, respectively. Of patients below 60years, 34% had taken early retirement due to RA, and only 15% of patients with a HAQ of 2 or higher were working. Productivity losses were estimated at euro5076, of which indemnity payments covered euro1944. Direct health care costs were euro11,757 in the societal perspective and euro9216 in the perspective of the national health insurance. Direct non-medical costs (including informal care) were euro4857 and euro136 respectively. Costs to society increased from euro9400 in mild disease to euro40,700 in severe disease, and to public payers from euro6000 to euro19,000. Utility decreased simultaneously from 0.80 to 0.06. CONCLUSION: The study confirms overall findings in other studies in other countries, and provides the first estimate of all costs by disease severity in France.
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| 13. |
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| 14. |
- Kobelt, Gisela
(författare)
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Health economic assessment of medical technology in chronic progressive diseases : multiple sclerosis and rheumatoid arthritis
- 2003
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- This thesis developed a method for economic evaluation in non-fatal chronic progressive diseases, applied to multiple sclerosis (MS) and rheumatoid arthritis (RA). In economic evaluation different treatment strategies are compared in terms of their costs and their health benefits. If an alternative has a better outcome, but is also more costly, as is the case for the new treatments introduced for MS and RA, the extra cost for the incremental benefit, i.e. cost-effectiveness, is estimated. The challenge for economic evaluation in chronic progressive disease is the complexity of these pathologies where acute symptoms are present permanently or intermittently, while at the same time the severity of the disease progresses. Symptoms can or cannot represent risk factors. Treatment can be symptomatic or disease modifying or both, and economic evaluation must therefore take both symptoms and progression. into account. The method developed describes disease progression with functional disability measures, relates costs and quality of life (utility) to different levels of functional disability, incorporates temporary symptoms, and expresses the effectiveness of treatments as the gain in quality-adjusted life-years (QALYs). Disease progression is estimated from epidemiological cohort studies, costs and utility are collected in specially designed large observational studies, the effectiveness of treatment is taken from clinical trial data and the cost-effectiveness is estimated using long-term models (Markov models). The studies show that the models capture disease progression and symptoms, costs and quality of life adequately, but that the results are highly dependent on the quality of the underlying data and the assumptions made for extrapolating to the long term. The three papers in MS illustrate how a model can be developed from a clinical trial, improved over time, as new date become available, and adapted to different patient populations. Extrapolation of the clinical trial data underestimated disease progression compared to the natural history data. As a consequence, the cost per QALY gained with 3-year treatment over a 10-year timeframe dropped from 342'700 SEK in the first study to 257'200 SEK in the second. When the model is applied to patients with active disease at higher risk of progression, the cost per QALY gained was further reduced to 72'000 SEK. The three papers in RA illustrate how a model can be based on epidemiological data and adjusted to allow incorporating clinical trial data. The models based on two independent epidemiological cohorts of newly diagnosed patients in Sweden and the UK showed a strikingly similar outcome, with patients having an average of 5.1 QALYs over 10 years. However, costs were very different, due to large differences in indirect costs between the two countries. The models were adapted to patients with more advanced disease treated with infliximab in a one-year trial, and a loss of effectiveness after the trial was incorporated. Treatment was shown to be cost-saving in Sweden, while the cost per QALY gained in the UK was 18'400£. It was not possible to adapt the model to patients with very long standing disease treated in clinical practice with etanercept or infliximab due to lack of data in the epidemiological data sets. Treatment was therefore compared to baseline, resulting in a cost per QALY gained between 340'000 SEK and 500'000 SEK. The thesis shows that the method is appropriate and feasible, but the results are highly dependent on the availability of appropriate data.
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| 15. |
- Kobelt, Gisela
(författare)
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Health economic evaluation: why? When? How?
- 2013
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Ingår i: Expert Review of Neurotherapeutics. - : Informa UK Limited. - 1744-8360 .- 1473-7175. ; 13:12, s. 33-37
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Forskningsöversikt (refereegranskat)abstract
- Advances in research and better understanding of the pathophysiology of diseases have resulted in an increase in the number of available health interventions that compete for finite public resources. Explicit choices must therefore be made about funding.
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| 16. |
- Kobelt, Gisela
(författare)
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Health economic issues in rheumatoid arthritis
- 2006
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Ingår i: Scandinavian Journal of Rheumatology. - : Informa UK Limited. - 1502-7732 .- 0300-9742. ; 35:6, s. 415-425
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Forskningsöversikt (refereegranskat)abstract
- The objectives of treatment in rheumatoid arthritis (RA) are to reduce temporary symptoms due to inflammatory activity and, more importantly, to preserve function. The introduction of potent disease-modifying anti-rheumatic drugs (DMARDs) in recent years has increased the opportunities for effective treatment. However, these treatments come at a substantially higher cost than traditional DMARDs and therefore compete with other essential interventions for limited resources. They have triggered a debate on whether they represent an efficient use of resources, which patients should be treated, when, and for how long. Cost-effectiveness analysis attempts to estimate the trade-offs involved in these decisions and to provide information that can help in making them. However, in chronic progressive diseases, health gains and any potential associated economic benefits are often most evident in the long term. As a consequence, the impact of new treatments has to be estimated using models that can project available knowledge, such as results from clinical trials or short-term follow-up studies in clinical practice, into the future. These models also allow scenarios to be explored that provide the best value for money, for example by defining subgroups for which treatment is most effective, or criteria that define when treatment should be stopped. Economic evaluation in RA has a long tradition, with the first study performed about 20 years ago. However, with the recent drug introductions, the field has witnessed an explosion of economic studies. Modelling techniques have become more sophisticated to overcome concerns about their validity. At the same time, they may appear less transparent, making it difficult for non-specialists to understand the details. This article, rather than reviewing all published models and comparing them, attempts to illustrate the inputs required for such studies, and the influence that different approaches and datasets can have on the results.
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| 17. |
- Kobelt, Gisela, et al.
(författare)
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Modeling the cost-effectiveness of a new treatment for MS (natalizumab) compared with current standard practice in Sweden
- 2008
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Ingår i: Multiple Sclerosis Journal. - : SAGE Publications. - 1352-4585 .- 1477-0970. ; 14:5, s. 679-690
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Tidskriftsartikel (refereegranskat)abstract
- Objective To estimate the cost-effectiveness of a new treatment (natalizumab) for multiple sclerosis ( MS) compared with current standard therapy with disease-modifying drugs (DMDs) in Sweden. Methods A Markov model was constructed to illustrate disease progression based on functional disability ( the Expanded Disability Status Scale (EDSS)). The effectiveness of natalizumab was based on a 2-year clinical trial in 942 patients ( AFFIRM). The effectiveness of current DMDs was estimated from a matched sample of 512 patients in the Stockholm MS registry. Patients withdrawing from treatment were assumed to follow the disease course of 824 patients with relapsing-remitting disease at onset in the Ontario natural history cohort. Costs and utilities are based on a recent observational study in 1339 patients. All data sets were available at the patient level. Main results are presented from the societal perspective, over a 20-year time frame, in 2005 Euros ( is an element of 1 = 9.25 SEK). Results In the base case, treatment with natalizumab was less expensive and more effective than treatment with current DMDs. When only healthcare costs were considered, the cost per quality-adjusted life year gained with natalizumab was is an element of 38 145. Results are sensitive only to the time horizon of the analysis and assumptions about effectiveness of natalizumab beyond the trial. Conclusions This cost-effectiveness analysis used registry data, cohort and observational studies to extrapolate the efficacy findings of natalizumab from the AFFIRM clinical trial to measure effectiveness in clinical practice. The analysis results suggest that for the population considered, natalizumab provides an additional health benefit at a similar cost to current DMDs from a societal perspective.
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| 18. |
- Kobelt, Gisela, et al.
(författare)
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The burden of ankylosing spondylitis in Spain.
- 2008
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Ingår i: Value in Health. - : Elsevier BV. - 1098-3015. ; 11:3, s. 408-415
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To investigate the burden of ankylosing spondylitis (AS) in Spain, as baseline for economic evaluation of the use of biological agents. METHODS: A cross-sectional retrospective observational study was performed in 601 patients with AS in Spain, using a methodology developed in studies in the United Kingdom and Canada. Patients were mailed a questionnaire asking about their health-care consumption, out-of-pocket expenses, work capacity, need for informal care during the past 3 months, as well as quality of life. Patient's current functional status and disease activity level was assessed using the Bath functional and disease activity indexes (BASFI and BASDAI). RESULTS: The mean age (median) was 47.8 (12.4) years, and the mean disease duration was 18.8 years. Eighty percent of patients were male, and slightly more than half of patients below 65 years of age were working. The mean (median) BASDAI and BASFI scores were 4.3 (2.5) and 3.8 (2.9),respectively, and all levels of disease severity were represented. The mean (median) total annual cost per patient is estimated at euro 20,328 (euro 7920). Direct health care represented 22.8%, investments (adaptations of house and devices) and informal care 43.5%, and productivity losses 33.7%. Costs increased significantly with worsening disease, in particular diminishing physical function, covering a range between euro 5000 and euro 75,000 per patient and year. The mean (median) utility was 0.59 (0.30). Utility showed a significant inverse relation with BASFI and BASDAI, covering a range from 0.80 for patients with BASFI/BASDAI below 3 to 0.25 for patients with BASFI/BASDAI greater than 7. CONCLUSIONS: As in studies in other countries, all types of costs accelerate steeply with worsening disease while utility decreases significantly, indicating the need to prevent disease progression.
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| 19. |
- Kobelt, Gisela, et al.
(författare)
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The burden of rheumatoid arthritis and access to treatment: outcome and cost-utility of treatments
- 2008
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Ingår i: European Journal of Health Economics. - : Springer Science and Business Media LLC. - 1618-7601 .- 1618-7598. ; 8:Suppl. 2, s. 95-106
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Tidskriftsartikel (refereegranskat)abstract
- Within the series of articles investigating the burden of rheumatoid arthritis (RA), this paper reviews the methods used for economic assessment of the RA treatments by HTA agencies and other bodies involved in cost-effectiveness analysis and the current status of the field. The overall methods, as well as the challenges, of cost-effectiveness analysis in RA are common to all chronic progressive diseases where much of the treatment benefit is delayed, while costs occur immediately. Also, as in all disabling diseases, much of the costs occur outside the health-care system, due to the rapid loss of work capacity and the need for informal care in the later stages of the disease. Thus, it is essential to adopt a long-term view and consider costs from the perspective of society, rather than the health-care service, to increase the relevance of the results for policy making.
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| 20. |
- Kobelt, Gisela, et al.
(författare)
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The cost-effectiveness of infliximab in the treatment of ankylosing spondylitis in Spain. Comparison of clinical trial and clinical practice data.
- 2008
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Ingår i: Scandinavian Journal of Rheumatology. - : Informa UK Limited. - 1502-7732 .- 0300-9742. ; 37:1, s. 62-71
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To estimate the cost-effectiveness of treating ankylosing spondylitis (AS) with infliximab (Remicade(R)) in Spain for up to 40 years. Methods: A previously published disease model was adapted to the Spanish setting using resource consumption from a cross-sectional burden of an illness study in 601 patients in Spain. Cost-effectiveness estimates were based on a placebo-controlled clinical trial as well as an open clinical study in Spain. In the model, patients with insufficient response to treatment at 12 weeks [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) <4 or >/=50% reduction] discontinue treatment. The results are presented in 2005 euros, from societal and health-care payer perspectives. Results: In the societal perspective, infliximab treatment dominates standard treatment in both analyses. In the perspective of the health-care system, with the assumption that, over the long term, functional ability of patients on treatment would decline at half the natural rate, the cost per quality-adjusted life year (QALY) gained was estimated at EUR 22 519 (double-blind trial) and EUR 8866 (open study). Assuming that patients' function on treatment remains stable, the cost-effectiveness ratios are EUR 15 157 and EUR 5307, respectively. Under the most conservative assumption (no effect of treatment on progression), the ratios are EUR 31 721 and EUR 13 659, respectively. In addition, the results are sensitive to the time horizon and discontinuation rates. Conclusions: Our results indicate that infliximab therapy for patients with active AS should be cost-effective both in the societal perspective (dominating) and in the perspective of the health-care system (ranges from EUR 5300 to EUR 32 000 per QALY) in Spain.
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| 21. |
- Kobelt, Gisela, et al.
(författare)
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The long-term cost of multiple sclerosis in France and potential changes with disease-modifying interventions.
- 2009
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Ingår i: Multiple Sclerosis Journal. - : SAGE Publications. - 1477-0970 .- 1352-4585. ; 15, s. 741-751
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Tidskriftsartikel (refereegranskat)abstract
- ObjectiveTo evaluate the long-term costs and quality of life (QoL) with and without disease-modifying treatments (DMTs) of patients with multiple sclerosis (MS).MethodsData on resource consumption, productivity losses, QoL (utility), and fatigue were collected from 1355 patients registered with a patient association and descriptive analyses was performed.A Markov model was developed to estimate costs and utility over 20 years using the survey data. Disease progression without DMTs was taken from an epidemiological cohort in France (EDMUS cohort, LYON). Progression under DMTs was estimated from the Stockholm MS registry. Results are presented as cost per quality-adjusted life-years (QALYs), from the societal perspective, in EUR2007, discounted at 3%.ResultsMean Expanded Disability Status Scale (EDSS) was 4.4 and mean total annual costs per patient were EUR44,400, of which 47% were productivity losses and 11% informal care. Public payers cover an estimated 48% of costs. Mean utility was 0.52, and the loss compared with the normal population was estimated at 0.28. Costs and utility ranged from EUR16,000 and 0.79 at EDSS 1 to EUR76,000 and 0.11 at EDSS 8-9.Over 20 years, costs were estimated at EUR429,000 and QALYs at 8.96 for patients without DMTs and at EUR433,207 and 9.24 QALYs if all patients were starting treated with DMTs at EDSS 1-3.ConclusionAlthough the data for this analysis come from different sources, the results indicate that the cost increase with DMTs is moderate.
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| 22. |
- Kobelt, Gisela
(författare)
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Treating to target with etanercept in rheumatoid arthritis: cost-effectiveness of dose reductions when remission is achieved.
- 2014
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Ingår i: Value in Health. - : Elsevier BV. - 1098-3015. ; 17:5, s. 537-544
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Tidskriftsartikel (refereegranskat)abstract
- Current management of rheumatoid arthritis (RA) focuses on inducing remission as early as possible to avoid lasting joint damage, and maintenance of remission has become important. A 12-month clinical trial in 834 patients with moderate RA investigated whether etanercept 50 mg/wk could be reduced to half dose or discontinued in patients who achieved low disease activity after 36 weeks.
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| 23. |
- Kobelt-Nguyen, Gisela, et al.
(författare)
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Cost-utility analysis of interferon beta-1B in secondary progressive multiple sclerosis using natural history disease data
- 2002
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Ingår i: International journal of technology assessment in health care. - 1471-6348 .- 0266-4623. ; 18:1, s. 127-138
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Tidskriftsartikel (refereegranskat)abstract
- Different cost-effectiveness analyses have been presented for interferon beta-1b (IFNB) in the treatment of secondary progressive multiple sclerosis (SPMS). All studies have used modeling techniques since any effect on progression of disability achieved during a clinical trial will last beyond the trial. Different approaches to extrapolation have been taken, but generally they have been based on disease progression and relapse rates in clinical trials. The problem with this approach is that the population in clinical trials is a selected group of patients, which has the potential to bias results. A better method for extrapolation is to use epidemiologic data. The objective of this study is to incorporate natural history data for MS into a previously presented cost-utility model and to compare the two methods of extrapolation. Clinical trial data were used to model disease progression during the first 3 years in the model. To extrapolate beyond the trial (10 years), data on progression of disability were available from a geographically based epidemiologic study of the natural history of MS in Canada. There were 568 patients who had converted to SPMS during the follow-up that were included in the data set. Mean costs and utilities for each Markov state were calculated from a population-based cross-sectional study in Sweden. The extrapolation using clinical trial data appears to have underestimated the progression of disability in the long term and thus also the potential benefit of treatment. Using the epidemiologic data, the incremental cost per QALY is SEK 257,000 (US $25,700; US $1 = SEK 10; November 2000) when all costs (direct, informal care, and indirect) are included (discounted 3%). This compares to SEK 342,000 in the previous model. The lower cost-effectiveness ratio is mostly due to a larger QALY gain with treatment than in the previous model (0.217 compared with 0.162). Cost-effectiveness analysis in SPMS requires that the effect of treatment beyond clinical trials be included. The method of extrapolation clearly affects the results, and when available, epidemiologic data should be used. Using the longitudinal data from Canada, the cost-utility ratios for IFNB-1b in the treatment of SPMS appear well within the acceptable range.
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| 24. |
- Lekander, Ingrid, et al.
(författare)
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The Comparison of Trial Data-Based and Registry Data-Based Cost-Effectiveness of Infliximab Treatment for Rheumatoid Arthritis in Sweden Using a Modeling Approach
- 2013
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Ingår i: Value in Health. - : Elsevier BV. - 1098-3015. ; 16:2, s. 251-258
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To evaluate the precision of the predictive cost-effectiveness assessment based on a phase 3 clinical trial with infliximab for the treatment of rheumatoid arthritis in Swedish clinical practice. Methods: Three patient cohorts were identified: the patients included in the infliximab trial (ATTRACT), patients initially treated with infliximab from a Swedish registry (STURE), a subset of these registry patients meeting inclusion criteria for the ATTRACT trial was the third patient cohort; two sets of assumptions in relation to the efficacy data were evaluated: "ATTRACT" (efficacy data over the duration of the trial) and "STURE" (effectiveness data over 10 years). In addition, the impact of including the placebo effect for the comparator was evaluated as a basis for the calculation of cost-effectiveness by using a modeling approach. A health economic model was utilized to estimate the cost per quality-adjusted life-year (QALY) gained. Results: The results for the three patient cohorts ranged from cost saving to a cost per QALY gained of (sic)2,400 and (sic)24,900 to (sic)26,000 when the ATTRACT and STURE assumptions were used, respectively. Sensitivity analyses indicated that the inclusion of placebo effect had the largest effect on the results, increasing the cost per QALY gained to approximately (sic)50,000 for all patient cohorts. Conclusions: The treatment effect of infliximab measured in clinical trials and clinical practice results in comparable cost-effectiveness ratios, as calculated by using a modeling approach, whereas the assumptions made in relation to the effectiveness data and the chosen comparator have a large impact on the results. This reinforces the value of early modeling studies based on randomized clinical trial data, but assumptions made need to be carefully assessed.
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| 25. |
- Lekander, Ingrid, et al.
(författare)
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The cost-effectiveness of TNF-inhibitors for the treatment of rheumatoid arthritis in Swedish clinical practice
- 2013
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Ingår i: European Journal of Health Economics. - : Springer Science and Business Media LLC. - 1618-7601 .- 1618-7598. ; 14:6, s. 863-873
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Tidskriftsartikel (refereegranskat)abstract
- The objective was to estimate the cost-effectiveness of TNF-inhibitors for the treatment of rheumatoid arthritis in Swedish clinical practice, both as a first and second biological treatment, with or without the combination of conventional DMARDs. Further sub-group analysis of etanercept treatment was performed. Patient level data were obtained from three regions of the Swedish Rheumatology Registers. The dataset contained 2,558 patients who had started TNF-inhibitor treatment, 1,049 with etanercept as their first biological treatment. A total of 819 patients had switched to a second TNF-inhibitor, of which 425 to etanercept. A Markov cohort model was used in which health states of disease severity were classified according to HAQ and DAS28. Disease progression and discontinuation rates of TNF-inhibitors were based on the registry and for the comparator on published literature. Mortality, costs and utilities were based on Swedish data. The main analysis had a societal perspective over 20 years and efficacy was measured in quality-adjusted life-years (QALYs). TNF-inhibitor treatment was associated with an increase in QALYs and an incremental cost compared to no biological treatment. The cost per QALY gained with the three TNF-inhibitors ranged from a,not sign50,000 to a,not sign120,000, with lower estimates for TNF-inhibitors used in combination with MTX and as a first biologic. At a progression of 0.045 for the comparator, most values remain within the accepted range for cost-effectiveness. These results demonstrate that the cost per QALY for TNF-inhibitors was higher than in previous assessments based on registry data and that the results were sensitive to the HAQ progression of the comparator.
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| 26. |
- Lindgren, Peter, et al.
(författare)
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Modeling the cost-effectiveness of treatment of rheumatoid arthritis with rituximab using registry data from Southern Sweden
- 2009
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Ingår i: International Journal of Technology Assessment in Health Care. - 1471-6348. ; 25:2, s. 181-189
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: The aim of this study was to estimate the cost-effectiveness of rituximab in patients not responding adequately to the first tumor necrosis factor (TNF) inhibitor using a model constructed to predict resource consumption and health outcomes in a population-based registry of biological treatments in Southern Sweden (SSATG). Methods: The model was developed as a discrete event simulation model, using SSATG data for the years 1999-2007. The data set included 1,903 patients with complete data on treatments (up to three treatment lines), functional capacity (HAQ), disease activity (DAS28), and utility (EQ-5D). Resource consumption was based on a regular population-based survey of patients in Southern Sweden. Rituximab was incorporated as second line treatment, using effectiveness data for the active group (N = 311) in a clinical trial comparing rituximab to placebo (REFLEX). It is thus compared to the mix of second line biologics used in SSATG. The analysis starts after failure of the first TNF inhibitor. Results are reported as costs ((sic)2008) per quality-adjusted life-year (QALY; both discounted 3 percent), for the societal perspective in Sweden. Results: Total costs in the rituximab strategy are estimated at (sic)401,100 compared with (sic)403,000 in the TNF-inhibitor arm. Total QALYs are 5.98 and 5.78, respectively. The findings were found to be robust in extensive sensitivity analysis. Conclusions: In our model, a strategy where rituximab is used as second line treatment after failure of the first TNF inhibitor provides a small saving (essentially due to the lower price of rituximab) and a QALY gain (due to better effect than the mix of second line TNF inhibitors).
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| 27. |
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| 28. |
- Lundqvist, J, et al.
(författare)
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The burden of rheumatoid arthritis and access to treatment: determinants of access
- 2008
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Ingår i: European Journal of Health Economics. - : Springer Science and Business Media LLC. - 1618-7601 .- 1618-7598. ; 8:Suppl. 2, s. 87-93
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Tidskriftsartikel (refereegranskat)abstract
- As pan of the study "The Burden of Rheumatoid Arthritis (RA) and Patient Access to Treatment", this paper reviews the impact on access to RA drugs of the approval processes, pricing and funding decisions and times to market (access) in different countries. In addition, an overview of health technology assessments (HTA) and the economic literature related to RA treatments is provided. The time from approval to market access ranged from immediate to over 500 days in the countries included in the study. A total of 55 HTA reports were identified, 40 of them in the period between 2002 and 2006; 29 were performed by European HTA agencies, 14 in Canada and 7 in the United States. A total of 239 economic evaluations related to RA were identified in a specialized health economic database (HEED).
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| 29. |
- Neymark, N, et al.
(författare)
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The costs of treating glaucoma with combinations of topical drugs in Spain
- 2008
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Ingår i: European Journal of Ophthalmology. - 1120-6721. ; 18:1, s. 52-59
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Tidskriftsartikel (refereegranskat)abstract
- PURPOSE. This study describes the treatment in ordinary clinical practice in Spain of patients with glaucoma with a two-drug combination therapy. The authors present the treatment outcome as end-of-period intraocular pressure (IOP) and the calculated direct medical costs over a 2-year period. METHODS. Data were extracted retrospectively from patient charts recording the use of all medical resources related to glaucoma. Costs were estimated using unit costs from public sources ( 2005). Descriptive cost analysis according to combination treatment at baseline was performed. RESULTS. The study included 216 patients from 21 centers. Around half of the patients were started on a beta-blocker/prostaglandin analogue combination, while the rest received various other combinations containing either an alpha 2-agonist or a carbonic anhydrase inhibitor. Across the seven groups considered, there was a statistically significant difference in the costs of the least and the two most costly groups, while the confidence intervals were overlapping in all other pairwise comparisons. The least costly drug combination was brimonidine/timolol. Assessing IOP at the end of follow-up, all the groups were equally effective ( overlapping confidence intervals). In a multivariate regression analysis, the drug combination did not have an independent, significant impact on total direct medical costs, drug costs, or end-of-period IOP. Significant determinants of these variables were surgical interventions and one or more changes of drug combination during the follow-up. CONCLUSIONS. Costs are determined by the response to treatment. Inadequate response triggers treatment changes and sometimes eventually surgical interventions, thereby increasing costs significantly.
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| 30. |
- O'Conor, Richard, et al.
(författare)
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Urge Incontinence: Quality of Life and Patients' Valuation of Symptom Reduction
- 1998
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Ingår i: PharmacoEconomics. - : Springer Science and Business Media LLC. - 1179-2027 .- 1170-7690. ; 14:5, s. 531-539
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Tidskriftsartikel (refereegranskat)abstract
- Objective: Previous studies have demonstrated the effect of incontinence, and urge incontinence in particular, on patients' quality of life. This study assessed the effects of urge incontinence on quality of life and measured the value of a reduction in symptoms. Design: A self- administered questionnaire was mailed to 591 patients with urge or mixed incontinence. 495 (83.8%) surveys were returned with complete quality of life and symptom data. Of the total sample, 411 patients received the willingness- to-pay (WTP) survey, from which 257 (62.53%) returns were judged complete and reliable. Information was collected about the number of micturitions and urinary leakages. Health-related quality of life (HR-QOL) was measured using the Short Form 36 (SF-36) Health Survey. Socioeconomic characteristics were also recorded. Value was assessed with a binary WTP question. Main outcome measures and results: Quality of life among the sample population was significantly lower in 5 of 8 dimensions compared with the general US population, and was significantly related to the severity of the symptoms in 6 of 8 dimensions. The median (mean) willingness to pay was $US27.24 ($US87.74) per month for a 25% reduction in micturitions and leakages, and $US75.92 ($US244.54) per month for a 50% reduction in micturitions and leakages. As expected, the willingness to pay was significantly related to the size of the reduction in micturitions and leakages, and household income. Conclusions: Patients with incontinence perceive substantial benefits from a reduction in the number of micturitions and leakages.
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| 31. |
- Pentek, Marta, et al.
(författare)
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Costs of rheumatoid arthritis in Hungary
- 2007
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Ingår i: Journal of Rheumatology. - 0315-162X. ; 34:6, s. 1437-1439
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)
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| 32. |
- Strömbeck, Britta, et al.
(författare)
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Cost of Illness from the Public Payers' Perspective in Patients with Ankylosing Spondylitis in Rheumatological Care.
- 2010
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Ingår i: Journal of Rheumatology. - : The Journal of Rheumatology. - 0315-162X .- 1499-2752. ; 37, s. 2348-2355
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To estimate the incremental costs to public payers for patients with ankylosing spondylitis (AS) of working age compared with reference subjects from the general population. METHODS: We investigated total costs for 3 years (2005-2007) in 116 outpatients under 66 years of age with AS attending rheumatological care in Malmö, Sweden. Mean (SD) age was 46 (11) years and mean (SD) disease duration was 24 (11) years. Two subjects perAS patient matched for age, sex, and residential area were selected from the Population Register to serve as a reference group. We retrieved data concerning sick leave, prescription drugs, and healthcare consumption from Swedish health-cost registers by the unique personal identification numbers. RESULTS: The mean total cost for the 3-year period 2005-2007 was US $37,095 (SD $30,091) for patients with AS, and $11,071 (SD $22,340) for the reference group. The mean indirect cost was $19,618 and $5905, respectively. Mean cost for healthcare was $8998 for the AS patients and $4187 for the reference subjects, and mean cost for drugs was $8479 and $979, respectively. The patients with AS treated with biological therapy constituted 80% of the total drug cost, but just 40% of the cost for disability pension. CONCLUSION: Patients with AS had 3-fold increase in costs compared to reference subjects from the general population, and the drug costs were almost 10 times as high. Production losses (indirect cost) represented more than half of total cost (53%).
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