Healthcare Resource Utilization and Cost Burden of BCG-Treated Non-Muscle Invasive Bladder Cancer Patients in Germany: A Retrospective Claims Analysis.

Background: Intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC) is typically managed with transurethral resection of the bladder tumour (TURBT) followed by intravesical Bacillus Calmette-Guérin (BCG) immunotherapy; however, NMIBC patients can become refractory or unresponsive to BCG treatment, and/or progress to muscle-invasive bladder cancer (MIBC). Healthcare resource utilization (HCRU) and costs in these patient populations are high. Methods: A retrospective longitudinal cohort design of adult (≥18 years) patients with bladder cancer and BCG treatment (01/01/2012-31/12/2017) was conducted using data from a representative subset of the German statutory health insurance database. During the follow-up period after last BCG, patients were categorized into subgroups of No further NMIBC treatment, Continuous treatment for NMIBC, or MIBC evidence; HCRU and costs were tabulated for each subgroup and for the entire cohort. Results: A total of 1049 patients met the study inclusion criteria (mean age, 70.9 years; 84.8% male). Across the different subgroups, patients showing MIBC evidence had more than two times higher hospitalization rates compared to the other subgroups. Overall, the entire BCG-treated cohort's total direct medical cost including hospitalizations, outpatient care and drugs was €33.9 million and €9250 per patient-year. Cost for patients with MIBC evidence was much higher, at €17,983 per patient-year, than patients with No further NMIBC treatment (€6617) and patients with Continuous treatment for NMIBC (€7786). Across the subgroups, hospitalization was the largest driver of cost and contributed the most to cost for those with MIBC evidence. Conclusion: The overall cost burden of this BCG-treated cohort of 1049 patients is high (€38 million whereof 4.1 million are indirect costs) over a mean follow-up of 3.9 years; economic burden is especially substantial for patients who fail BCG treatment and those who progress.

Patient Preferences for Treatment of Bacillus Calmette-Guérin-unresponsive Non-muscle-invasive Bladder Cancer: A Cross-country Choice Experiment.

Background: Patients with non-muscle-invasive bladder cancer (NMIBC) that is unresponsive to bacillus Calmette-Guérin (BCG) immunotherapy face a difficult choice. Immediate radical cystectomy (RC) is effective but might represent overtreatment. Continuing bladder preservation with medical therapy is an alternative, but it risks progression to muscle-invasive bladder cancer (MIBC) and a reduction in survival. Objective: To understand the trade-offs patients are willing to make in selecting treatments for BCG-unresponsive NMIBC. Design setting and participants: Adults with NMIBC from the UK, France, Germany, and Canada who reported current receipt of BCG, disease unresponsive to BCG, or receipt of RC in the previous 12 mo after failure of BCG were recruited to participate in an online choice experiment. Patients were asked to make repeated choices between two hypothetical medical treatments and the option to undergo immediate RC. The medical treatments required trade-offs between the time to RC, the mode and frequency of administration, the risk of experiencing serious side effects, and the risk of disease progression. Outcome measurements and statistical analysis: Error component logit models were used to calculate relative attribute importance (RAI) scores as the maximum percentage contribution to a preference and acceptable benefit-risk trade-offs. Results and limitations: Most of the 107 participants (average age 63 yr) never selected RC (89%) as their preferred option in the choice experiment. Preferences were most affected by time to RC (RAI 55%), followed by risk of progressing to MIBC (RAI 25%), medication administration (RAI 12%), and the risk of serious side effects (RAI 8%). To increase the time to RC from 1 yr to 6 yr, patients accepted a 43.8% increase in the risk of progression and a 66.1% increase in the risk of serious side effects. Conclusions: Patients with BCG-treated NMIBC valued bladder-sparing treatments and were willing to make substantial benefit-risk trade-offs to delay RC. Patient summary: Adults with bladder cancer not invading the bladder muscle completed an online experiment in which they chose between hypothetical medications and bladder removal. The results show that patients would be willing to accept different risks associated with medications to delay bladder removal. Patients considered disease progression the most important risk of medicinal treatment.

Elicitation of Health State Utilities Associated with Progression from Bacillus Calmette-Guerin (BCG) Unresponsive Non-muscle Invasive Bladder Cancer (NMIBC).

OBJECTIVES: The treatments for high-grade non-muscle invasive bladder cancer (NMIBC) vary between bladder preserving intravesical approaches and radical cystectomy. The impact of these treatments on health-related quality of life may vary widely. The purpose of this study was to elicit the general public's perspective on quality of life, measured as utility scores associated with treatment for Bacillus Calmette-Guerin (BCG)-unresponsive NMIBC and disease progression, for supporting economic evaluation of newly developed treatments for NMIBC. MATERIALS AND METHODS: Part I involved the development and testing of health states describing NMIBC, which was informed by a rapid review, expert input and a patient advisor. Part II involved elicitation of societal utility values for the different health states. Time trade-off (TTO) interviews were conducted with members of the UK general public. Five health states described different NMIBC scenarios including disease recurrence and progression. Participants ranked each health state, followed by the TTO valuation exercise. Descriptors included NMIBC symptom severity, impact and treatment characteristics. RESULTS: In total, 202 members of the general public participated. The mean age was 46 (standard deviation [SD] 14.6) years. Sample mean (SD) EQ-5D-5L visual analogue scale (VAS) and index scores were 83.2 (12.3) and 0.89 (0.18), respectively. Mean utilities were 0.781 for No High-Grade Recurrence, 0.586 for High-Grade Recurrence, 0.572 for > 1-Year Post-cystectomy and 0.283 for metastatic disease. The First Year Post-cystectomy path health state had a mean utility of 0.288. Pairwise comparisons found statistically significant differences between utilities (p < 0.001), except between High-Grade Recurrence and > 1-Year Post-cystectomy (p = 0.524). There were significant differences in utility scores by age and employment status. CONCLUSION: This study provides utility scores for health states describing living with NMIBC, which is associated with a significant health-related quality-of-life burden. These values address an existing gap in available data and have the potential to be used in models evaluating the cost-effectiveness of both current and newly developed treatments for bladder cancer.

The use of 5-aminosalicylates in Crohn's disease: a retrospective study using the UK Clinical Practice Research Datalink.

BACKGROUND: There are few recent studies on the use of 5-aminosalicylates (5-ASA) as therapy for Crohn's disease (CD) in routine clinical practice. The aim of this database investigation was to provide real-world evidence on 5-ASA use in CD. METHODS: Patients with CD, aged ≥18 years when first prescribed 5-ASA (index date) and having received 5-ASA at any time between 01 January 2006 and 07 May 2018, were included for analysis. Outcomes included treatment patterns and resource use. RESULTS: Of 21,456 patients with CD, 9492 (44.2%) had been prescribed 5-ASA, with the majority (5606; 59.1%) starting on oral 5-ASA as monotherapy. 58.3% (5537) of patients on 5-ASA did not require dose change, 67.6% (6416) did not require supplementary treatment (e.g., corticosteroids, immunosuppressants, etc.), and 4.6% (436) required a switch to another treatment. Resource use was significantly decreased in the year after vs. year before 5-ASA initiation (including: specialist referrals, hospitalizations and hospital days; all P<0.001). Patients remained on 5-ASA for a median of 4.7 years (interquartile range 1.2-10.1). 25.3% (2406) of patients were still on 5-ASA at 10 years. There was a significant correlation between earlier use of 5-ASA following diagnosis and longer 5-ASA retention (P<0.001). CONCLUSIONS: 5-ASA is widely used as a long-term treatment for CD, as evidenced by continuation rates extending beyond 10 years in a quarter of patients. CD-related healthcare resource use decreased significantly in the year following 5-ASA initiation. Earlier use was associated with longer retention.

Budesonide with multi-matrix technology as second-line treatment for ulcerative colitis: evaluation of long-term cost-effectiveness in the Netherlands.

AIMS: Budesonide with multi-matrix technology (MMX) is an oral corticosteroid, shown to have high topical activity against ulcerative colitis (UC) while maintaining low systemic bioavailability with few adverse events. The aim of this study was to evaluate the cost-effectiveness of budesonide MMX versus commonly used corticosteroids, in the second-line treatment of active mild-to-moderate UC in the Netherlands. MATERIALS AND METHODS: An eight-state Markov model with an 8 week cycle length captured remission, four distinct therapy stages, hospitalization, possible colectomy and mortality. Remission probability for budesonide MMX was based on the CORE-II study. Population characteristics were derived from the Dutch Inflammatory Bowel Disease South Limburg cohort (n = 598) and included patients with proctitis (39%), left-sided (42%) and extensive disease (19%). Comparators (topical budesonide foam and enema, oral budesonide and prednisolone) were selected based on current Dutch clinical practice. Treatment effects were evaluated by network meta-analysis using a Bayesian framework. Cost-effectiveness analysis was performed over a 5 year time horizon from a societal perspective, with costs, health-state and adverse event utilities derived from published sources. Outcomes were weighted by disease extent distribution and corresponding comparators. RESULTS: Budesonide MMX was associated with comparable quality-adjusted life year (QALY) gain versus foam and oral formulations (+0.01 QALYs) in the total UC population, whilst being cost-saving (EUR 366 per patient). Probabilistic sensitivity analysis evaluated an 86.6% probability of budesonide MMX being dominant (cost-saving with QALY gain) versus these comparators. Exploratory analysis showed similar findings versus prednisolone. LIMITATIONS: Differing definitions of trial end-points and remission across trials meant indirect comparison was not ideal. However, in the absence of head-to-head clinical data, these comparisons are reasonable alternatives and currently offer the only comparison of second-line UC treatments. CONCLUSIONS: In the present analysis, budesonide MMX was shown to be cost-effective versus comparators in the total UC population, for the second-line treatment of active mild-to-moderate UC in the Netherlands.

Costs for stroke in Sweden 2009 and developments since 1997.

OBJECTIVES: The aim of this study was to estimate direct and indirect excess costs attributable to stroke in Sweden in 2009 and to compare these with similar estimates from 1997. METHODS: Data on first-ever stoke admissions in the first half of 2009 from the Swedish national stroke register (RS) were used for cost calculations and compared with results from 1997 also using RS data. A societal perspective was taken including the acute and follow-up phase, rehabilitation, stroke re-admissions, drugs, home- and residential care services for activities of daily life (ADL) support, and indirect costs for premature death and productivity losses (2009 prices). Survival was extrapolated to estimate the lifetime present value cost of stroke. RESULTS: The societal lifetime present value cost for stroke in 2009 was €68,800 per patient (ADL support: 59 percent; productivity losses: 21 percent). Women had higher costs than men in all age groups as a result from greater need for ADL support. Patients treated at a stroke unit indicated low incremental cost per life-year gained compared with those who had not. The total lifetime cost increased between 1997 and 2009. Hospitalization costs per patient were stable, while long-term costs for home- and residential care services increased. CONCLUSIONS: Changes in patient characteristics, longer expected survival, and possibly in the Swedish stroke care, have led to higher annual and lifetime costs per patient in 2009 compared with 1997. A comprehensive national stroke care performance register like RS may be suitable for health economic assessments.

Is testosterone replacement therapy in males with hypogonadism cost-effective? An analysis in Sweden.

INTRODUCTION: Testosterone replacement therapy (TRT) has been recommended for the treatment of primary and secondary hypogonadism. However, long-term implications of TRT have not been investigated extensively. AIM: The aim of this analysis was to evaluate health outcomes and costs associated with life-long TRT in patients suffering from Klinefelter syndrome and late-onset hypogonadism (LOH). METHODS: A Markov model was developed to assess cost-effectiveness of testosterone undecanoate (TU) depot injection treatment compared with no treatment. Health outcomes and associated costs were modeled in monthly cycles per patient individually along a lifetime horizon. Modeled health outcomes included development of type 2 diabetes, depression, cardiovascular and cerebrovascular complications, and fractures. Analysis was performed for the Swedish health-care setting from health-care payer's and societal perspective. One-way sensitivity analyses evaluated the robustness of results. MAIN OUTCOME MEASURES: The main outcome measures were quality-adjusted life-years (QALYs) and total cost in TU depot injection treatment and no treatment cohorts. In addition, outcomes were also expressed as incremental cost per QALY gained for TU depot injection therapy compared with no treatment (incremental cost-effectiveness ratio [ICER]). RESULTS: TU depot injection compared to no-treatment yielded a gain of 1.67 QALYs at an incremental cost of 28,176 EUR (37,192 USD) in the Klinefelter population. The ICER was 16,884 EUR (22,287 USD) per QALY gained. Outcomes in LOH population estimated benefits of TRT at 19,719 EUR (26,029 USD) per QALY gained. Results showed to be considerably robust when tested in sensitivity analyses. Variation of relative risk to develop type 2 diabetes had the highest impact on long-term outcomes in both patient groups. CONCLUSION: This analysis suggests that lifelong TU depot injection therapy of patients with hypogonadism is a cost-effective treatment in Sweden. Hence, it can support clinicians in decision making when considering appropriate treatment strategies for patients with testosterone deficiency.

Modelling the benefits of early diagnosis of pancreatic cancer using a biomarker signature.

Pancreatic cancer (PC) has a poor prognosis, with a 5-year survival of 3-4%. This is mainly due to late diagnosis because of diffuse symptoms, where 80-85% of the patients are inoperable. Consequently, early diagnosis would be of significant benefit, resulting in a potential 5-year survival of 30-40%. However, new technologies must be carefully evaluated concerning effectiveness and healthcare costs. We have developed a framework for modelling cost and health effects from early detection of PC, which for the first time allowed us to analyse its cost-effectiveness. A probabilistic cohort model for estimating costs and quality adjusted life-years (QALY) arising from screening for PC, compared to a "wait-and-see"-approach, was designed. The test accuracy, Swedish survival and costs by tumour stage, expected life gain from early detection and pretest probabilities in risk groups, were retrieved from previous investigations. In a cohort of newly diagnosed diabetic patient (incidence 0.71%) the incremental cost per QALY gained (ICER) was €13,500, which is considered cost-effective in Europe. Results were mainly sensitive to the incidence with the ICER ranging from €315 to €204,000 (familial PC 35% and general population 0.046%, respectively). This is the first study focusing on clinical implementation of advanced testing and what is required for novel technologies in cancer care to be cost-effective. The model clearly demonstrated the potential of multiplexed proteomic-testing of PC and also identified the requirements for test accuracy. Consequently, it can serve as a model for assessing the possibilities to introduce advanced test platforms also for other cancer indications.

Mapping health outcome measures from a stroke registry to EQ-5D weights.

PURPOSE: To map health outcome related variables from a national register, not part of any validated instrument, with EQ-5D weights among stroke patients. METHODS: We used two cross-sectional data sets including patient characteristics, outcome variables and EQ-5D weights from the national Swedish stroke register. Three regression techniques were used on the estimation set (n=272): ordinary least squares (OLS), Tobit, and censored least absolute deviation (CLAD). The regression coefficients for "dressing", "toileting", "mobility", "mood", "general health" and "proxy-responders" were applied to the validation set (n=272), and the performance was analysed with mean absolute error (MAE) and mean square error (MSE). RESULTS: The number of statistically significant coefficients varied by model, but all models generated consistent coefficients in terms of sign. Mean utility was underestimated in all models (least in OLS) and with lower variation (least in OLS) compared to the observed. The maximum attainable EQ-5D weight ranged from 0.90 (OLS) to 1.00 (Tobit and CLAD). Health states with utility weights <0.5 had greater errors than those with weights ≥ 0.5 (P<0.01). CONCLUSION: This study indicates that it is possible to map non-validated health outcome measures from a stroke register into preference-based utilities to study the development of stroke care over time, and to compare with other conditions in terms of utility.

Health economic evaluation of the Lund Integrated Medicines Management Model (LIMM) in elderly patients admitted to hospital.

OBJECTIVE: To evaluate the cost effectiveness of a multidisciplinary team including a pharmacist for systematic medication review and reconciliation from admission to discharge at hospital among elderly patients (the Lund Integrated Medicines Management (LIMM)) in order to reduce drug-related readmissions and outpatient visits. METHOD: Published data from the LIMM project group were used to design a probabilistic decision tree model for evaluating tools for (1) a systematic medication reconciliation and review process at initial hospital admission and during stay (admission part) and (2) a medication report for patients discharged from hospital to primary care (discharge part). The comparator was standard care. Inpatient, outpatient and staff time costs (Euros, 2009) were calculated during a 3-month period. Dis-utilities for hospital readmissions and outpatient visits due to medication errors were taken from the literature. RESULTS: The total cost for the LIMM model was €290 compared to €630 for standard care, in spite of a €39 intervention cost. The main cost offset arose from avoided drug-related readmissions in the Admission part (€262) whereas only €66 was offset in the Discharge part as a result of fewer outpatient visits and correction time. The reduced disutility was estimated to 0.005 quality-adjusted life-years (QALY), indicating that LIMM was a dominant alternative. The probability that the intervention would be cost-effective at a zero willingness to pay for a gained QALY compared to standard care was estimated to 98%. CONCLUSIONS: The LIMM medication reconciliation (at admission and discharge) and medication review was both cost-saving and generated greater utility compared to standard care, foremost owing to avoided drug-related hospital readmissions. When implementing such a review process with a multidisciplinary team, it may be important to consider a learning curve in order to capture the full advantage.

Societal value of stem cell therapy in stroke--a modeling study.

BACKGROUND: Stroke is one of the major causes of disability in the adult population and represents a heavy social and economic burden. Currently available therapeutic tools to support the recovery of impaired brain functions are quite limited. Animal studies have demonstrated that neuronal replacement and partial reconstruction of neural circuitry or modulation of the recovery process is possible with cell transplantation in the damaged adult brain. Stem cell therapy (SCT) may promote functional recovery also in stroke patients, thereby improving quality of life and reducing costs. Our aim was to estimate the potential societal value of SCT in stroke patients. METHODS: We created a decision-analytic model in Microsoft Excel 2010 to assess life-long costs and quality-adjusted life years (QALYs) of SCT versus standard care for stroke patients from a societal perspective. The model structure consisted of 7 health states in accordance with the modified Rankin Scale (mRS). We modeled for age (55, 65, and 75 years), functional status at discharge (mRS 2, 3, and 4), effectiveness of SCT (50 and 25% increase in the probability to improve 1 mRS grade), mode of stem cell administration, risk of recurrent stroke, complications of intervention, and use of immunosuppressive drugs. The difference between an assumed societal willingness to pay for a QALY gain in Sweden (110,400 USD) and the cost per QALY gain resulting from the model was interpreted as the value of SCT. RESULTS: Increased survival (1.06 life years) and improved functional status gave rise to an estimated gain of 1.34 QALY in a cohort of patients aged 55 with mRS 2 at hospital discharge. Although the SCT intervention increased costs by 64,014 USD (excluding cost of stem cells), the costs of intervention were offset mainly by decreased productivity losses. In total, the intervention saved 19,055 USD, i.e., at a price of 19,055 USD for stem cells, the SCT would be cost neutral. The societal value of SCT was 166,500 USD. CONCLUSIONS: The application of the health-economic model to Sweden shows that in younger stroke patients with moderate disability, the societal value of SCT given a zero price of stem cells is 166,500 USD. Although the transplantation itself is more costly, SCT offers potential for cost offset and cost savings in a long-term perspective by reducing the disability after stroke. The therapy appeared cost effective under a wide range of assumptions. Hence, further research and development in stem cells suitable for stroke therapy could potentially produce great value to society.

Costs and quality of life for psoriatic patients at different degrees of severity in southern Sweden - a cross-sectional study.

OBJECTIVES: Knowledge of the societal costs of psoriasis is limited. This study estimated the cost of care, psoriasis area and severity index (PASI), and quality of life in a defined patient population in Sweden. METHODS: A prevalence-based prospective recruitment of patients visiting two Swedish dermatology clinics between September and December 2009 was performed, collecting resource utilization for health care contacts, treatment, travelling, and productivity loss during 1 month. RESULTS: 164 patients were included. Mean total cost per patient-month was 994€. Main cost drivers were outpatient visits and light therapy (49%), biological drugs (20%) and productivity loss (22%). Total cost for topical treatment only (TT; 34%) was 369€, light therapy (LT; 24%) 1,274€, traditional systemic treatment (TST; 26%) 1,085€ and biological systemic treatment (BST; 16%) 1,709€ per patient-month. Main cost drivers were: outpatient visits (56%) in TT as well as for LT (78%), productivity loss (40%) in TST, and biological drugs (71%) among BST patients. There was no clear relationship between clinical (PASI) or subjective (DLQI) severity estimations and costs. CONCLUSIONS: The one-month cost-of-illness amounted to almost 1,000€/month, with great variations. Despite 1,190€ difference in drug cost for TST vs BST, total cost per month differed by 623€ because of offsets from improved productivity. A trend towards lower severity and reductions in outpatient and topical treatment costs was seen.

Medical resource utilization and cost of HIV-related care in the highly active antiretroviral therapy era at a University Clinic in Sweden.

INTRODUCTION: Little is known regarding healthcare costs for HIV/AIDS patients in the era of highly active antiretroviral therapy (HAART) and subgroups of patients according to the severity and progression of HIV infection in Sweden. The objective of this study is therefore to describe the direct medical resource use and cost of healthcare for HIV patients at a university clinic in Sweden. METHODS: A patient registry database for HIV treatment at the Department of Infectious Diseases, Sahlgrenska University Hospital, between 2000 and 2005 provided information on patient characteristics, antiretroviral drugs and dosages, tests and diagnostic procedures, outpatient visits and inpatient stays. The review used publicly available unit costs with a county council perspective, expressed in 2006 Euros. RESULTS: Two hundred and eighty-five patients with a mean age of 38 years in 2000 (64% men) were followed for 1368 patient-years. They had a mean (median) of 6.3 (0) inpatient days, 4.1 (3.7) physician visits, 4.2 (3.8) nurse visits, 2.6 (0.7) counsellor visits and 11.5 (7.7) tests and diagnostic procedures per patient-year. Only 12 deaths were recorded during the study period, and the proportion of treated patients with successful treatment (HIV-RNA < 50 copies/mL) increased from 74% to 92% during the period. The mean cost per patient-month amounted to €1069. The main cost driver was HIV drugs (51%), followed by inpatient stays (including hospitalizations for opportunistic infections; 22%), outpatient physician, nurse or therapist visits (19%) and diagnostics and tests (7%). All non-drug costs increased with a decreasing CD4 cell count. CONCLUSIONS: Overall, approximately half of the direct costs of HIV treatment were not related to antiretroviral treatment. The non-antiretroviral costs were inversely correlated with HIV-induced immune deficiency.

Cost-effectiveness of dasatinib versus high-dose imatinib in patients with Chronic Myeloid Leukemia (CML), resistant to standard dose imatinib--a Swedish model application.

BACKGROUND: Chronic myeloid leukemia (CML) is a progressive disease, consisting of three phases, chronic, accelerated and blast phase. Treatment with imatinib has demonstrated high response rates and improved prognosis for patients with CML. The emergence of imatinib resistance is a major concern. Dasatinib is an oral kinase inhibitor of BCR-ABL that has been developed for treating CML patients across all phases of disease who are resistant or intolerant to imatinib. OBJECTIVES: The objective of this study was to assess the cost-effectiveness of dasatinib versus high-dose imatinib treatment in chronic phase CML patients, resistant to lower doses of imatinib (< or =600 mg) in Sweden. METHODS AND DATA: A Markov simulation model was adapted to Swedish treatment practice. The model was populated with efficacy data from clinical trials, resource utilisation by expert opinion, published quality of life data and unit prices from official price lists. A life-long, societal perspective was used and sensitivity analyses were performed to test the robustness of the results. RESULTS: The results showed that chronic phase CML patients resistant to standard dose imatinib gain on average 0.67 life-years, or 0.62 quality adjusted life-years, when treated with dasatinib 140 mg/day compared with high-dose imatinib 800 mg/day. The incremental societal cost amounts to EUR 4 250 during the lifetime period, or EUR6880 per QALY gained. CONCLUSION: The results indicate that dasatinib is a cost-effective treatment among imatinib-resistant CML patients in Sweden in comparison to imatinib 800 mg/daily.

Infliximab paediatric Crohn's disease educational plan: a European, cross-sectional, multicentre evaluation.

BACKGROUND: The infliximab (Remicade; Schering-Plough, Kenilworth, NJ, USA) Risk Management Plan included the development, execution and tracking of an education programme directed towards prescribers of infliximab for patients with paediatric Crohn's disease (the Infliximab Paediatric Crohn's Disease Educational Plan). The programme content consisted of educational materials and communications aimed at educating prescribers on the risks associated with infliximab use. OBJECTIVE: To evaluate the effectiveness of the risk minimization plan. METHODS: Evaluation focused on two components: documentation of training of sponsors' personnel, and evaluation of awareness among prescribing physicians in European countries. Treating physicians, identified both independently of the sponsor (6 countries) and by the sponsor (24 countries), were surveyed using a structured questionnaire. RESULTS: Training of internal staff on the educational programme was performed and completed by every person designated an appropriate candidate for the programme in all European countries. The independent survey conducted in Germany, France, Italy, Spain, Sweden and the UK indicated that around 90% of the physicians were either paediatric gastroenterologists (57%) or paediatricians (33%). The great majority (96%) of the interviewed physicians were currently treating paediatric Crohn's disease, and most were currently using infliximab in their treatment of the disease. More specifically, 82% of gastroentrologists treating paediatric Crohn's disease were using infliximab; among paediatricians, the proportion was lower (42%). Ninety-six percent of paediatric gastroenterologists or gastroenterologists declared themselves aware of the benefits and risks of using infliximab for the treatment of paediatric Crohn's disease; in comparison, fewer paediatricians (82%) declared themselves aware of these benefits and risks. The majority initially gained awareness through congresses and workshops, and at the time of the survey only 25% declared that they were made aware of the benefits and risks through the educational programme. However, the majority of physicians reported that they had been approached by the sponsor's personnel in France (98%), Italy (100%), Spain (83%) and Sweden (70%). In Germany and the UK this proportion was 42%. Almost all physicians were aware of the need to perform tuberculosis (TB) and cancer screening prior to initiating therapy with infliximab, and to screen for hypersensitivity reactions before, during and after treatment. Ninety percent of the physicians were aware of the need to update immunization therapy before initiating therapy and, except in Italy (92% aware), around 50% of the physicians were aware of the need to provide patients with the infliximab Patient Alert Card. In the other European countries where the survey took place among physicians identified by the sponsor, 99% of paediatric gastroenterologists and 90% of gastroenterologists or paediatricians declared themselves aware of the benefits and risks of using infliximab for the treatment of paediatric Crohn's disease, and all of them were aware of the risk of TB and opportunistic infections and the need to perform TB and cancer screening prior to initiating therapy with infliximab. CONCLUSIONS: Overall, the results of the evaluation of the Infliximab Paediatric Crohn's Disease Educational Plan were satisfactory. The objective of education of internal personnel of the pharmaceutical companies distributing infliximab was completely achieved; over 90% of physicians reported being aware of the benefits and risks of infliximab for the treatment of paediatric Crohn's disease. Further work should be carried out across all countries to educate physicians on providing patients with the infliximab Patient Alert Card. In Germany and the UK in particular, where <50% of physicians reported having been approached by the sponsor's personnel, further work is needed to raise awareness of the educational programme.

Direct hospital resource utilization and costs of treating patients with multiple myeloma in Southwest Sweden: a 5-year retrospective analysis.

BACKGROUND: Approximately 570 patients are diagnosed with multiple myeloma (MM) in Sweden each year. Few studies have estimated the cost of treatment for these patients. OBJECTIVE: The purpose of this study was to retrospectively investigate the direct hospital resource utilization and costs associated with the treatment of patients with MM in southwest Sweden. METHODS: Patients aged > or =18 years who initiated first-line chemotherapy in the year 2001 at hospitals in southwestern Sweden were included in this retrospective chart review. Direct hospital-based resources and their corresponding costs (year-2006 euros) for each patient were calculated until the patient's death, or until December 31, 2005. Costs for outpatient and terminal stage care related to MM were not included. RESULTS: Ninety-four patients were included; 20 were still alive at study completion. Mean age at diagnosis was 76 years and patients were followed for a mean of 32.7 months; 55% were males and 74% had at least 1 comorbidity. First-, second-, and third-line treatment lasted a mean of 24.3, 5.8, and 2.6 months, and included 2.8, 2.6, and 3.1 chemotherapy drugs per patient, respectively. Of the 80 patients who received first-line chemotherapy, 72 were prescribed melphalan and 55 patients received a combination of melphalan and prednisone, as recommended by Swedish treatment guidelines. The mean total cost per patient was euro88,199, or euro2770 per patient-month. Therapy-induced and comorbidity-related events constituted 42% of total costs, as much as autologous stem-cell transplantation and inpatient care together. Chemotherapy, bisphosphonate, and blood cell-enhancement drugs each amounted to only 2% of total costs, but chemotherapy drugs increased from euro29/month in first-line therapy to euro453/month in third-line therapy. CONCLUSIONS: The cost of treating Swedish patients with MM varied greatly between individuals but, overall, chemotherapy drugs constituted only a minor part of the total monthly cost (2%), whereas costs for inpatient stays and therapy-induced adverse events or comorbidity-related events accounted for 35% and42%, respectively. There was no significant differencein monthly cost between treatment lines.

The effect of atrial fibrillation on stroke-related inpatient costs in Sweden: a 3-year analysis of registry incidence data from 2001.

OBJECTIVE: Atrial fibrillation (AF) is an important risk factor for stroke. It is prevalent in approximately one-fourth of stroke patients, and predictive of worse outcomes. This study aimed to analyze the effect of AF on stroke-related inpatient costs among first-ever stroke patients in Sweden. METHODS: Hospitalizations and death records were monitored for 3 years in 6611 first-ever stroke patients. For stroke as primary diagnosis, inpatient costs were calculated on the basis of length of stay at different wards. For stroke as secondary diagnosis, costs were based on diagnosis-related groups. RESULTS: Patients with AF (24% of all patients) were older (80 years vs. 73 years), had a higher prevalence of hypertension (49% vs. 41%) and/or diabetes (22% vs. 19%), higher risk of experiencing a restroke, and higher case fatality rate (43% vs. 25%) than patients without AF. The average cost per patient over 3 years was 9004 euros, with no statistically significant difference between AF and non-AF patients. However, a multiple regression analysis showed that the presence of AF resulted in higher costs after considering a number of background factors. Among patients surviving the index event, AF patients had on average 818 euros higher inpatient costs over 3 years than non-AF patients (10,192 euros vs. 9374 euros, P < 0.01). The difference in costs was highest for patients aged <65 years, with a difference of 4412 euros (P < 0.01). CONCLUSION: AF-related strokes are associated with higher 3-year inpatient costs than non-AF strokes when controlling for factors such as case fatality rates, other risk factors for stroke, and age.

Estimating the value of novel interventions for Parkinson's disease: an early decision-making model with application to dopamine cell replacement.

A long-term cost-effectiveness model for early decision-making and estimation of outcomes of novel therapeutic procedures for Parkinson's disease (PD) was developed based on the Hoehn and Yahr (HY) stages of PD. Results provided support for model validity. Model application to a future dopamine cell replacement therapy indicated long-term cost offsets and gains in quality-adjusted life years (QALYs) in early onset PD (HY III-IV), as compared to standard drug therapy. The maximum price premium (i.e., profit or compensation for developmental costs) for the intervention to remain cost-effective was estimated to euro12000-64000 according to cost-per-QALY thresholds of euro38000-70000 and depending on whether all or only medical direct costs are considered. The study illustrates the value of early health economic modeling and the described model shows promise as a means to estimate outcomes and aid decision-making regarding novel interventions for PD.

Cost of stroke in Sweden: an incidence estimate.

OBJECTIVES: To estimate the excess cost of stroke in Sweden and the potential costs that could be avoided by preventing first-ever strokes. METHODS: We adopted the incidence approach for estimating the present value of both direct and indirect costs. Data on mortality, stroke recurrence, and inpatient care were estimated from a national register of patient data with a four-year follow-up period. To estimate costs for social services, we used survey data on living conditions before stroke onset and at three and at twenty-four months. Costs for outpatient visits, rehabilitation, drugs, and production losses due to premature death and early retirement were estimated on the basis of both published and nonpublished sources. Lifetime costs were based on life tables adjusted for excess mortality of stroke, and costs in year 4 were extrapolated to subsequent years. RESULTS: The present value direct cost for an average stroke patient is SEK513,800 (USdollars 56,024 or Euro60,825). The corresponding indirect cost is SEK125,110 (USdollars13,640 or Euro14,810). Almost 45 percent of the direct costs were attributable to social services. Women had higher costs than men, and costs for survivors increased with age due to social services. CONCLUSIONS: With an incidence of 213 first-ever strokes per 100,000 individuals, the total excess direct and indirect cost of stroke would be SEK12.3 billion (approximately US$1.3 billion or Euro1.5 billion). Hence, there are large potential cost offsets both in the health-care sector and in the social service sector if the incidence of first-ever stroke could be reduced.

Health care systems in transition: Sweden

The Health Systems in Transition (HiT) series provide detailed descriptions of health systems in the countries of the WHO European Region as well as some additional OECD countries. An individual health system review (HiT) examines the specific approach to the organization, financing and delivery of health services in a particular country and the role of the main actors in the health system. It describes the institutional framework, process, content, and implementation of health and health care policies. HiTs also look at reforms in progress or under development and make an assessment of the health system based on stated objectives and outcomes with respect to various dimensions (health status, equity, quality, efficiency, accountability).