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Objective: A combination of vinorelbine and cisplatin is a standard treatment in non-small-cell lung cancer; oral vinorelbine is registered in 45 countries. Pemetrexed and cisplatin are recommended in front-line chemotherapy of non-squamous non-small-cell lung cancer (NS-NSCLC). The objective of this study was to conduct a cost minimization analysis from the perspective of the national health service (NHS) in each of 12 European countries, based on a randomized phase II study in NS-NSCLC (NAVoTRIAL01), with 100 oral vinorelbine plus cisplatin patients (arm A) and 51 pemetrexed plus cisplatin patients (arm B).Research Design and Methods: Country-specific costs and DRG codes considered included those relating to anticancer drugs, administration settings (out-patient/in-patient/at home), serious adverse events (defined as involving hospitalization and considered due to anticancer drugs) and concomitant medications. Relevant costs were calculated based on country-specific reimbursement procedures and official tariffs.Main Outcome Measures: Cost and savings per patient.Results: Using the NHS perspective, savings per patient treated with oral vinorelbine ranged from €1317 (Denmark) to €35,001 (Germany). Expressed as percentages, savings per patient treated with oral vinorelbine compared with pemetrexed ranged between 5% (France) and 83% (Czech Republic). Pooled average costs for each treatment arm across the 12 countries resulted in cost savings for payers of €12,871, favoring oral vinorelbine plus cisplatin.Conclusions: Given the reported efficacy with both regimens, this pan-European economic analysis provides compelling evidence supporting oral vinorelbine use over pemetrexed for the treatment of NS-NSCLC. Oral vinorelbine provides similar efficacy and an easily manageable safety profile at lower overall cost per patient treated, combined with an easier/more convenient mode of administration. Sensitivity analysis across varied scenarios demonstrated the robustness of the results. The principle weakness of our study was its reliance upon a single small scale study to provide efficacy data, since this is the only study conducted in this specific population of patients. Further large scale trials are needed to confirm these results. [ABSTRACT FROM AUTHOR]

Objective. To characterize the impact of etanercept (ETN) in AS on cost, work productivity and quality of life (QoL).Methods. A Phase 4, open-label, multi-centre (UK, Scandinavia) extension study in AS. Eligible subjects (n = 84) were treated for 36–52 weeks with ETN 50 mg s.c. once weekly. Analysis included direct costs (transformed out-patient and in-patient care elements), indirect costs (sick leave and lost working days), efficacy and QoL.Results. Annualized direct and indirect costs decreased (55.5%, P ≤ 0.008) during ETN treatment, as did out-patient and in-patient episodes (physiotherapist/physician visits, P = 0.012). Work productivity and QoL increased.Conclusion. ETN therapy significantly reduces direct and indirect health-care costs and increases work ability and QoL in AS.Trial Registration. EUDRACT, https://eudract.ema.europa.eu/, 2006-001061-42. [ABSTRACT FROM PUBLISHER]

Bipolar disorder is a chronic affective disorder that causes significant economic burden to patients, families and society. It has a lifetime prevalence of approximately 1.3%. Bipolar disorder is characterised by recurrent mania or hypomania and depressive episodes that cause impairments in functioning and health-related quality of life. Patients require acute and maintenance therapy delivered via inpatient and outpatient treatment. Patients with bipolar disorder often have contact with the social welfare and legal systems; bipolar disorder impairs occupational functioning and may lead to premature mortality through suicide. This review examines the symptomatology of bipolar disorder and identifies those features that make it difficult and costly to treat. Methods for assessing direct and indirect costs are reviewed. We report on comprehensive cost studies as well as administrative claims data and program evaluations. The majority of data is drawn from studies conducted in the US; however, we discuss European studies when appropriate. Only two comprehensive cost-of-illness studies on bipolar disorder, one prevalence-based and one incidence-based, have been reported. There are, however, several comprehensive cost-of-illness studies measuring economic burden of affective disorders including bipolar disorder. Estimates of total costs of affective disorders in the US range from $US30.4–43.7 billion (1990 values). In the prevalence-based cost-of-illness study on bipolar disorder, total annual costs were estimated at $US45.2 billion (1991 values). In the incidence-based study, lifetime costs were estimated at $US24 billion. Although there have been recent advances in pharmacotherapy and outpatient therapy, hospitalisation still accounts for a substantial portion of the direct costs. A variety of outpatient services are increasingly important for the care of patients with bipolar disorder and costs in this area continue to grow. Indirect costs due to morbidity and premature mortality comprise a large portion of the cost of illness. Lost workdays or inability to work due to the disease cause high morbidity costs. Intangible costs such as family burden and impaired health-related quality of life are common, although it has proved difficult to attach monetary values to these costs. [ABSTRACT FROM AUTHOR]

Objective: The primary objective of this study was to estimate the cost effectiveness of treating diabetic foot ulcers with becaplermin (Regranex) plus good wound care (GWC) compared with GWC alone in a variety of European healthcare settings. A secondary objective was to analyse the effect of different treatment practices on the economics of caring for diabetic foot ulcers.Design and Setting: Markov-based simulation study from the perspective of a national health system.Methods: A 12-month Markov computer simulation model was used to assess the cost effectiveness in 4 European countries of treating diabetic foot ulcers with becaplermin plus GWC versus GWC alone. Transition probabilities were taken from a prospective study of 183 patients and becaplermin efficacy was based on 20-week healing rates in a recent meta-analysis of clinical trials involving 449 patients. Country-specific treatment cost data were collected in collaboration with local economic consultations and combined with the disease model to estimate the incremental cost per ulcer-free month gained. The model was then run using hypothetical low- and high-intensity resource usage profiles to investigate the economics of caring for diabetic foot ulcers.Results: Over the course of 1 year, individuals who received becaplermin plus GWC were, on average, predicted to spend an additional 0.81 months (24% longer) free of ulcers and to experience a 9% lower risk of undergoing a lower extremity amputation than individuals who received GWC alone. Consequently, becaplermin plus GWC was estimated to be net cost saving in Sweden, Switzerland and the UK. In France, the addition of becaplermin was estimated to add $US19 (1999 values) for each additional ulcer-free month gained. There were substantial intercountry differences in treatment practices and the costs of treating diabetic foot ulcers.Conclusions: Becaplermin may be a cost-effective treatment for neuropathic diabetic foot ulcers in a wide range of European settings. In Sweden, Switzerland and the UK, becaplermin may even be cost saving. Substantial intercountry differences in resource patterns appear, at least partly, to be the logical outcome of differences in unit costs. [ABSTRACT FROM AUTHOR]

Objective: To assess the cost effectiveness of emedastine, a new antihistamine, versus levocabastine in the treatment of acute allergic conjunctivitis (AAC) in Belgium, France, Germany, The Netherlands, Norway, Portugal and Sweden.Design and Setting: Randomised double-blind multicountry clinical trial followed by economic modelling from the treatment provider perspective.Patients: A total of 221 patients (109 emedastine, 112 levocabastine) with AAC were included.Methods: The clinical trial compared the efficacy and safety of emedastine 0.05% and levocabastine 0.05%, both twice daily, for 42 days, using ocular redness, itching, days without symptoms and clinical failure as outcome measures. The cost of first-line treatment failure, including visits, drugs and laboratory examinations, was established in each country from a panel of ophthalmologists and general practitioners. Full sensitivity analyses were conducted.Results: From day 7 to 42, patients treated with emedastine had less itching (p < 0.001) and less redness (p < 0.001). The failure rate was 10% less (p < 0.02) with emedastine and patients treated with emedastine had an incremental 8.5 days (p < 0.01) without symptoms. Emedastine and levocabastine were equally well tolerated. In all European countries, the cost of failure was lower with emedastine. Emedastine was found to be economically dominant relative to levocabastine, i.e. more effective and less expensive, in Belgium, Germany, Portugal and Sweden; in France, The Netherlands and Norway the incremental cost was low (less than 1 euro per additional symptom-free day).Conclusion: Through a model based on a randomised clinical trial and cost estimates of treatment failure derived from practitioner interviews, emedastine is a cost-effective treatment of AAC. [ABSTRACT FROM AUTHOR]

A short term (6-month) cost-effectiveness model has been developed to simulate current medical practice and disease progression in patients with type 2 (non-insulin-dependent) diabetes mellitus uncontrolled by diet and exercise. The model is based on decision-analytical techniques and includes probabilities of switching between treatments, the reason for the switch and the most common switch options. Effectiveness and economic measures are the 2 main outcomes. In order to assess effectiveness, we use symptom-free days with acceptable control (SFDACs), which represent each day of treatment without adverse events or symptoms, and with acceptable control of glucose and lipids. For the economic evaluation, only incremental costs incurred directly by a health insurance system are considered. This model should prove useful in the evaluation of new oral antidiabetic agents, since the short term aim of antidiabetic therapy is to provide adequate control in the absence of adverse effects and symptoms (a prerequisite for successful long term treatment). Furthermore, short term analysis provides data for comparing initial investment in drug therapy with potential savings over a longer treatment period. [ABSTRACT FROM AUTHOR]

To address the economic issues posed by the introduction of 5-hydroxytryptamine3 receptor antagonist (5-HT3 RA), we performed a cost-effectiveness analysis based on clinical trial data published in the recent literature. Cost calculations include initial treatment and a second-line salvage treatment. The average cost and incremental cost were established. Incremental cost corresponds to the extra cost involved in achieving total control of emesis in 1% extra patients. If 5-HT3 RA is not part of the initial treatment, salvage treatment with ondansetron is not cost-effective. Moreover, starting with the combination of ondansetron plus dexamethasone saves more money than starting with ondansetron alone. However, if the difference in emesis control is only minimal, treatment with the 5-HT3 RA remains more expensive. [ABSTRACT FROM AUTHOR]

The article comments on the study which attempts to derive and compare non-medical costs of visual impairment in Europe. There was an extensive review of cost estimates and cost-of-illness calculations that put the annual cost of an elderly person with visual impairment at 4,980 pounds. A further possible difference requiring exploration is sponsorship because it independently produced estimates of cost effectiveness ratios which apparently tend to be higher than those sponsored by the manufacturer, when assessing the same product.