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Search Results: 1 - 10 of 144469 matches for " F. Simoens "
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Sorafenib for advanced renal cell carcinoma in real-life practice: a literature review  [PDF]
Steven Simoens
Health (Health) , 2011, DOI: 10.4236/health.2011.32016
Abstract: Sorafenib is a new treatment indicated for patients with advanced renal cell carcinoma who have failed prior cytokine-based therapy or are considered unsuitable for such therapy. Although treatment with sorafenib under ‘ideal trial conditions’ has been extensively studied, registration and reimbursement authorities are also interested in the behavior of sorafenib in real-life practice. This study aims to conduct a literature review of the dosage and treatment duration; safety, tolerability and effectiveness; costs and cost-effectiveness of sorafenib in routine clinical care. Studies were identified by searching PubMed, Embase, Centre for Reviews and Dissemination databases, Cochrane Database of Systematic Reviews, and EconLit up to November 2010. The literature search included articles published in peer-reviewed journals, congress abstracts, and internal studies of Bayer Schering Pharma. Eight studies were included. An open-label study observed stable disease for at least eight weeks in 80% of patients. The most common drug-related adverse events were hand-foot skin reaction, rash, hypertension, and fatigue. Although treatment with sorafenib led to fewer dose reductions, it was also associated with a shorter treatment duration, less time to pro-gression and a shorter survival time as compared to sunitinib. Monthly health care costs were lower with sorafenib as compared to sunitinib. A post-marketing surveillance study showed that patients rated the tolerability and effectiveness of sorafenib as very good, good or sufficient. In conclusion, the current evidence is too limited to derive conclusions and existing studies suffer from methodological shortcomings.
Budget impact of a 10% ready-to-use intravenous immunoglobulin in the treatment of primary immunodeficiency in Belgium  [PDF]
Steven Simoens
Health (Health) , 2009, DOI: 10.4236/health.2009.13030
Abstract: The aim of this study is to compute the budget impact of adopting Kiovig, a new ready-to-use 10% liquid immunoglobulin preparation, as a treatment for primary immunodeficiency from the perspective of the Belgian health care payer. The analysis compared the “world with Kiovig” to the “world without Kiovig” and calculated how a change in the mix of immunoglobulins used to treat primary immunodeficiency would impact drug spending during 2010-2014. Data on the number of patients, immunoglobulin market shares and drug unit costs were derived from the IMS Health hospital disease database and from Belgian sources. The number of Belgian patients suffering from primary immunodefi-ciency is expected to increase from 2,378 pa-tients in 2010 to 2,447 patients in 2014. The budget impact of adopting Kiovig is likely to be modest, raising the immunoglobulin drug bud- get for this patient population by 0.4%-1.3% per year. The budgetary increase originated from the higher price of Kiovig as compared with other products, although the impact of Kiovig was limited by its anticipated slow market penetra-tion. There is a need for more and better data on the Belgian immunoglobulin market.
Pharmacotherapeutic aspects of treating knee osteoarthritis with glucosamine sulfate  [PDF]
Steven Simoens, Gert Laekeman
Health (Health) , 2010, DOI: 10.4236/health.2010.27107
Abstract: Glucosamine sulfate is a natural constituent of cartilage and is used in the treatment of knee osteoarthritis. The aim of this study is to provide a short but comprehensive pharmacotherapeutic update on treating knee osteoarthritis with glucosamine sulfate. A literature search was conducted of PubMed, Centre for Reviews and Dissemination databases, Cochrane Reviews and EconLit up to January 2010. The literature review indicated that the mechanism of action of glucosamine sulfate is based on hypothesis, but its treatment effects in knee osteoarthritis are symptomatic. With steady-state peak concentrations at the 1,500 mg dosage in the range of 10 µM, it is estimated that only 2% of glucosamine is incorporated in the cartilage. A once-daily dosage of 1,500 mg of glucosamine sulfate is licensed for the treatment of symptomatic osteoarthritis and has been shown to reduce pain, improve function and exhibit similar safety to placebo. Glucosamine sulfate is likely to be a cost-effective treatment of knee osteoarthritis. In conclusion, a once-daily dosage of 1,500 mg of glucosamine sulfate is likely to be a safe, effective and cost-effective treatment of knee osteoarthritis as compared to placebo.
Factors Affecting the Cost Effectiveness of Antibiotics
Steven Simoens
Chemotherapy Research and Practice , 2011, DOI: 10.1155/2011/249867
Abstract: In an era of spiraling health care costs and limited resources, policy makers and health care payers are concerned about the cost effectiveness of antibiotics. The aim of this study is to draw on published economic evaluations with a view to identify and illustrate the factors affecting the cost effectiveness of antibiotic treatment of bacterial infections. The findings indicate that the cost effectiveness of antibiotics is influenced by factors relating to the characteristics and the use of antibiotics (i.e., diagnosis, comparative costs and comparative effectiveness, resistance, patient compliance with treatment, and treatment failure) and by external factors (i.e., funding source, clinical pharmacy interventions, and guideline implementation interventions). Physicians need to take into account these factors when prescribing an antibiotic and assess whether a specific antibiotic treatment adds sufficient value to justify its costs.
Health Economic Assessment: A Methodological Primer
Steven Simoens
International Journal of Environmental Research and Public Health , 2009, DOI: 10.3390/ijerph6122950
Abstract: This review article aims to provide an introduction to the methodology of health economic assessment of a health technology. Attention is paid to defining the fundamental concepts and terms that are relevant to health economic assessments. The article describes the methodology underlying a cost study (identification, measurement and valuation of resource use, calculation of costs), an economic evaluation (type of economic evaluation, the cost-effectiveness plane, trial- and model-based economic evaluation, discounting, sensitivity analysis, incremental analysis), and a budget impact analysis. Key references are provided for those readers who wish a more advanced understanding of health economic assessments.
Health Economic Assessment: Cost-Effectiveness Thresholds and Other Decision Criteria
Steven Simoens
International Journal of Environmental Research and Public Health , 2010, DOI: 10.3390/ijerph7041835
Abstract: An article published in this Journal argued that New Zealand does not apply a cost-effectiveness threshold because medicines are funded within a fixed budget and because cost-effectiveness is only one of nine criteria that inform decisions. This Comment has explained that, from a theoretical perspective, the cost-effectiveness threshold model is not inconsistent with these two arguments. The observed annual variation in incremental cost-effectiveness ratios in New Zealand may originate from yearly differences in new medicines that request reimbursement and in the budget size, and from the fact that decision makers take into account other decision criteria in addition to cost-effectiveness.
Health Economics of Antibiotics
Steven Simoens
Pharmaceuticals , 2010, DOI: 10.3390/ph3051348
Abstract: Antibiotics have made a significant contribution to improving patient health, but policy makers and health care payers are concerned about the costs of antibiotics in addition to their effectiveness. This paper aims to assess the value of antibiotics by examining incremental cost-utility ratios of antibiotics. Evidence was derived from cost-utility analyses of antibiotics included in the Tufts-New England Center Cost-Effectiveness Analysis Registry through September 2009. The analysis included 85 incremental cost-utility ratios from 23 cost-utility analyses. The findings showed that 38.8% of incremental cost-utility ratios related to dominant antibiotics ( i.e., more effective and less costly than the comparator); 45.9% referred to antibiotics that improved effectiveness, but also increased costs; and 15.3% related to dominated antibiotics ( i.e., less effective and more costly than the comparator). The median ratio was 748 € per quality-adjusted life year. Using threshold values of 20,000 € per quality-adjusted life year and 50,000 € per quality-adjusted life year, the probability that an antibiotic provides value for money was 64% and 67%, respectively. The current evidence base suggests that the majority of antibiotics provide value for money and that antibiotics can aid decision makers to attain further population health improvements, whilst containing pharmaceutical expenditures.
Pricing and reimbursement of orphan drugs: the need for more transparency
Steven Simoens
Orphanet Journal of Rare Diseases , 2011, DOI: 10.1186/1750-1172-6-42
Abstract: Although orphan drug pricing follows the same economic logic as drug pricing in general, the monopolistic power of orphan drugs results in high prices: a) orphan drugs benefit from a period of marketing exclusivity; b) few alternative health technologies are available; c) third-party payers and patients have limited negotiating power; d) manufacturers attempt to maximise orphan drug prices within the constraints of domestic pricing and reimbursement policies; and e) substantial R&D costs need to be recouped from a small number of patients.Although these conditions apply to some orphan drugs, they do not apply to all orphan drugs. Indeed, the small number of patients treated with an orphan drug and the limited economic viability of orphan drugs can be questioned in a number of cases. Additionally, manufacturers have an incentive to game the system by artificially creating monopolistic market conditions.Given their high price for an often modest effectiveness, orphan drugs are unlikely to provide value for money. However, additional criteria are used to inform reimbursement decisions in some countries. These criteria may include: the seriousness of the disease; the availability of other therapies to treat the disease; and the cost to the patient if the medicine is not reimbursed. Therefore, the maximum cost per unit of outcome that a health care payer is willing to pay for a drug could be set higher for orphan drugs to which society attaches a high social value.There is a need for a transparent and evidence-based approach towards orphan drug pricing and reimbursement. Such an approach should be targeted at demonstrating the relative effectiveness, cost-effectiveness and economic viability of orphan drugs with a view to informing pricing and reimbursement decisions.A rare disease is a disease with a very low prevalence. In the European Union (EU), rare diseases are defined as life-threatening or chronically debilitating diseases with a prevalence of 5 out of 10,000 ind
The Portuguese generic medicines market: a policy analysis
Simoens,Steven;
Pharmacy Practice (Internet) , 2009, DOI: 10.4321/S1886-36552009000200002
Abstract: objectives: this study aims to conduct a descriptive analysis of the policy environment surrounding the generic medicines retail market in portugal. the policy analysis focuses on supply-side measures (i.e. market access, pricing, reference-pricing and reimbursement of generic medicines) and demand-side measures (i.e. incentives for physicians to prescribe, for pharmacists to dispense and for patients to use generic medicines). methods: the policy analysis was based on an international literature review. also, a simulation exercise was carried out to compute potential savings from substituting generic for originator medicines in portugal using ims health data. results: portugal has developed a successful generic medicines market by increasing reimbursement of generic medicines (until october 2005), by introducing a reference-pricing system, by encouraging physicians to prescribe by international non-proprietary name (inn), and by allowing generic substitution by pharmacists. however, the development of the generic medicines market has been hindered by the existence of copies, pricing regulation, certain features of the reference-pricing system, weak incentives for physicians to prescribe generic medicines and a financial disincentive for pharmacists to dispense generic medicines. increased generic substitution would be expected to reduce public expenditure on originator medicines by 45%. conclusions: the development of the portuguese generic medicines market has mainly been fuelled by supply-side measures. to support the further expansion of the market, policy makers need to strengthen demand-side measures inciting physicians to prescribe, pharmacists to dispense and patients to use generic medicines.
Editorial - Pharmacoeconomics & Health Economics: Opening Access to Science and Practice
Steven Simoens
The Open Pharmacoeconomics & Health Economics Journal , 2009, DOI: 10.2174/1876824500901010001]
Abstract: 1-2
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