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Biomedical subjects

M J Nuijten

Publications and source records attributed to M J Nuijten.

15 recordsLinked to original sources
PubMed2001

Cost effectiveness of emedastine versus levocabastine in the treatment of allergic conjunctivitis in 7 European countries.

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.

Benzimidazoles↗
PubMed2001

A cost-cost study comparing etanercept with infliximab in rheumatoid arthritis.

OBJECTIVE: The objective of this study was to compare the total costs associated with the administration of two different tumour necrosis factor (TNF) strategies used in the treatment of rheumatoid arthritis (RA): etanercept, a soluble TNF receptor that can be administered at home by subcutaneous injection, versus infliximab, an antibody that requires an intravenous infusion in a hospital outpatient setting. DESIGN AND SETTING: The main analytical framework of the study was a cost-cost analysis comparing the total annual costs associated with the administration of etanercept and infliximab in adult RA patients. The perspective of the study was that of the Dutch society. An economic model was constructed to determine the costs of both treatments. The cost evaluation included direct medical costs, direct nonmedical costs and indirect costs. The base-case analysis compared monotherapy with etanercept versus a combination therapy with infliximab and methotrexate. Data for the economic model came from published literature, expert opinion and official price and tariff lists. All costs were in 1999 values. PATIENTS AND PARTICIPANTS: The analysis was performed for the adult RA population eligible for treatment with etanercept or infliximab in The Netherlands. MAIN OUTCOME MEASURES AND RESULTS: The analysis showed that the total annual drug costs per patient do not differ substantially between infliximab and etanercept, with costs of Netherland guilders (NLG)31,526 (12,610 US dollars) and NLG31,334 (12,534 US dollars), respectively. However, the other medical costs (i.e. excluding the costs of the two drugs themselves) are substantially higher for infliximab due to the additional costs associated with administration in an outpatient clinic and the use of methotrexate [NLG 12,621 (5048 US dollars) versus NLG269 (107 US dollars) for etanercept]. The impact of direct nonmedical costs (transportation) and indirect costs were negligible. Overall treatment with infliximab is more expensive than treatment with etanercept with total costs of NLG45 115 (18,046 US dollars) and NLG3I,621 (12,648 US dollars), respectively (42.7% increase). CONCLUSIONS: Based on the assumptions used in the model, we may conclude that the use of etanercept compares favourably with infliximab from a budgetary and health economic perspective: the total costs are substantially lower when the efficacy of etanercept is assumed to be at least equivalent to the efficacy of infliximab.

Adult↗
PubMed2000

Bridging decision analytic modelling with a cross-sectional study. Application to Parkinson's disease.

The ideal study design for demonstrating the possible health outcomes and costs associated with a new drug would be a naturalistic prospective study. However, it is not often feasible to derive the required information from scientifically sound prospective studies. In these cases, decision analytic models may provide some of the missing information. However, the use of a Delphi panel to gather data for these models is a major concern because of potential bias and data accuracy. Because reimbursement of pharmaceuticals is often based on economic data derived from modelling studies, it is obvious that potential bias due to the use of Delphi panels should be minimised. In this manuscript we present an alternative data source for modelling studies: the cross-sectional study. Data from such studies can be used to yield costs and utilities for Markov health states. The overall combined design may be considered a hybrid between a naturalistic prospective study and a modelling study by maximising the pros and minimising the cons of both types of design, including an increase of external validity. This hybrid design is based on bridging the probabilities derived from the literature and clinical trials with information on costs and utilities from a cross-sectional study. This design also has logistical advantages, namely a shorter required study duration compared with prospective naturalistic studies for chronic diseases. This combined design was illustrated using a Markov model for Parkinson's disease.

Cross-Sectional Studies↗
PubMed2000

Introduction to the pharmacoeconomics of herbal medicines.

This article explores the need to perform pharmacoeconomic evaluations of herbal medicines and assesses the extent to which this approach has been applied so far to these products. There seems to be no compelling need for pharmacoeconomic analyses of herbal over-the-counter medicines, but such analyses are certainly warranted for herbal prescription medicines that have a high level of reimbursement. Such preparations are used in Germany, in particular, where physicians prescribed ginkgo, hawthorn, St John's wort, horse-chestnut and saw palmetto to a value of more than DM50 million each in 1996. In our survey, only a single pharmacoeconomic study, of uncertain quality, was found on these 5 herbs, whereas several pharmacoeconomic reports on synthetic competitors were retrieved. The time has come to submit highly reimbursed herbal prescription medicines to the same rigorous pharmacoeconomic evaluations as their synthetic competitors. At present, such studies are particularly important for Germany, but in the future they may also become relevant for other countries, inside as well as outside Europe.

Costs and Cost Analysis↗
PubMed1999

Measuring sensitivity in pharmacoeconomic studies. Refining point sensitivity and range sensitivity by incorporating probability distributions.

OBJECTIVE: The aim of the present study is to describe a refinement of a previously presented method, based on the concept of point sensitivity, to deal with uncertainty in economic studies. DESIGN: The original method was refined by the incorporation of probability distributions which allow a more accurate assessment of the level of uncertainty in the model. In addition, a bootstrap method was used to create a probability distribution for a fixed input variable based on a limited number of data points. The original method was limited in that the sensitivity measurement was based on a uniform distribution of the variables and that the overall sensitivity measure was based on a subjectively chosen range which excludes the impact of values outside the range on the overall sensitivity. PATIENTS AND PARTICIPANTS: The concepts of the refined method were illustrated using a Markov model of depression. MAIN OUTCOME MEASURES AND RESULTS: The application of the refined method substantially changed the ranking of the most sensitive variables compared with the original method. The response rate became the most sensitive variable instead of the 'per diem' for hospitalisation. CONCLUSIONS: The refinement of the original method yields sensitivity outcomes, which greater reflect the real uncertainty in economic studies.

Economics, Pharmaceutical↗
PubMed1998

Applications of modelling studies.

There is increasing use of economic evaluation to support decision-makers in health services for allocation of scarce healthcare resources. However, information necessary for economic evaluations cannot always be derived from well-conducted prospective clinical studies, and decision-analytical models can be used to provide some of the missing information. A number of applications of decision-analytical models are discussed, including submissions to authorities for reimbursement purposes, pharmacoeconomic programme development, portfolio investment decisions, marketing and communication strategies, and applications in disease management.

Decision Making↗
PubMed1998

The selection of data sources for use in modelling studies.

Economic analysis has become increasingly important in healthcare in general, and particularly with respect to pharmaceuticals. Therefore, it is vital that the methods used in such evaluations are carefully scrutinised and refined. However, guidelines contain only a limited number of recommendations for the use of secondary data in modelling studies. In this manuscript, the selection of data sources in modelling studies will be addressed. The objectives of this manuscript are as follows: (i) to present a general strategy on how to determine the appropriateness of a data source for a model; and (ii) to present recommendations on a transparent reporting format for the selection of data sources.

Drug Costs↗
PubMed1998

Reporting format for economic evaluation. Part I: Application to the Dutch healthcare system.

This article presents the first version of the reporting format for economic valuation that was created in 1995 by a multidisciplinary taskforce. The members of this taskforce come from a broad spectrum of backgrounds within the healthcare field and participated in the exercise voluntarily. The format presented should be understood as the preferred Dutch structure for the reporting of any study on economic evaluation. In view of the many areas of contention that exist within the field, this format only gives normative directions in those areas in which consensus exists, as evidenced by the current published international guidelines. A regular review and adaptation of this format will be needed to reflect advances in the field.

Delivery of Health Care↗
PubMed1998

Reporting format for economic evaluation. Part II: Focus on modelling studies.

This article presents the first version of a reporting format for modelling studies which is based on a general reporting format by our taskforce, which was published in the previous issue of this journal. The use of decision-analytical models for economic evaluations is increasing because, in practice, it is not always possible to derive information from prospective studies. However, the acceptance of modelling studies is generally lower than prospective studies not only because of the use of secondary data, but also because the reports of modelling studies do not always have sufficient transparency. Hence, a standardised reporting format may improve the transparency and, consequently, the acceptance of modelling studies. This article presents an example of a reporting format for economic evaluation based on modelling studies, which may facilitate the development of future guidelines for modelling studies. The format consists of a number of headings, which are followed by a brief recommendation on the content. This format does not deal with methodology and data management, but especially addresses validation and quality assurance, which may increase the transparency of the report.

Decision Support Techniques↗
PubMed1997

Measuring sensitivity in pharmacoeconomic studies. An integration of point-sensitivity and range-sensitivity.

The level of uncertainty with regard to the outcomes of pharmacoeconomic studies cannot be completely covered by the statistical methods routinely employed to handle uncertainty in clinical research. Sensitivity analysis is the most common methodology to deal with the extra uncertainty associated with pharmacoeconomics, and has also been incorporated in recent guidelines on healthcare evaluation. However, the execution of a sensitivity analysis and the interpretation of its results have not yet been standardised, which may lead to subjectivity and consequently weaken the value of economic evaluations. This article presents a method of dealing more systematically with uncertainty and eliminating potential bias in sensitivity analysis, with regard to the measurement of sensitivity and the comparison of the degree of sensitivity between variables. An assessment of the disadvantages of using slope as a measure of sensitivity leads to 2 types of sensitivity analyses (point-sensitivity and range-sensitivity), which are integrated into one method for the measurement of sensitivity.

Economics, Pharmaceutical↗
PubMed1996

[Economic contribution of mofetil mycofenolate as preventive immunosuppressive treatment after renal transplantation from cadaver].

OBJECTIVES: The economic impact resulting from the clinical consequences of immunosuppressive strategy using mycophenolate mofetil in new renal transplant recipients was conducted considering the viewpoint of the health insurance system. METHODS: The analysis was based on the results of three controlled randomized double-blind clinical trials comparing mycophenolate mofetil with placebo or azathioprine in 1003 out of 1493 included patients respectively. Health care costs associated with each event were determined by 7 French experts in renal transplantation working in six different hospitals. Direct cumulative costs for each strategy were compared. RESULTS: The studies demonstrated a difference in the incidence of acute rejection and treatment failures whatever the cause. The three trials showed that, compared with current strategies, use of mycophynolate mofetil in the immunosuppression protocol generated a 19 to 38% cost reduction during the 6 months after transplantation. Cost reduction resulted from lower incidence of acute rejection and the subsequent nephrectomics and dialysis sessions. The sensitivity analysis on the most important cost factors-cost of hospitalization per day and number of hospitalization days-confirmed strength of the results. CONCLUSION: Use of mycophenolate mofetil in the immunosuppressive prophylaxis protocol after renal transplantation allows a reduction in the direct costs during the 6 months following transplantation.

Adult↗
PubMed1995

A Markov process analysis comparing the cost effectiveness of maintenance therapy with citalopram versus standard therapy in major depression.

The objective of this study was to demonstrate the cost effectiveness of long term maintenance treatment with citalopram versus standard therapy (defined as short term antidepressant treatment) in patients with major depression in Germany. We chose doxepin, amitriptyline and trimipramine as standard therapy because these drugs are the leading antidepressants in that country. A Markov process analysis was used to model health status and economic outcomes as they accrued over a 1-year follow-up period. The main outcome measures were time without depression, direct costs and indirect costs (work days lost). All costs were in 1993 Deutsche marks. The clinical data were obtained from the published literature and US clinical practice guidelines; the associated unit costs of the medical resources used were derived from official German tariff lists. The results show that, compared with standard therapy, long-term maintenance treatment with citalopram is associated with a mean increase in time without depression of 7.9% (8.2 vs 7.6 months). The total costs of maintenance treatment with citalopram were substantially lower than with standard therapy (DM7985 vs DM11,948 per patient per year. In addition, both the direct and indirect costs of maintenance treatment with citalopram (DM3764 vs DM4221 per patient, respectively) were lower than with standard therapy (DM4577 vs DM7371 per patient, respectively). In conclusion, the study demonstrates that one year's maintenance treatment with citalopram is both more effective and less costly than standard therapy in the treatment of patients with major depression.

Amitriptyline↗
PubMedDate not supplied

Cost-effectiveness analysis of entacapone in Parkinson's disease: a Markov process analysis.

OBJECTIVE: The objective of this study was to examine the cost-effectiveness of a complementary treatment with entacapone versus usual care only in patients with Parkinson's disease. METHODS: The setting for this study was the Netherlands. A Markov process model was constructed to model the average quality-adjusted life years (QALYs) and the costs of both treatments. The model examined a period of 5 years in order to capture the influence of symptom improvement and disease progression. Data for the construction of the model were derived from published literature, including large, multicenter, randomized clinical trials in patients with end-of-dose motor fluctuations. Costs were obtained from published sources. RESULTS: The results of the baseline analysis showed that the use of entacapone as complementary therapy in Parkinson's disease slightly decreased the total average discounted costs from NLG 111,317 to NLG 110,038, while effectiveness increased from 2.42 to 2.56 QALYs (a 6% increase). In addition, entacapone substantially increased time without severe fluctuations by 0.63 years. Sensitivity analyses confirmed the robustness of these findings. CONCLUSION: The study shows that entacapone is a cost-effective treatment in patients with Parkinson's disease: entacapone yields higher effectiveness in terms of both effectiveness measures (time without severe fluctuations and QALYs), while costs remain quite similar to those for usual care. The additional drug costs for entacapone are offset by reductions in other costs.

Aged↗
PubMedDate not supplied

Assessment of clinical guidelines for continuation treatment in major depression.

OBJECTIVE: The primary objective of this study was to assess the appropriateness of the existing Dutch clinical guidelines for the treatment of depression from a health-economic perspective. The existing guidelines recommend continuation treatment for a period up to 9 months. METHODS: The assessment was based on a Markov model using decision-analytic techniques. For this analysis we defined six mutually exclusive states defined by the existence of depression and type of treatment. The outcomes for the model were defined as: time without depression (TWD), quality-adjusted life years (QALYs), direct medical costs, and cost of lost productivity. The primary perspective of the study was that of the third-party payer, while the secondary perspective was that of the society in 1999. The probabilities of clinical events and therapeutic choices as well as the utilities were based on published literature. The medical resource use related to each state was abstracted from published literature and expert opinion. The associated 1999 unit costs of the used medical resources were derived from official Dutch tariff lists of allowable reimbursements. Indirect costs in this model were based on lost productivity only. RESULTS: The results of the primary analysis showed that the use of the guidelines is not cost-effective. Continuation treatment for a period of 9 months increases the total direct medical costs (NLG 1276 vs. NLG 474), decreases the costs resulting from lost productivity (NLG 304 vs. NLG 909), increases total costs (NLG 1580 vs. NLG 1383) and increases TWD (96.9% vs. 86.4%). However, continuation treatment does not change the utility outcomes (0.60 vs. 0.61 QALYs) for both treatment strategies. Hence continuation treatment is not cost-effective from either a third-party payer perspective or a societal perspective. A scenario analysis showed that an extension of the continuation treatment to maintenance treatment might result in a favorable cost-effectiveness outcome of the treatment guideline. CONCLUSION: In conclusion, based on the assumptions used in the model, the current Dutch treatment guidelines for depression are only appropriate from a health-economic perspective if continuation treatment is extended to maintenance treatment.

Antidepressive Agents, Tricyclic↗