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Evaluation medico-economique de milnacipran dans la prevention des episodes depressifs [Clinico-economic assessment of milnacipran in the prevention of depressive episodes] |
Lafuma A, Dardennes R, Fagnani F, Pribil C, Bisserbe J C, Berdeaux G |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology The use of milnacipran, 50 mg twice daily, for the prevention of recurrent depressive episodes. This treatment was compared with no preventive treatment. In both strategies, the patient also had follow-up visits with a psychiatrist.
Economic study type Cost-effectiveness analysis.
Study population The study population comprised patients who had already suffered from a depressive episode, and who had recovered from this episode within a 6-month period whilst being treated with milnacipran.
Setting The setting was primary and secondary care. The economic study was carried out in France.
Dates to which data relate The effectiveness estimates were obtained from studies published between 1970 and 1998. The resource use data were obtained from studies published between 1993 and 1998. The price year was 1998.
Source of effectiveness data The effectiveness data were derived from a review and synthesis of completed studies.
Modelling A Markov state transition model was used to model the costs and the benefits of the two strategies.
Outcomes assessed in the review The outcomes assessed in the review were:
the incidence of depressive episodes,
the suicide rates for depressed patients,
the suicide rates for non-depressed patients, and
the rate of treatment discontinuation.
Study designs and other criteria for inclusion in the review The study designs and other criteria for inclusion in the review were not reported in detail. However, the main clinical study used for the analysis was a double-blind randomised clinical trial.
Sources searched to identify primary studies Criteria used to ensure the validity of primary studies Methods used to judge relevance and validity, and for extracting data Number of primary studies included At least 13 primary studies were included in the review.
Methods of combining primary studies The results of the individual primary studies were combined in the narrative.
Investigation of differences between primary studies Results of the review The incidence of depressive episodes and the rate of treatment discontinuation were not reported in the study.
The annual suicide rate for depressed patients was 0.5%.
The annual suicide rate for non-depressed patients in remission was 0.02%.
Measure of benefits used in the economic analysis The outcome measure used in the economic analysis was the number of relapses prevented with milnacipran, compared with no treatment.
Direct costs Discounting was not carried out as the time horizon was one year. The quantities and the costs were reported separately. The costs were for the preventive drug regimen (milnacipran), the follow-up visits with a psychiatrist during remission, hospitalisation (rate and duration) during a depressive episode, and the drug regimen during a depressive episode. The quantity/cost boundary adopted was that of the national health insurance system. The quantities were estimated from published data, and were validated in some cases by expert opinion. The cost estimates were derived using the Markov model. The price year was 1998.
Statistical analysis of costs No statistical analysis of the costs was reported.
Indirect Costs Discounting was not carried out as the time horizon was one year. The quantities and the costs were not reported separately. The indirect costs included the costs due to absence from salaried work. The average number of days missed from work was obtained from a published study (data not reported). The cost to the national health system of compensating patients for days on which they were unable to work was obtained from official publications. The indirect costs were adjusted to account for the proportion of patients not employed in salaried work. The price year appears to have been 1996.
Sensitivity analysis One-way sensitivity analyses were carried out on the rate of hospitalisation due to the recurrence of a depressive episode (2.4, 12 and 25.2%). A subgroup analysis was conducted on patients who started the preventive treatment with an HDRS score less than 5, indicating fewer residual symptoms of depression.
Estimated benefits used in the economic analysis The rate of recurrence of depression was 23.42% with milnacipran and 30.7% with placebo.
The rate of recurrence prevented with milnacipran was, therefore, 7.28%.
The length of follow-up was one year.
It was not reported whether the side-effects were included in the analysis.
Cost results The total annual direct and indirect costs per patient, assuming a hospitalisation rate of 12% when a depressive episode occurs, were 6,824 Ffr with no preventive treatment and 7,947 Ffr with milnacipran. The difference in costs was 1,123 Ffr. The duration of follow up was one year.
Synthesis of costs and benefits The costs and the benefits were not combined. A subgroup analysis was performed for patients with fewer depressive symptoms at the beginning of the preventive treatment. This found milnacipran to be even more effective, and for the strategy to be cost-saving at a hospitalisation rate of 12% for depressive episodes. In the main analysis, the results were sensitive to the rate of hospitalisation.
Authors' conclusions Preventive treatment with milnacipran appears to be clinically and economically justified for patients at high risk of hospitalisation when having a recurrence, and even more so for patients with fewer depressive symptoms at the initiation of the preventive treatment.
CRD COMMENTARY - Selection of comparators The selection of the comparators was justified as no preventive treatment was the standard practice for patients with depression. You should decide if this intervention is widely used in your own setting.
Validity of estimate of measure of effectiveness In general, the source of the estimates of effectiveness was well reported. The estimates were derived credibly from the primary studies and were combined using the narrative method. However, it was not stated whether a systematic review of the literature had been carried out. In addition, there was a lack of detail relating to the methodology used to conduct the review. This information could have strengthened the validity of the effectiveness measure
Validity of estimate of costs In general, the costing was well conducted and reported. From the cost perspective adopted, the national health insurance system, all the relevant categories of cost were included in the analysis. In addition, for each category of cost, all the relevant costs were included. Some of the costs were reported separately from the quantities. A sensitivity analysis was conducted on some of the quantities. The indirect costs were included in the analysis. The price year was reported.
There were, however, some negative aspects of the costing. Firstly, no statistical analyses were conducted on the resource use or prices. Secondly, it was unclear whether the charges were used to proxy prices.
Other issues The authors did not make comparisons with other economic evaluations of preventive strategies. The issue of generalisability to other settings was not addressed. The analysis could have been strengthened by conducting an incremental cost-effectiveness analysis. The authors do not appear to have presented their results selectively. The study analysed patients with a history of depressive episodes and this was reflected in the authors' conclusions. The authors reported a further limitation to their study: some of their assumptions, such as the hospitalisation rate, were conservative and would tend to underestimate the cost-effectiveness of the strategy.
Implications of the study Preventive treatment with milnacipran should be given to patients at high risk of hospitalisation during a depressive episode, and to those with few symptoms of depression at treatment initiation.
Bibliographic details Lafuma A, Dardennes R, Fagnani F, Pribil C, Bisserbe J C, Berdeaux G. Evaluation medico-economique de milnacipran dans la prevention des episodes depressifs. [Clinico-economic assessment of milnacipran in the prevention of depressive episodes] L'Encephale 1999; 25(5): 401-407 Indexing Status Subject indexing assigned by NLM MeSH Acute Disease; Adult; Antidepressive Agents /economics /therapeutic use; Clinical Trials as Topic; Cost-Benefit Analysis; Cyclopropanes /economics /therapeutic use; Depression /economics /prevention & Female; Follow-Up Studies; France; Humans; Male; Markov Chains; Mental Health Services /economics; Secondary Prevention; Treatment Outcome; control AccessionNumber 22000006142 Date bibliographic record published 31/08/2002 Date abstract record published 31/08/2002 |
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