Cost-effectiveness analyses for mirtazapine and sertraline in dementia: Randomised controlled trial

James Lindesay, DM, Department of Psychiatry, University of Leicester
The British journal of psychiatry: the journal of mental science (Impact Factor: 7.99). 12/2012; 202(2). DOI: 10.1192/bjp.bp.112.115212
Source: PubMed

ABSTRACT BACKGROUND: Depression is a common and costly comorbidity in dementia. There are very few data on the cost-effectiveness of antidepressants for depression in dementia and their effects on carer outcomes. AIMS: To evaluate the cost-effectiveness of sertraline and mirtazapine compared with placebo for depression in dementia. METHOD: A pragmatic, multicentre, randomised placebo-controlled trial with a parallel cost-effectiveness analysis (trial registration: ISRCTN88882979 and EudraCT 2006-000105-38). The primary cost-effectiveness analysis compared differences in treatment costs for patients receiving sertraline, mirtazapine or placebo with differences in effectiveness measured by the primary outcome, total Cornell Scale for Depression in Dementia (CSDD) score, over two time periods: 0-13 weeks and 0-39 weeks. The secondary evaluation was a cost-utility analysis using quality-adjusted life years (QALYs) computed from the Euro-Qual (EQ-5D) and societal weights over those same periods. RESULTS: There were 339 participants randomised and 326 with costs data (111 placebo, 107 sertraline, 108 mirtazapine). For the primary outcome, decrease in depression, mirtazapine and sertraline were not cost-effective compared with placebo. However, examining secondary outcomes, the time spent by unpaid carers caring for participants in the mirtazapine group was almost half that for patients receiving placebo (6.74 v. 12.27 hours per week) or sertraline (6.74 v. 12.32 hours per week). Informal care costs over 39 weeks were £1510 and £1522 less for the mirtazapine group compared with placebo and sertraline respectively. CONCLUSIONS: In terms of reducing depression, mirtazapine and sertraline were not cost-effective for treating depression in dementia. However, mirtazapine does appear likely to have been cost-effective if costing includes the impact on unpaid carers and with quality of life included in the outcome. Unpaid (family) carer costs were lower with mirtazapine than sertraline or placebo. This may have been mediated via the putative ability of mirtazapine to ameliorate sleep disturbances and anxiety. Given the priority and the potential value of supporting family carers of people with dementia, further research is warranted to investigate the potential of mirtazapine to help with behavioural and psychological symptoms in dementia and in supporting carers.

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Available from: Renee Romeo, Sep 26, 2015
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    • "Comorbid depression is very common amongst those with dementia, and although antidepressants may have little effect in improving depressive symptoms [31], they may have some benefits in improving agitation [32, 33]. Over one-third of care home residents receive antidepressants [34], sometimes for longer than necessary [35]. "
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    ABSTRACT: Objectives. People with dementia are susceptible to adverse effects of medicines. However, they are not always closely monitored. We explored (1) feasibility and (2) clinical impact of nurse-led medication monitoring. Design. Feasibility "before-and-after" intervention study. Setting. Three care homes in Wales. Participants. Eleven service users diagnosed with dementia, taking at least one antipsychotic, antidepressant, or antiepileptic medicine. Intervention. West Wales Adverse Drug Reaction (ADR) Profile for Mental Health Medicines. Outcome Measures. (1) Feasibility: recruitment, retention, and implementation. (2) Clinical impact: previously undocumented problems identified and ameliorated, as recorded in participants' records before and after introduction of the profile, and one month later. Results. Nurses recruited and retained 11 of 29 eligible service users. The profile took 20-25 minutes to implement, caused no harm, and supplemented usual care. Initially, the profile identified previously undocumented problems for all participants (mean 12.7 (SD 4.7)). One month later, some problems had been ameliorated (mean 4.9 (3.6)). Clinical gains included new prescriptions to manage pain (2 participants), psoriasis (1), Parkinsonian symptoms (1), rash (1), dose reduction of benzodiazepines (1), new care plans for oral hygiene, skin problems, and constipation. Conclusions. Participants benefited from structured nurse-led medication monitoring. Clinical trials of our ADR Profile are feasible and necessary.
    The Scientific World Journal 02/2014; 2014(7456):843621. DOI:10.1155/2014/843621 · 1.73 Impact Factor
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    ABSTRACT: To systematically review approaches and instruments used to derive utility weights in cost-utility analyses (CUAs) within the field of mental disorders and to identify factors that may have influenced the choice of the approach. We searched the databases DARE (Database of Abstracts of Reviews of Effects), NHS EED (National Health Service Economic Evaluation Database), HTA (Health Technology Assessment), and PubMed for CUAs. Studies were included if they were full economic evaluations and reported quality-adjusted life-years as the health outcome. Study characteristics and instruments used to estimate utility weights were described and a logistic regression analysis was conducted to identify factors associated with the choice of either the direct (e.g. standard gamble) or the preference-based measure (PBM) approach (e.g. EQ-5D). We identified 227 CUAs with a maximum in 2009, 2010, and 2012. Most CUAs were conducted in depression, dementia, or psychosis, and came from the US or the UK, with the EQ-5D being the most frequently used instrument. The application of the direct approach was significantly associated with depression, psychosis, and model-based studies. The PBM approach was more likely to be used in recent studies, dementia, Europe, and empirical studies. Utility weights used in model-based studies were derived from only a small number of studies. We only searched four databases and did not evaluate the quality of the included studies. Direct instruments and PBMs are used to elicit utility weights in CUAs with different frequencies regarding study type, mental disorder, and country.
    PharmacoEconomics 11/2013; 31(12). DOI:10.1007/s40273-013-0107-9 · 2.45 Impact Factor
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    ABSTRACT: Background: Collaborative care is an effective treatment for the management of depression but evidence on its cost-effectiveness in the UK is lacking. Aims: To assess the cost-effectiveness of collaborative care in a UK primary care setting. Methods: An economic evaluation alongside a multi-centre cluster randomised controlled trial comparing collaborative care with usual primary care for adults with depression (n = 581). Costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICER) were calculated over a 12-month follow-up, from the perspective of the UK National Health Service and Personal Social Services (i.e. Third Party Payer). Sensitivity analyses are reported, and uncertainty is presented using the cost-effectiveness acceptability curve (CEAC) and the cost-effectiveness plane. Results: The collaborative care intervention had a mean cost of 272.50 pound per participant. Health and social care service use, excluding collaborative care, indicated a similar profile of resource use between collaborative care and usual care participants. Collaborative care offered a mean incremental gain of 0.02 (95% CI: -0.02, 0.06) quality-adjusted life-years over 12 months, at a mean incremental cost of 270.72 pound (95% CI: -202.98, 886.04), and resulted in an estimated mean cost per QALY of 14,248 pound. Where costs associated with informal care are considered in sensitivity analyses collaborative care is expected to be less costly and more effective, thereby dominating treatment as usual. Conclusion: Collaborative care offers health gains at a relatively low cost, and is cost-effective compared with usual care against a decision-maker willingness to pay threshold of 20,000 per QALY gained. Results here support the commissioning of collaborative care in a UK primary care setting.
    PLoS ONE 08/2014; 9(8):e104225. DOI:10.1371/journal.pone.0104225 · 3.23 Impact Factor
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