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vi Interventions in Alzheimer’s Disease KCE reports 111C Assuming drug therapy causes a delay in institutionalisation, as most models do, is however contradictory with the available evidence as discussed above. The many AD cost-effectiveness models based on this assumption (and which may have been used to justify drug reimbursement) are therefore unreliable. In general, model-based economic evaluations of non-pharmaceutical interventions suffered from the same limitations as those described above for the evaluations of pharmaceutical interventions in the treatment of AD. The short-term outcomes used in those evaluations were changes in the scale score between AD interventions and usual care, for which significant differences were reported in the trial. The limitation with this approach is that such change in scale score do not translate easily into clinically meaningful final outcomes. Therefore the results of such economic evaluations are difficult to interpret. Despite these shortcomings there are indications from a single UK trial that group-based cognitive stimulation sessions in patients with mild to moderate dementia in day-care or care homes is promising and might be cost-effective. Studies with longer term follow-up are needed to feed cost-effectiveness models. One step in this direction is the study of Mittelman et al. demonstrating a significant reduction in the rate of institutionalisation with enhanced counseling and support of AD patients’ caregivers. Economic studies based on these results would be highly informative. ANALYSIS OF BELGIAN DRUG PRESCRIPTION DATA In Belgium the three ChEIs are reimbursed by the RIZIV/INAMI for mild to moderately severe AD (MMSE > 11) since mid 2002. Ebixa/memantine is reimbursed in moderate to severe AD (MMSE >3,
KCE reports 111C Interventions in Alzheimer’s Disease vii Analysis of overall survival of patients after starting ChEI therapy using a Cox proportional hazard model showed age, male sex, concomitant antipsychotic use, ChEI first prescription in a hospital or an elderly home, as well as institutionalisation itself were all highly significant predictors of mortality in this model (which did not include a direct measure of behaviour or disease severity). There were no significant differences between ChEIs. Concomitant use of an antidepressant was not a significant predictor of mortality. In hospitalized patients who started ChEI therapy a slightly increased early mortality was observed during the first 6 months following ChEI therapy initiation. Although the cause of the excess mortality was not studied, most probably the excess mortality can be attributed to severe comorbidity. RECOMMENDATIONS Clinical Practice Reimbursement • Physicians should limit the use of antipsychotics in AD patients to situations where their use is absolutely necessary. Our data analysis confirmed previous studies demonstrating that the use of antipsychotics is associated with a significant increase in mortality. • Initiation of ChEI treatment in hospitalised medically instable AD patients should be judged carefully given the slightly increased early mortality in such patients. • As robust clinical efficacy and cost-effectiveness data are lacking, reimbursement of Ginkgo biloba cannot be justified. • Awaiting further data on the combination treatment of ChEI plus memantine, the reimbursement of memantine in monotherapy should be questioned given the very weak (to absent) clinical efficacy of memantine monotherapy and the lack of robust cost-effectiveness data. • Based on their well documented low level of clinical efficacy reimbursement of ChEIs can be continued but should be the subject of a revision of the reimbursement criteria as foreseen under article 38 of the law of December 21, 2001. It should be noted that robust costeffectiveness of ChEIs has not been demonstrated as the assumptions on clinical effectiveness used in the models were not confirmed by clinical trials. • As medicines for Alzheimer’s Disease are being prescribed mainly to geriatric patients is seems appropriate to take into account during the revision procedures the possible benefits on behavioural disturbances in these patients. • The non-pharmaceutical intervention which has shown to delay institutionalisation while maintaining quality of life of the caregiver and the patient (based on the Mittelman study), should be implemented in Belgium, ideally as a large randomized trial sponsored by government. The cost-effectiveness of such intervention should also be studied. Methodological Recommendations in the Context of Reimbursement Policies • Health technology assessments should include as much as possible all sources of evidence and not only trials published. Exchange of information with national and European medicines agencies is required as they have access to a more complete set of trial data.
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KCE reports 33 Effects and costs of
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