title: Health economic evaluation of treatments for Alzheimer's disease: impact of new diagnostic criteria.
abstract: The socio-economic impact of Alzheimer's disease (AD) and other dementias is enormous, and the potential economic challenges ahead are clear given the projected future numbers of individuals with these conditions. Because of the high prevalence and cost of dementia, it is very important to assess any intervention from a cost-effectiveness viewpoint. The diagnostic criteria for preclinical AD suggested by the National Institute on Aging and Alzheimer's Association workgroups in combination with the goal of effective disease-modifying treatment (DMT) are, however, a challenge for clinical practice and for the design of clinical trials. Key issues for future cost-effectiveness studies include the following: (i) the consequences for patients if diagnosis is shifted from AD-dementia to predementia states, (ii) bridging the gap between clinical trial populations and patients treated in clinical practice, (iii) translation of clinical trial end-points into measures that are meaningful to patients and policymakers/payers and (iv) how to measure long-term effects. To improve cost-effectiveness studies, long-term population-based data on disease progression, costs and outcomes in clinical practice are needed not only in dementia but also in predementia states. Reliable surrogate end-points in clinical trials that are sensitive to detect effects even in predementia states are also essential as well as robust and validated modelling methods from predementia states that also take into account comorbidities and age. Finally, the ethical consequences of early diagnosis should be considered.
authors.affiliation: Department of Neurobiology, Care Sciences and Society, Alzheimer's Disease Research Center, Karolinska Institutet, Stockholm, Sweden; Centre for Research & Development, Uppsala University/County of Gävleborg, Gävle, Sweden.
authors.forename: A
authors.initials: A
authors.lastname: Wimo
authors.forename: C
authors.initials: C
authors.lastname: Ballard
authors.forename: C
authors.initials: C
authors.lastname: Brayne
authors.forename: S
authors.initials: S
authors.lastname: Gauthier
authors.forename: R
authors.initials: R
authors.lastname: Handels
authors.forename: R W
authors.initials: RW
authors.lastname: Jones
authors.forename: L
authors.initials: L
authors.lastname: Jonsson
authors.forename: A S
authors.initials: AS
authors.lastname: Khachaturian
authors.forename: M
authors.initials: M
authors.lastname: Kramberger
mesh_terms: D000544:Alzheimer Disease / Q000150:complications / Q000175:diagnosis / Q000191:economics / Q000628:therapy; D015415:Biomarkers / Q000032:analysis; D002986:Clinical Trials as Topic / Q000191:economics; D003362:Cost-Benefit Analysis; D003704:Dementia / Q000175:diagnosis / Q000209:etiology; D018450:Disease Progression; D017048:Health Care Costs; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000191:economics; D062706:Prodromal Symptoms; D012959:Socioeconomic Factors
chemical_list: D015415:Biomarkers
keywords: Alzheimer's disease; clinical trials; dementia; diagnosis; health economics