Qualitative classification of AD patients using dependency levels is a simple and validated approach. Applying this approach showed that institutionalisation and the most 'dependent' status were independently and significantly associated with high care cost.

The understanding of the benefit risk profile, and relative effectiveness of a new medicinal product, are initially established in a circumscribed patient population through clinical trials. There may be uncertainties associated with the new medicinal product that cannot be, or do not need to be resolved before launch. Postlicensing or postlaunch evidence generation (PLEG) is a term for evidence generated after the licensure or launch of a medicinal product to address these remaining uncertainties. PLEG is thus part of the continuum of evidence development for a medicinal product, complementing earlier evidence, facilitating further elucidation of a product's benefit/risk profile, value proposition, and/or exploring broader aspects of disease management and provision of healthcare. PLEG plays a role in regulatory decision making, not only in the European Union but also in other jurisdictions including the USA and Japan. PLEG is also relevant for downstream decision‐making by health technology assessment bodies and payers. PLEG comprises studies of different designs, based on data collected in observational or experimental settings. Experience to date in the European Union has indicated a need for improvements in PLEG. Improvements in design and research efficiency of PLEG could be addressed through more systematic pursuance of Scientific Advice on PLEG with single or multiple decision makers. To date, limited information has been available on the rationale, process or timing for seeking PLEG advice from regulators or health technology assessment bodies. This article sets out to address these issues and to encourage further uptake of PLEG advice.

Several clinical trials have demonstrated the efficacy and safety of the NMDA antagonist memantine in moderately severe to severe Alzheimer's disease (AD) patients. A 28-week pharmacoeconomic study conducted in the US also showed a reduction of total healthcare costs and informal care compared to placebo. Long-term implications of memantine treatment were modelled in the UK and Finland and revealed reductions in dependency, institutionalization and costs. However, these conclusions were not directly applicable to the Spanish setting where patients are mainly treated within the community. The objective of this study was to estimate the long-term implications in terms of costs and health benefits of memantine therapy compared to standard care using a Spanish adaptation of previous models over a 2-year time horizon. As in previous adaptations, Markov health states were defined as a combination of severity (mild-moderate, moderately severe, severe) and dependency plus death as the absorbing state. Spain-specific data (costs, mortality and epidemiological data) were obtained from local and recently published cohorts of AD patients. Data on the effectiveness of memantine were derived from a randomized double-blind placebo-controlled clinical trial of 252 moderately severe to severe AD patients. Effectiveness was measured as the time spent in a non-dependent health state. The evaluation was conducted over 2 years, while the efficacy of memantine was applied for 1 year only in order to ensure a conservative approach. The robustness of the model was tested by conducting stochastic analyses and various sensitivity analyses on the key assumptions. Patients receiving standard care were estimated to spend 6 months in a non-dependent state and to incur average total costs of Euro 24,700 over 2 years. The memantine strategy was associated with an additional 2.5 months in a non-dependent state and a Euro 700 cost reduction. Monte-Carlo simulations and sensitivity analyses supported these findings. Memantine appears to be cost-effective compared with standard care in moderately severe to severe AD patients in a Spanish setting. The prolonged independence provided by memantine treatment translated into cost reductions which offset drug costs and resulted in overall cost-savings.

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A qualitative tool was recently developed for evaluation of dependency in a demented population. This tool assesses the impact of cognitive impairment on functional status, taking into account disability in both the basic and the instrumental activities of daily living. The purpose of the present paper was to study the impact of dependency on informal caregivers who assist demented patients at home, with this new useful tool. Methods: A cross-sectional analysis was undertaken of the subgroup of 145 demented patients of the National Dementia Economic Study, aged Ն65 years, living in the community, with an available caregiver. A neuropsychological assessment of patients (Mini-Mental State Examination) and a comprehensive evaluation of caregivers (quality of life, Short Form Health Survey-36, depression, Sense of Competence) were recorded. A total of 32.4% were dependent, disabled in both basic and instrumental functions, 42.1% were non-dependent but with instrumental functional disabilities and 25.5% were non-dependent. Impact of dependency on the caregiver's experience was significant for different aspects (satisfaction with caregiving, subjective burden, quality of life, depression). Medical and non-medical costs increased with the severity of functional disability. Findings indicate that this tool is also useful to assess the impact of progression of functional disability in patients with dementia, on the caregiver issues. The consequences appeared both on personal feelings and on quality of life and financial involvement in management of the patient. Cognitive impairment appears to have more moderate repercussions in these areas.