Pharmacological Therapy for People with Alzheimer's Disease: The Balance of Clinical Effectiveness, Ethical Issues and Social and Healthcare Costs

Abstract

The drive for evidence based practice and cost-effective use of pharmacological therapies has advantages, but can also be problematic. These difficulties are particularly challenging in the context of long-term conditions, such as Alzheimer's disease. The complexity of the illness, the variable and complex pattern of service use and the difficulty of conducting long term clinical trials are extremely difficult to factor into a meaningful cost effectiveness model. In Alzheimer's disease, the additional impact on caregivers as well as the person with dementia should be considered. In the current article we give a brief overview of the clinical effectiveness of cholinesterase inhibitors for the treatment of Alzheimer's disease, discuss in detail the NICE appraisal of these treatments in the UK as an example of an attempt at a standardised evaluation of cost-effectiveness and discuss a proposed way forward to achieve a unified and consistent approach to the assessment of cost-effectiveness for anti-dementia therapies.

Ethics and economics: the case for mental healthcare

“…NICE recommended donepezil, galantamine and rivastigmine, but only for the treatment of moderate disease, denying the drugs to patients in the early stages of the disease with only mild symptoms and those with more severe Alzheimer's disease. Although the guidance on the use of these drugs was less restrictive than earlier drafts (Ballard 2007), the recommendations were badly received and were the subject of a High Court judicial review. The Court found in favour of NICE on five out of the six grounds presented and NICE was required to amend its guidance (National Institute for Clinical Excellence 2008a).…”

“…Of the first 22 NICE technology appraisals reviewed by Raftery (2001), half stated that cost per QALY estimates were very difficult or impossible to estimate, mainly because of the lack of data on the effect on patient quality of life. This was a major limitation in the Alzheimer's disease appraisal (Ballard 2007). More often than not, the preferred solution is to base resource allocation decisions on decision models swimming in assumptions and expert opinions.…”

“…NICE has since considered the comments received from stakeholders and concluded that the technical inaccuracies highlighted were insufficient to change the original conclusions of the guidance (National Institute for Health and Clinical Excellence 2009). Since the publication of the 2007 appraisal a number of commentators, in particular the Alzheimer's Society (Ballard 2007), have published responses highlighting both ethical and methodological concerns about the NICE appraisal process.…”

“…One of the major criticisms of the NICE appraisal on Alzheimer's disease was the underestimate of carer benefit and the exclusion and underestimate of certain costs, in particular the cost of concurrent medication and full-time care (Ballard 2007). Similarly, among the methodological challenges of undertaking economic evaluations for NICE in ADHD, Griffin and colleagues (2008) highlight the potential underestimation of the benefits of treatment through the exclusion of the impact on the family and the underestimation of costs through the exclusion of relevant costs relating to education, crime and productivity.…”

Implementación de un programa de estimulación cognitiva en personas con demencia tipo Alzheimer: un estudio piloto en chilenos de la tercera edad

“…Actualmente, el manejo terapéutico de la demencia se enfoca principalmente en el tratamiento farmacológico, utilizando básicamente sustancias procolinérgicas (donepezilo y la galantamina) (Fuentes, Donoso, Slachevsky & Villalobos, 2008). Sin embargo, a pesar de los resultados favorables (Olin & Schneider, 2002;Whitehead et al, 2004), la terapia farmacológica ha presentado ciertas limitaciones clínicas, cuestionamientos en su eficacia terapéutica a largo plazo en ámbi-tos cognoscitivos, emocionales y conductuales y, además, resultados de "costo-beneficio" desfavorables (Ballard, Sorensen & Sharp, 2007;Spector, Woods & Orrell, 2010;Sramek & Cutler, 1999), por lo cual se considera como una terapia insuficiente, si es que no se acompaña de terapia no farmacológica (Deus, 2006).…”