Commentary on “A roadmap for the prevention of dementia II. Leon Thal Symposium 2008.” Primary prevention of dementia in Alzheimer's disease: A perspective from prevention research in cardiovascular disease and stroke

Fillit, Howard; Nash, David T.; Shineman, Diana W.

doi:10.1016/j.jalz.2009.01.012

Cited by 1 publication

(1 citation statement)

References 27 publications

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“…The practical value of delaying the progression of dementia may be viewed as limited, particularly if the cost of therapy is high. Slowing the rate of progression may not be viewed as necessarily beneficial, since the state of being demented itself is a seriously impaired and generally undesirable one (28). Patients may show no symptomatic improvement and cannot internally validate the decrease in rate of disease progression.…”

Section: Challenges Unique To Defining Value In Ad Disease Modifying mentioning

confidence: 99%

Novel approaches to incorporating pharmacoeconomic studies into phase III clinical trials for Alzheimer's disease

Fillit

Cummings

Neumann

et al. 2010

The Journal of nutrition, health and aging

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The societal and individual costs of Alzheimer's disease are significant, worldwide. As the world ages, these costs are increasing rapidly, while health systems face finite budgets. As a result, many regulators and payers will require or at least consider phase III cost-effectiveness data (in addition to safety and efficacy data) for drug approval and reimbursement, increasing the risks and costs of drug development. Incorporating pharmacoeconomic studies in phase III clinical trials for Alzheimer's disease presents a number of challenges. We propose several specific suggestions to improve the design of pharmacoeconomic studies in phase III clinical trials. We propose that acute episodes of care are key outcome measures for pharmacoeconomic studies. To improve the possibility of detecting a pharmacoeconomic impact in phase III, we suggest several strategies including; study designs for enrichment of pharmacoeconomic outcomes that include co-morbidity of patients; reducing variability of care that can affect pharmacoeconomic outcomes through standardized care management; employing administrative claims data to better capture meaningful pharmacoeconomic data; and extending clinical trials in open label follow-up periods in which pharmacoeconomic data are captured electronically by administrative claims. Specific aspects of power analysis for pharmacoeconomic studies are presented. The particular pharmacoeconomic challenges caused by the use of biomarkers in clinical trials, the increasing use of multinational studies, and the pharmacoeconomic challenges presented by biologicals in development for Alzheimer's disease are discussed. In summary, since we are entering an era in which pharmacoeconomic studies will be essential in drug development for supporting regulatory approval, payor reimbursement and integration of new therapies into clinical care, we must consider the design and incorporation of pharmacoeconomic studies in phase III clinical trials more seriously and more creatively.

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Section: Challenges Unique To Defining Value In Ad Disease Modifying mentioning

confidence: 99%

Novel approaches to incorporating pharmacoeconomic studies into phase III clinical trials for Alzheimer's disease

Fillit

Cummings

Neumann

et al. 2010

The Journal of nutrition, health and aging

View full text Add to dashboard Cite

show abstract

Commentary on “A roadmap for the prevention of dementia II. Leon Thal Symposium 2008.” Primary prevention of dementia in Alzheimer's disease: A perspective from prevention research in cardiovascular disease and stroke

Cited by 1 publication

References 27 publications

Novel approaches to incorporating pharmacoeconomic studies into phase III clinical trials for Alzheimer's disease

Novel approaches to incorporating pharmacoeconomic studies into phase III clinical trials for Alzheimer's disease

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