Economic analysis of opportunities to accelerate Alzheimer's disease research and development

Abstract

The development of disease-modifying treatments for Alzheimer's disease (AD) faces a number of barriers. Among these are the lack of surrogate biomarkers, the exceptional size and duration of clinical trials, difficulties in identifying appropriate populations for clinical trials, and the limitations of monotherapies in addressing such a complex multifactorial disease. This study sets out to first estimate the consequent impact on the expected cost of developing disease-modifying treatments for AD and then to estimate the potential benefits of bringing together industry, academic, and government stakeholders to co-invest in, for example, developing better biomarkers and cognitive assessment tools, building out advanced registries and clinical trial-readiness cohorts, and establishing clinical trial platforms to investigate combinations of candidate drugs and biomarkers from the portfolios of multiple companies. Estimates based on interviews with experts on AD research and development suggest that the cost of one new drug is now $5.7 billion (95% confidence interval (CI) $3.7–9.5 billion) and could be reduced to $2.0 billion (95% CI $1.5–2.9 billion). The associated acceleration in the arrival of disease-modifying treatments could reduce the number of case years of dementia by 7.0 million (95% CI 4.4–9.4 million) in the United States from 2025 through 2040.

A novel technology for objective, accurate and non-invasive early diagnosis and monitoring of Alzheimer’s disease in clinics and clinical trials

“…All disease-modifying clinical trials have failed to date. Each trial costs the pharmaceutical industry on average $5.7 Billion for drug development and testing [14]. A doctor's diagnosis of Alzheimer's disease determines the course of a patient's clinical management and potential decision for enrollment in a clinical trial.…”

The pitfalls of crowdfunding Alzheimer's disease research

“…The reality is that Alzheimer's drugs are very expensive and so far proved ineffective. Estimates suggest that the cost of one new drug is now $5.7 billion [53]. Funding for such exuberant failures is primarily through federal finance which for Alzheimer's disease is through a In 2018, the NIH's spending on Alzheimer's and related dementias research was estimated at $1.9 billion.…”

Public-private Partnerships in Biomedical Research and Health Innovation for Alzheimer's Disease and other Dementias

“…According to Scott (2014), the estimated total costs for the development of an effective (diseasemodifying) therapy for Alzheimer's disease would be USD 5.7 billion -approximately five times the commonly cited costs (of approximately USD 1 billion) to develop a new, innovative drug (Bunnage, 2011;DiMasi, Hansen and Grabowski, 2003;Sternitzke, 2010). However, due to the use of different methods (for example, the inclusion of research costs not directly related to a specific drug), data sources, and research and development time periods, there are large variations in cost estimates for the delivery of a new drug (Adams and Brantner 2006;Morgan et al, 2011).…”

“…Researchers have learnt important lessons from failures of therapeutic concepts in clinical trials, and are now testing new options, which take into consideration the multifactorial nature of Alzheimer's disease (Fitzgerald, 2014;Herrup, 2013). The following recommendations have been made in order to overcome persisting barriers in research and health innovation (Scott, 2014): 1) investing in diagnostic research for early detection and disease stratification; 2) streamlining enrolment of participants into clinical trials through candidate registries; 3) implementing qualified biomarkers in clinical trials; 4) strengthening of preclinical and translational research; and 5) establishing research networks and combining capabilities of stakeholders. In Alzheimer's disease, the aims and objectives of stakeholders are as diverse as the issues ahead.…”