RESEARCH TRIANGLE PARK, N.C. – The capitalized cost of bringing the first effective disease-modifying Alzheimer’s drug to market will approach $5.7 billion—three times the typical cost of drug development, according to a draft report by RTI International.
New biomarkers, patient registries, data sharing, and novel partnerships could lower that cost by 65 percent, to about $2 billion.
The draft report, funded by New York Academy of Sciences and presented at the Alzheimer’s Disease Summit: Path to 2025, found that speeding the availability of an Alzheimer’s drug that can slow or reverse the disease by 2025 could have tremendous benefit for patients and health systems. Introducing an effective Alzheimer’s treatment by 2025 is projected to avert 7 million case-years of dementia and upwards of $100 billion in costs of care over a 15-year period in the United States alone.
“As the burden of Alzheimer’s disease escalates worldwide, efforts to develop effective treatments are failing to keep pace because of high costs and risks associated with Alzheimer’s drug development,” said Troy Scott, a senior economist at RTI and the paper’s lead author. “Our research showed that investing in the infrastructure supporting Alzheimer’s drug development, so it is more streamlined and efficient, could bring down costs and speed progress toward approval of drugs that slow or reverse the disease.”
Alzheimer’s disease and other dementias currently affect more than 35 million people worldwide, with 2010 healthcare expenditures alone reaching more than $600 billion. The burden of Alzheimer’s disease is projected to rise steeply as the number of people living with it doubles by 2035, and triples by 2060, because of the aging population. Despite numerous large-scale drug trials, a treatment that can slow or reverse the progression of Alzheimer’s has thus far proven elusive - current therapies treat only symptoms.
“Alzheimer’s disease is a global emergency. It robs people of dignity in their final years and takes a debilitating toll on national economies,” said New York Academy of Sciences President and CEO Ellis Rubinstein. “Progress in developing new therapies has been unacceptably slow, and so we must rethink how Alzheimer’s research is carried out so that scientific breakthroughs get to patients faster.”
The report considers the likely economic impacts of adopting a series of recommendations made by government agencies, expert panels, and other bodies to streamline how Alzheimer’s drugs are developed and tested. Among the reforms recommended are:
- Developing more reliable disease markers to measure the progression of Alzheimer’s disease in different patients and better match people with treatments likely to work for them
- Making clinical trials more efficient and less costly by establishing registries of eligible patients and using “adaptive” trial designs that enable patients to switch among therapies
- Establishing data-sharing agreements through which companies make available pre-competitive research results so that others can learn from them
- Promoting public-private partnerships that pool resources from governments and industry to co-invest in Alzheimer’s drug development and testing
The report estimates that implementing these and other reforms to Alzheimer’s drug development would reduce the total cost of developing an effective Alzheimer’s treatment by nearly $4 billion and reduce the overall timeline to a successful drug, bringing both more in line with the industry average. In turn, the reforms would also lead to increased private investment in Alzheimer’s drug development.
“The high costs and risks of Alzheimer’s drug development are crippling companies’ efforts to bring effective treatments to market,” says George Vradenburg, chairman and co-founder of the Global CEO Initiative on Alzheimer ’s disease. “There is growing consensus that big scientific challenges in Alzheimer’s must be addressed collaboratively, in a pre-competitive context, to reduce inefficiencies and shorten the timeline to success.”
The report, “The Economic Analysis of Opportunities to Accelerate Alzheimer’s Research and Development,” was presented today as a working draft to elicit comments and evaluation by the Alzheimer’s experts at the Summit. A final version of the report will be published in Annals of the New York Academy of Sciences in early 2014, and is intended to serve as a further stimulus for action among stakeholders in the Alzheimer’s field.