For decades, researchers and consumers have been hoping that an effective cure for Alzheimer’s disease would soon be found. That time may be here, following reports that in a large clinical trial, a new drug was able to reduce the plaques in the brains of patients and slow the progression of dementia. But a RAND report questions whether the healthcare system would be able to handle the demands the new therapy would place on it.
Projected capacity is insufficient to handle the expected caseload, RAND found, predicting that patients would have to wait an average of 18.6 months for treatment in 2020. Approximately 2.1 million patients would develop Alzheimer’s dementia between 2020 and 2040 while on waiting lists, the report warns.
The drug, known as BAN2401, is the first to show evidence that it reduces the amyloid levels associated with Alzheimer’s while also slowing cognitive decline, as compared with patients who received placebo. In the trial, 81% of 161 patients taking the highest dose showed major drops in amyloid levels and also had cognitive declines 30% slower than control groups.
The 30% decline is impressive but, as the RAND report notes, it would require quick action to identify and treat patients who are still in the early stages of Alzheimer’s, no mean feat considering what RAND says is “limited capacity of dementia specialists to evaluate and diagnose patients” as well as a lack of imaging and infusion centers need to confirm diagnoses and treat patients.
“While significant effort is being put into developing treatments to slow or block the progression of Alzheimer’s dementia, little work has been done to get the medical system ready for such an advancement,” said Jodi Liu, lead author of the study and a policy researcher at RAND, a nonprofit research organization. “While there is no certainty an Alzheimer’s therapy will be approved soon, our work suggests that health care leaders should begin thinking about how to respond to such a breakthrough.
“Addressing the capacity constraints may turn out to be as challenging as developing an effective treatment, as it requires solving a complex puzzle consisting of payment policy, regulatory requirements, workforce considerations, and capacity planning at the national and local levels, combined with awareness campaigns,” Liu’s report cautioned.
The drug’s developers, for their part, are pledging to make the drug available to patients as soon as possible.
“This is the first late-stage anti-amyloid antibody study to successfully achieve statistically significant results at 18 months, further validating the amyloid hypothesis,” said Lynn Kramer, chief clinical officer and chief medical officer with the Neurology Business Group at Eisai, which developed the drug along with Biogen.
The trial results were presented orally at the Alzheimer’s Association International Conference (AAIC) 2018 in Chicago yesterday.
In its analysis, RAND said that wait times for specialist appointments would be the most challenging obstacle to receiving treatment for Alzheimer’s disease. Two possible thought challenging solutions are to increase productivity of the existing specialist workforce and to qualify more specialists for dementia care.
Access to PET scans could become a factor, though expanding the use of mobile scanners could help, RAND said, adding that an alternative is the use of Alzheimer’s tests based on cerebrospinal fluid, which do not require dedicated equipment and can be conducted in primary care settings.
Home infusions could also speed delivery of treatment once diagnosis is complete.
An estimated 5.5 million Americans live with Alzheimer’s dementia today, with the number projected to increase to 11.6 million by 2040.