Medicare policy and bureaucracy are keeping promising new treatments from reaching the over 6 million Americans who suffer from the progressive, fatal disease. Alzheimers has stumped scientists for a century even though $42 billion has been invested in research and development of drugs to treat the disease. Now, with hope on the horizon, Alzheimer’s patients and their caregivers are frustrated as two treatments with significant clinical benefit are on the shelf…waiting.
Joe Grogan, a senior fellow at the University of Southern California’s Schaeffer Center for Health Policy & Economics and former director of the Domestic Policy Council in the White House, described the two new treatments in the Chicago Tribune:
“ …one, lecanemab, approved by the Food and Drug Administration and another, donanemab, recently endorsed by its advisory panel — and a scientific pathway that could one day point the way toward a cure.”
After more than 150 trials that ended in failure, at last, we have two with success rates. Grogan states,
“Eisai’s Leqembi (lecanemab) received FDA approval more than a year ago after demonstrating a 27% decline in early disease progression; donanemab achieved 35%. But rather than cover the drug for seniors who need it, the Centers for Medicare and Medicaid Services (CMS), which administers Medicare, restricted access, citing the very safety concerns the FDA scrutinized before granting approval.”
But time is working against Alzheimer patients and their families. These drugs work best in the early stages of the disease but it could be months before the FDA approves donanemab. Patients who could see results from treatment today may not be eligible tomorrow. The result? After more than a year on the market, the drug has reached only 5,000 patients.
Why? Money and bureaucracy. Joe Grogan gives details,
“Though the FDA reviewed the data and determined lecanemab’s benefit outweighed the risks, CMS continues to press for more data on its clinical benefit and safety. The agency isn’t supposed to consider cost in a coverage decision, but that certainly seems to be a factor. It effectuated one of the largest premium increases in the history of the Medicare program to manage the projected budget impact of a similar Alzheimer’s drug, Aduhelm — then restricted access to it and rebalanced premiums.”
The tool used to nullify these drugs is “coverage with evidence development,” or CED. This program was designed to speed new technologies to market, protect patients and spur innovation. But CMS has warped its purpose, using CED to impede access not only to Alzheimer’s treatments but to diagnostic too.”
CED has affected the diagnosis of Alzheimers. PET scans are the gold standard for diagnosing Alzheimer’s by confirming the presence of amyloid plaque in the brain. Another scan after treatment confirms that plaques have been removed. CMS tied up these tests in CED for more than a decade, only last October concluding what’s been known for years: the preponderance of data supports using PET scans to diagnose Alzheimer’s disease.
New drugs that deliver the most benefit when administered early in the progression of disease… a timely, accurate diagnosis. Now our agencies must refocus their efforts to ensure safe, equitable access to these new treatment tools.
But the problems don’t stop there. Grogan writes,
“…even where a patient can get access to the drug under CED, the process is burdensome for physicians, who must enter patient data in an approved registry or study to secure Medicare coverage. This adds an uncompensated layer of bureaucracy to the management of a disease that is already very complex to diagnose and treat. CMS maintains that its digital database is easy to use, but the policy is disconnected from the reality on the ground.
Neurologists’ offices are packed trying to manage the demands of an aging population. Appointments can be backed up for more than a year. Memory centers at elite medical institutions can train staff to navigate these additional tasks, but remote facilities are struggling.”
In short, too few patients have ready access to the treatment. Donanemab faces all the same headwinds. Let’s hope a swift FDA approval is followed by swift adoption of a new CMS policy that helps ensures people who need these treatments can get them in a timely way. Alzheimers patients should not have to wait.
Read Joe Grogan’s complete article here.