FDA Greenlights 'Breakthrough' Alzheimer's Drug Amid Risk and Cost Concerns

Leqembi, a breakthrough drug for Alzheimer's disease, as received the FDA’s nod for use, but medical experts caution about potential side effects, and call for training medical professionals before use.

US authorities granted full approval to a drug for Alzheimer's disease on Thursday. The drug, called Leqembi, is administered intravenously and has been specifically endorsed by the Food and Drug Administration (FDA) for patients with moderate dementia and other associated symptoms with early-stage Alzheimer's.

This decision has potential implications for coverage under Medicare and other American health insurance plans, offering treatment options for individuals affected by the disease. The drug has shown credible evidence of modestly slowing down the cognitive deterioration caused by the disease.

The Japanese pharmaceutical company Eisai previously obtained conditional approval from the FDA in January based on initial findings that indicated the effectiveness of Leqembi in targeting the sticky brain plaque associated with the disease.

Before FDA Approval

The FDA has verified earlier findings by conducting a comprehensive data analysis from a more extensive study involving 1,800 patients. The results confirmed that the drug effectively decelerated the decline in memory and cognitive abilities by approximately five months among individuals who received the treatment compared to those who were administered a placebo.

“This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease,” Dr. Teresa Buracchio, FDA’s neurology drug director, stated.

Side Effects

Leqembi's prescribing information will feature a notable cautionary statement, emphasizing the most serious risks linked to the drug. It warns about the possibility of brain swelling and bleeding, which are infrequent, but potentially harmful side effects. The label acknowledges that similar problems have been observed in other Alzheimer's medications that target brain plaque.

Prescription and Administration

Medical centers and hospitals have issued warnings about the potential time needed to initiate patients on the drug.

Before prescribing Leqembi, doctors must verify that patients have the specific brain plaque that the drug targets. Additionally, nurses must receive training to administer the medication properly, and patients must undergo regular brain scans to monitor for any signs of swelling or bleeding. It is important to note that hospitals incur additional expenses for imaging and administration services in addition to the cost of the drug itself.

“The risks are very vivid. Within the first few months, you may have small bleeds or swelling in your brain, which may or may not be symptomatic and if not detected in time can cause disability,” Dr. Jason Karlawish, co-director of the University of Pennsylvania’s Penn Memory Center, disclosed to media sources.

Cost of Treatment

The cost of new Alzheimer's drugs, specifically those targeting brain plaque, has raised concerns about the potential strain on the program responsible for caring for 60 million seniors. Leqembi, valued at around $26,500 for a year's supply of bi-weekly intravenous treatments, further amplifies these financial worries.

Most Americans living with Alzheimer's receive their health coverage through Medicare. Medicare administrator Chiquita Brooks-LaSure stated that now that Leqembi has received full FDA approval, Medicare will begin covering the cost of the drug. However, the government is introducing extra conditions, such as mandatory enrollment in a federal registry, to monitor the real-world safety and effectiveness of the medication.

Certain Medicare patients may be responsible for paying the standard 20 percent of Leqembi’s cost. However, the specific amount will vary depending on their coverage details and plan.