Leqembi, a medication for Alzheimer’s disease, received FDA approval in early January.
The FDA’s accelerated pathway, which permits drug launches before they are proven to benefit patients, was used to speed up the process.
Leqembi mildly slowed down the disease in studies, but doctors are unsure of how that extends into things like better patient independence.
According to the Japanese manufacturer Eisai, Leqembi has been delivered to specialty drug distribution facilities in the United States, from where it can be delivered to hospitals or medical facilities.
However, its launch in the United States has been especially slow, still being expected “very soon” and here’s why!
- Costs and Coverage
The cost of treatment for a year is about $26,500.
If a patient is determined to be a candidate for Leqembi and they are able to find a physician and healthcare system willing to assist them, they will be able to begin the treatment.
For now, there are not many alternatives to self-pay.
The majority of patients who might be eligible for this medication are on Medicare, but the federal program’s current coverage is limited, only paying for the patients who are enrolled in specific drug testing research trials.
The problem is that no such studies accepting new patients are available.
Chief public policy officer for Alzheimer’s Association, Robert Egge, pointed out that “There’s a theoretical door (to coverage) that’s completely slammed shut.”
If the drug is given complete FDA approval, coverage is probably going to change, most likely later in the year.
For now, Leqembi is offered to some patients, including those on Medicare, for free, through an assistance program run by Eisai which is based in part on the patient’s financial need.
According to neurologist Dr. Sarah Kremen, it can take doctors anywhere from a few months to more than a year to diagnose a patient and determine if they are a candidate for Leqembi.
The first step for a doctor is to identify mild dementia in a patient.
The doctor must then determine what brought about the condition, whether it was a stroke, brain injury, Alzheimer’s disease, Parkinson’s disease, or another condition.
If it’s linked to Alzheimer’s, medical professionals must find out if the patient’s brain contains amyloid protein because the new drug seeks to stop the progression of Alzheimer’s by getting rid of that protein.
According to Kremen, after considering all of this, some health professionals might still be hesitant to recommend Leqembi because they are unsure of how the drug may impact their daily lives.
- Delivering Treatment
Before beginning to provide Leqembi, healthcare systems must first develop plans for delivering such drugs which can take months.
This prepping may involve teaching nurses how to administer the drug and ensuring that prescribing healthcare providers can identify the candidates for it.
Repetitive brain scans are required for patients, in order to monitor any side effects.
Before they feel fully comfortable writing a prescription for it, doctors might want to be sure that such a plan is in place, Kremen stated.