The U.S. Food and Drug Administration on Friday authorized Eisai Co Ltd and Biogen Inc‘s Alzheimer’s drug lecanemab for the therapy of early types of the deadly, brain-wasting illness.
Like their earlier Alzheimer’s drug Aduhelm, lecanemab, to be offered below the model identify Leqembi, belongs to a category of therapies that purpose to gradual illness development by eradicating sticky clumps of the poisonous protein beta amyloid from the mind.
Here’s what we learn about entry to the drug up to now:
PATIENT POPULATION
Leqembi was authorized for sufferers with Alzheimer’s illness, and is advisable to be used in individuals with delicate cognitive impairment or early Alzheimer’s – the identical inhabitants through which the drug was examined.
To qualify for therapy, sufferers might want to have a particular diagnostic take a look at – both a PET scan of the mind or spinal faucet – to substantiate the presence of amyloid within the mind.
MEDICARE COVERAGE
The firms mentioned the drug can be obtainable to sufferers throughout or earlier than the week of Jan. 23. However, most sufferers must pay out of pocket for the drug, which prices $26,500 a 12 months, as insurance coverage protection will likely be restricted.
The U.S. Centers for Medicare & Medicaid Services (CMS) mentioned Leqembi falls below its present coverage severely limiting protection of amyloid-lowering medicine to individuals enrolled in an authorized scientific trial if the drug has gone by the FDA’s accelerated approval course of.
CMS, which runs the nationwide Medicare healthcare plan for these age 65 and older, mentioned in an announcement it’s at present reviewing all obtainable information and “may reconsider” its protection resolution. The company added that it could present broader protection if the drug receives customary FDA approval. The firms mentioned they intend to use for full approval shortly.
“Given the data behind lecanemab, there is a case that Eisai can make for CMS reimbursement for the drug,” mentioned BMO analyst Evan Seigerman, including that the drugmaker might want to negotiate with the company.
SAFETY
The drug comes with a requirement that sufferers endure 4 MRI scans over the course of 14 weeks to test for indicators of Amyloid Related Imaging Abnormalities or “ARIA,” a sort of momentary mind swelling that’s often seen with medicine that take away amyloid from the mind.
In some sufferers, the sort of mind swelling has led to hemorrhages. Because of that, Leqembi’s label urges medical doctors to warn sufferers of this danger, particularly if sufferers are already taking blood thinners.
The label urges medical doctors to be particularly cautious in giving the clot-busting stroke therapy generally known as a tissue plasminogen activator, or t-PA, to sufferers taking Leqembi, saying it might improve the danger of bleeding within the mind.
Because of this danger, some physicians have mentioned they’d not suggest Leqembi for sufferers on blood thinners.
