Alzheimer's drug Leqembi gets full FDA approval. Medicare coverage will likely follow (npr.org)

The Food and Drug Administration has fully approved Leqembi, the first drug shown to slow down Alzheimer's disease. Andrew Harnik/AP

To read more of Jon Hamilton's article, please click here.

The Food and Drug Administration has fully approved the first drug shown to slow down Alzheimer's disease.

The action means that Leqembi, whose generic name is lecanemab, should be widely covered by the federal Medicare health insurance program, which primarily serves adults age 65 and older. So more people who are in the early stages of the disease will have access to the drug – and be able to afford it.

"It's not something that's going to stop the disease or reverse it," says Dr . Sanjeev Vaishnavi, director of clinical research at the Penn Memory Center. "But it may slow down progression of the disease and may give people more meaningful time with their families."

In studies reviewed by the FDA, Leqembi appeared to slow declines in memory and thinking by about 27% after 18 months of treatment. It also dramatically reduced the sticky beta-amyloid plaques that tend to build up in the brains of people with Alzheimer's.

Frankly speaking, although I hope and pray this is a step forward, this approval may cause more harms than benefits. I spent 4o years treating human beings, many of whom suffered late life cognitive decline. I never prescribed the current meds (Aricept, Namenda) which the FDA had approved because the trials showed a months long delay in subjects' nursing home placement - no prevention of mental decline was ever proven - and they had bad side effects.

There certainly is a lot of frustration in the Alzheimer's community as there have been no scientific breakthroughs in what causes this devastation. Subjects getting Lequembi were shown to have declined more slowly (by less than half a point on the testing scale) after 18 months RX than the controls. Lequembi is proven to remove the abnormal proteins (amyloid plaques and tau) in the brain, but it is still not certain whether they are part of the cause of this disease or the scars of its ravishing process. While it gives hope, this RX comes with a lot of baggage.

(1) A patient would need a brain MRI and a lumbar puncture to qualify.

(2) The patient has to be in the early stages of disease, which means he/she takes on the risk of the medicine while relatively high functioning in the world and a very uncertain of the future path of decline (if any).

(3) The patient needs periodic brain scans to monitor for bleeding in the brain which is known to happen with this treatment. Of course, the bleeding could be catastrophic.

(4) While the studies do demonstrate a statistical delay in cognitive decline, it is not certain that this would be dramatic enough to be noted by individual patients or by the neurologists in all of their practice.

(5) It is given by injection every 2 weeks for the rest of your life.

(6) The medicine, itself costs $26,500 (list price) per year but the required care and tests will add substantially to that. The total cost to Medicare may be as much as $2.6 billion a year.

(7) Because there is a large and increasing population of Americans developing Altzheimer's Disease the aggregate cost to Medicare may be quite substantial, even to increasing everyone's premiums and costing increasing tax subsidy.

(8) Thus we will have increasing resources (taxes) devoted to a marginal treatment among an insured, elderly population, while our national political budgeting system will not allocate tax money for quality maternal care, home visiting programs, child care, quality education, needed nutrition and housing among other high impact social programs.

What do you think?

Alzheimer's drug Leqembi gets full FDA approval. Medicare coverage will likely follow (npr.org)

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