On Thursday, the Food and Drug Administration gave full approval to the drug Lekembi for patients who are in the early stages of Alzheimer’s disease, and Medicare said it would cover 80 percent of the $26,500-a-year cost of the drug. The decisions by the two federal agencies will vastly expand access to the drug, but also create a dilemma for patients and their families.
There are many factors, both financial and medical, to be evaluated. Here are answers to some important questions:
How well does the medicine work?
Lekambi is not a cure for Alzheimer’s, and the drug does not seem to improve patients’ memory or cognitive abilities. It also does not stop the disease from getting worse. What Lekembi can do is slow down cognitive decline in patients who are in the early stages of the disease. Data from a large clinical trial showed the drug may work slower for about five months over an 18-month period for those patients.
There is likely to be a wide variation in how the drug may affect a patient’s daily life. For some people, Lekembi may mean several additional months of being able to follow a prescription, balance a checkbook, or perform other activities without help. For others, the effects may be much more subtle and barely noticeable.
Are there any risks in taking it?
Yes. The medicine can cause swelling or bleeding in the brain which is often mild or moderate and goes away on its own but can be severe and in very rare cases can be fatal. The FDA was so concerned about these side effects that it required a “black-box warning” — the most urgent level — on the drug labeladding that the drug can cause “serious and life-threatening events”.
Patients who are at higher risk include those who are taking blood-thinning medication, those who have had more than four microbleedings in the brain and those who have an Alzheimer’s-associated gene mutation called APOE4 – especially if they have Has two copies of the mutation. They, along with their doctors, should consider whether the increased safety risk outweighs their desire for a drug that may modestly slow cognitive decline.
A large clinical trial of the drug found that about 13 percent of patients receiving Lekembi experienced brain swelling, but most of those cases were mild or moderate. Less than 2 percent of patients who received a placebo experienced such swelling. Most brain swelling causes no symptoms and usually heals within a few months.
About 17 percent of patients receiving Lekembi experienced brain bleeding, compared to 9 percent of patients receiving placebo. The study noted that the most common symptom of cerebral hemorrhage was dizziness.
Who is eligible to take Lekembi?
Lekembi – which is administered by intravenous infusion in a doctor’s office or clinic every two weeks – will be available for people with early-stage Alzheimer’s and for those with a pre-Alzheimer’s condition called mild cognitive impairment. About 1.5 million people in the United States fit that description. An additional 5 million people with Alzheimer’s will not be eligible for Lekembi because their disease is too advanced.
The FDA-required label on the drug instructs doctors not to treat patients without testing to confirm they have one of the hallmarks of Alzheimer’s: a build-up of the protein amyloid in the brain, which Lekembi attacks. Amyloid levels can be assessed with a PET scan, spinal tap, or newly available blood tests.
How much do we have to pay?
Most patients will be old enough for Medicare, which has said it will pay 80 percent of the drug’s $26,500 annual cost. Patients would be left with about $6,600 in co-pays, putting the drug out of financial reach for many. Some or all of that co-pay may be covered by the supplemental private insurance policies that many Medicare patients have.
However, this involves potentially thousands of dollars in additional costs – including medical visits for the infusion and regular brain scans. Some Alzheimer’s experts have estimated that the total cost of taking Lekembi could be around $90,000 per year, With 80 percent coverage, the treatment could potentially cost patients about $18,000 out-of-pocket per year.
How should people and their families decide?
Talk to your doctor. If your doctor isn’t well-versed in Alzheimer’s treatment, consider speaking with a specialist. The most important thing is to discuss the decision with medical experts who will carefully explain the risks to your specific situation.
To learn those risks, ask for genetic testing to determine if you have the APOE4 gene mutation. People with two copies of that mutation — about 15 percent of Alzheimer’s patients — are at particularly high risk of swelling and bleeding in the brain.
There are other factors to consider as well. Will it become a burden to go to the clinic every two weeks to get the medicine?
And, importantly, how do you and your family perceive your current cognitive status and how does it affect your life? Because Lekambi is for people with mild symptoms, some people may be less willing to take the safety risk, but others may find it especially important to try a drug that can keep them in this mild phase a little longer. Is.
