Are expensive new Alzheimer’s drugs worth it?

Are expensive new Alzheimer's drugs worth it?

Breakthrough Drugs bring Hope in Alzheimer’s Disease Research

The field of Alzheimer’s disease research is abuzz with the breakthrough new drugs that clear amyloid beta plaques from the brain. These drugs, such as Leqembi (lecanemab), Aduhelm (aducanumab), and donanemab, have provided solid proof that abnormal amyloid proteins are indeed one of the culprits behind Alzheimer’s, ending decades of debate over the so-called “amyloid hypothesis.” Patients on anti-amyloid drugs experience a significant slowing down of mental deterioration, confirming the role of amyloid in the disease process, according to Rebecca Edelmayer, senior director of scientific engagement for the Alzheimer’s Association.

However, amidst all the hype surrounding these drugs, Alzheimer’s experts caution patients and their families to be wary. Many patients will not be eligible to take these anti-amyloid drugs. Currently, these drugs are primarily aimed at individuals in the early stages of Alzheimer’s or dementia. Additionally, these drugs come with side effects that may prevent their use in people taking blood thinners or with certain genetic risk factors.

Moreover, these drugs have a limited ability to slow down Alzheimer’s progression. Patients would have to undergo continuous transfusions, MRIs, PET scans, and other tests during the treatment process. Dr. Eric Widera, a professor of geriatrics at the University of California, San Francisco, describes donanemab, the latest drug making a splash, as a “very complicated drug that requires a tremendous amount of monitoring.” The current healthcare system is not adequately equipped to handle the complexities associated with these drugs outside of specialized memory and aging centers.

Concerns have also been raised regarding the potential financial burden of these expensive drugs on Medicare. However, Dr. Ronald Petersen, director of the Mayo Clinic Alzheimer’s Disease Research Center, dismisses these worries, as only a small percentage of Alzheimer’s patients will be eligible for anti-amyloid treatment. The cost factor, although significant, will not have a dramatic impact on the healthcare system as a whole.

Drugs Making the Latest Headlines

July has been marked by earth-shaking developments in anti-amyloid treatment. Leqembi became the first Alzheimer’s drug to receive full approval from the U.S. Food and Drug Administration, making it eligible for Medicare coverage. Meanwhile, donanemab showed superior results in clinical trial phase 3, outperforming both Leqembi and Aduhelm. These three drugs are monoclonal antibodies that attach to amyloid beta, helping remove the problem protein from the brain.

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During the donanemab trial, participants in the earliest stage of the disease experienced a 60% slowing of decline compared to the placebo group, according to Edelmayer. Nearly half of the participants in the early stages of the disease who received donanemab showed no clinical progression at one year. This represents valuable time gained at an earlier stage of the disease process.

However, a series of accompanying editorials in the Journal of the American Medical Association raised concerns about cost, access, and safety risks associated with anti-amyloid drugs. Although donanemab effectively cleared amyloid plaques in 80% of the treatment group, disease progression was only delayed by about four months during the 18-month trial. Dr. Eric Widera points out that while the drug is doing something, it’s not producing significant absolute numbers. On one Alzheimer’s scale, donanemab slowed disease progression by about 3 points on a scale running from 0 to 144 points.

This discrepancy between the efficient clearance of amyloid and the limited benefits suggests that Alzheimer’s is driven by more than just the plaques. Abnormal tau proteins and other factors likely play a role in the disease. Therefore, a combination approach of treatments targeting various aspects is necessary for effective disease management.

Balancing Risks and Benefits

While these drugs offer hope, not all Alzheimer’s patients will be eligible, and those who are eligible will need to undergo a careful evaluation process before treatment can begin. The baseline MRI imaging helps track changes and potential side effects, as removing amyloid from the brain increases the risk of brain bleeding or cerebral edema. The donanemab trial reported a significant number of patients experiencing brain bleeding and swelling, with three fatalities related to drug-related complications.

Consequently, individuals taking blood thinners or with genetic risk factors for Alzheimer’s, such as carrying the apolipoprotein E4 (APOE4) gene, are not recommended for these drugs due to heightened risks. Pre-existing conditions like poorly controlled diabetes, hypertension, or cancer may also affect eligibility. Regular MRIs and PET scans, along with monthly or twice-monthly drug infusions, are additional requirements to track potential side effects.

Nevertheless, for some Alzheimer’s patients, the small benefits these drugs offer are worth considering. Slowing down the rate of decline, even if not a complete reversal, may be significant for those individuals. However, for others, the risks associated with these drugs may outweigh the potential benefits.

Another concern is the inconsistent access to these treatments. Mayo Clinic is initially offering anti-amyloid treatment only to patients living within 100 miles to ensure proper follow-up and safety. There are worries that other medical centers may not implement stringent monitoring systems, potentially leading to adverse outcomes for patients receiving these drugs. Access to anti-amyloid treatment must be equitable and available to anyone who qualifies, regardless of their location or income.

In conclusion, the recent breakthrough in anti-amyloid drugs brings hope to the field of Alzheimer’s disease research. While these drugs provide remarkable clinical benefits, it is crucial to weigh the risks and benefits carefully. Alzheimer’s patients and their families need to have open conversations with their doctors to determine if these drugs are suitable for their specific circumstances. Additionally, a holistic approach that includes targeting other factors beyond amyloid is necessary for effective treatment.