EMA's turnaround on Lecanemab
Somewhat surprisingly, EMA reversed its negative decision on Lecanemab to treat Alzheimer's disease. However, I still think it is unlikely that the product will reach Swedish patients anytime soon.
In August, I wrote about EMA rejecting Lecanemab to treat Alzheimer’s disease (in Swedish). In a somewhat surprising turnaround, EMA has re-considered and recommends marketing authorization (which is now likely to be the decision by the commission). However, I guess it is still a very long way for patients in Sweden (and patients in many other European countries) to get access to Lecanemab.
Waiting on a final NICE recommendation
In England, where MHRA gave market authorization to Lecanemab earlier this year, the final NICE recommendation is still pending. The preliminary recommendation was not to use Lecanemab (or Donanemab) in the NHS, (mostly?) based on cost-effectiveness considerations. The final recommendation is expected early next year.
As has been discussed in several reports, e.g., by the US ICER organization, the pricing of Lecanemab can be considered a challenge for payers and society, both in light of the modest (modeled) patient benefits (a lifetime gain of 0.5 QALYs in the ICER report) and also given the high prevalence of the condition. The cost challenge is driven by both the cost of the drug and the substantial costs of administrating infusions and monitoring potential side effects. If Eisai/Biogen is not willing to offer quite substantial discounts to the European market, I find it highly unlikely that patients will see access anytime soon (at least in “cost-effectiveness countries”).
A new area for diabetes drugs?
A lot of research is ongoing in the Alzheimer’s space, which has seen many drug candidates fail over the years. The UK Alzheimer’s Society has singled out three interesting candidates to watch. It includes two drugs in the “amyloid-hypothesis” space, including an Eli Lilly drug (producer of Donanemab). This drug is intended to have a more efficient mode of administration (moving away from infusions), which can also be important from a cost perspective.
Most interestingly (I think), a third drug (or class of drugs) to watch includes Semaglutide (yes, here as well…). Several observational studies have found an association between newer glucose-lowering drugs (GLP-1s and SGLT2s) and a lower risk of dementia and Alzheimer’s. The figure is a summary from a review paper by Huilin Tang (PhD graduate from the University of Florida as of this week, where I was on the committee) that has several ongoing papers documenting interesting results on GLP-1s and Alzheimer’s (Huilin’s Google Scholar).
Given the non-randomized nature of these studies, confounding is, of course, a concern. Therefore, it will be very interesting to follow the results from the randomized trials now run by Novo Nordisk to assess if semaglutide has a beneficial effect on patients with early Alzheimer’s disease. Results are likely to come in by 2026 or so. The market for GLP-1s can continue to grow?