Neurologists at the Clinical Trials on Alzheimer’s Disease (CTAD) annual meeting welcomed the introduction of the first US Food and Drug Administration-approved anti-amyloid antibody for early Alzheimer’s disease to also win Medicare coverage – Eisai Co., Ltd./Biogen, Inc.’s Leqembi (lecanemab) – but also noted the thoughtful process their affiliated health care centers are undertaking to make sure the therapy gets to appropriate patients.
Key Takeaways
-
Treating early Alzheimer’s disease with anti-amyloid therapies, like Eisai/Biogen’s Leqembi, involves PET scans, MRI monitoring, genetic testing and infusion of the medicines – a complicated process for doctors, health care systems and their patients.
-
Neurologists at the recent CTAD meeting detailed the protocols that their health care facilities have devised for administering anti-amyloid antibodies to appropriate patients
The FDA converted Leqembi’s accelerated approval to a traditional approval on 6 July, and the Centers for Medicare and Medicaid Services (CMS) simultaneously announced that Medicare would cover the drug. However, the product’s rollout is complex given the requirements and recommendations in Leqembi’s label for amyloid PET scans to establish disease pathology, MRIs to monitor for amyloid-related imaging abnormalities (ARIA) and genetic testing to assess APOE4 status, due to carriers of the gene, particularly homozygotes, having higher ARIA risk
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Scrip for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?
