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Alzheimer International Society sends letter to support Senator Bernie Sanders Regarding Alzheimer Drug Cost
SUNNYVALE, CA, USA, June 9, 2023/EINPresswire.com/ — The Alzheimer International Society (AIS) informed Senator Bernie Sanders, Chairman U.S. Senate Committee on Health, Education, Labor, and Pensions that it fully supports the content of his letter to Secretary Xavier Becerra (June 7, 2023) regarding the cost of the Alzheimer’s Drug, lecanemab (Leqembi), its clinical benefit, and the plan to charge patients $26,500 per year for the drug. The Institute for Clinical and Economic Review, an independent non-profit organization, has estimated that this drug should be sold for as little as $8,900 per year based on its effectiveness.
AIS pointed out in its letter to senator Sanders that the recently released data for Leqembi has not demonstrated that drug therapy slows cognitive and functional decline over 18 months. Further, the reported 27% as the clinical benefit of Leqembi can be misleading and a wrong comparison.
As reported by van Dyck et al. [1], CDR-SB score increased 1.21 points in 18 months from the study start (baseline) of 3.2 in the Leqembi group and 1.65 in the control group.
According to a recent peer-review publication [2], the 0.45 difference is often interpreted as 27% less cognitive decline (0.45/1.65) in the clinical benefit of Leqembi treatment is misleading and erroneous. The actual difference in the CDR-SB scores in the Leqembi (4.21) and control groups (4.86), is only 9.3% (0.45/4.86), which is unlikely to provide clinically meaningful benefit in people living with mild to moderate Alzheimer’s disease. [3]
“In addition to the lack of evidence of a clinically meaningful benefit, Leqembi is associated with amyloid related imaging abnormalities (ARIA), an adverse event which manifests as edema or microhemorrhages (bleeding in the brain), that occurred in 21% of patients taking the drug in the clinical trial”, stated Les Hamasaki, Executive Director of AIS. He continued: “At least 3 deaths in the ongoing open-label extension phase of the study have been linked to co-administration of the thrombolytic drug alteplase. Development of ARIA, seen in one in five patients taking Leqembi, could potentially lead to unmasking of trial participants, introducing bias and complicating the interpretation of results. We therefore support Senator Sanders call to question and reduce the reimbursement coverage of all FDA approved anti-amyloid drugs for Alzheimer’s disease.”
About Alzheimer International Society
Alzheimer International Society™ is a non-profit organization with the goal to facilitate and accelerate research to find prevention and treatment therapeutics for Alzheimer’s disease, and to provide services and support to our stakeholders around the world. https://www.alzint.com.
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CONTACT:
Les Hamasaki
Executive Director
Alzheimer International Society
Sunnyvale, CA 94086 USA
Tel: 1-408-797-0010
Email: media@alzint.com
www.alzint.com
Reference:
1. van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in early Alzheimer’s disease. N Engl J Med 2023;388:9-21
2. Kurkinen, M, Fułek M, Fułek, K, Beszłej JA, Kurpas D, Leszek J. The Amyloid Cascade Hypothesis in Alzheimer’s Disease: Should We Change Our Thinking? Biomolecules 2023, 13, 453. https://doi.org/10.3390/biom13030453
3. Landsdall CJ, McDougall F, Butler LM et al. Establishing clinically meaningful change on out-come assessments frequently used in trials of mild cognitive impairment due to Alzheimer’s dis-ease. J Prev Alzheimers Dis 2023:10(1):9-18
Les Hamasaki
Alzheimer International Society
+1 408-797-0010
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