Rejecting False Claims from Markov Simulations in Alzheimer's Disease

Langley, Paul

doi:10.24926/iip.v14i3.5701

Cited by 1 publication

(1 citation statement)

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“…Predictive models for cost efficacy are one method that has been suggested to assist with the decision-making process. 44 By accepting the use of assumed values, modeling cannot completely account for all the potential “real-world” scenarios of patients across the spectrum of disease progression. Recently, The Institute for Clinical and Economic Review (ICER) used Markov modeling to assess cost-effectiveness of formulary addition of lecanemab.…”

Section: Discussionmentioning

confidence: 99%

Lecanemab: A Second in Class Therapy for the Management of Early Alzheimer’s Disease

Yoon,

Groff,

Criss

2024

Innov Pharm

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The Food and Drug Administration granted traditional approval of lecanemab for the treatment of Alzheimer’s disease (AD). Lecanemab is a humanized anti-amyloid monoclonal antibody directed towards Aβ protofibrils. Lecanemab is the only drug that targets Aβ soluble protofils and has shown statistical differences in mild AD or mild cognitive impairment. In its landmark phase III trial, lecanemab was shown to slow the progression of clinical decline, and a reduction in amyloid protein accumulation. The difference in mean CDR-SOB score improvement between the treatment and placebo groups was -0.45, of which the clinical significance could be argued. Amyloid burden was also considerably reduced as well, but the true clinical consequence of this reduction remains to be seen. This beneficial impact on daily living is offset by rare but serious side effects including amyloid-related imaging abnormalities (ARIA) causing cerebral edema (ARIA-E) or cerebral microhemorrhages or hemosiderin deposits (ARIA-H). Benefits of therapy must be considered against the risk of cerebral microhemorrhages and edema. Affordability must also be taken into consideration. The current estimated yearly cost for twice monthly lecanemab infusion is $26,500. In addition to the significant cost challenges, the frequent infusions may pose concerns related to access. Additional agents within this class are in the pipelines with possibly increased efficacy or decreased adverse events.

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Section: Discussionmentioning

confidence: 99%