Consequences of Increased Life Expectancy with LEQEMBI treatment for Early AD, on its Estimated Benefits
What could be the consequences of increased life expectancy with LEQEMBI treatment for Alzheimer’s Disease, on its estimated benefits?
In the news they provided on January 6, 20212 (1), Eisai described their approach to pricing LEQEMBI (Lecanemab), a disease-modifying treatment for early Alzheimer’s Disease (AD). When approved, the treatment is expected to be reserved for patients with MCI or mild dementia stage of AD after confirmation of amyloid beta pathology (Early AD). The Eisai document describes the social impact of AD in the US, and the value of LEQEMBI adoption to U.S. society. The document is remarkable for its transparency and is easy to read. The pricing logic is based on the LEQEMBI clinical P3 efficacy (Clarity trial) results which were used to update a validated disease model, the Alzheimer’s disease Archimedes Condition Event (AD ACE), an individual patient-level model(2) with a focus on predicting the trajectory of cognitive decline and simulating the effects of early interventions in AD. Based on an average expected duration of 3.6 years – the treatment is stopped once the patient reaches the moderate AD stage,
LEQEMBI was estimated to slow clinical decline and delay disease progression by nearly 3 years on average (mainly progression from MCI to mild AD and from mild to moderate AD), resulting in an increase in patient’s expected time in Early AD while reducing the time in more advanced severe states (sic). As a result, LEQEMBI treatment would add 0.64 quality-adjusted life years (QALY) compared to standard of care (SOC). With a modified societal perspective of $ 200,000 willingness-to-pay (WTP) threshold per QALY gained and avoidance of AD management costs estimated at $ -7,415, the per-patient-per-year value of LEQEMBI treatment to US society was calculated to be $37,600, higher than the launch pricing of $ 26,500 per year.
In situations such as this economic simulation, one needs to consider that a treatment that delays disease progression by 3 years could impact life expectancy. Hence the added years at the end of a patient’s life could add to AD management costs and offset at least to some degree the reduction in AD management costs that resulted from the increase in the patient’s expected time in Early AD. Thus, the delay of progression and the reduced mortality could work against each other with respect to savings. This underscores the importance of sensitivity analysis of the simulations, and this may have been done for LEQEMBI.
However, only RW evidence gained over a long enough observation period will allow patients, their families, caregivers, healthcare providers, payers, Eisai and shareholders to figure this out.
(1) https://www.prnewswire.com/news-releases/eisais-approach-to-us-pricing-for-leqembi-lecanemab-a-treatment-for-early-alzheimers-disease-sets-forth-our-concept-of-societal-value-of-medicine-in-relation-to-price-of-medicine-301715694.html
(2) https://doi.org/10.1016/j.trci.2018.01.001
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Pharma industry veteran with 30+ years in large Pharma & in leading small biotechs, spearheading large initiatives and securing funding, psychiatry practice and research for 10+ years.