Eisai announces Leqembi U.S. launch pricing at $26,500 per year

Eisai (ESALY) and Biogen (BIIB) announced that under the Accelerated Approval Pathway the U.S. Food and Drug Administration has approved lecanemab-irmb, brand name in the U.S. Leqembi, 100 mg/mL injection for intravenous use, a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta for the treatment of Alzheimer’s disease. Eisai stated: "Based on hhc – human health care – concept, our corporate philosophy, Eisai is committed to improve patients health outcomes and quality of life, simplify care delivery, increase health system efficiency and spur future investments in Alzheimer’s disease. We consider a holistic approach in assessing value and making decisions that may affect patient access, so that our Leqembi pricing approach can maximize value for all stakeholders. This approach includes clinical outcome assessments of our medicines and the benefits we deliver to patients, their families and caregivers as the ‘clinical value,’ as well as the projected ‘social value’ that help improve patients’ and caregivers’ quality of life and productivity. Moreover, we assess the simulated impact of our medicines on reducing demand for health services and global burden of disease as potential ‘economic value’ while enhancing further innovations in AD… While we estimate the per-patient-per-year value of Leqembi treatment to the U.S. society to be $37,600, Eisai decided to price Leqembi below quantified societal value at the wholesale acquisition cost, or WAC, of $26,500 per year, which is an estimated annual price based on 10mg/kg IV biweekly for average U.S. patient weight of 75kg based on Study 201 and Clarity AD, aiming to promote broader patient access, reduce overall financial burden, and support health system sustainability. As such, the WAC for the 200mg vial is $254.81 and the WAC for the 500mg vial is $637.02. Actual annualized pricing may vary by patient. In addition, Eisai continues to pursue a less frequent maintenance dosing regimen for Leqembi, such as monthly instead of current biweekly regimen, upon significant amyloid beta clearance to prevent re-accumulation of amyloid beta biomarkers while maintaining clinical efficacy. This could further lower the yearly cost of Leqembi during the maintenance dosing phase, for example, from $26,500 to potentially about half of this figure given less amount of drugs… The price of Leqembi at a yearly cost of $26,500 is $11,100 below the projected societal value of $37,600, and a less frequent maintenance dosing regimen will further lower the yearly cost well below the projected societal value. Taking these savings as well as discounts and rebates within the U.S. healthcare system into consideration, over 10 years cumulatively, the gradual adoption of Leqembi treatment at this pricing approach could give back about 60% of the potential positive social impact of several tens of billion dollars to the U.S. society."