Lecanemab Medicine 06 June 2023 Extended indication Leqembi is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early Alzheimer’s disease) who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology. Therapeutic value No estimate possible yet Total cost € 461,700,000.00 Registration phase Positive CHMP opinion Product Active substance Lecanemab Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Dementia Extended indication Leqembi is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early Alzheimer’s disease) who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology. Current proprietary name Already available biosimilars / generics Proprietary name Leqembi Manufacturer Eisai Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Amyloid beta-protein inhibitor. In de klinische studie zowel subcutaan als intraveneus getest. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Yes Submission date January 2023 Expected Registration January 2025 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie november 2024. Therapeutic value Current treatment options Cholinesteraseremmers. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Grote fase 3 NEJM jan 23. Lecanemab reduceerde markers van amyloid in vroege AD en gaf verminderde achteruitgang in cognitie ten opzichte van placebo bij 18 maanden folllow-up. Er werden wel ernstige bijwerkingen gevonden. Dit is mogelijk het eerste 'diseasemodifying' geneesmiddel dat goedgekeurd zal worden. Het is een monoklonaal antilichaam tegen Amyloid (net zoals Aduhelm, echter net een andere binding aan het Amyloid). Op alle uitkomsten zijn significante resultaten gevonden. Het klinisch effect is matig, echter kan je iemand 6 tot 12 maanden langer zelfstandig laten functioneren. Duration of treatment Frequency of administration 1 times every 2 weeks Dosage per administration 10 mg/kg References NCT03887455 Additional remarks 10mg per kilogram (mg/kg) biweekly (once every 2 weeks) administered as i.v. infusion or 720mg weekly administered as subcutaneous injection. Expected patient volume per year Patient volume 19,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References http://www.levenmetalzheimer.nl/content/alzheimer/feiten-cijfers.asp, https://www.sfk.nl/publicaties/PW/2016/inzet-medicijnen-bij-dementie-loopt-terug(1); Expertopinie (2) Additional remarks In Nederland zijn 270.000 mensen dement. Hiervan hebben 160.000 tot 190.000 mensen de ziekte van Alzheimer (maximaal 70%). In totaal waren er 30.000 geneesmiddelen gebruikers, die medicijnen kregen tegen dementie (SFK), uitgaande van 70% zal het maximaal gaan om 21.000 patiënten (1). Indien er een nauw label komt (MCI/Mild AD, voorzichtigheid bij APOE4 dragers en geen microbloedingen of antistolling gebruik). Wordt er gedacht dat er 19.000 patiënten in aanmerking komen (2). Expected cost per patient per year Cost € 24,300.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Eisai.com EISAI’S APPROACH TO U.S. PRICING FOR LEQEMBI™ (LECANEMAB), A TREATMENT FOR EARLY ALZHEIMER’S DISEASE, SETS FORTH OUR CONCEPT OF “SOCIETAL VALUE OF MEDICINE” IN RELATION TO “PRICE OF MEDICINE” Additional remarks In een bericht op de website van de fabrikant wordt een prijs van $26,500 per patiënt per jaar genoemd. Dit zou betekenen dat het product omgerekend €24.300 zou kosten. De prijs in Nederland is echter nog niet bekend. Fabrikant: 'Eisai decided to price LEQEMBI below quantified societal value at the wholesale acquisition cost (WAC) of $26,500 per year (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.' Potential total cost per year Total cost € 461,700,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks