Bamlanivimab/ etesevimab Medicine 08 June 2021 Extended indication Combination for the treatment of COVID-19. The review will also look at bamlanivimab used alone. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Bamlanivimab/ etesevimab Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Viral infections other Extended indication Combination for the treatment of COVID-19. The review will also look at bamlanivimab used alone. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Eli Lilly Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Bamlanivimab and etesevimab are two monoclonal antibodies with activity against COVID-19 Registration Registration route Centralised (EMA) Type of trajectory Accelerated assessment Particularity Unknown ATMP Unknown Submission date March 2021 Expected Registration November 2021 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Hoewel Lilly in een eerder stadium met VWS sprak over de levering van bamlanivimab. Alleen heeft Lilly inmiddels besloten om de monotherapie niet meer verder te vervolgen en zich te focussen op de combinatie therapie bamlanivimab en etesivimab. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation In de fase 3 studie werden1.035 hoog risico patiënten met vroege covid binnen 3 dagen behandeld. Er werd 70% reductie in Covid gerelateerde ziekenhuisopname waargenomen (11/518 versus 36/517). En geen overlijdens in actieve arm versus 10 in de placebo groep. Duration of treatment Frequency of administration Dosage per administration References BLAZE-1; BLAZE-2 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Het mogelijke patiëntvolume per jaar zal afhankelijk zijn van het verloop van de epidemie. Expected cost per patient per year Cost References https://www.clinicaltrialsarena.com/comment/eli-lillys-monoclonal-antibody-bamlanivimab/ Additional remarks Uit een artikel blijkt dat de Verenigde Staten voor $1.250 per 700mg bamlanivimab heeft ingekocht van de fabrikant. De prijs in Nederland is nog niet bekend. Potential total cost per year Total cost 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