Zanubrutinib Medicine 06 June 2023 Extended indication Brukinsa in combination with obinutuzumab is indicated for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies. Therapeutic value No estimate possible yet Total cost € 11,752,000.00 Registration phase Registered Product Active substance Zanubrutinib Domain Hematology Reason of inclusion Indication extension IND Main indication Indolent non-Hodgkin’s lymphoma Extended indication Brukinsa in combination with obinutuzumab is indicated for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies. Current proprietary name Already available biosimilars / generics Proprietary name Brukinsa Manufacturer Astex Portfolio holder Mechanism of action Tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date March 2023 Expected Registration November 2023 Orphan drug Yes Registration phase Registered Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options CD-20 Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De rosewood trial (ZInzani JCO 2023) laat een ORR voordeel zien van Zanubrutinib-obinutuzumab versus obinutuzumab monotherapie (69% versus 46%), echter heeft CD20 monotherapie al niet de voorkeur in de behandelrichtlijn. Er zijn veel andere behandelopties die eerder ingezet zullen worden dan de CD20 BTK-remmer combinatietherapie. Duration of treatment Frequency of administration Dosage per administration References NCT03332017 Additional remarks Expected patient volume per year Patient volume 90 - 135 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Pakketadvies sluisgeneesmiddel axicabtagene ciloleucel (Yescarta®) voor volwassenen met recidiverend of refractair DLBCL en PMBCL na 2 of meer lijnen systemische therapie, ZIN 2019 Additional remarks In de budget impact analyse van het pakketadvies wordt een inschatting gemaakt van 90 tot 135 patiënten 3 jaar na marktintroductie. De verwachting is dat door concurrentie zanubrutinib nauwelijks ingezet zal worden voor deze indicatie. Expected cost per patient per year Cost € 70,000.00 - 138,000.00 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 https://www.pharmacytimes.com/news/trending-news-today-beigene-sets-price-for-zanubrutinib-for-mantle-cell-lymphoma Additional remarks In de Verenigde Staten is de lijstprijs voor zanubrutinib gesteld op $12,935 (ongeveer €11.500). Voor de behandeling van een jaar zou dat €138.000 bedragen. Zanubrutinib zal de concurrentie aan moeten gaan met ibrutinib, wat €69.839 per jaar kost. Naar verwachting zal de prijs in Europa vergelijkbaar zijn. Potential total cost per year Total cost € 11,752,000.00 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