Polatuzumab vedotin Medicine 07 June 2022 Extended indication Polatuzumab vedotin in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone, is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma Therapeutic value Possibly no place in the treatment regimen Total cost € 0.00 Registration phase Registered Product Active substance Polatuzumab vedotin Domain Hematology Reason of inclusion Indication extension IND Main indication Aggressive non-Hodgkin’s lymphoma Extended indication Polatuzumab vedotin in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone, is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma Current proprietary name Already available biosimilars / generics Proprietary name Polivy Manufacturer Roche Portfolio holder Roche Mechanism of action Antibody-drug conjugate Route of administration Intravenous Therapeutical formulation Intravenous drip 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 November 2021 Expected Registration May 2022 Orphan drug Yes Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie ontvangen in maart 2022. Therapeutic value Current treatment options Chemotherapie Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation In de fase 3 studie POLARIX werd een statistisch significant verschil gevonden voor de progressievrije overleving (PFS) ten opzichte van de standaard chemotherapie. Er wordt verwacht dat dit geneesmiddel mogelijk niet ingezet zal worden gezien de beperkte winst in PFS en er geen (algehele overleving) OS voordeel is. Duration of treatment Maximal 18 week / weeks Frequency of administration 1 times every 3 weeks Dosage per administration 1,8 mg/kg References NCT03274492https://ash.confex.com/ash/2021/webprogram/Paper154729.html Additional remarks Maximaal 6 cycli. Expected patient volume per year Patient volume 0 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR (1); Expert opinie & IKNL (2); Expert opinie (3) Additional remarks Volgens IKNL data uit 2018 waren e 1565 totale incidentele DLBCL patiënten (1). 85% van deze patiënten kreeg R-CHOP als eerstelijnsbehandeling (2). Er komen dus maximaal 1330 patiënten in aanmerking voor deze behandeling. Er wordt verwacht dat er geen plaats is voor dit middel gezien beperkte winst in PFS en er geen OS voordeel is (3). Expected cost per patient per year Cost € < 61,851.00 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 Medicijnkosten.nl Additional remarks Er is een financieel arrangement overeengekomen voor R/R-DLBCL. Polivy infusiepoeder flacon 30mg is dus € 2.061,7324 excl. Btw Polivy infusiepoeder flacon 140mg is dus € 9.621,43 excl. Btw Uitgaande van een dosering per toediening van 1,8mg/kg bij een persoon van 78,5kg (CBS) = 141,3mg gemiddeld. Dus 5x 30mg nodig: €10.308,662 per cyclus. Toediening van 1x per 3 weken voor maximaal 6 cycli komt het in Nederland neer op: €61.851,97. Potential total cost per year Total cost € 0.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Chronic lymphocytic leukaemia; Non-Hodgkin's lymphoma; Richter's syndrome References Adis Insight Additional remarks Per februari 2022 bevinden deze indicaties zich in fase 2. Other information Additional remarks