Ibrutinib Medicine 07 June 2022 Extended indication Extension of indication to include treatment with Imbruvica in combination with bendamustine and rituximab (BR) of adult patients with previously untreated mantle cell lymphoma (MCL) who are unsuitable for autologous stem cell transplantation Therapeutic value No estimate possible yet Total cost € 1,338,064.00 Registration phase No registration expected Product Active substance Ibrutinib Domain Hematology Reason of inclusion Indication extension IND Main indication Aggressive non-Hodgkin’s lymphoma Extended indication Extension of indication to include treatment with Imbruvica in combination with bendamustine and rituximab (BR) of adult patients with previously untreated mantle cell lymphoma (MCL) who are unsuitable for autologous stem cell transplantation Current proprietary name Already available biosimilars / generics Proprietary name Imbruvica Manufacturer Janssen Portfolio holder Mechanism of action Tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Proteïnekinaseremmer. Remt irreversibel Bruton’s tyrosinekinase. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date March 2022 Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Teruggetrokken door de fabrikant in december 2022. Therapeutic value Current treatment options Rituximab-CHOP Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation In de klinische studie zijn positieve resultaten behaald op PFS, maar er is geen OS winst behaald. Er wordt niet verwacht dat het een standaardbehandeling zal worden. De dosering is wat hoger dan bij patiënten met CLL. Duration of treatment Frequency of administration 1 times a day Dosage per administration 560mg References NCT01776840 Additional remarks Expected patient volume per year Patient volume < 16 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Fabrikant; Budget impact analyse van ibrutinib (Imbruvica) bij de behandeling van chronische lymfatische leukemie (patiënten zonder 17p of TP53 mutaties) Additional remarks De incidentie van MCL in Nederland was in 2015, 187 patiënten waarvan 130 patiënten ouder zijn dan 65 jaar. Ongeveer 12% van de patiënten hiervan komt in aanmerking voor deze behandeling. Het geschatte aantal patiënten komt daarmee op 12% x 130 = 16 patiënten per jaar. Expected cost per patient per year Cost € 83,629.00 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 G-standaard Additional remarks Lijstprijs (€57,28/tablet 140mg) x maximaal gebruik per jaar (4 tabletten/dag x 365 dagen) = €83.629. Potential total cost per year Total cost € 1,338,064.00 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