Polatuzumab vedotin Medicine 13 December 2018 Extended indication Previously treated adult patients with diffuse large B-cell lymphoma who are not candidates for hematopoietic stem cell transplant Therapeutic value Possible added value Total cost Registration phase Registration application pending Product Active substance Polatuzumab vedotin Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Aggressive non-Hodgkin’s lymphoma Extended indication Previously treated adult patients with diffuse large B-cell lymphoma who are not candidates for hematopoietic stem cell transplant Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Roche Portfolio holder Mechanism of action Antibody-drug conjugate Route of administration Intravenous Therapeutical formulation Powder for solution for infusion Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks CD79b-targeted antibody drug conjugate that preferentially delivers a potent anti-mitotic agent (monomethyl auristatin E, or MMAE) to B-cells, resulting in anticancer activity against B-cell malignancies. Registration Registration route Centralised (EMA) Type of trajectory Accelerated assessment Particularity New medicine with Priority Medicines (PRIME) ATMP Unknown Submission date January 2019 Expected Registration September 2019 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Fabrikant verwacht in het gunstigste geval een registratie in Q4 2019. Therapeutic value Current treatment options geen Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Verbeterde PFS en OS ten opzichte van bendamustine+rituximab. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 1.8 mg/kg References NCT03274492,Sehn et al 2018 Studie: GO29365 Additional remarks Phase III: Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) intravenously (IV), placebo for vincristine IV, rituximab 375 milligrams per square meter (mg/m^2) IV, cyclophosphamide 750 mg/m^2 IV, and doxorubicin 50 mg/m^2 IV on Day 1 and prednisone 100 milligrams per day (mg/day) orally (PO) on Days 1-5 of every 21-day cycle for 6 cycles. Rituximab 375 mg/m^2 IV will be administered as monotherapy in Cycles 7 and 8. Toelichting fabrikant: "In de internationale studie wordt bendamustine+rituximab als vergelijkende arm gebruikt, aangezien dit op internationaal niveau een veelgebruikte (maar niet geregistreerde) combinatie is. Behandelduur nog onbekend op basis van huidige resultaten, maar is maximaal 6 behandelcycli." Expected patient volume per year Patient volume < 250 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Beoordeling ibrutinib. Zorginstituut Nederland Additional remarks De incidentie van DLBCL (en varianten) in Nederland in 2015 was 1.214 patiënten. Ongeveer 40% van de patiënten reageert niet op de eerste lijnsbehandeling. Ongeveer 50% van de patienten wordt in de tweedelijn behandeld met autologe stamceltransplantatie. Dit betekent dat 50% van de patienten in aanmerking zou komen voor behandeling met polatuzumab vedotin. Expected cost per patient per year Cost References Additional remarks Over de prijs van polatuzumab vedotin is nog geen informatie beschikbaar. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Fabrikant Additional remarks Indication extension Indication extensions Yes Indication extensions Er zijn studies gaande naar eerstelijns behandeling DLBCL en relapsed/refractair folliculair lymfoom References clinicaltrials.gov Additional remarks Other information Additional remarks