Obinutuzumab Medicine 09 January 2018 Extended indication Gazyvaro in combination with chemotherapy, followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced follicular lymphoma (indolent non-hodgkin lymphoma (1L)). Therapeutic value Possible equal value Total cost € 9,625,000.00 Registration phase Unknown Product Active substance Obinutuzumab Domain Oncology and Hematology Reason of inclusion Main indication Lymphoma Extended indication Gazyvaro in combination with chemotherapy, followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced follicular lymphoma (indolent non-hodgkin lymphoma (1L)). Current proprietary name Already available biosimilars / generics Proprietary name Gazyvaro Manufacturer Roche Portfolio holder Mechanism of action Unknown 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 Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration September 2017 Orphan drug Yes Registration phase Unknown Reimbursement Medicine sluice Additional remarks Dit is een indicatie-uitbreiding. Geregistreerd september 2017. Al op de markt voor NHL 2L en FL. Therapeutic value Current treatment options Chemotherapie plus rituximab Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Geen overlevingswinst, beperkte plek. Duration of treatment Frequency of administration 11 times a year Dosage per administration 1000 mg References EPAR Additional remarks D1+D8+D15 in kuur 1 en D1 in de volgende 5 tot 7 kuren, gevolgd door onderhoudsbehandeling elke 2 maanden gedurende 2 jaar of tot progressie Expected patient volume per year Patient volume 50 - 500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Fabrikant Additional remarks Totaal aantal patiënten met nieuw gediagnosticeerd folliculair lymfoom volgens NKR: 480. Incidentie folliculair lymfoom in NL (NKR 2016), waarbij wordt aangenomen dat 60% in aanmerking komt voor een behandeling met obinutuzumab. Van max. naar realistisch patiëntenaantal: gezien de beschikbaarheid van andere behandelopties voor deze patiënten. Expected cost per patient per year Cost € 30,000.00 - 40,000.00 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 Medicijnkosten.nl Additional remarks Verwachting is zelfde prijs als voor huidige indicatie. €3.957,86 per 1000 mg. Potential total cost per year Total cost € 9,625,000.00 Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks