Atezolizumab Medicine 12 June 2018 Extended indication First line treatment of advanced non-squamous non-small cell lung cancer (NSCLC). Combination of Tecentriq, Avastin and chemotherapy. Therapeutic value No judgement Total cost € 27,050,000.00 Registration phase Registration application pending Product Active substance Atezolizumab Domain Oncology and Hematology Reason of inclusion Main indication Lung cancer Extended indication First line treatment of advanced non-squamous non-small cell lung cancer (NSCLC). Combination of Tecentriq, Avastin and chemotherapy. Current proprietary name Already available biosimilars / generics Proprietary name Tecentriq 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 An engineered anti-PD-L1 antibody,. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Indication extension ATMP Unknown Submission date April 2018 Expected Registration December 2018 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Sluis-product, financieel arrangement van toepassing. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration 1200 mg References NCT02366143 Additional remarks Participants will receive IV infusion of atezolizumab (1200 mg) and bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel (200 mg/m2) and carboplatin ( AUC 6 mg/ml/min) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Expected patient volume per year Patient volume 270 - 811 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Pakketadvies Atezolizumab Additional remarks NKR 2016: 9289 diagnoses NSCLC, stadium 3 en 4. 35% niet-plaveiselcel. 60% onvangt eerstelijnsbehandeling, waarvan 50% chemotherapie. Dit komt neer op een totaal van 811 patiënten. Realistisch volume: marktaandeel delen met nivolumab en pembrolizumab: 33,3%; 270 patiënten. Expected cost per patient per year Cost € 40,000.00 - 60,000.00 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 Dit is enkel voor Atezolizumab. Potential total cost per year Total cost € 27,050,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Er lopen meerdere PhIII studies. References clinicaltrials.gov Additional remarks Other information Additional remarks