Atezolizumab Medicine 12 June 2018 Extended indication Extension of indication to include in combination with bevacizumab, paclitaxel and carboplatin the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (NSCLC) Therapeutic value Possible added value Total cost € 27,750,000.00 Registration phase Registered and reimbursed Product Active substance Atezolizumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Extension of indication to include in combination with bevacizumab, paclitaxel and carboplatin the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (NSCLC) Current proprietary name Already available biosimilars / generics Proprietary name Tecentriq Manufacturer Roche Portfolio holder Mechanism of action PD-1 / PD-L1 inhibitor 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 Unknown ATMP Unknown Submission date February 2018 Expected Registration March 2019 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Deze potentiele indicatie-uitbreiding is gebaseerd op de klinische studie IMpower150. Positieve CHMP-opinie in januari 2019. Geregistreerd in maart 2019. Therapeutic value Current treatment options Pembrolizumab / bevacizumab / chemotherapie in de toekomst ook andere immuuntherapieën Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Studieresultaten tonen een verbeterde PFS en OS. De verwachting is dat het in de praktijk niet in de eerste lijn zal worden opgenomen maar in lijn 2 of 3. Duration of treatment Average 8.2 month / months Frequency of administration 1 times every 3 weeks Dosage per administration 1200 mg References NCT02366143; Socinski et al. 2018. NEJM. Additional remarks Participants will receive IV infusion of atezolizumab (1.200 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 222 - 888 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Pakketadvies Atezolizumab; American Cancer Society Additional remarks Jaarlijks presenteren er ongeveer 4.500 patiënten per jaar met NSCLC stadium IV. Ongeveer 47% van deze patiënten heeft een niet-plaveiselcelcarcinoom (2.115). Hiervan ontvangt 60% een eerstelijnsbehandeling (1.269) waarvan 70% chemotherapie (888). De verwachting is dat dit aantal patiënten gedeeld zal moete worden met nivolumab en pembrolizumab in de eerste lijn. Gezien de overige behandelopties met immuuntherapie is de verwachting dat het in de praktijk niet in de eerste lijn zal worden opgenomen maar in lijn 2 of 3. 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 Fabrikant Additional remarks Op basis van lijstprijs per vial (1.200 mg) van €4.145,00 (enkel voor atezolizumab),De gemiddelde behandelduur van atezolizumab in N-SQ NSCLC is onbekend. Er wordt momenteel rekening gehouden met de mediaan. Voor alle indicaties van atezolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot en met 31 december 2019). Voor de indicatie blaaskanker zit atezolizumab nog in de sluis. Potential total cost per year Total cost € 27,750,000.00 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 lopen meerdere PhIII studies. References clinicaltrials.gov en huidige horizonscan. Additional remarks Other information Additional remarks