Atezolizumab Medicine 07 December 2022 Extended indication Tecentriq in combination with bevacizumab for the treatment of adults with hepatocellular carcinoma (a cancer that starts in the liver), when the cancer has been removed by surgery or other techniques and is at high risk of coming back Therapeutic value No estimate possible yet Total cost € 10,000,000.00 Registration phase No registration expected Product Active substance Atezolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Liver cancer Extended indication Tecentriq in combination with bevacizumab for the treatment of adults with hepatocellular carcinoma (a cancer that starts in the liver), when the cancer has been removed by surgery or other techniques and is at high risk of coming back Current proprietary name Already available biosimilars / generics Proprietary name Tecentriq Manufacturer Roche Portfolio holder Roche Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Concentrate for solution for infusion Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date September 2023 Expected Registration February 2025 Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Fabrikant heeft MAA in september 2024 teruggetrokken. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation In de klinische studie was er een mediane follow-up van 17,4 maanden, IRF-RFS HR was 0,72 (95% CI: 0.56, 0.93; P = 0.0120). Voorlopig zal deze behandeling de PASKWIL-criteria met deze follow-up duur en HR nog niet halen. IMbrave050-studie nog niet gepubliceerd. Alleen PFS-data bekend van AACR 2023 (HR>0.70). Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 1200 mg References NCT04102098 (IMbrave050) Additional remarks Expected patient volume per year Patient volume 100 - 300 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References (1) NKR; (2) Hack et al 2020 Future Oncology; (3) Expertopinie; Additional remarks Totaal aantal nieuwe HCC-patiënten in 2021 per jaar 787 patiënten. Hiervan bevonden zich er 200 in stadium 4 (1). Op basis van recente literatuur vinden er ongeveer 100 resecties voor HCC per jaar plaats (2). Als echter ook patiënten in aanmerking komen die radiofrequente ablatie (RFA) of trans arteriële chemo-embolisatie (TACE) ondergaan hebben zou het patiëntvolume op maximaal 300 patiënten uit kunnen komen (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 Additional remarks Op basis van lijstprijs per vial (1.200mg atezolizumab) van €4.145. Kosten per patiënt per jaar zijn een inschatting in verband met onbekende behandelduur. Voor alle indicaties van atezolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot en met 31 december 2026). Potential total cost per year Total cost € 10,000,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks