Atezolizumab Medicine 06 June 2023 Extended indication In combination with cabozantinib patients with mCRPC previously treated with novel hormonal therapy (NHT). Therapeutic value No estimate possible yet Total cost € 135,000,000.00 Registration phase Clinical trials Product Active substance Atezolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Prostate cancer Extended indication In combination with cabozantinib patients with mCRPC previously treated with novel hormonal therapy (NHT). 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 2025 Expected Registration March 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Niet gefiled bij EMA, overall survival eindpunt niet gehaald (contact-02 studie). Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 1200 mg References NCT04446117 Additional remarks Expected patient volume per year Patient volume < 3,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Pembrolizumab; NKR, CAPRI en Zinnige Zorg verbetersignalement: Zinnig gebruik van geneesmiddelen bij patiënten met castratie refractair prostaatcarcinoom Additional remarks Totaal aantal nieuwe prostaatkankerpatiënten per jaar is meer dan 12.000. Patiënten geregistreerd in de NKR 2016 met "cM0cNX, cM0cN0, cMcN1, cM1, pM1" betreft 8.226 in totaal. Het gaat hierbij om zo’n 2.400 tot 3.000 CRPC patiënten (bron: CAPRI). Gezien bijna alle patiënten CRPC uitzaaiingen hebben is de verwachting dat het bijna de gehele groep mCRPC patiënten betreft. Expected cost per patient per year Cost € 35,000.00 - 55,000.00 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 https://zoek.officielebekendmakingen.nl/stcrt-2023-30299.html Additional remarks Op basis van lijstprijs per vial (1.200mg atezolizumab) van €3.700. 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). Zie publicatie in Staatscourant van 6 november 2023. Potential total cost per year Total cost € 135,000,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Verschillende indicaties References Product Development Portfolio Additional remarks Other information Additional remarks