Cemiplimab Medicine 08 June 2021 Extended indication Extension of indication to include monotherapy treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Therapeutic value No estimate possible yet Total cost € 7,280,000.00 Registration phase Registration application pending Product Active substance Cemiplimab Domain Oncology Reason of inclusion Indication extension IND Main indication Cervical cancer Extended indication Extension of indication to include monotherapy treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Current proprietary name Already available biosimilars / generics Proprietary name Libtayo Manufacturer Sanofi Portfolio holder Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Infusion fluid Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks PD-1 receptor antagonist Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date November 2021 Expected Registration December 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks De fabrikant verwacht registratie rond december 2022. Therapeutic value Current treatment options Bevacizumab, chemotherapie. 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 350 mg References NCT03257267 Additional remarks Expected patient volume per year Patient volume < 80 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Horizonscan Geneesmiddelen; pembrolizumab + chemo (1L combo) cervical cancer, NKR 2019 incidentie baarmoederhalskanker Additional remarks Het cervixcarcinoom wordt in Nederland jaarlijks bij ongeveer 912 vrouwen vastgesteld. Er wordt verwacht dat er 70-80 patiënten in aanmerking zullen komen voor eerstelijnsbehandeling met pembrolizumab in combinatie met chemo. Voor de tweedelijn monotherapie cemiplimab komt hierdoor naar verwachting een deel van deze groep in aanmerking. Expected cost per patient per year Cost € 91,000.00 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 Lijstprijs zoals vermeld in de G-Standaard van Z-Index Additional remarks 1 maal per 3 weken €5.721,10 inclusief btw dus €5.248,72 exclusief btw. Uitgaande van een heel behandeljaar zouden de kosten maximaal zo'n €91.000 betreffen. Potential total cost per year Total cost € 7,280,000.00 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 NSCLC References Fabrikant Additional remarks Other information Additional remarks