Niraparib Medicine 10 June 2020 Extended indication As monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. Therapeutic value No judgement Total cost € 50,244,375.00 Registration phase Registered Product Active substance Niraparib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Ovarian cancer Extended indication As monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. Current proprietary name Already available biosimilars / generics Proprietary name Zejula Manufacturer GSK Portfolio holder Mechanism of action PARP inhibitor Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date March 2020 Expected Registration November 2020 Orphan drug Yes Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in september 2020. Niraparib is in de sluis geplaatst. Therapeutic value Current treatment options Non-BRCA Actieve surveillance na platinum-bevattende chemotherapie. Bij BRCA mogelijk olaparib. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Naar verwachting zullen PARP-remmers ingezet gaan worden in de eerste lijn. Duration of treatment Frequency of administration 1 times a day Dosage per administration 100 mg tot 300 mg References NCT02655016 Additional remarks Schema voor dosis reductie opgenomen in SMPC. In de PRIMA trial is de startdosering voor patiënten <77kg of met een platelet count <150.000 per kubieke millimeter 200 mg per dag. Voor behandelduur wordt de PFS gebruikt. Non-BRCA patiënten populatie is de PFS is respectievelijk 8 en 19 maanden in de HR proficient en HR deficient/BRCAwildtype groep. In de HRd/BRCAmut groep is de PFS 22 maanden. (HR=homologous recombination) Ref: PRIMA trial Expected patient volume per year Patient volume < 625 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Weiderpass and Tyczynski. Mol Diagn Ther. 2015 Dec;19(6):351-64; expertopinie. Additional remarks In 2018 waren er 1.155 diagnoses epitheliaal ovariumcarcinoom, 126 diagnoses extraovarieel ovariumcarcinoom en 61 diagnoses tubacarcinoom. In totaal zijn dit 1.342 patiënten. Hiervan heeft 47% stadium III (631) en 26% stadium IV (349), wat samen 980 patiënten betreft. Van deze groep hebben 735 patiënten (75%) een hooggradige vorm van ovariumcarcinoom. Van deze groep hebben 625 patiënten (85%) een complete of gedeeltelijke respons (onafhankelijk van BRCA/HDR). Expected cost per patient per year Cost € 80,391.00 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; z-index mei 2020. Additional remarks €80.391 per jaar op basis van maximaal constante dosering van 200mg per dag 56 stuks verpakking [niet rekening houdend met dose interruptie/reducties] 100mg 56 stuks €6.167 per verpakking. Niraparib is in de sluis geplaatst tot er een financieel arrangement is overeengekomen. Potential total cost per year Total cost € 50,244,375.00 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 Small cell lung cancer References adisinsight Additional remarks Lopende fase 3 studie. Other information Additional remarks