Olaparib Medicine 12 June 2018 Extended indication Extension of indication to include the use of Lynparza as a montherapy for the maintenance treatment of adult patients with newly diagnosed advanced BRCA-mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to first-line platinum-based chemotherapy. Therapeutic value No judgement Total cost € 2,175,000.00 Registration phase Registration application pending Product Active substance Olaparib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Ovarian cancer Extended indication Extension of indication to include the use of Lynparza as a montherapy for the maintenance treatment of adult patients with newly diagnosed advanced BRCA-mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to first-line platinum-based chemotherapy. Current proprietary name Already available biosimilars / generics Proprietary name Lynparza Manufacturer AstraZeneca Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks PARP inhibitor Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2018 Expected Registration September 2019 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks SOLO-1 trial, Moore et al. N Engl J Med. 2018 Oct 21 Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Median 24.6 month / months Frequency of administration 2 times a day Dosage per administration 300 mg References NCT01844986; Moore et al. N Engl J Med. 2018 Oct 21 Additional remarks Expected patient volume per year Patient volume < 87 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; CieBOM Additional remarks In 2015 zijn 347 patiënten geregistreerd met ovariumcarcinoom stadium 4, hiervan heeft de helft waarschijnlijk een BRCA mutatie. Dat betekent maximaal 174 patiënten. Realistisch (gezien concurrentie en 2L behandeling) maar de helft hiervan voor het middel in aanmerking komen. Expected cost per patient per year Cost € 20,000.00 - 30,000.00 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 Medicijnkosten.nl Additional remarks Tablet 50 mg kost €11,78 p.p.p.j. gebaseerd op 300 mg per dag, 365 dagen lang (€25.798,20). Potential total cost per year Total cost € 2,175,000.00 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