Olaparib Medicine 09 January 2018 Extended indication Tabletten ipv capsules voor onderhoudsbehandeling platinum sensitief recidief ovariumcarcinoom. Therapeutic value No judgement Total cost € 5,438,160.00 Registration phase Unknown Product Active substance Olaparib Domain Oncology and Hematology Reason of inclusion Main indication Ovarian cancer Extended indication Tabletten ipv capsules voor onderhoudsbehandeling platinum sensitief recidief ovariumcarcinoom. Current proprietary name Already available biosimilars / generics Proprietary name Lynparza Manufacturer AstraZeneca Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date August 2017 Expected Registration June 2018 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Bestaande indicatie, andere toedieningsvorm. Therapeutic value Current treatment options Olaparib capsules Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 20 month / months Frequency of administration 2 times a day Dosage per administration 300 mg References Additional remarks Fabrikant: Bron: Studies of olaparib in ovarian cancer 2 (SOLO2): A Phase 3 study of olaparib — an investigational PARP inhibitor — as maintenance monotherapy in women with platinum-sensitive relapsed BRCA-positive ovarian cancer, peritoneal cancer, and/or fallopian tube cancer. ClinicalTrials.gov number: NCT01874353 Expected patient volume per year Patient volume 79 - 89 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant Additional remarks Fabrikant: Max. patiëntvolume gebaseerd op NKR, epidemiologische gegevens over BRCAm, op literatuur gebaseerde aannames t.a.v. respons op platinumbehandeling (literatuurverwijzingen terug te vinden in richtlijnen ovarium carcinoom en erfelijk ovariumcarcinoom). Realistisch patiëntvolume gebaseerd op NKR, epidemiologische gegevens over BRCAm, op literatuur gebaseerde aannames t.a.v. respons op platinumbehandeling (literatuurverwijzingen terug te vinden in richtlijnen ovarium carcinoom en erfelijk ovariumcarcinoom) en marktervaring van afgelopen 2 jaar. Expected cost per patient per year Cost € < 64,740.00 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 Additional remarks 13 x €4.980 (huidige prijs olaparib per 28 dagen) = €64.740 p.p.p.j. max. Toetreding van concurrenten op korte termijn verwacht. Potential total cost per year Total cost € 5,438,160.00 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 Ovarian cancer - first-line maintenance in high risk advanced BRCAm patients who are in response to first line platinum-based chemotherapy (PhIII). References Additional remarks Other information Additional remarks