Olaparib Medicine 08 December 2020 Extended indication Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer. Therapeutic value Possible added value Total cost € 15,383,907.00 Registration phase Registration application pending Product Active substance Olaparib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer. Current proprietary name Already available biosimilars / generics Proprietary name Lynparza Manufacturer AstraZeneca Portfolio holder Mechanism of action PARP inhibitor Route of administration Oral Therapeutical formulation Tablet 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 October 2021 Expected Registration August 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Fabrikant verwacht indiening in de tweede helft van 2021. Therapeutic value Current treatment options Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation De resultaten van de studie zijn inmiddels bekend en gepubliceerd. Mediane follow-up van 2,5 jaar, de 3-jaars invasieve ziekte vrije overleving was 85,9% in de olaparib groep en 77,1% in de placebo groep. De hazard ratio voor invasieve ziekte of sterfte, 0,58. De verwachting is dat het de PAKSWILL-criteria zal halen. Duration of treatment Median 350 day / days Frequency of administration 2 times a day Dosage per administration 300 mg References NCT02032823 (OLYMPIA) https://www.nejm.org/doi/full/10.1056/NEJMoa2105215 Additional remarks Expected patient volume per year Patient volume 158 - 316 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL 2018; Pakketadvies palbociclib (Ibrance®) Additional remarks Invasief mammacarcinoom HER2 negatief kwam in 2018 bij 16.312 patiënten voor. Hiervan bevond 46% zich in stadium II of III. IKNL data geeft aan dat er 6.863 patiënten HER2 plus TNBC zijn, 42%. Daarnaast wordt 5%-10% van de borstkankers veroorzaakt door BRCA mutaties. Dit zou betekenen dat er uiteindelijk 158-316 patiënten in aanmerking zullen komen voor deze behandeling. Expected cost per patient per year Cost € 64,911.00 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 G-standaard Additional remarks Behandelduur is tot aan progressie of maximaal 12 maanden; 300mg 2 maal daags. De kosten van 1 tablet zijn €44,46. Voor de behandeling van een jaar betekent dit €64.911,60. Potential total cost per year Total cost € 15,383,907.00 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 Treatment in combination with abiraterone acetate in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC) who have not received prior chemotherapy or new hormonal agents (NHAs) mCRPC (first-line setting). (PROPEL). References Additional remarks Other information Additional remarks