Olaparib Medicine 09 January 2018 Extended indication Extension of indication to include patients with metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, a subpopulation of homologous recombination repair (HRR) gene mutations. Therapeutic value No judgement Total cost € 8,000,000.00 Registration phase Registered Product Active substance Olaparib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Prostate cancer Extended indication Extension of indication to include patients with metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, a subpopulation of homologous recombination repair (HRR) gene mutations. 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 December 2019 Expected Registration November 2020 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie september 2020. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Profund studie is positief (NEJM 2020; 382:2091-2102). Patiënten moeten BRCA1, BRCA2, of ATM mutatie hebben. Duration of treatment Median 7.4 month / months Frequency of administration 2 times a day Dosage per administration 300mg References NCT02987543; fabrikant. Additional remarks Expected patient volume per year Patient volume 100 - 300 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References bron: NKR en Zinnige Zorg verbetersignalement: Zinnig gebruik van geneesmiddelen bij patiënten met castratie refractair prostaatcarcinoom, Na et al. Eur Urol. 2017 May;71(5):740-747, N Engl J Med 2020; 382:2091-2102 DOI: 10.1056/NEJMoa1911440 Additional remarks Totaal aantal nieuwe prostaatkankerpatiënten per jaar is meer dan 12000. Patienten geregistreerd in de NKR 2016 met "cM0cNX, cM0cN0, cMcN1, cM1, pM1" betreft 8226 in totaal. Na starten van antihormonale therapie zal maximaal 20% van de patiënten binnen vijf jaar CRPC ontwikkelen (1645 patiënten), de inschatting is dat het in maximaal 20 % gaat om een mutatie in BRCA en ATM. De verwachting is echter dat het lager zal zijn, inschatting 100 - 300 patiënten. Expected cost per patient per year Cost € 40,000.00 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 G-standaard; fabrikant. Additional remarks De lijstprijs van een tablet 150 mg is €44,46 per tablet. Bij een dosering van 300mg tweemaal daags komt dit neer op €177,84 per dag. Bij behandeling van een volledig jaar is de totaalprijs €64.911,60 (365*4*€44,46). De mediane behandelduur is echter 7,4 maanden dus de kosten voor een behandeling zullen (€64.911,60/12)*7,4 = €40.029 bedragen. Potential total cost per year Total cost € 8,000,000.00 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 Colorectal cancer; Non-small cell lung cancer; Squamous cell cancer. References Adisinsight. Additional remarks Lopende fase 3 studies. Other information Additional remarks