Rucaparib Medicine 05 December 2023 Extended indication Treatment of metastatic castration resistant prostate cancer (CRPC) associated with a deleterious alteration in either the BRCA1, BRCA2 or ATM genes. Therapeutic value No estimate possible yet Total cost € 10,000,000.00 Registration phase Clinical trials Product Active substance Rucaparib Domain Oncology Reason of inclusion Indication extension IND Main indication Prostate cancer Extended indication Treatment of metastatic castration resistant prostate cancer (CRPC) associated with a deleterious alteration in either the BRCA1, BRCA2 or ATM genes. Current proprietary name Already available biosimilars / generics Proprietary name Rubraca Manufacturer Clovis Portfolio holder Mechanism of action PARP inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Small molecule inhibitor of poly-adenosine diphosphate [ADP] ribose polymerase (PARP) Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2024 Expected Registration 2025 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Inmiddels is deze studie afgerond en in behandeling bij de FDA. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De duur van imaging-based progression-free survival was significant langer in de rucaparib groep dan in de controle groep, zowel in de BRCA subgroep (median, 11,2 maanden en 6,4 maanden; hazard ratio, 0.50; 95% confidence interval [CI], 0,36 tot 0,69) en in de intention-to-treat groep (median, 10.2 months and 6.4 months, respectively; hazard ratio, 0.61; 95% CI, 0.47 to 0.80; P<0.001 for both comparisons). Het effect bij patiënten met een BRCA-mutatie lijkt relevant. De verwachting is dat de ATM subgroep niet zal voldoen aan de PASKWIL-criteria. Duration of treatment Frequency of administration 2 times a day Dosage per administration 600mg References TRITON2 (NCT02952534); TRITON3 (NCT02975934) Additional remarks The recommended rucaparib dose is 600mg orally twice daily with or without food. Patients receiving rucaparib for mCRPC should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. Expected patient volume per year Patient volume 100 - 300 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 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 12.000. Patiënten geregistreerd in de NKR 2016 met "cM0cNX, cM0cN0, cMcN1, cM1, pM1" betreft 8.226 in totaal. Na starten van anti hormonale therapie zal maximaal 20% van de patiënten binnen vijf jaar CRPC ontwikkelen (1.645 patiënten), de inschatting is dat het in maximaal 20 % gaat om een mutatie in BRCA en ATM. De verwachting is dat de ATM subgroep niet zal voldoen aan de PASKWIL-criteria. Inschatting hooguit 100 tot 300 patiënten. Expected cost per patient per year Cost € < 50,000.00 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 Bij een behandeling van 2 maal per dag 600mg gedurende een jaar komen de kosten uit op ongeveer €50.000. Potential total cost per year Total cost € 10,000,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks