Encorafenib Medicine 03 June 2025 Extended indication Encorafenib in combination with cetuximab and FOLFOX is indicated for the first line treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation Therapeutic value No estimate possible yet Total cost € 17,136,000.00 Registration phase Positive CHMP opinion Product Active substance Encorafenib Domain Oncology Reason of inclusion Indication extension IND Main indication Colon cancer Extended indication Encorafenib in combination with cetuximab and FOLFOX is indicated for the first line treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation Current proprietary name Already available biosimilars / generics Proprietary name Braftovi Manufacturer Pierre Fabre Portfolio holder Mechanism of action Serine / threonine kinase inhibitor Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Encorafenib is al vergoed voor BRAF V600E-mutant Colorectal cancer na twee eerdere lijnen. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date November 2025 Expected Registration July 2026 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in mei 2026. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De tussentijdse analyse laat veelbelovende resultaten zien voor de nieuwe behandeling: "OR (EC+mFOLFOX6: 60.9%; SOC: 40.0%; odds ratio, 2.4; 95% CI: 1.4–4.3). Median duration of response 13.9 versus 11.1 maanden. At this first interim analysis of overall survival, the hazard ratio was 0.47 (95% CI: 0.318–0.691)." Duration of treatment Frequency of administration 1 times a day Dosage per administration 300 mg References NCT04607421 (BREAKWATER); Kopetz et al. Nature. 2025 Additional remarks Expected patient volume per year Patient volume < 357 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2023 (1); Meyer et al. EJSO. 2022 (2); van Nassau et al. Int J Cancer. 2025 (3). Additional remarks In 2023 waren er 2.665 diagnoses dikkedarm- en endeldarmkanker stadium IV (1). 14% verslechtert van stadium I-III naar stadium IV (2). In 2023 waren er 9.150 diagnoses dikkedarm- en endeldarmkanker stadium I-III (1). Er wordt daarom uitgegaan dat er jaarlijks 2.665 + (9.150 x 14%) = 3.946 patiënten bij komen met stadium IV dikkedarm- en endeldarmkanker. Ongeveer 9% van deze patiënten heeft de BRAF V600E mutatie (3). Er wordt uitgegaan van 3.946 x 9% = 357 patiënten per jaar. Expected cost per patient per year Cost € < 48,000.00 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 Een capsule van 75 mg Braftovi kost €35,82 (incl. BTW). Een jaarbehandeling bij een dagelijkse toediening van 300 mg kost dan €47.979 (excl. BTW) (€35,82/1,09*4*365). Hierbij zijn de kosten van cetuximab nog niet opgeteld. Potential total cost per year Total cost € 17,136,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks