Encorafenib Medicine 05 December 2023 Extended indication Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation. Therapeutic value No estimate possible yet Total cost € 12,225,000.00 Registration phase Registered and not reimbursed Product Active substance Encorafenib Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation. Current proprietary name Already available biosimilars / generics Proprietary name Braftovi Manufacturer Pierre Fabre Portfolio holder Pierre Fabre Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks BRAF remmers Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date October 2023 Expected Registration August 2024 Orphan drug No Registration phase Registered and not reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie juli 2024 Therapeutic value Current treatment options Ametinib Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Lopende fase 2 studie in zowel behandelde als onbehandelde patiënten. Duration of treatment Frequency of administration Dosage per administration References NCT03915951 Additional remarks Expected patient volume per year Patient volume < 75 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2021 (1) Yan N, Guo S, Zhang H, Zhang Z, Shen S, Li X. BRAF-Mutated Non-Small Cell Lung Cancer: Current Treatment Status and Future Perspective. Front Oncol. 2022 Mar 31;12:863043. doi: 10.3389/fonc.2022.863043. PMID: 35433454; PMCID: PMC9008712 (2) Additional remarks In 2021 waren er 10.096 diagnoses NSCLC in Nederland. Dit betrof 1.727 patiënten in stadium I, 822 patiënten in stadium II, 2.231 patiënten in stadium III, 5.247 patiënten in stadium IV (1). Ongeveer 2% betreft een BFAF mutatie, waarvan de helft een V600 mutatie betreft (2). Dit betekent dat er ongeveer 75 patiënten in aanmerking zullen komen Expected cost per patient per year Cost € < 163,000.00 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; SmPC Additional remarks Deze inschatting is gebaseerd op een eerdere indicatie voor melanoom. 450mg encorafenib (6 capsules van 75 mg) een maal per dag gedurende een jaar kost in totaal €83.687,03. Daarnaast moeten patiënten ook een maal per dag zes capsules binimetinib innemen (15mg). Dit kost per jaar €79.140,40. In totaal kost deze behandeling dus €162.827,43. Potential total cost per year Total cost € 12,225,000.00 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