Dabrafenib / trametinib Medicine 04 December 2025 Extended indication Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2). Therapeutic value No estimate possible yet Total cost € 77,360,000.00 Registration phase Registered Product Active substance Dabrafenib / trametinib Domain Oncology Reason of inclusion Indication extension IND Main indication Thyroid cancer Extended indication Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2). Current proprietary name Already available biosimilars / generics Proprietary name Tafinlar / Mekinist Manufacturer Novartis Portfolio holder Mechanism of action Combination therapy 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 ATMP No Submission date September 2025 Expected Registration May 2026 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in maart 2026. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation In de fase III‑trial CDRB436J12301 bij 153 patiënten met lokaal gevorderd of gemetastaseerd, RAI‑refractair BRAF‑positief gedifferentieerd schildkliercarcinoom liet de combinatie dabrafenib + Trametinib een significant voordeel zien ten opzichte van placebo. De mediane progressievrije overleving bedroeg 12,8 maanden versus 3,7 maanden (HR 0,38; p < 0,001), en de objectieve respons was 57,4% versus 3,8% (p < 0,001). Hoewel er een positieve trend in overall survival werd gezien, was dit niet statistisch significant. Het veiligheidsprofiel was consistent met eerdere bevindingen, met de meest voorkomende bijwerkingen koorts en anemie, en serieuze retinopathie bij 6,9% van de patiënten. Duration of treatment Frequency of administration Dosage per administration References NCT04940052 (CDRB436J12301); ESMO 2025 presentatie; Expertopinie. Additional remarks Expected patient volume per year Patient volume < 800 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2022 (1) Additional remarks De incidentie schildklierkanker was 895 patiënten in 2022 (1), hiervan heeft ongeveer 86% gedifferentieerd schildklierkanker (papillaire, folliculaire en Hurthle cell carcinoom) (n=760). Expected cost per patient per year Cost € < 96,700.00 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 Pakketadvies sluisgeneesmiddel dabrafenib in combinatie met trametinib (Tafinlar® en Mekinist®) bij de adjuvante behandeling van volwassen patiënten met melanoom in stadium III met een BRAF V600-mutatie. Zorginstituut Nederland. 2020. Additional remarks Bij een behandelduur van 12 maanden komen de kosten van dabrafenib op €48.140 en van trametinib op €48.509. In totaal kost de behandelding daarmee €96.648. Potential total cost per year Total cost € 77,360,000.00 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