Dabrafenib / trametinib Medicine 04 December 2025 Extended indication Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1). Therapeutic value No estimate possible yet Total cost € 125,000.00 Registration phase Positive CHMP opinion Product Active substance Dabrafenib / trametinib Domain Oncology Reason of inclusion Indication extension IND Main indication Skin cancer Extended indication Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1). 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 BRAK en MEK-kinaseremmer Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date July 2025 Expected Registration June 2026 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume < 5 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2022 (1); Declaratiedata (2). Additional remarks Melanoom bij adolescenten is relatief zeldzaam (1). Op basis van gebruikersdata van dabrafenib / trametinib zullen er niet meer dan vijf extra patiënten in aanmerking komen voor deze indicatieuitbreiding (2). Expected cost per patient per year Cost € 20,000.00 - 30,000.00 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 Declaratiedata Additional remarks De gemiddelde vergoeding van dabrafenib / trametinib bij melanoom voor volwassenen zit tussen de €20.000 en €30.000. Potential total cost per year Total cost € 125,000.00 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