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Dabrafenib / Trametinib

Tafinlar / Mekinist

Extended indication Adjuvante behandeling van stadium III melanoom met een BRAFV600 mutatie na volledige resectie.
Therapeutic value No judgement
Total cost 22,725,000.00
Registration phase Registration application pending

Product

Active substance Dabrafenib / Trametinib
Domain Oncology and Hematology
Main indication Skin cancer
Extended indication Adjuvante behandeling van stadium III melanoom met een BRAFV600 mutatie na volledige resectie.
Proprietary name Tafinlar / Mekinist
Manufacturer Novartis
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks BRAF en MEK kinase remmer

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Indication extension
Submission date November 2017
Expected Registration September 2018
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options Follow-up zonder medicamenteuze behandeling of clinical trial
Therapeutic value No judgement
Duration of treatment Median 11 month / months
Frequency of administration 1 times a day
Dosage per administration 300 mg / 2 mg
References Long et al. N Engl J Med. 2017 Nov 9;377(19):1813-1823.
Additional remarks Dabrafenib 2 maal per dag 150 mg, Trametinib 1 maal per dag 2mg

Expected patient volume per year

Patient volume

128 - 175

Market share is generally not included unless otherwise stated.
References Fabrikant; NKR; Ascierto et al. J Transl Med. 2012; 10: 85
Additional remarks NKR 2015: 427 diagnoses melanoom stadium 3. 50% van melanoom is BRAF mutated. Inschatting van de fabrikant bij Nivolumab is 350. Dit zou 175 patiënten betekenen. Novartis: 500 melanoompatiënten, (75% wordt verwezen naar een melanoomcentrum) x (95% krijgt een BRAF test) x (90% treatment rate) x (40% market share). 128 patiënten totaal.

Expected cost per patient per year

Cost 150,000.00
Additional remarks Decentrale prijs afspraak met 14 expertise centra. Capsule Dabrafenib 50 mg kost €39,05. Tablet Trametinib 2 mg kost €231,02. Op basis van een behandelduur van 11 maanden komt dit neer op €153.562,20. In totaal maximaal 12 maanden adjuvante behandeling.

Potential total cost per year

Total cost

22,725,000.00

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.

Off label use

Off label use No

Indication extension

Indication extension Yes
Indication extensions Triplet dab+tram+pdr001 voor BRAF+ gemetastaseerd melanoom.
References Clinicaltrials.gov

Other information

There is currently no futher information available.