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Apalutamide

Erleada

Extended indication Niet-gemetastaseerde castratie resistente prostaat carcinoom (hoog risico).
Therapeutic value No judgement
Total cost 2,332,000.00
Registration phase Registered and reimbursed

Product

Active substance Apalutamide
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Prostate cancer
Extended indication Niet-gemetastaseerde castratie resistente prostaat carcinoom (hoog risico).
Proprietary name Erleada
Manufacturer Janssen
Mechanism of action Antiandrogen
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks Androgeen receptor inhibitor.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date February 2018
Expected Registration January 2019
Orphan drug No
Registration phase Registered and reimbursed
Additional remarks Positieve CHMP-opinie november 2018. Geregistreerd in januari 2019.

Therapeutic value

Therapeutic value No judgement
Frequency of administration 1 times a day
Dosage per administration 240 mg
References Fabrikant; NCT01946204; Scrip; Smith et al. N Engl J Med. 2018 Apr 12;378(15):1408-1418.
Additional remarks Improved metastasis-free survival in SPARTAN trial (feb 2018).

Expected patient volume per year

Patient volume

53

Market share is generally not included unless otherwise stated.
References NKR; Kanker.nl
Additional remarks In 2016 werden 1.600 diagnoses prostaatcarcinoom stadium 3 gesteld. 10% hiervan is hormoonresistent (n=160). Apalutamide zal binnen deze indicatie moeten moeten concurreren met enzalutamide en darolutamide dus wordt uitgegaan van 1/3 marktaandeel (n=53).

Expected cost per patient per year

Cost 44,000.00
References Prestatie- en tariefbeschikking add-ongeneesmiddelen
Additional remarks Erleada tablet filmomhuld 60mg, 112 stuks kost €3.357,20. Bij een behandelduur van een jaar 240 mg per dag komt dit totaal neer op €43.763,50

Potential total cost per year

Total cost

2,332,000.00

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
References clinicaltrials.gov
Additional remarks geen fase III studies voor andere indicaties dan in de horizonscan. In horizonscan: Chemo-naieve gemetastaseerde castratie resistente prostaat carcinoom, in combinatie met abiraterone & gemetastaseerde hormoon-gevoelige, hoog-volume prostaat carcinoom.

Other information

There is currently no futher information available.