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Apalutamide

Erleada

Extended indication gemetastaseerd hormoongevoelig prostaatcarcinoom in combinatie met androgeendeprivatie (ADT).
Therapeutic value No judgement
Total cost 8,448,000.00
Registration phase Registration application pending

Product

Active substance Apalutamide
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Prostate cancer
Extended indication gemetastaseerd hormoongevoelig prostaatcarcinoom in combinatie met androgeendeprivatie (ADT).
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 July 2019
Expected Registration May 2020
Orphan drug No
Registration phase Registration application pending
Additional remarks Fabrikant verwacht registratie in Q2 2020

Therapeutic value

Current treatment options Docetaxel, abiraterone, ADT, ADT + RT
Therapeutic value No judgement
Duration of treatment Not found
Frequency of administration 1 times a day
Dosage per administration 240 mg
References NCT02489318; Chi et al. N Engl J Med. 2019 Jul 4;381(1):13-24.

Expected patient volume per year

Patient volume

< 192

Market share is generally not included unless otherwise stated.
References NKR; Kanker.nl
Additional remarks 2.302 diagnoses prostaatkanker stadium 4 in 2016. Ongeveer 25% van deze groep patiënten is hormoongevoelig (n=575). Gezien de concurrentie binnen deze indicatie wordt uitgegaan van maximaal 1/3 marktaandeel (n=192).

Expected cost per patient per year

Cost 44,000.00
References Prestatie- en tariefbeschikking add-ongeneesmiddelen
Additional remarks Erleada tablet filmomhuld 60mg. Per verpakking van 112 tabletten, €3.357,76. Bij een behandelduur van een jaar 240 mg per dag komt dit totaal neer op € 43.770,80

Potential total cost per year

Total cost

8,448,000.00

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.

Other information

There is currently no futher information available.