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 comments
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 comments
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 comments
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 comments
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 comments
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 comments
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.