Extended indication Adult men with newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in com
Therapeutic value No judgement
Total cost 7,680,000.00
Registration phase Registration application pending

Product

Active substance Enzalutamide
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Prostate cancer
Extended indication Adult men with newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in combination with androgen depreviation therapy.
Proprietary name Xtandi
Manufacturer Astellas
Mechanism of action Antiandrogen
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks Anti-androgeen, remmer van de androgeenreceptorsignalering.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date July 2019
Expected Registration July 2020
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options BSC, docetaxel + prednison, abirateron + prednison
Therapeutic value No judgement
Frequency of administration 1 times a day
Dosage per administration 160 mg
References NCT02677896
Additional remarks Studieresultaten verwacht in Q4/2020.

Expected patient volume per year

Patient volume

< 192

Market share is generally not included unless otherwise stated.

References NKR
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 40,000.00
References Fabrikant; G-standaard; SmPC.
Additional remarks Minimale kosten indien patiënt slechts 1 verpakking van €3.080 euro per verpakking verbruikt omdat medicatie na 1 maand wordt gediscontinueerd. Uitgaande van het verbruik van 1 verpakking per 28 dagen en een behandeling van >12 maanden komt dit dit neer op 13 verpakkingen voor een jaar en dus €40.040.

Potential total cost per year

Total cost

7,680,000.00

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 Yes

Indication extension

Indication extension Yes
Indication extensions Niet gemetastaseerde castratieresistente prostaatkanker (nmCRPC); nmHSPC
References NCT02003924; NCT02319837

Other information

There is currently no futher information available.