Extended indication The treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination
Therapeutic value No estimate possible yet
Total cost 18,750,000.00
Registration phase Registered and reimbursed

Product

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

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date July 2019
Expected Registration April 2021
Orphan drug No
Registration phase Registered and reimbursed
Additional comments Positieve CHMP-opinie in maart 2021.

Therapeutic value

Current treatment options BSC, docetaxel + prednison, abirateron + prednison.
Therapeutic value No estimate possible yet
Duration of treatment Median 12.8 month / months
Frequency of administration 1 times a day
Dosage per administration 160mg
References NCT02677896; Armstrong AJ et al., 2019 J Clin Oncol. 2019 Nov 10;37(32):2974-2986.

Expected patient volume per year

Patient volume

< 500

Market share is generally not included unless otherwise stated.

References NKR en ARCHES
Additional comments Totaal aantal nieuwe prostaatkankerpatiënten per jaar is meer dan 12.000. Patiënten geregistreerd in de NKR 2016 met "cM0cNX, cM0cN0, cMcN1, cM1, pM1" betreft 8.226 in totaal. Echter, uitgaande van de ARCHES studie gaat het mogelijk slechts in 5% van de prostaat kankerpatiënten om gemetastaseerde hormoon gevoelige prostaatkanker (410). Aantal is afhankelijk van hoe vroeg patiënten zich melden. Uiteindelijke inschatting: maximaal 500 patiënten die reëel gezien in aanmerking zullen komen.

Expected cost per patient per year

Cost 37,500.00
References Fabrikant; G-standaard; SmPC.
Additional comments Uitgaande van het verbruik van 1 verpakking per 28 dagen en een behandeling van >12 maanden komt dit neer op 13 verpakkingen voor een jaar en dus €37.500.

Potential total cost per year

Total cost

18,750,000.00

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 nmHSPC
References NCT02003924; NCT02319837.
Additional comments nmCRPC is reeds geregistreerd.

Other information

There is currently no futher information available.