Extended indication Treatment in combination with abiraterone acetate in patients with metastatic Castration-resistant P
Therapeutic value No estimate possible yet
Total cost 195,000,000.00
Registration phase Clinical trials

Product

Active substance Olaparib
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Prostate cancer
Extended indication Treatment in combination with abiraterone acetate in patients with metastatic Castration-resistant Prostate Cancer (mCRPC) who have not received prior chemotherapy or new hormonal agents (NHAs) for metastatic castration-resistant prostate cancer (mCRPC) (first-line setting).
Proprietary name Lynparza
Manufacturer AstraZeneca
Mechanism of action PARP inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials
Additional comments Fabrikant verwacht indiening eind 2021 en registratie eind 2022

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Er zijn nog geen resultaten uit de studie bekend. De verwachting is echter dat het mogelijk een grote impact kan hebben in deze lijn.
Frequency of administration 2 times a day
Dosage per administration 300 mg
References NCT03732820

Expected patient volume per year

Patient volume

< 3,000

Market share is generally not included unless otherwise stated.

References NKR, CAPRI en Zinnige Zorg verbetersignalement: Zinnig gebruik van geneesmiddelen bij patiënten met castratie refractair prostaatcarcinoom
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. Het gaat hierbij om zo’n 2.400-3.000 CRPC patiënten (bron: CAPRI). Gezien bijna alle patiënten met CRPC uitzaaiingen hebben is de verwachting bijna de gehele groep mCRPC patiënten betreft.

Expected cost per patient per year

Cost < 65,000.00
Additional comments Prijs per jaar is (4*€44,46*365) is zo'n €65.000. Echter, de behandelduur is nog niet bekend.

Potential total cost per year

Total cost

195,000,000.00

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

There is currently nothing known about off label use.

Indication extension

Indication extension No
References Fabrikant

Other information

There is currently no futher information available.