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Olaparib

Lynparza

Extended indication

Treatment in combination with abiraterone and prednisone or prednisolone for the treatment of adult

Therapeutic value

No estimate possible yet
Total cost

195,000,000.00
Registration phase

Registered

Product

Active substance

Olaparib
Domain

Oncology
Reason of inclusion

Indication extension
Main indication

Prostate cancer
Extended indication

Treatment in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated.
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

January 2022
Expected Registration

December 2022
Orphan drug

No
Registration phase

Registered
Additional remarks 
Fabrikant verwacht registratie eind 2022. 
Olaparib is per 26 augustus 2022 breed uitgesloten van het basispakket voor nieuwe indicaties. (https://zoek.officielebekendmakingen.nl/stcrt-2022-22265.html).
Positieve CHMP-opinie november 2022.

Therapeutic value

Therapeutic value

No estimate possible yet
Substantiation

Uit de interim resultaten van de studie (NCT03732820) bleek een significant effect op de rPFS (24,8 versus 16,6 maanden; hazard ratio [HR] 0.66, 95% confidence interval [CI] 0.54–0.81; P<0.0001). De resultaten lijken met name gedreven door HRR status.
Frequency of administration

2 times a day
Dosage per administration

300 mg
References 
NCT03732820, NCT03012321

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 remarks 
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 tot 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 remarks 
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.