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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 Positive CHMP opinion

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 January 2023
Orphan drug No
Registration phase Positive CHMP opinion
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 2.400-3.000 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.