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 comments
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 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.