Extended indication Monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer
Therapeutic value Possible added value
Total cost 5,300,000.00
Registration phase Registered and reimbursed

Product

Active substance Olaparib
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Prostate cancer
Extended indication Monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. (only BRCA mutations included in the indication).
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
Submission date December 2019
Expected Registration November 2020
Orphan drug No
Registration phase Registered and reimbursed
Additional comments Positieve CHMP-opinie september 2020. Geregistreerd in november 2020. Aanspraak Status ZN: Ja (april 2021).

Therapeutic value

Therapeutic value Possible added value
Substantiation Profound studie is positief met aangetoonde OS voordeel (NEJM 2020; 382:2091-2102). Patiënten in Cohort A in de studie moeten BRCA1, BRCA2, of ATM mutatie hebben. Indicatie bevat alleen BRCA gemuteerde patiënten. Positief cieBOM advies in november 2020.
Duration of treatment Median 7.4 month / months
Frequency of administration 2 times a day
Dosage per administration 300mg
References NCT02987543; Fabrikant.

Expected patient volume per year

Patient volume

100 - 165

Market share is generally not included unless otherwise stated.

References bron: NKR en Zinnige Zorg verbetersignalement: Zinnig gebruik van geneesmiddelen bij patiënten met castratie refractair prostaatcarcinoom, DOI: 10.1056/NEJMoa1911440 doi: 10.1155/2020/4986365. eCollection 2020.
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 8226 in totaal. Na starten van anti hormonale therapie zal maximaal 20% van de patiënten binnen vijf jaar CRPC ontwikkelen (1.645 patiënten), de inschatting is dat het in maximaal 10 % gaat om een mutatie in BRCA 1/2. De verwachting is echter dat het lager zal zijn, inschatting 100-165 patiënten.

Expected cost per patient per year

Cost 40,000.00
References G-standaard; fabrikant.
Additional comments De lijstprijs van een tablet 150mg is €44,46 per tablet. Bij een dosering van 300mg tweemaal daags komt dit neer op €177,84 per dag. Bij behandeling van een volledig jaar is de totaalprijs €64.911,60 (365*4*€44,46). De mediane behandelduur is echter 7,4 maanden dus de kosten voor een behandeling zullen (€64.911,60/12)*7,4 = €40.029 bedragen.

Potential total cost per year

Total cost

5,300,000.00

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 Yes
Indication extensions - Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer (OlympiA) -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) mCRPC (first-line setting). (PROPEL).
References Adisinsight.
Additional comments Lopende fase 3 studies.

Other information

There is currently no futher information available.