Olaparib

Extended indication	Prostate cancer - monotherapy for BRCA 1/2 or ATM gene-mutated metastatic castration resistant prostate cancer (mCRPC) in patients who have received a prior taxane-based chemotherapy and at least one newer hormonal agent (abiraterone or enzalutamide).
Therapeutic value	No judgement
Total cost	393,750.00
Registration phase	Clinical trials

Product

Active substance	Olaparib
Domain	Oncology and Hematology
Main indication	Prostate cancer
Extended indication	Prostate cancer - monotherapy for BRCA 1/2 or ATM gene-mutated metastatic castration resistant prostate cancer (mCRPC) in patients who have received a prior taxane-based chemotherapy and at least one newer hormonal agent (abiraterone or enzalutamide).
Proprietary name	Lynparza
Manufacturer	AstraZeneca
Route of administration	Oral
Therapeutical formulation	Tablet
Budgetting framework	Intermural (MSZ)

Registration

Registration route	Centralised (EMA)
Particularity	Indication extension
Orphan drug	No
Registration phase	Clinical trials

Therapeutic value

Therapeutic value	No judgement

Expected patient volume per year

Patient volume	15 - 30 Market share is generally not included unless otherwise stated.
References	NKR; Na et al. Eur Urol. 2017 May;71(5):740-747; Kirby et al. Int J Clin Pract. 2011 Nov;65(11):1180-92
Additional remarks	NKR 2015: 2.568 gevallen van prostaatkanker, stadia 3 en 4. Ongeveer 6% van prostaattumoren heeft een mutatie in BRCA of ATM (154). 10-20% van de prostaatkankerpatienten ontwikkelt CRCP (15-30).

Patient volume

15 - 30

Market share is generally not included unless otherwise stated.

References

NKR; Na et al. Eur Urol. 2017 May;71(5):740-747; Kirby et al. Int J Clin Pract. 2011 Nov;65(11):1180-92

Additional remarks

NKR 2015: 2.568 gevallen van prostaatkanker, stadia 3 en 4. Ongeveer 6% van prostaattumoren heeft een mutatie in BRCA of ATM (154). 10-20% van de prostaatkankerpatienten ontwikkelt CRCP (15-30).

Expected cost per patient per year

Cost	15,000.00 - 20,000.00
References	Medicijnkosten.nl; NCT02987543; GIPdatabank
Additional remarks	€11,78 voor een capsule van 50mg. Kosten geschat op basis van behandelschema in klinische studies en huidige vergoeding per gebruiker voor geregistreerde indicaties.

Potential total cost per year

Total cost	393,750.00 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.

Total cost

393,750.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.