Olaparib

Extended indication	Lynparza is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.
Therapeutic value	No judgement
Total cost	4,111,030.00
Registration phase	Registered and reimbursed

Product

Active substance	Olaparib
Domain	Oncology and Hematology
Reason of inclusion	Indication extension
Main indication	Breast cancer
Extended indication	Lynparza is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.
Proprietary name	Lynparza
Manufacturer	AstraZeneca
Mechanism of action	PARP inhibitor
Route of administration	Oral
Therapeutical formulation	Tablet
Budgetting framework	Intermural (MSZ)
Additional remarks	PARP inhibitor

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
Submission date	April 2018
Expected Registration	April 2019
Orphan drug	No
Registration phase	Registered and reimbursed
Additional remarks	Positieve CHMP-opinie februari 2019. Geregistreerd in april 2019.

Therapeutic value

Current treatment options	Concurrentie van alle parp-remmers.
Therapeutic value	No judgement
Duration of treatment	Median 8 month / months
Frequency of administration	2 times a day
Dosage per administration	300 mg
References	Robson, M. et al. N. Engl. J. Med. 2017 377, 523–533.
Additional remarks	Mediane behandelduur is 8,2 maanden.

Expected patient volume per year

Patient volume	< 95 Market share is generally not included unless otherwise stated.
References	Fabrikant; Kankerzorginbeeld 2014; IKNL; OlympiAD publicatie.
Additional remarks	De fabrikant geeft aan niet meer dan 95 patiënten te verwachten. De marktpenetratie zal laag zijn omdat er vele concurrerende producten beschikbaar zijn.

Patient volume

< 95

Market share is generally not included unless otherwise stated.

References

Fabrikant; Kankerzorginbeeld 2014; IKNL; OlympiAD publicatie.

Additional remarks

De fabrikant geeft aan niet meer dan 95 patiënten te verwachten. De marktpenetratie zal laag zijn omdat er vele concurrerende producten beschikbaar zijn.

Expected cost per patient per year

Cost	43,274.00
References	Fabrikant
Additional remarks	De lijstprijs van een tablet 150 mg is €44,46 per tablet. Bij 300 mg tweemaal daags komt dit neer op €177,84. Bij een behandelduur van 8 maanden is het totaal €43.274,40 (((365/12)8)4*€44,46).

Potential total cost per year

Total cost	4,111,030.00 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

4,111,030.00

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.