Extended indication Extension of indication to include the use of Lynparza as a montherapy for the maintenance treatment
Therapeutic value No judgement
Total cost 2,175,000.00
Registration phase Registration application pending

Product

Active substance Olaparib
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Ovarian cancer
Extended indication Extension of indication to include the use of Lynparza as a montherapy for the maintenance treatment of adult patients with newly diagnosed advanced BRCA-mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to first-line platinum-based chemotherapy.
Proprietary name Lynparza
Manufacturer AstraZeneca
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks PARP inhibitor

Registration

Registration route Centralised (EMA)
Submission date 2018
Expected Registration September 2019
Orphan drug No
Registration phase Registration application pending
Additional remarks SOLO-1 trial, Moore et al. N Engl J Med. 2018 Oct 21

Therapeutic value

Therapeutic value No judgement
Duration of treatment Median 24.6 month / months
Frequency of administration 2 times a day
Dosage per administration 300 mg
References NCT01844986; Moore et al. N Engl J Med. 2018 Oct 21

Expected patient volume per year

Patient volume

< 87

Market share is generally not included unless otherwise stated.

References NKR; CieBOM
Additional remarks In 2015 zijn 347 patiënten geregistreerd met ovariumcarcinoom stadium 4, hiervan heeft de helft waarschijnlijk een BRCA mutatie. Dat betekent maximaal 174 patiënten. Realistisch (gezien concurrentie en 2L behandeling) maar de helft hiervan voor het middel in aanmerking komen.

Expected cost per patient per year

Cost 20,000.00 - 30,000.00
References Medicijnkosten.nl
Additional remarks Tablet 50 mg kost €11,78 p.p.p.j. gebaseerd op 300 mg per dag, 365 dagen lang (€25.798,20).

Potential total cost per year

Total cost

2,175,000.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.