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Olaparib

Lynparza

Extended indication Extension of indication to include the use of Lynparza tablets as monotherapy for the treatment of a
Therapeutic value No judgement
Total cost 4,000,000.00
Registration phase Registration application pending

Product

Active substance Olaparib
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Prostate cancer
Extended indication Extension of indication to include the use of Lynparza tablets as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene mutations (germline and/or somatic) who have progressed following a prior new hormonal agent.
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 Registration application pending
Additional remarks Fabrikant verwacht registratie in Q4 2020.

Therapeutic value

Therapeutic value No judgement
Duration of treatment Median 7.4 month / months
Frequency of administration 2 times a day
Dosage per administration 300 mg
References NCT02987543; fabrikant

Expected patient volume per year

Patient volume

100

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 prostaatkankerpatiënten ontwikkelt CRPC (15-30). Het gaat echter niet om een 1e lijns behandeling. Om die reden zal het aantal patiënten dat in aanmerking komt voor dit middel naar schatting eerder rond de 100 patiënten per jaar liggen.

Expected cost per patient per year

Cost 40,000.00
References G-standaard; fabrikant
Additional remarks De lijstprijs van een tablet 150 mg is €44,46 per tablet. Bij een dosering van 300 mg 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

4,000,000.00

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 Yes
Indication extensions Colorectal cancer; Non-small cell lung cancer; Squamous cell cancer
References adisinsight
Additional remarks Lopende fase 3 studies.

Other information

There is currently no futher information available.