Version 6

Olaparib

Medicine

Extended indication Extension of indication for Lynparza in combination with durvalumab is indicated for the maintenance treatment of adult patients with primary advanced
Therapeutic value No estimate possible yet
Total cost € 74,624,000.00
Registration phase Registered

Product

Active substance Olaparib
Domain Oncology
Reason of inclusion Indication extension IND
Main indication Oncology other
Extended indication Extension of indication for Lynparza in combination with durvalumab is indicated for the maintenance treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) whose disease has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel.
Proprietary name Lynparza
Manufacturer AstraZeneca
Portfolio holder AstraZeneca
Route of administration Unknown
Therapeutical formulation Unknown
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date October 2023
Expected Registration August 2024
Orphan drug No
Registration phase Registered
Medicine sluice Broadly excluded

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
Substantiation In de intention-to-treat-populatie werd een statistisch significant PFS-voordeel waargenomen in de durvalumab- arm (hazard ratio [HR], 0,71 [95% CI, 0,57 tot 0,89]; P = 0,003) en de durvalumab + olaparib-armen (HR, 0,55). [95% CI, 0,43 tot 0,69]; P < 0,0001) versus controle. De durvalumab + olaparib-arm had een statistisch significant 45% lager risico op ziekteprogressie of overlijden versus de controlegroep (HR, 0,55 [95% CI, 0,43 tot 0,69]; P < 0,0001; mediane PFS 15,1 versus 9,6 maanden. Vooraf gespecificeerde, verkennende subgroepanalyses toonden PFS-voordeel aan bij dMMR (HR [durvalumab versus controle], 0,42 [95% CI, 0,22 tot 0,80]; HR [durvalumab + olaparib versus controle], 0,41 [95% BI, 0,21 tot 0,75]) en pMMR-subgroepen (HR [durvalumab versus controle], 0,77 [95% BI, 0,60 tot 0,97]; HR [durvalumab + olaparib versus controle] 0,57; [95% BI, 0,44 tot 0,73]); en in PD-L1-positieve subgroepen (HR [durvalumab versus controle], 0,63 [95% BI, 0,48 tot 0,83]; HR [durvalumab + olaparib versus controle], 0,42 [95% BI, 0,31 tot 0,57]).
References NCT04269200 https://ascopubs.org/doi/full/10.1200/JCO.23.02132

Expected patient volume per year

Patient volume < 583

Market share is generally not included unless otherwise stated.
References (1) NKR 2021 (2) Huijgens AN, Mertens HJ. Factors predicting recurrent endometrial cancer. Facts Views Vis Obgyn. 2013;5(3):179- (3) https://pubmed.ncbi.nlm.nih.gov/24753943/.
Additional remarks Er waren in 2021 in totaal 2.221 patiënten met een endometriumcarcinoom (1). De verdeling van het aantal patiënten per FIGO stadium is 80,9% voor stadium1, 4,8% stadium 2, 11,5% stadium 3 en 2,9% stadium 4(2). De kans op recidief is 6,5% (stadium 1), 20% (stadium 2), 37,5% (stadium 3) en 66,7% (stadium 4) (3). Dit betekent dat er ongeveer 583 patiënten in aanmerking komen.

Expected cost per patient per year

Cost € < 128,000.00

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.
References G-standaard
Additional remarks Kosten van cobinatiebehandeling totaal: IMF Eerst 6 cycli 1.120mg driewekelijkse dosering (1x558,72+2x2.328,0 = €5.214), gevolgd door ongeveer 8 maanden 1.500 vier wekelijkse dosering. 3x2.328,0=6.984. (31.284+55.872) 87.156 per patiënt. LYN 41.95 per 150mg tablet, 300mg 2xdaags, €167,80 per dag voor 8 maanden lang (alleen onderhoudsfase) = 167,80x30,44*8 = €40.860 / Totaal = €128.016 (87.156+40.860)

Potential total cost per year

Total cost € 74,624,000.00

Off label use

Indication extension

Other information