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Pembrolizumab

Keytruda

Extended indication Keytruda, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment
Therapeutic value No estimate possible yet
Total cost 43,740,000.00
Registration phase Registered

Product

Active substance Pembrolizumab
Domain Oncology
Reason of inclusion Indication extension
Main indication Oncology other
Extended indication Keytruda, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy
Proprietary name Keytruda
Manufacturer MSD
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Infusion fluid
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date April 2024
Expected Registration November 2024
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP-opinie in september 2024

Therapeutic value

Current treatment options Dostarlimab
Therapeutic value No estimate possible yet
Substantiation Dostarlimab wordt enkel ingezet bij MMR deficiënte patiënten. Pembrolizumab kan tevens voor patiënten met tumor proficiënte MMR ingezet worden. De onderlinge plaatsbepaling is echter nog onduidelijk.
Frequency of administration 1 times every 3 weeks
References NCT03914612 (KEYNOTE-868/NRG-GY018); Eskander et al. NEJM. 2023.
Additional remarks The administration of pembrolizumab was planned in 6 cycles every 3 weeks, followed by up to 14 maintenance cycles every 6 weeks.

Expected patient volume per year

Patient volume

< 486

Market share is generally not included unless otherwise stated.
References NKR 2022 (1).
Additional remarks In 2022 waren er 2.181 patiënten met baarmoederlichaam kanker gediagnosticeerd, waarvan 486 in stadium 3 en 4 (1). Gezien het een eerstelijnsbehandeling is zal een deel van de patiënten hiervoor in aanmerking komen.

Expected cost per patient per year

Cost < 90,000.00
Additional remarks Voor alle indicaties van pembrolizumab geldt een financieel arrangement dat is voortgekomen uit de onderhandelingen in de sluis. Apothekersinkoopprijs per november 2017: €2.624,38 per injectieflacon 25mg/ml FL 4ml (oplossing). Uitgaande van een behandeling van een maal per drie weken 200mg voor 12 maanden zou dat gaan om maximaal €90.000 per patiënt per jaar.

Potential total cost per year

Total cost

43,740,000.00

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.