Expand all sections

Pembrolizumab

Keytruda

Extended indication Keytruda, in combination with axitinib, is indicated for the first-line treatment of advanced renal
Therapeutic value No judgement
Total cost 11,250,000.00
Registration phase Registered and reimbursed

Product

Active substance Pembrolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Kidney cancer
Extended indication Keytruda, in combination with axitinib, is indicated for the first-line treatment of advanced renal cell carcinoma (RCC) in adults.
Proprietary name Keytruda
Manufacturer MSD
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Anti-PD-1

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date January 2019
Expected Registration September 2019
Orphan drug No
Registration phase Registered and reimbursed
Additional remarks Positieve CHMP-opinie juli 2019. Positief advies CieBOM: https://www.nvmo.org/bom/eerstelijns-combinatiebehandeling-met-pembrolizumab-en-axitinib-bij-het-gemetastaseerd-heldercellig-niercelcarcinoom/?meta

Therapeutic value

Therapeutic value No judgement
Frequency of administration 1 times every 3 weeks
Dosage per administration 200 mg
References SmPC
Additional remarks Maximaal 2 jaar behandeling

Expected patient volume per year

Patient volume

150 - 300

Market share is generally not included unless otherwise stated.
References NKR; Zinnige Zorg verbetersignalement: Dure oncolytica. ZIN 2017; Lam et al. World J Urol 2005;23(3):202-212.
Additional remarks De incidentie RCC is ongeveer 2.300 patiënten (NKR), hiervan heeft ongeveer 85% heldercellig RCC (N=1956) (Zinnige Zorg verbetersignalement: Dure oncolytica). Ongeveer 42% (N=825) heeft op moment van diagnose of in een later stadium (met/zonder nefrectomie) stage IIIb/IV RCC (Lam et al. 2005). De prognose van de patiënten bepaalt de behandelkeuze. Het marktaandeel zal afhangen van de nog onbekende therapeutisch waarde van dit middel ten opzichte van de huidige standaard therapieën en de nieuw te registreren (PD(L)1 combinatie therapieën. Uiteindelijke inschatting: zo'n 150-300 patiënten.

Expected cost per patient per year

Cost 40,000.00 - 60,000.00
References G-Standaard
Additional remarks Voor alle indicatie van pembrolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot en met juni 2020). AIP per november 2017: €2.624,38 per injectieflacon 25 mg/mg flacon 4 ml (oplossing). Inschatting: in lijn met andere indicaties.

Potential total cost per year

Total cost

11,250,000.00

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

Off label use No
References Fabrikant

Indication extension

Indication extension Yes
Indication extensions Indicatieuitbreidingen worden weergegeven in de Horizonscan (Maagkanker, Hoofd- en halskanker, huidkanker, Longkanker, etc.)
References Fabrikant en Horizonscan

Other information

There is currently no futher information available.