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Pembrolizumab

Keytruda

Extended indication First-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK po
Therapeutic value Possible added value
Total cost 27,750,000.00
Registration phase Registered and reimbursed

Product

Active substance Pembrolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Lung cancer
Extended indication First-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations in combination with pemetrexed and platinum chemotherapy.
Proprietary name Keytruda
Manufacturer MSD
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 April 2018
Expected Registration September 2018
Orphan drug No
Registration phase Registered and reimbursed
Additional remarks Dit is een indicatie-uitbreiding. Aanvraag ingetrokken in november 2017. Na nieuwe indiening een positieve CHMP-opinie in juli 2018. Geregistreerd in september 2018.

Therapeutic value

Therapeutic value Possible added value
Substantiation Fabrikant verwacht mogelijke meerwaarde: "Keynote 189 (fase III studie, NEJM publicatie): after a median follow-up of 10.5 months, the estimated rate of overall survival at 12 months was 69.2% (95% confidence interval [CI], 64.1 to 73.8) in the pembrolizumab-combination group versus 49.4% (95% CI, 42.1 to 56.2) in the placebocombination group (hazard ratio for death, 0.49; 95% CI, 0.38 to 0.64; P<0.001). Improvement in overall survival was seen across all PD-L1 categories that were evaluated. Median progression-free survival was 8.8 months (95% CI, 7.6 to 9.2) in the pembrolizumab-combination group and 4.9 months (95% CI, 4.7 to 5.5) in the placebo-combination group (hazard ratio for disease progression or death, 0.52; 95% CI, 0.43 to 0.64; P<0.001). Adverse events of grade 3 or higher occurred in 67.2% of the patients in the pembrolizumab-combination group and in 65.8% of those in the placebo-combination group."
Frequency of administration 1 times every 3 weeks
Dosage per administration 200 mg
References Fabrikant (SmPC)

Expected patient volume per year

Patient volume

222 - 888

Market share is generally not included unless otherwise stated.
References NKR 2016; American Cancer Society; Pakketadvies Atezolizumab; Expertopinie
Additional remarks Jaarlijks presenteren er ongeveer 4.500 patiënten per jaar met NSCLC stadium IV. Ongeveer 47% van deze patiënten heeft een niet-plaveiselcelcarcinoom (2.115). Hiervan ontvangt 60% een eerstelijnsbehandeling (1.269) waarvan 70% chemotherapie (888). Gezien de overige behandelopties met immuuntherapie in de eerste lijn zal er slechts een deel van de patiënten voor deze behandeling in aanmerking komen. Er wordt hiervoor uitgegaan van 25% (222).

Expected cost per patient per year

Cost 40,000.00 - 60,000.00
References Fabrikant (G-Standaard)
Additional remarks Voor alle indicatie van pembrolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot eind 2019). AIP per nov 2017: €2.624,38 per injectieflacon 25MG/ML FL 4ML (oplossing). € 1.312,19 per injectieflacon 50MG FL (poeder). Inschatting: in lijn met andere indicaties.

Potential total cost per year

Total cost

27,750,000.00

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 Indicatie-uitbreidingen worden weergegeven in de Horizonscan (Maagkanker, Hoofd- en halskanker, huidkanker, Borstkanker, Nierkanker, etc.)
References Fabrikant

Other information

There is currently no futher information available.