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Pembrolizumab

Keytruda

Extended indication Keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squa
Therapeutic value No judgement yet
Registration phase Registered and reimbursed

Product

Active substance Pembrolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Head and neck cancer
Extended indication Keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a ≥ 50% TPS and progressing on or after platinum-containing chemotherapy. (2L)
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 December 2017
Expected Registration September 2018
Orphan drug No
Registration phase Registered and reimbursed
Additional remarks Al geregistreerd door FDA. Positieve CHMP-opinie juli 2018. Geregistreerd in september 2018.

Therapeutic value

Current treatment options Nivolumab, Durvalumab, Tremelimumab
Therapeutic value No judgement yet
Frequency of administration 1 times every 3 weeks
Dosage per administration 200 mg
References Fabrikant (SmPC)

Expected patient volume per year

References NKR 2015
Additional remarks Totaal 3.202, per stadia: 1) 970; 2) 300; 3) 427; 4) 1.189. Gezien de huidige behandelopties / concurrentie zal het realistisch patiëntvolume lager liggen. Schatting 100 patiënten.

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

There is currently nothing known about the possible total cost.

Off label use

Off label use No
References Fabrikant

Indication extension

Indication extension Yes
Indication extensions Indicatie-uitbreidingen worden weergegeven in de Horizonscan (Maagkanker, Huidkanker, Borstkanker, Longkanker, Nierkanker, etc.)
References Fabrikant

Other information

There is currently no futher information available.