Extended indication Gastric, metastatic, 1L
Therapeutic value No judgement
Total cost 6,850,000.00
Registration phase Clinical trials

Product

Active substance Pembrolizumab
Domain Oncology and Hematology
Main indication Stomach cancer
Extended indication Gastric, metastatic, 1L
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)
Particularity Indication extension
Submission date 2018
Expected Registration 2019
Orphan drug No
Registration phase Clinical trials
Additional remarks Scrip pipeline watch 22 dec 2017: Phase III Interim/Top-line Results KEYNOTE-061: missed primary endpoint. Pembrolizumab heeft in de sluis gezeten, de afspraken die gedurende die periode zijn gemaakt t.a.v. de vergoeding gelden ook voor deze indicatie-uitbreiding.

Therapeutic value

Therapeutic value No judgement
Frequency of administration 1 times every 3 weeks
Dosage per administration 200 mg
References Fabrikant
Additional remarks Toedieningsfrequentie is 1 maal per 3 weken

Expected patient volume per year

Patient volume

< 137

Market share is generally not included unless otherwise stated.

References NKR
Additional remarks In 2016 waren er gemiddeld 555 nieuwe patiënten met cardia of non-cardia maagadenocarcinoom stadium IV. Ongeveer twee derde van deze patiënten werd behandeld in de 1e lijn (370 patiënten). Daarnaast werden 350 patiënten per jaar behandeld met palliatieve chemotherapie. Schatting voor percentage patiënten dat na progressie op 1e lijns systemische therapie start met 2e lijns systemische therapie is 37% (137 patiënten).

Expected cost per patient per year

Cost 40,000.00 - 60,000.00
References Medicijnkosten.nl, AIP fabrikant.
Additional remarks AIP per nov 2017: €2624,38 per injectieflacon 25MG/ML FL 4ML (oplossing). € 1312,19 per injectieflacon 50MG FL (poeder).

Potential total cost per year

Total cost

6,850,000.00

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.