Extended indication Extension of indication for treatment with pembrolizumab plus trastuzumab in combination with standa
Therapeutic value No estimate possible yet
Total cost 19,440,000.00
Registration phase Registration application pending

Product

Active substance Pembrolizumab
Domain Oncology
Reason of inclusion Indication extension
Main indication Stomach cancer
Extended indication Extension of indication for treatment with pembrolizumab plus trastuzumab in combination with standard of care chemotherapy for adults with HER2 positive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Proprietary name Keytruda
Manufacturer MSD
Portfolio holder 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 February 2023
Expected Registration February 2024
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
Frequency of administration 1 times every 3 weeks
Dosage per administration 200 mg
References NCT03615326

Expected patient volume per year

Patient volume

173 - 259

Market share is generally not included unless otherwise stated.

References 1) IKNL 2021 2) expert opinie op basis van literatuur 3) declaratiedat en expertopinie
Additional remarks 622 cardiacarcinoom en 1.109 maagcarcinoom onafhankelijk van het stadium (1). 10 tot 15% van alle maagkanker HER2 is positief (2). Gegeven de gebruikersaantallen bij trastuzumab is de inschatting dat er maximaal 150 tot 200 patiënten in aanmerking zullen komen voor deze behandeling.

Expected cost per patient per year

Cost < 90,000.00
References G-standaard
Additional remarks AIP per november 2017: €2.624,38 per injectieflacon 25mg/ml, flacon 4ml (oplossing). Uitgaande van een behandeling van 1maal per 3 weken 200mg voor 12 maanden zou dat gaan om maximaal €90.000 per patiënt per jaar. Voor pembrolizumab is een financieel arrangement van toepassing tot 1 januari 2027. Aankomende indicatie uitbreidingen vallen onder deze overeenkomst, mits zij voldoen aan stand der wetenschap en praktijk.

Potential total cost per year

Total cost

19,440,000.00

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

Indication extension Yes

Other information

There is currently no futher information available.