Pembrolizumab

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
Therapeutic value	No estimate possible yet
Total cost	15,750,000.00
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	December 2023
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	150 - 200 Market share is generally not included unless otherwise stated.
References	1) IKNL 2020 2) expert opinie op basis van literatuur 3) declaratiedat en expertopinie
Additional remarks	561 cardiacarcinoom en 1.063 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.

Patient volume

150 - 200

Market share is generally not included unless otherwise stated.

References

1) IKNL 2020 2) expert opinie op basis van literatuur 3) declaratiedat en expertopinie

Additional remarks

561 cardiacarcinoom en 1.063 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 2024. Aankomende indicatie uitbreidingen vallen onder deze overeenkomst, mits zij voldoen aan stand der wetenschap en praktijk.

Potential total cost per year

Total cost	15,750,000.00 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.

Total cost

15,750,000.00

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

There is currently nothing known about off label use.

Indication extension

Indication extension	Yes

Other information

There is currently no futher information available.