Pembrolizumab

Extended indication	KEYTRUDA, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early‑stage triple‑negative breast cancer at high risk of recurrence.
Therapeutic value	Possible added value
Total cost	156,150,000.00
Registration phase	Registered

Product

Active substance	Pembrolizumab
Domain	Oncology
Reason of inclusion	Indication extension
Main indication	Breast cancer
Extended indication	KEYTRUDA, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early‑stage triple‑negative breast cancer at high risk of recurrence.
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
Submission date	August 2021
Expected Registration	May 2022
Orphan drug	No
Registration phase	Registered
Additional remarks	Positieve CHMP-opinie verkregen in april 2022.

Therapeutic value

Therapeutic value	Possible added value
Substantiation	NEJM 2020 februari met resultaten pathologische responsen en toxiciteit. PFS na eerste interim analyse (15,5 maanden) lijkt beter in pembrolizumab groep dan enkel neoadjuvante chemotherapie. 3 jaar follow up en HR <0.7 bij PFS zal tot voorlopige goedkeuring CieBOM leiden.
Frequency of administration	1 times every 3 weeks
Dosage per administration	200 mg
References	NCT02819518
Additional remarks	Maximaal 1 jaar behandeling. Nota bene: voor mono en combinatie therapie ook 1 x 400mg per 6 weken mogelijk.

Expected patient volume per year

Patient volume	< 1,735 Market share is generally not included unless otherwise stated.
References	NKR 2018 (1);
Additional remarks	In 2018 waren er 1.735 diagnoses van mammacarcinoom HR-, HER- waarbij een chirurgische ingreep is gedaan.

Patient volume

< 1,735

Market share is generally not included unless otherwise stated.

References

NKR 2018 (1);

Additional remarks

In 2018 waren er 1.735 diagnoses van mammacarcinoom HR-, HER- waarbij een chirurgische ingreep is gedaan.

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 1 x per 3 weken 200mg voor 12 maanden zou dat gaan om maximaal €90.000 per patiënt per jaar. De behandelduur die voor deze indicatie onderzocht wordt is maximaal 12 maanden. 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	156,150,000.00 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

156,150,000.00

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 Geneesmiddelen (maagkanker, hoofd- en halskanker, huidkanker, longkanker, nierkanker, et cetera)
References	Fabrikant

Other information

There is currently no futher information available.