Extended indication Keytruda as monotherapy is indicated for the treatment of the following MSI‑H or dMMR tumours in adu
Therapeutic value No estimate possible yet
Total cost 15,390,000.00
Registration phase Registered

Product

Active substance Pembrolizumab
Domain Oncology
Reason of inclusion Indication extension
Main indication Oncology other
Extended indication Keytruda as monotherapy is indicated for the treatment of the following MSI‑H or dMMR tumours in adults with: unresectable or metastatic colorectal cancer after previous fluoropyrimidine‑based combination therapy; advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum‑containing therapy in any setting and who are not candidates for curative surgery or radiation; unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.
Proprietary name Keytruda
Manufacturer 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 July 2021
Expected Registration April 2022
Orphan drug No
Registration phase Registered
Additional comments Registratie verkregen in april 2022

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation De response rate was 34,3% (95% CI, 28.3% to 40.8%). Mediane progressie-vrije survival was 4.1 maanden (95% CI, 2.4 to 4.9 maanden) en mediane overall survival was 23,5 maanden.
Frequency of administration 1 times every 3 weeks
Dosage per administration 200 mg
References NCT02563002; NCT02628067
Additional comments Treatment duration approximately 2 years.

Expected patient volume per year

Patient volume

< 171

Market share is generally not included unless otherwise stated.

References NKR; Bonneville et al. JCO Precis Oncol. 2017
Additional comments mCRC valt niet onder deze beoordeling; pembrolizumab heeft hier een formele eerstelijns indicatie. Voor de overige indicaties worden er jaarlijks in Nederland 2.286 patiënten gediagnosticeerd met stadium IV. Gemiddeld komt MSI-H voor bij ongeveer 4% van alle tumoren. Dit komt neer op 171 patiënten van bovenstaand volume. Per subtype zal dit percentage echter variëren.

Expected cost per patient per year

Cost < 90,000.00
References G-standaard
Additional comments 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. 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

15,390,000.00

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.