Extended indication Keytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatme
Therapeutic value Possible added value
Total cost 6,750,000.00
Registration phase Registered

Product

Active substance Pembrolizumab
Domain Oncology
Reason of inclusion Indication extension
Main indication Oncology other
Extended indication Keytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD‑L1 with a CPS ≥ 1.
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
Submission date October 2021
Expected Registration April 2022
Orphan drug No
Registration phase Registered
Additional comments Positieve CHMP-opinie ontvangen in maart 2022.

Therapeutic value

Therapeutic value Possible added value
Substantiation In de fase 3 KEYNOTE-826 trial, waarin KEYTRUDA plus chemotherapie met of zonder bevacizumab (the KEYTRUDA regimen) gegeven werd is een statistisch significant resultaat op overall survival (OS) (HR=0.64 [95% CI, 0.50-0.81]; p=0.0001) en progressie-vrije survival (PFS) (HR=0.62 [95% CI, 0.50-0.77]; p<0.0001) behaald ten opzichte van chemotherapie met of zonder bevacizumab.
Frequency of administration 1 times every 3 weeks
Dosage per administration 200mg
References SMPC Keytruda, NCT03635567.
Additional comments - Bij mono therapie eenmaal in de 6 weken 400mg mogelijk; - tot maximaal 2 jaar behandeling.

Expected patient volume per year

Patient volume

70 - 80

Market share is generally not included unless otherwise stated.

References DGOG
Additional comments Er wordt verwacht dat er 70-80 patiënten in aanmerking zullen komen voor deze behandeling. Deze inschatting is gedaan op basis van huidige getallen van bevacizumab bij cervixcarcinoom.

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

6,750,000.00

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
Indication extensions Indicatie uitbreidingen worden weergegeven in de Horizonscan Geneesmiddelen.
References Fabrikant.

Other information

There is currently no futher information available.