Extended indication Extension of indication to include pembrolizumab in combination with lenvatinib for the treatment of
Therapeutic value No estimate possible yet
Total cost 900,000.00
Registration phase Registration application pending

Product

Active substance Pembrolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Other oncology
Extended indication Extension of indication to include pembrolizumab in combination with lenvatinib for the treatment of advanced endometrial carcinoma in adults who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation.
Proprietary name Keytruda
Manufacturer MSD
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date March 2021
Expected Registration January 2022
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options Chemotherapie
Therapeutic value No estimate possible yet
Duration of treatment Maximal 2 year / years
Frequency of administration 1 times every 3 weeks
Dosage per administration 200 mg
References KEYNOTE-775 (NCT03517449).
Additional comments Lenvatinib 20 mg een per 3 weken.

Expected patient volume per year

Patient volume

< 10

Market share is generally not included unless otherwise stated.

References NKR; Follow-up after primary therapy for endometrial cancer: a systematic review. Fung-Kee-Fung. Gynecol Oncol. 2006 Jun;101(3):520-9. Epub 2006 Mar 23.; Sorbe B, Juresta C, Ahlin C. Natural history of recurrences in endometrial carcinoma. Oncol Lett. 2014;8(4):1800–1806. doi:10.3892/ol.2014.2362.
Additional comments Er waren in 2018 in totaal 1.931 patiënten met een endometriumcarcinoom. Daarvan betrof het in 177 gevallen een carcinoom van stadium 4. De recurrence rate voor endometrium carcinoom bedraagt ongeveer 10%-20%. Dit zou betekenen dat er in de tweede lijn of later mogelijk minder dan 10 patiënten in aanmerking komen voor deze behandeling.

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.

Potential total cost per year

Total cost

900,000.00

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 Indicatieuitbreidingen worden weergegeven in de Horizonscan Geneesmiddelen.
References Fabrikant.

Other information

There is currently no futher information available.