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Pembrolizumab

Keytruda

Extended indication Adjuvant treatment in monotherapy of adults with renal cell carcinoma (RCC) at intermediate-high or
Therapeutic value No estimate possible yet
Total cost 48,600,000.00
Registration phase Registration application pending

Product

Active substance Pembrolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Kidney cancer
Extended indication Adjuvant treatment in monotherapy of adults with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
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 July 2021
Expected Registration February 2022
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Dit jaar te verwachten survival data in september.
Frequency of administration 1 times every 3 weeks
Dosage per administration 200mg
References SMPC Keytruda, NCT03142334.
Additional remarks Bij monotherapie eenmaal in de 6 weken 400mg mogelijk; tot maximaal 1 jaar behandeling.

Expected patient volume per year

Patient volume

< 540

Market share is generally not included unless otherwise stated.
References NKR
Additional remarks Op basis van de inclusiecriteria van de Keynote-564, komen er jaarlijks maximaal 540 patiënten voor deze behandeling in aanmerking.

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. 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

48,600,000.00

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.