Extended indication

Locally Advanced Head and Neck Squamous Cell Carcinoma With Chemoradiation.

Therapeutic value

No judgement yet

Total cost

33,750,000.00

Registration phase

Clinical trials

Product

Active substance

Pembrolizumab

Domain

Oncology and Hematology

Reason of inclusion

Indication extension

Main indication

Head and neck cancer

Extended indication

Locally Advanced Head and Neck Squamous Cell Carcinoma With Chemoradiation.

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

2021

Expected Registration

April 2022

Orphan drug

No

Registration phase

Clinical trials

Additional comments
Fabrikant verwacht indiening in 2021 en registratie in het tweede kwartaal van 2022.

Therapeutic value

Therapeutic value

No judgement yet

Substantiation

Op dit moment loopt de Keystone-421 studie nog.

Frequency of administration

1 times every 3 weeks

Dosage per administration

200mg

References
SMPC KEYTRUDA; NCT03040999
Additional comments
- tot maximaal 1 jaar behandeling.

Expected patient volume per year

Patient volume

< 375

Market share is generally not included unless otherwise stated.

References
NKR, expertopinie
Additional comments
Er zijn in totaal 2.855 met SCC van het hoofd-halsgebied. 375 hiervan hebben stadium III.

Expected cost per patient per year

Cost

< 90,000.00

References
G-standaard
Additional comments
Voor alle indicatie van pembrolizumab geldt een financieel arrangement dat is voortgekomen uit de onderhandelingen in de sluis. AIP per november 2017: €2.624,38 per injectieflacon 25MG/ML FL 4ML (oplossing). Uitgaande van een behandeling van 1 x per 3 weken 200 mg voor 12 maanden zou dat gaan om maximaal €90.000 per patiënt per jaar.

Potential total cost per year

Total cost

33,750,000.00

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.

References
Fabrikant

Other information

There is currently no futher information available.