Pembrolizumab

Extended indication	Extension of indication to include in combination with chemoradiotherapy (external beam radiation therapy followed by brachytherapy) the treatment of high-risk locally advanced cervical cancer in adults who have not received prior definitive therapy.
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Pembrolizumab
Domain	Oncology
Reason of inclusion	Indication extension
Extended indication	Extension of indication to include in combination with chemoradiotherapy (external beam radiation therapy followed by brachytherapy) the treatment of high-risk locally advanced cervical cancer in adults who have not received prior definitive 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	October 2023
Expected Registration	August 2024
Registration phase	Registration application pending

Therapeutic value

Current treatment options	Chemoradiatie
Therapeutic value	No estimate possible yet
Substantiation	Stadium IB2-IVa krijgt CRT; een (klein) deel zal contra-indicaties hebben, maar merendeel krijgt CRT. ESMO 2023 LBA toont positieve PFS data (mediaan in beide armen nog niet bereikt) met een HR 0,7.
References	Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047) ClinicalTrials.gov ID NCT04221945; Study Completion (Estimated) 2024-12-07; expertopinie

Expected patient volume per year

Patient volume	< 500 Market share is generally not included unless otherwise stated.
References	IKNL; expert
Additional remarks	CRT is vrijwel altijd de eerste behandeling van locally advanced ziekte. Incidentie rond de 500 op basis van IKNL data per subgroep.

Patient volume

< 500

Market share is generally not included unless otherwise stated.

References

IKNL; expert

Additional remarks

CRT is vrijwel altijd de eerste behandeling van locally advanced ziekte. Incidentie rond de 500 op basis van IKNL data per subgroep.

Expected cost per patient per year

References	G-standaard
Additional remarks	AIP per november 2017: €2.624,38 per injectieflacon 25mg/ml, flacon 4ml (oplossing). Voor pembrolizumab is een financieel arrangement van toepassing tot 1 januari 2027. Aankomende indicatie uitbreidingen vallen onder deze overeenkomst, mits zij voldoen aan stand der wetenschap en praktijk.

References

G-standaard

Additional remarks

AIP per november 2017: €2.624,38 per injectieflacon 25mg/ml, flacon 4ml (oplossing). Voor pembrolizumab is een financieel arrangement van toepassing tot 1 januari 2027. Aankomende indicatie uitbreidingen vallen onder deze overeenkomst, mits zij voldoen aan stand der wetenschap en praktijk.

Potential total cost per year

There is currently nothing known about the possible total cost.

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.