Encorafenib

Braftovi

Extended indication	Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.
Therapeutic value	No estimate possible yet
Total cost	12,225,000.00
Registration phase	Registered

Product

Active substance	Encorafenib
Domain	Oncology
Reason of inclusion	Indication extension
Main indication	Lung cancer
Extended indication	Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.
Proprietary name	Braftovi
Manufacturer	Pierre Fabre
Portfolio holder	Pierre Fabre
Route of administration	Oral
Therapeutical formulation	Capsule
Budgetting framework	Intermural (MSZ)
Additional remarks	BRAF remmers

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	October 2023
Expected Registration	August 2024
Orphan drug	No
Registration phase	Registered
Additional remarks	Positieve CHMP opinie juli 2024

Therapeutic value

Current treatment options	Ametinib
Therapeutic value	No estimate possible yet
Substantiation	Lopende fase 2 studie in zowel behandelde als onbehandelde patiënten.
References	NCT03915951

Expected patient volume per year

Patient volume	< 75 Market share is generally not included unless otherwise stated.
References	NKR 2021 (1) Yan N, Guo S, Zhang H, Zhang Z, Shen S, Li X. BRAF-Mutated Non-Small Cell Lung Cancer: Current Treatment Status and Future Perspective. Front Oncol. 2022 Mar 31;12:863043. doi: 10.3389/fonc.2022.863043. PMID: 35433454; PMCID: PMC9008712 (2)
Additional remarks	In 2021 waren er 10.096 diagnoses NSCLC in Nederland. Dit betrof 1.727 patiënten in stadium I, 822 patiënten in stadium II, 2.231 patiënten in stadium III, 5.247 patiënten in stadium IV (1). Ongeveer 2% betreft een BFAF mutatie, waarvan de helft een V600 mutatie betreft (2). Dit betekent dat er ongeveer 75 patiënten in aanmerking zullen komen

Patient volume

< 75

Market share is generally not included unless otherwise stated.

References

NKR 2021 (1) Yan N, Guo S, Zhang H, Zhang Z, Shen S, Li X. BRAF-Mutated Non-Small Cell Lung Cancer: Current Treatment Status and Future Perspective. Front Oncol. 2022 Mar 31;12:863043. doi: 10.3389/fonc.2022.863043. PMID: 35433454; PMCID: PMC9008712 (2)

Additional remarks

In 2021 waren er 10.096 diagnoses NSCLC in Nederland. Dit betrof 1.727 patiënten in stadium I, 822 patiënten in stadium II, 2.231 patiënten in stadium III, 5.247 patiënten in stadium IV (1). Ongeveer 2% betreft een BFAF mutatie, waarvan de helft een V600 mutatie betreft (2). Dit betekent dat er ongeveer 75 patiënten in aanmerking zullen komen

Expected cost per patient per year

Cost	< 163,000.00
References	Medicijnkosten.nl; SmPC
Additional remarks	Deze inschatting is gebaseerd op een eerdere indicatie voor melanoom. 450mg encorafenib (6 capsules van 75 mg) een maal per dag gedurende een jaar kost in totaal €83.687,03. Daarnaast moeten patiënten ook een maal per dag zes capsules binimetinib innemen (15mg). Dit kost per jaar €79.140,40. In totaal kost deze behandeling dus €162.827,43.

Potential total cost per year

Total cost	12,225,000.00 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.

Total cost

12,225,000.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.

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