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Alectinib

Alecensa

Extended indication

The adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA ALK-posi

Therapeutic value

No estimate possible yet
Total cost

3,887,740.80
Registration phase

Clinical trials

Product

Active substance

Alectinib
Domain

Oncology
Reason of inclusion

Indication extension
Main indication

Lung cancer
Extended indication

The adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA ALK-positive NSCLC
Proprietary name

Alecensa
Manufacturer

Roche
Portfolio holder

Roche
Mechanism of action

Tyrosine kinase inhibitor
Route of administration

Oral
Therapeutical formulation

Capsule
Budgetting framework

Intermural (MSZ)

Registration

Registration route

Centralised (EMA)
Type of trajectory

Normal trajectory
ATMP

No
Submission date

2024
Expected Registration

October 2025
Orphan drug

No
Registration phase

Clinical trials

Therapeutic value

Current treatment options

Chemotherapie
Therapeutic value

No estimate possible yet
Duration of treatment

Maximal 24 month / months
Frequency of administration

2 times a day
Dosage per administration

600mg
References 
https://www.ema.europa.eu/en/documents/product-information/alecensa-epar-product-information_nl.pdf
https://classic.clinicaltrials.gov/ct2/show/NCT03456076

Expected patient volume per year

Patient volume

36 - 84

Market share is generally not included unless otherwise stated.
References 
https://www.zorginstituutnederland.nl/publicaties/adviezen/2021/11/15/pakketadvies-osimertinib-tagrisso-bij-niet-kleincellige-longkanker-nsclc
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9020874/
Additional remarks 
Volgens de budget impact analyse van osimertinib in de adjuvante NSCLC indicatie doen zich jaarlijks 1.193 stadium IB-IIIA  gereseceerd NSCLC  patiënten voor. Hiervan heeft minimaal 3% en maximaal 7% een ALK mutatie. Het jaarlijks patiëntvolume komt hiermee op minimaal 36 en max 84.

Expected cost per patient per year

Cost

64,795.68
References 
Z-index en SMPC Alecensa
Additional remarks 
Volgens de Z-index bedraagt de prijs voor Alecensa 150mg 240 stuks €5.399,64. De dosering is 600mg 2x daags. Hiermee komen de jaarlijkse kosten op €64.795,68 per patiënt.

Potential total cost per year

Total cost

3,887,740.80

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.