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Alectinib

Alecensa

Extended indication Alecensa as monotherapy is indicated as adjuvant treatment following complete tumour resection for a
Therapeutic value No estimate possible yet
Total cost 3,887,700.00
Registration phase Positive CHMP opinion

Product

Active substance Alectinib
Domain Oncology
Reason of inclusion Indication extension
Main indication Lung cancer
Extended indication Alecensa as monotherapy is indicated as adjuvant treatment following complete tumour resection for adult patients with ALK‑positive NSCLC at high risk of recurrence
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 November 2023
Expected Registration June 2024
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP-opinie april 2024

Therapeutic value

Current treatment options Chemotherapie
Therapeutic value No estimate possible yet
Duration of treatment Maximal 23.9 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 64,795.00
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

3,887,700.00

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.