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.