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Alectinib

Alecensa

Extended indication First line treatment of adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC)
Therapeutic value No judgement
Total cost 4,800,000.00

Product

Active substance Alectinib
Domain Oncology and Hematology
Main indication Lung cancer
Extended indication First line treatment of adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC), ALK+, 1L.
Proprietary name Alecensa
Manufacturer Roche
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date February 2017
Expected Registration December 2017
Orphan drug No
Additional remarks Dit is een indicatie-uitbreiding. Positieve CHMP-opinie oktober 2017.

Therapeutic value

Current treatment options Crizotinib, Ceritinib
Therapeutic value No judgement
Duration of treatment Median 25.6 month / months
Frequency of administration 1 times a day
Dosage per administration 600 mg
Additional remarks Fabrikant: geschatte mediane behandelduur is op basis van klinische studie (J-ALEX studie).

Expected patient volume per year

Patient volume

90 - 150

Market share is generally not included unless otherwise stated.
References Fabrikant
Additional remarks Fabrikant: Max. patiëntvolume gebaseerd op incidentie niet-plaveiselcel stadium IV NSCLC. Waarvan het in ongeveer 5% van de patiënten een ALK mutatie betreft. Van max. naar realistisch patiëntvolume gezien de beschikbaarheid van andere behandelopties voor deze patiënten.

Expected cost per patient per year

Cost < 40,000.00
References Medicijnkosten.nl; Fabrikant
Additional remarks Behandeling is dagelijks 600 mg. Per caspsule van 150 mg kost Alectinib €27,36. Bij een geheel jaar: 4x€27,36x365=€39.945. Fabrikant geeft aan: €5.782 voor 224 x 150 mg verpakking.

Potential total cost per year

Total cost

4,800,000.00

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.