Extended indication First line treatment of advanced non-squamous non-small cell lung cancer (NSCLC). Combination of Tec
Therapeutic value No judgement
Total cost 27,025,000.00
Registration phase Registration application pending

Product

Active substance Atezolizumab
Domain Oncology and Hematology
Main indication Lung cancer
Extended indication First line treatment of advanced non-squamous non-small cell lung cancer (NSCLC). Combination of Tecentriq, Avastin and chemotherapy.
Proprietary name Tecentriq
Manufacturer Roche
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks An engineered anti-PD-L1 antibody,.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Indication extension
Submission date April 2018
Expected Registration December 2018
Orphan drug No
Registration phase Registration application pending
Additional remarks Sluis-product, financieel arrangement van toepassing.

Therapeutic value

Therapeutic value No judgement
Dosage per administration 1200 mg
References NCT02366143
Additional remarks Participants will receive IV infusion of atezolizumab (1200 mg) and bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel (200 mg/m2) and carboplatin ( AUC 6 mg/ml/min) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase.

Expected patient volume per year

Patient volume

270 - 811

Market share is generally not included unless otherwise stated.

References NKR; Pakketadvies Atezolizumab
Additional remarks NKR 2016: 9289 diagnoses NSCLC, stadium 3 en 4. 35% niet-plaveiselcel. 60% onvangt eerstelijnsbehandeling, waarvan 50% chemotherapie. Dit komt neer op een totaal van 811 patiƫnten. Realistisch volume: marktaandeel delen met nivolumab en pembrolizumab: 33,3%; 270 patiƫnten.

Expected cost per patient per year

Cost 40,000.00 - 60,000.00
References Medicijnkosten.nl
Additional remarks Dit is enkel voor Atezolizumab.

Potential total cost per year

Total cost

27,025,000.00

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

Indication extension Yes
Indication extensions Er lopen meerdere PhIII studies.
References clinicaltrials.gov

Other information

There is currently no futher information available.