Extended indication Extension of indication to include Tecentriq in combination with nab-paclitaxel and anthracycline-ba
Therapeutic value No estimate possible yet
Total cost 40,000,000.00
Registration phase Registration application pending

Product

Active substance Atezolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Breast cancer
Extended indication Extension of indication to include Tecentriq in combination with nab-paclitaxel and anthracycline-based chemotherapy for the neoadjuvant treatment of adult patients with locally advanced or early Triple Negative Breast Cancer (TNBC).
Proprietary name Tecentriq
Manufacturer Roche
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments An engineered anti-PD-L1 antibody

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date December 2020
Expected Registration October 2021
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options Chemotherapie - trastuzumab - pertuzumab
Therapeutic value No estimate possible yet
Frequency of administration 1 times every 2 weeks
Dosage per administration 840 mg
References Fabrikant, IMpassion031

Expected patient volume per year

Patient volume

1,000

Market share is generally not included unless otherwise stated.

References NKR
Additional comments NKR 2018: 1.735 diagnoses mammacarcinoom HR-, HER-. Hiervan betreft het 549 patiënten in stadium 1, 812 patiënten in stadium 2, 252 patiënten in stadium 3 en 122 patiënten in stadium 4. Een deel van de patiënten met stadium 2 komen in aanmerking voor deze behandeling en alle patiënten met stadium 3. Schatting: in totaal kunnen er zo'n 1.000 patiënten in aanmerking komen.

Expected cost per patient per year

Cost 30,000.00 - 50,000.00
Additional comments Afhankelijk van behandelduur. Deze is op dit moment onbekend. Om die reden op basis van andere indicaties van atezolizumab de inschatting gemaakt dat deze mogelijk €30.000-€50.000 per patiënt per jaar kan gaan kosten. Voor alle indicaties van atezolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot en met 31 december 2023).

Potential total cost per year

Total cost

40,000,000.00

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 Zie indicatieuitbreidingen in de Horizonscan Geneesmiddelen op het gebied van: huidkanker, longkanker, leverkanker, blaaskanker, nierkanker en borstkanker.
References Horizonscan Geneesmiddelen

Other information

There is currently no futher information available.