Version 5

Durvalumab

Medicine

Extended indication Imfinzi in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy as adjuvant treatment, is indicat
Therapeutic value No estimate possible yet
Total cost € 99,640,000.00
Registration phase Registered

Product

Active substance Durvalumab
Domain Oncology
Reason of inclusion Indication extension IND
Main indication Lung cancer
Extended indication Imfinzi in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements.
Proprietary name Imfinzi
Manufacturer AstraZeneca
Portfolio holder AstraZeneca
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date January 2024
Expected Registration April 2025
Orphan drug No
Registration phase Registered
Medicine sluice Broadly excluded
Additional remarks Positieve CHMP-opinie in februari 2025.

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
Substantiation Bij de eerste tussentijdse analyse van event-free survival (met 31,9% data maturity) was de event-free survival in de aangepaste intention-to-treat populatie significant langer in de durvalumab-groep dan in de placebogroep; de gestratificeerde hazard ratio voor ziekteprogressie, recidief of overlijden was 0,68 (95% betrouwbaarheidsinterval [CI], 0,53-0,88; P=0,004).
Frequency of administration 1 times every 3 weeks
Dosage per administration 1,500 mg
References NCT03800134 (AEGEAN); Heymach et al. NEJM. 2023.
Additional remarks Administer IMFINZI as an intravenous infusion over 60 minutes after dilution. Patients with a body weight of ≥ 30 kg: Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy* every 3 weeks for up to 4 cycles prior to surgery. Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery. Patients with a body weight of < 30 kg: Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy* for up to 4 cycles prior to surgery. Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.

Expected patient volume per year

Patient volume 1,514 - 2,246

Market share is generally not included unless otherwise stated.
References NKR 2020 (1);
Additional remarks In totaal zijn er op basis van bovenstaande data 2.246 patiënten met stadium IB-IIIA NSCLC (1). Op dit moment wordt neo-adjuvante behandeling in Nederland enkel gegeven aan patiënten in stadium 1B en 2, dit betreft (418+206+632=1.256 patiënten). Daarnaast komt mogelijk de groep patiënten die chirurgie ontvangt bij stadium 3A in aanmerking voor deze therapie, dit betreffen (258 patiënten). Over deze laatste groep dient echter nog te worden besloten hoe de behandelingen in de praktijk gaat lopen, gezien er ook voor kan worden gekozen om bij een grotere groep patiënten chirurgie toe te passen (maximaal alle 990 patiënten met Stadium 3A). Om die reden zal het patiëntvolume dat in aanmerking komt 1.514 tot 2.246 patiënten betreffen.

Expected cost per patient per year

Cost € 53,000.00

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.
Additional remarks Op basis van de prijs in Denemarken Imfinzi concentraat 50 mg/ml 10 ml €2,156.45.

Potential total cost per year

Total cost € 99,640,000.00

Off label use

Indication extension

Other information