Extended indication Imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first
Therapeutic value Possibly no place in the treatment regimen
Total cost 27,276,000.00
Registration phase Registered

Product

Active substance Durvalumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Lung cancer
Extended indication Imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).
Proprietary name Imfinzi
Manufacturer 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
Submission date December 2019
Expected Registration August 2020
Orphan drug No
Registration phase Registered
Additional comments Voor deze indicatie is durvalumab in de sluis geplaatst, Positieve CHMP-opinie in juli 2020.

Therapeutic value

Current treatment options Chemotherapie en immuuntherapie
Therapeutic value Possibly no place in the treatment regimen
Substantiation De HR voor OS in de Caspian studie zoals gepresenteerd op het WCLC was 0.74, wat mogelijk zal leiden tot een negatief CieBOM advies.
Duration of treatment Median 28 week / weeks
Frequency of administration 1 times every 3 weeks
Dosage per administration 1500 mg
References NCT03043872

Expected patient volume per year

Patient volume

500 - 700

Market share is generally not included unless otherwise stated.

References NKR
Additional comments In 2016 werden er 1.118 diagnoses stadium 4 SCLC geregistreerd. Inschatting patiëntvolume is sterk afhankelijk van precieze indicatie. De inschatting is dat er uiteindelijk 500-700 patiënten in aanmerking kunnen komen voor deze behandeling (gelijk aan de inschatting voor atezolizumab en pembrolizumab).

Expected cost per patient per year

Cost 34,920.00 - 56,000.00
References G-standaard; fabrikant.
Additional comments De dosis durvalumab is 1.500mg. Prijs per toediening is (3 x €2.328) = €6.984. De eerste 4 cycles wordt dit elke 3 weken gegeven. Daarna elke 4 weken durvalumab monotherapie. Voor 5,1 maanden (median PFS) weken is dit €6.984x5 = €34.920. Durvalumab wordt in combinatie gegeven met chemotherapie. De kosten hiervan zijn in bovenstaande berekening niet meegenomen. Voor durvalumab geldt een financieel arrangement voor oncologische indicaties en zit nog in de sluis voor deze indicatie.

Potential total cost per year

Total cost

27,276,000.00

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 Nog voor veel indicaties in ontwikkeling, monotherapie en in combinatie met tremelimumab. Meerdere studies teruggetrokken, 1 fase 3 studie loopt nog: Monotherapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR Non-small Cell Lung Cancer (NSCLC) After Failure of at Least 1 Previous EGFR-directed Tyrosine Kinase Inhibitor (TKI) and Platinum-doublet Chemotherapy.

Other information

There is currently no futher information available.