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.