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Durvalumab / Tremelimumab

Imfinzi / Tremelimumab

Extended indication Non-small cell lung cancer (NSCLC) stage IV, in combination with tremelimumab, 1L.
Therapeutic value No judgement
Total cost 14,800,000.00
Registration phase Clinical trials

Product

Active substance Durvalumab / Tremelimumab
Domain Oncology and Hematology
Main indication Lung cancer
Extended indication Non-small cell lung cancer (NSCLC) stage IV, in combination with tremelimumab, 1L.
Proprietary name Imfinzi / Tremelimumab
Manufacturer AstraZeneca
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Anti PD-L1 + anti CTLA-4.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Indication extension
Submission date 2018
Expected Registration 2019
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Nivolumab; Pembrolizumab
Therapeutic value No judgement
Frequency of administration 1 times every 2 weeks
Dosage per administration 10 mg/kg / 1 mg/kg
References Fabrikant; NCT02453282
Additional remarks Toedingsfrequentie: Durvalumab 1 maal per 2 weken; Tremelimumab 1 maal per 4 weken met een maximum van 4 doses.

Expected patient volume per year

Patient volume

296

Market share is generally not included unless otherwise stated.
References NKR; Fabrikant
Additional remarks NKR 2015: 5.304 diagnoses niet-kleincellig longcarcinoom stadium 4. Fabrikant: realistisch volume bedraagt 296 patiënten

Expected cost per patient per year

Cost 40,000.00 - 60,000.00
Additional remarks Verwacht in lijn met andere immunotherapieën. €1.098,16 voor nivolumab 10mg per ml fl 10 ml; €3.355,96 voor pembrolizumab 25 mg per ml fl 4ml. Berekening gebasseerd op EPAR.

Potential total cost per year

Total cost

14,800,000.00

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

Off label use No

Indication extension

Indication extension Yes
Indication extensions Nog voor veel indicaties in ontwikkeling, monotherapie en in combinatie met tremelimumab. Meerdere studies teruggetrokken, 1 PhIII 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.