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Osimertinib

Tagrisso

Extended indication Monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-s
Therapeutic value No judgement
Total cost 23,497,200.00
Registration phase Registered and reimbursed

Product

Active substance Osimertinib
Domain Oncology and Hematology
Main indication Lung cancer
Extended indication Monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
Proprietary name Tagrisso
Manufacturer AstraZeneca
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks Osimertinib binds irreversibly to epidermal growth factor receptor (EGFR) proteins with a T790M mutation, as well as EGFR proteins with a L858R mutation, and to EGFR proteins with an exon 19 deletion.

Registration

Registration route Centralised (EMA)
Particularity Indication extension
Submission date 2017
Expected Registration June 2018
Orphan drug No
Registration phase Registered and reimbursed
Additional remarks Positieve opinie CHMP april 2018. Tweedelijnsbehandeling reeds op de markt. Breakthrough Therapy granted by the FDA.

Therapeutic value

Current treatment options Eerstelijns Tyrosine Kinase Inhibitors (TKIs): Erlotinib, Gefitinib, Afatinib.
Therapeutic value No judgement
Duration of treatment Median 16.2 month / months
Frequency of administration 1 times a day
Dosage per administration 80 mg
References Soria, J. et al. N. Engl. J. Med. Online ahead of print (2017)
Additional remarks Mediane behandelduur is 16,2 maanden.

Expected patient volume per year

Patient volume

214 - 428

Market share is generally not included unless otherwise stated.
References Fabrikant; NKR
Additional remarks Volgens de IKNL cijfers was het aantal patiënten met NSCLC in 2015 9.546. Het aantal NSCLC patiënten met EGFR mutaties in 1L is ongeveer 5 tot 10%. Hiervan heeft 80% gemetastaseerde ziekte. In de praktijk zullen niet alle patiënten vanwege comorbiditeiten in aanmerking komen voor een behandeling, maar ongeveer 80%. Verder is het testgehalte voor mutaties volgens de PALGA database (van pathologen) 70%. Dit brengt het totale aantal patiënten op 214 tot 428 patiënten.

Expected cost per patient per year

Cost 73,200.00
References Fabrikant
Additional remarks Berekening: 12 x €6.100 (huidige prijs van osimertinib per 30 dagen) = €73.200 p.p.p.j. max

Potential total cost per year

Total cost

23,497,200.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.