Extended indication Patiënten ROS1-positief geavanceerde of gemetastaseerde NSCLC
Therapeutic value No judgement yet
Total cost 18,000,000.00
Registration phase Registration application pending

Product

Active substance Entrectinib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Lung cancer
Extended indication Patiënten ROS1-positief geavanceerde of gemetastaseerde NSCLC
Manufacturer Roche
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks Inhibitor of the tyrosine kinases TrkA (coded by the gene NTRK1), TrkB (coded by the gene NTRK2), TrkC (coded by the gene NTRK3), ROS1 (coded by the gene ROS1), and ALK (coded by the gene ALK).

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date January 2019
Expected Registration February 2020
Registration phase Registration application pending

Therapeutic value

Current treatment options Crizotinib
Therapeutic value No judgement yet
Frequency of administration 1 times a day
Dosage per administration 600mg
References Fabrikant; clinicaltrials.gov and Doebele et al. 2018 (IASLC)

Expected patient volume per year

Patient volume

50 - 150

Market share is generally not included unless otherwise stated.

References NKR; Bubendorf, et al., Virchows Arch. 2016; 469(5): 489–503., Epskamp PALGA/ pulmoscript 2015, expertopinie.
Additional remarks Jaarlijks presenteren er ongeveer 7.500 patiënten per jaar met NSCLC stadium IIIb/IV. 1-2% van alle NSCLC patiënten is ROS1 positief (75-150). Gezien maar 25% van de patienten getest wordt op ROS1 is de verwachting dat het aantal patiënten in de praktijk lager zal zijn. Van alle tumoren met wildtype EGFR/KRAS wordt 50% getest op ROS1. Patiëntvolume zal dan ook voorlopig lager zijn, verwachting rond de 50 patiënten.

Expected cost per patient per year

Cost < 180,000.00
References https://www.reuters.com/article/us-roche-hldg-fda-pricing/roche-cancer-treatment-priced-at-17050-a-month-lower-than-rival-vitrakvi-idUSKCN1V61G8
Additional remarks De lijstprijs voor entrectinib in de VS is gesteld op $17,050 per maand (ongeveer €15.000). Dit is ongeveer de helft van de prijs van concurrent larotrectinib (Bayer). Op jaarbasis bij behandeling van 12 maanden zou dit neerkomen op €180.000. Naar verwachting zal de EU prijs wat lager liggen.

Potential total cost per year

Total cost

18,000,000.00

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
References Fabrikant

Indication extension

Indication extension Yes
Indication extensions NTRK+
References Fabrikant

Other information

There is currently no futher information available.