Extended indication Treatment of patients with advanced gastrointestinal stromal tumour (GIST) who have received treatm
Therapeutic value No estimate possible yet
Total cost 2,000,000.00
Registration phase Registration application pending

Product

Active substance Ripretinib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Stomach cancer
Extended indication Treatment of patients with advanced gastrointestinal stromal tumour (GIST) who have received treatment with prior anticancer therapies. Prior anticancer therapies must include imatinib, sunitinib, and regorafenib (3 prior therapies).
Manufacturer Deciphera Pharmaceuticals
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional comments NCT03353753

Registration

Registration route Centralised (EMA)
Submission date September 2020
Expected Registration October 2021
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Current treatment options GIST wordt voornamelijk chirurgisch verwijderd. Indien dit niet effectief is, zijn imatinib, sunitinib and regorafenib in Europa geregistreerd om als behandeling te gebruiken. In de vierde lijn vindt normaal gesproken herintroductie van imatinib plaats of wordt gekozen voor een behandeling in studie. In de toekomst zal ripretinib met avapritinib gaan concurreren.
Therapeutic value No estimate possible yet
Substantiation De therapeutische waarde ten opzichte van imatinib en avapritinib is nog niet bekend.
Frequency of administration 1 times a day
Dosage per administration 150 mg
References NCT03353753

Expected patient volume per year

Patient volume

< 50

Market share is generally not included unless otherwise stated.

References NKR
Additional comments Het patiëntvolume in de vierde lijn zal naar verwachting laag zijn. In 2016 waren er 50 diagnoses van GIST stadium IV. Er zullen maximaal 50 patiënten per jaar in aanmerking komen, ervan uitgaande dat niet iedereen in de derde lijn behandeld wordt.

Expected cost per patient per year

Cost 40,000.00
Additional comments Kosten zullen mogelijk vergelijkbaar zijn met sunitinib. Uitgaande van (6 week cyclus, 4 weeks on, 2 weeks off) NCT03673501. Zal dit uitkomen op €179,29 per dag is €43.500 inclusief btw, exclusief btw = €40.000.

Potential total cost per year

Total cost

2,000,000.00

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

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Fase III studie GIST (2L).
References NCT03673501
Additional comments Fase 3 studie voor GIST in de tweede lijn.

Other information

There is currently no futher information available.