Version 2

Pralsetinib

Medicine

Extended indication Gavreto is indicated for the treatment of adults and pediatric patients 12 years of age and older with locally advanced or metastatic RET fusion-posit
Therapeutic value No estimate possible yet
Total cost € 1,950,000.00
Registration phase No registration expected

Product

Active substance Pralsetinib
Domain Oncology
Reason of inclusion Indication extension IND
Main indication Thyroid cancer
Extended indication Gavreto is indicated for the treatment of adults and pediatric patients 12 years of age and older with locally advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy following prior treatment with Tyrosine kinase inhibitors and not previously treated with a RET inhibitor.
Proprietary name Gavreto
Manufacturer Roche
Portfolio holder Roche
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional remarks Selectieve remmer van RET-kinase.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP Unknown
Submission date December 2021
Orphan drug No
Registration phase No registration expected
Additional remarks Roche heeft de registratie van deze indicatie van pralsetinib teruggetrokken.

Therapeutic value

Current treatment options Cabozantinib/vandetanib in de toekomst mogelijk ook selpercatinib
Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
Substantiation ARROW, een fase 1-2 studie, toonde een overall response rate van 71% (95% CI 48–89) aan in patiënten met treatment-naive RET-mutant medullary thyroid carcinoom en 60% (95% CI 46–73) in patiënten die eerder cabozantinib or vandetanib, of beide.
Frequency of administration 1 times a day
Dosage per administration 400mg
References https://www.sciencedirect.com/science/article/pii/S2213858721001200?via%3Dihub

Expected patient volume per year

Patient volume 10 - 20

Market share is generally not included unless otherwise stated.
References IKNL 2018(1); Expert opinie (2);
Additional remarks Er zijn maximaal 100 volwassen patiënten met schildkliercarcinoom (exclusief medullair). Mogelijk zo'n 10%-20% van deze groep zal "RET fusion positive" schildkliercarcinoom hebben (1). Bij de niet-medullaire schildkliercarcinoom wordt niet getest en gezien er daarvoor standaardbehandelingen is de inschatting dat er toch minder patiënten in aanmerking komen (2).

Expected cost per patient per year

Cost € < 130,000.00

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.
References G-standaard
Additional remarks Prijs voor Nederland nog niet bekend maar gelijke kosten verwacht met selpercatinib. Dit middel is voor deze indicatie in de sluis geplaatst tot er een financieel arrangement is overeengekomen.

Potential total cost per year

Total cost € 1,950,000.00

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information