Version 2

Toripalimab

Medicine

Extended indication Toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carci
Therapeutic value No estimate possible yet
Total cost € 3,800,000.00
Registration phase Registration application pending

Product

Active substance Toripalimab
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Oncology other
Extended indication Toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma (“NPC”)
Manufacturer Shanghai Junshi
Portfolio holder Shanghai Junshi
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP No
Submission date December 2022
Expected Registration February 2024
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
Substantiation In de interim PFS analyse werd een verbetering van de PFS gezien in de toripalimab arm vergeleken met de placebo arm: een mediane PFS van 11,7 versus 8 maanden, hazard ratio (HR) = 0,52 (95% confidence interval (CI): 0.36–0.74), P = 0.0003 (1). De data van de fase III studie is ook beschikbaar, JUPITER02. Op ASCO 23 werden de voorlopige OS data gepresenteerd: de mediane survival follow up was 30,1 maanden. Een significante verbetering van de OS werd gezien voor de patiënten die met toripalimab werden behandeld ten opzichte van placebo: HR = 0,63 (95% CI: 0.45-0.89), two-sided p = 0.0083. De mediane OS werd niet gehaald in de toripalimab arm en was 33,7 maanden in de placebo arm. De studie is echter in China uitgevoerd en het is nog de vraag of dit ook representatief is voor de Europese bevolking.
Frequency of administration 1 times every 3 weeks
Dosage per administration 240 mg
References NCT03581786, NCT02915432; Nature Medicine volume 27, pages 1536–1543 (2021) (1);

Expected patient volume per year

Patient volume < 95

Market share is generally not included unless otherwise stated.
References NKR 2021 (1)
Additional remarks In 2021 waren er 95 patiënten met NPC (1).

Expected cost per patient per year

Cost € 30,000.00 - 50,000.00

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 GIP databank
Additional remarks Mogelijk vergelijkbaar met andere PD1 remmers

Potential total cost per year

Total cost € 3,800,000.00

Off label use

Off label use Unknown

Indication extension

Indication extensions Yes
Indication extensions Meedere fase 3 studies (zie AdisInsight), nu momenteel 3 indicaties opgenomen hiervan op de Horizonscan (NSCLC, NPC en ESCC)
References Adis Insight

Other information