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Vonoprazan

Extended indication Patients With Helicobacter Pylori Infection
Therapeutic value Possible added value
Total cost 1,485,000.00
Registration phase Clinical trials

Product

Active substance Vonoprazan
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Bacterial infections
Extended indication Patients With Helicobacter Pylori Infection
Manufacturer Takeda
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2025
Expected Registration 2026
Orphan drug No
Registration phase Clinical trials
Additional remarks Indieningsdatum op basis van registratie bij de FDA.

Therapeutic value

Current treatment options Panclamox, lansoprazol
Therapeutic value Possible added value
Substantiation Dit betreft een maagzuurremmer, gecombineerd met antibiotica. Naar verwachting zal de potentie groter zijn dan andere protonpomp remmers. Het bijwerkingenprofiel is naar verwachting gunstiger (30% bijwerkingen versus 40% bijwerkingen bij lansoprazo).
Duration of treatment Average 14 day / days
Frequency of administration 3 times a day
Dosage per administration 20 mg
References NCT04167670
Additional remarks Participants will receive vonoprazan 20mg twice daily (BID) in conjunction with amoxicillin 1gr, three times daily, for 14 days.

Expected patient volume per year

Patient volume

< 13,500

Market share is generally not included unless otherwise stated.
References GIP databank
Additional remarks In 2022 waren er 13.298 gebruikers van Panclamox. De verwachting is dat vonoprazan een deel van de markt zal overnemen.

Expected cost per patient per year

Cost 70.00 - 150.00
Additional remarks Beperkte kosten, mogelijk vergelijkbaar met Panclamox (uitgaande van 7 tot 14 dagen, 2x per dag).

Potential total cost per year

Total cost

1,485,000.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.