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	2024
Expected Registration	2025
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.

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.

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.