Extended indication Rizmoic is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who ha
Therapeutic value No judgement
Total cost 1,575,000.00
Registration phase Registered

Product

Active substance Naldemedine
Domain Chronic immune diseases
Reason of inclusion New medicine (specialité)
Main indication Other chronic immune diseases
Extended indication Rizmoic is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have previously been treated with a laxative.
Proprietary name Rizmoic
Manufacturer Shionogi
Mechanism of action Receptor antagonist
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional remarks Peripherally-selective μ-opioid receptor antagonist

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date March 2017
Expected Registration February 2019
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP-opinie december 2018. Geregistreerd in februari 2019.

Therapeutic value

Current treatment options laxantia
Therapeutic value No judgement
Duration of treatment continuous
Frequency of administration 1 times a day
Dosage per administration 0,2 mg
References NCT01993940; NCT01965158; NCT01965652

Expected patient volume per year

Patient volume

200 - 500

Market share is generally not included unless otherwise stated.

References GIPdatabank; De Groot et al. Ned Tijdschr Geneeskd. 2010;154:A2224
Additional remarks In 2016 kregen 970.070 patiënten opioïden. Ongeveer 50-90% van de patiënten die worden behandeld met opioïden krijgt last van obstipatie. Dit zou 485.035-873.063 patiënten betekenen. Het daadwerkelijke patiëntvolume is sterk afhankelijk van de therapeutische waarde en de plaats in de behandeling. Potentieel is dit een grote groep patiënten. Dit middel zal waarschijnlijk worden ingezet wanneer andere geneesmiddelen niet werken. De inschatting is daarom enkele honderden patiënten.

Expected cost per patient per year

Cost < 4,500.00
References GoodRx.com
Additional remarks In de VS kosten 30 tabletten naldemedine 0,2 mg gemiddeld $383,13. Dit is de hoeveelheid voor gebruik van een maand, dus dit zou $4.597,56 per patient per jaar bedragen. De prijs in de EU is waarschijnlijk lager.

Potential total cost per year

Total cost

1,575,000.00

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 No

Other information

There is currently no futher information available.