Extended indication Duzallo is indicated in adults for the treatment of hyperuricaemia in gout patients who have not ach
Therapeutic value No judgement
Registration phase Registered

Product

Active substance Lesinurad / allopurinol
Domain Chronic immune diseases
Reason of inclusion New medicine (specialité)
Main indication Other chronic immune diseases
Extended indication Duzallo is indicated in adults for the treatment of hyperuricaemia in gout patients who have not achieved target serum uric acid levels with an adequate dose of allopurinol alone
Proprietary name Duzallo
Manufacturer Grunenthal
Mechanism of action Enzyme inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date August 2017
Expected Registration August 2018
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP-opinie in juli 2018. Geregistreerd in augustus 2018.

Therapeutic value

Therapeutic value No judgement
Substantiation Het nadeel van een combinatie tablet is dat de dosering allopurinol niet hoger of lager getitreerd kan worden. Ook wordt bij sommige patienten allopurinol niet verdragen en heeft een combinatie van lesinurad met febuxostat de voorkeur.
Frequency of administration 1 times a day
Dosage per administration 200/200 mg

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost 3,000.00 - 5,000.00
References GoodRx.com
Additional remarks Dit betreft een combinatietherapie, prijs zal wel iets omhoog gaan maar naar verwachting niet veel ten opzichte van monotherapie. Prijs in de VS ongeveer $400 voor 30 tabletten 200/200 mg. Dat komt dus neer op ongeveer $4.800 op jaarbasis.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No
References SPS

Other information

There is currently no futher information available.