Lesinurad / allopurinol Medicine 09 January 2018 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 Therapeutic value No judgement Total cost 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 Current proprietary name Already available biosimilars / generics Proprietary name Duzallo Manufacturer Grunenthal Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date August 2017 Expected Registration August 2018 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in juli 2018. Geregistreerd in augustus 2018. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 200/200 mg References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € 3,000.00 - 5,000.00 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 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 Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References SPS Additional remarks Other information Additional remarks