Tofacitinib Medicine 09 January 2018 Extended indication Xeljanz, in combination with a csDMARD, is indicated for the treatment of active PsA in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy (indicatie onder voorbehoud EMA proces) Therapeutic value No judgement Total cost € 6,915,600.00 Registration phase Unknown Product Active substance Tofacitinib Domain Chronic immune diseases Reason of inclusion Main indication Skin diseases Extended indication Xeljanz, in combination with a csDMARD, is indicated for the treatment of active PsA in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy (indicatie onder voorbehoud EMA proces) Current proprietary name Already available biosimilars / generics Proprietary name Xeljanz Manufacturer Pfizer Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Indicatie-uitbreiding. Al op de markt voor andere indicaties, waaronder RA. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date July 2017 Expected Registration July 2018 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options bDMARDs zoals etanercept, adalimumab. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 2 times a day Dosage per administration 5 mg References Additional remarks Expected patient volume per year Patient volume 131 - 1,093 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant Additional remarks Fabrikant (nov 2017): Op basis van NZa declaratie data: in totaal worden per jaar ongeveer 4600pt behandeld met een bDMARD. Hiervan zijn 661 patienten korter dan 12 maanden behandeld met bDMARDs (nieuwe patienten) en switchen er 432 patienten (switch patienten) van de ene bDMARD naar een andere bDMARD. Aangezien tofacitinib ingezet kan worden in dezelfde patientengroep zou maximaal 1093 patienten behandeld kunnen worden met tofacitinib. Klinische experts hebben ingeschat dat 10% van de nieuwe patienten (66pt) en 15% van de switch patienten (65pt) behandeld worden met tofacitinib in het eerste jaar na lancering. Dit komt neer op een marktpenentratie van 3% (131pt) van het totale biological/tofacitinib gebruik (4600pt). De marktpenentratie zou kunnen stijgen over de jaren heen. Expected cost per patient per year Cost € < 11,300.00 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 Fabrikant Additional remarks €11.300,00 pppj. Taxe prijs Xeljanz 56 stuks €863,27. Bij chronisch gebruik, dosering 2 maal daags 5 mg. Budget impact Xeljanz bij PsA is nihil door substitutie van bestaande PsA geneesmiddelen (analoog aan de BI berekeningen in de notificatie Xeljanz RA). Potential total cost per year Total cost € 6,915,600.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks