Adalimumab Medicine 09 January 2018 Extended indication RA, polyarticular juvenile idiopathic arthritis, active psoriatic arthritis, active ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis Therapeutic value Possible equal value Total cost € 3,000,000.00 Registration phase Unknown Product Active substance Adalimumab Domain Chronic immune diseases Reason of inclusion Main indication Rheumatism Extended indication RA, polyarticular juvenile idiopathic arthritis, active psoriatic arthritis, active ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis Current proprietary name Already available biosimilars / generics Proprietary name Cyltezo Manufacturer Boehringer Ingelheim Portfolio holder Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Biosimilar alternatief voor Humira. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date January 2017 Expected Registration November 2017 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Geregistreerd in november 2017. Therapeutic value Current treatment options Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 2 times a month Dosage per administration 40 mg References Additional remarks Toediening 1 maal per 2 weken Expected patient volume per year Patient volume 100 - 300 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Biosimilar dus deel van de bestaande patienten die op het origineel staan (Humira). Expected cost per patient per year Cost € < 15,000.00 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 Additional remarks Als het patent verloopt van origineel (Humira) medio 2018 is de verwachting dat de prijs reduceerd. Kosten Humira vooralsnog pppj: 15.000 Potential total cost per year Total cost € 3,000,000.00 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