Baricitinib Medicine 08 June 2021 Extended indication Systemic lupus erythematosus Therapeutic value No estimate possible yet Total cost € 3,734,934.00 Registration phase Clinical trials Product Active substance Baricitinib Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Other chronic immune diseases Extended indication Systemic lupus erythematosus Current proprietary name Already available biosimilars / generics Proprietary name Olumiant Manufacturer Eli Lilly Portfolio holder Mechanism of action JAK tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date 2022 Expected Registration 2023 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Datum verwachte indiening registratie is nog niet publiek beschikbaar. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Unmet need. Groot effect verwacht bij zeldzame indicaties. Duration of treatment Frequency of administration 1 times a day Dosage per administration 4 mg References Additional remarks Expected patient volume per year Patient volume < 357 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Op basis van inschatting Forigerimod (Rigerimod) / Belimumab Additional remarks In de beoordeling van Belimumab heeft het zorginstituut gerekend met: 'De prevalentie van SLE is 28-40 per 100.000 inwoners (~4.470 patiënten in Nederland). Ongeveer 8% van de patiënten met SLE heeft een hoge mate van ziekteactiviteit, ondanks een standaardbehandeling (zo’n 357 patiënten).' Expected cost per patient per year Cost € 10,462.00 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 Z-index juni 2021 Additional remarks De prijs voor een verpakking van 28 tabletten Olumiant 4mg bedraagt €804,81. 1 tablet kost €28,74. Bij een behandelduur van een jaar (13 verpakkingen) zou dat €10.462 bedragen. Olumiant studies voor SLE bevinden zich in fase 3. De definitieve dosering is nog niet vastgesteld. Potential total cost per year Total cost € 3,734,934.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Psoriasis; Conditioneel exzeem; Graft vs Host Disease; Arteritis, Giant Cell References Clinicaltrial.gov Additional remarks Other information Additional remarks