Mogamulizumab Medicine 12 June 2018 Extended indication Poteligeo is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy. Therapeutic value Possible added value Total cost € 900,000.00 Registration phase Registered Product Active substance Mogamulizumab Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Lymphoma Extended indication Poteligeo is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy. Current proprietary name Already available biosimilars / generics Proprietary name Poteligeo Manufacturer Kyowa Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Humanized monoclonal antibody targeting CC chemokine receptor 4 (CCR4). Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date November 2017 Expected Registration November 2018 Orphan drug Yes Registration phase Registered Reimbursement Medicine sluice Additional remarks Indiening gebaseerd op de MAVORIC trial. Positieve CHMP-opinie september 2018. Geregistreerd in november 2018. Therapeutic value Current treatment options Systemische chemotherapie Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Er bestaat een duidelijke unmet clinical need voor de systemische behandeling van patiënten met een CTCL. In Nederland zijn hiervoor nauwelijks behandelingen beschikbaar. Mogalizumab heeft in een gerandomiseerde fase 3 studie hogere ORR en langere PFS laten zien in verband met vorinostat (ASH 2017). Duration of treatment Frequency of administration 1 times a week Dosage per administration 1 mg/kg References NCT01728805 Additional remarks 1 mg/kg per week gedurende 4 weken in cyclus 1, daarna 1 maal per 2 weken. Expected patient volume per year Patient volume < 10 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Incidentie CTCL in 2016 (NKR): 131. Expertopinie schat het aantal patiënten per jaar in op minder dan 10. Expected cost per patient per year Cost € 60,000.00 - 120,000.00 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 Scrip Additional remarks ¥155,999 (ongeveer €1.200) per 20mg/5ml. Prijs min-max gebaseerd op 6-12 maanden behandeling van een patiënt van 70kg. Potential total cost per year Total cost € 900,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions HTLV-1 associated myelopathy (HAM), Adult T-cell Leukemia/Lymphoma. References clinicaltrials.gov Additional remarks Verwachting van patiëntaantal bij recidief ATLL betreft waarschijnlijk minder dan 5 patiënten per jaar. Other information Additional remarks