Hypericin Medicine 08 June 2021 Extended indication Patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides). Therapeutic value Possibly no place in the treatment regimen Total cost Registration phase Clinical trials Product Active substance Hypericin Domain Hematology Reason of inclusion New medicine (specialité) Main indication Indolent non-Hodgkin’s lymphoma Extended indication Patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides). Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Soligenix Portfolio holder Mechanism of action Other, see general comments Route of administration Cutaneous Therapeutical formulation Ointment Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Synthetic hypericin, the active ingredient in SGX301, tends to accumulate in T-cells. Once the hypericin is in the T-cells, it can be activated by safe, visible fluorescent light. When synthetic hypericin is activated it creates oxygen radicals which subsequently cause cellular toxicity, killing the targeted T-cells. Amerikaanse merknaam: Hybryte, merknaam in Nederland en of Europa nog niet bekend Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2023 Expected Registration 2024 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Estimated primary completion datum in december 2019. Therapeutic value Current treatment options Er bestaat een duidelijke unmet clinical need voor de behandeling van patiënten met een CTCL. In Nederland zijn hiervoor nauwelijks topicale behandelingen beschikbaar. Een voorbeeld therapie is systemische chemotherapie. Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn in vitro studies van hypericine die duiden op antiproliferatieve effecten en als topicaal product zijn er aanwijzingen dat het als fotosensitiser kan werken. Er wordt verwacht dat het weinig tot niet voorgeschreven gaat worden. Duration of treatment Frequency of administration 1 times every 2 weeks Dosage per administration References NCT02448381 Additional remarks 0.25% SGX301 in USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm^2 fluorescent light. Expected patient volume per year Patient volume < 126 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Er is een incidentie van126 patiënten cutane t-cellymfomen in 2018. Er wordt verwacht dat het weinig tot niet voorgeschreven gaat worden Expected cost per patient per year Cost References Additional remarks 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 Unknown Indication extensions References Additional remarks Other information Additional remarks