Thrombomodulin alfa Medicine 12 June 2019 Extended indication Septic shock (Sepsis) - with disseminated intravascular coagulation (DIC) Therapeutic value No estimate possible yet Total cost € 5,962,500.00 Registration phase Clinical trials Product Active substance Thrombomodulin alfa Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Other non-oncological hematological medications Extended indication Septic shock (Sepsis) - with disseminated intravascular coagulation (DIC) Current proprietary name Already available biosimilars / generics Proprietary name Recomodulin Manufacturer Asahi Kasei Portfolio holder Mechanism of action Anticoagulant Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Recombinant Human Thrombomodulin. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2021 Expected Registration 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Nov 18: The phase 3 trial (NCT01598831) is still recruiting pts, with an estimated study completion date of Dec 2019 (SPS) Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 0,06 mg/kg tot max 6 mg References NCT01598831 Additional remarks Expected patient volume per year Patient volume < 2,250 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References https://www.ntvg.nl/artikelen/sepsis-een-gecompliceerd-syndroom-met-belangrijke-medische-en-maatschappelijke/volledig; Additional remarks In Nederland worden naar schatting jaarlijks circa 9.000 patiënten op de Intensive Care opgenomen met ernstige sepsis. De inschatting is dat hiervan een kwart mogelijk een septische shock krijgt en (het maximale patiëntenaantal dat in aanmerking komt voor deze behandeling). Expected cost per patient per year Cost € 2,650.00 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 Thrombomodulin in disseminated intravascular coagulation and other critical conditions—a multi-faceted anticoagulant protein with therapeutic potential. Takashi Ito. Critical Care volume 23, Article number: 280 (2019) Additional remarks Op dit moment nog enkel in Japan beschikbaar de kosten voor een 6-daagse behandeling bedragen hier $3000. Potential total cost per year Total cost € 5,962,500.00 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 Phase 3: Idiopathic pulmonary fibrosis References Adis Insight Additional remarks Other information Additional remarks