Thrombomodulin alfa

Active substance Thrombomodulin alfa
Domain Cardiovascular diseases
Reason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)
Main indication Other non-oncological hematological medications
Extended indication Septic shock (Sepsis) - with disseminated intravascular coagulation (DIC)

Product

Proprietary name Recomodulin
Manufacturer Asahi Kasei
Mechanism of action Anticoagulant
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments Recombinant Human Thrombomodulin.

Registration

Registration route Centralised (EMA)
Submission date 2020
Expected Registration 2021
Orphan drug No
Registration phase Clinical trials
Additional comments Nov 18: The phase III trial (NCT01598831) is still recruiting pts, with an estimated study completion date of Dec 2019 (SPS)

Therapeutic value

Therapeutic value No judgement
Duration of treatment Not found
Frequency of administration 1 times a day
Dosage per administration 0,06 mg/kg tot max 6 mg
References NCT01598831

Expected patient volume per year

Patient volume

< 2,250

Market share is generally not included unless otherwise stated.

References https://www.ntvg.nl/artikelen/sepsis-een-gecompliceerd-syndroom-met-belangrijke-medische-en-maatschappelijke/volledig;
Additional comments 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
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 comments 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

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Phase 3: Idiopathic pulmonary fibrosis
References Adis Insight

Other information

There is currently no futher information available.