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)

1. 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.

2. 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)

3. 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

4. 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).

5. 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.

6. 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.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

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

9. Other information

There is currently no futher information available.