Extended indication Mucositis in head and neck cancer.
Therapeutic value No judgement yet
Total cost 11,475,000.00
Registration phase No registration expected

Product

Active substance Brilacidin
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Head and neck cancer
Extended indication Mucositis in head and neck cancer.
Manufacturer Innovation
Mechanism of action Antibiotic
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments First-in-class a synthetic, small-molecule defensin-mimetic, for treatment of bacterial infections.

Registration

Registration route Centralised (EMA)
Orphan drug No
Registration phase No registration expected
Additional comments Scrip pipeline watch 8 jan 2018: Delayed onset of severe oral symptoms. Updated Phase III Results. Op dit moment zijn er geen duidelijke aanwijzingen dat er binnen afzienbare tijd een registratieaanvraag zal worden ingediend.

Therapeutic value

Current treatment options Momenteel geen behandeling.
Therapeutic value No judgement yet
Substantiation Beperkte informatie beschikbaar.
Frequency of administration 3 times a day
Dosage per administration 3mg/ml
References NCT02324335
Additional comments De studie NCT02324335 heeft een behandelduur van 7 weken.

Expected patient volume per year

Patient volume

1,500 - 1,900

Market share is generally not included unless otherwise stated.

References NKR; Oncoline
Additional comments In 2015 werden 1.899 patiënten met hoofd- en hals tumoren behandeld met radiotherapie. Bij 80%-100% van deze patiënten treedt mucositis op als bijwerking van deze behandeling, dit bedraagt dus 1.519-1.899 patiënten.

Expected cost per patient per year

Cost 4,500.00 - 9,000.00
References http://www.ipharminc.com/new-blog/2019/4/9/brilacidin-competitive-positioning-market-opportunity-for-oral-mucositis.
Additional comments De fabrikant verwacht $5.000-$10.000 te kunnen vragen per behandeling. Omgerekend is dit ongeveer €4.500-€9.000

Potential total cost per year

Total cost

11,475,000.00

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Skin Infection (Bacterial Infection)
References Clinicaltrials.gov

Other information

There is currently no futher information available.