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Paclitaxel

Apealea / Paclical

Extended indication Epithelial ovarian, primary peritoneal or fallopian tube cancer in women relapsing 6 months or more
Therapeutic value No judgement
Total cost 3,470,000.00

Product

Active substance Paclitaxel
Domain Oncology and Hematology
Main indication Ovarian cancer
Extended indication Epithelial ovarian, primary peritoneal or fallopian tube cancer in women relapsing 6 months or more after 1L or 2L platinum-based chemo.
Proprietary name Apealea / Paclical
Manufacturer Oasmia
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Mogelijk alleen cremophor-intolerante patienten, kleine impact. Ook andere alternatieven bij intolerantie. Nieuwe formulering (Paclical/Apealea is a Cremophor- and albumin-free formulation of the well-known cytostatic paclitaxel combined with Oasmia’s excipient technology XR17.)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date February 2016
Expected Registration February 2018
Orphan drug No

Therapeutic value

Therapeutic value No judgement
Duration of treatment Not found

Expected patient volume per year

Patient volume

< 347

Market share is generally not included unless otherwise stated.
References NKR
Additional remarks Ovarium carcinoom NKR stadium 4: 347

Expected cost per patient per year

Cost 5,000.00 - 15,000.00
References Medicijnkosten.nl
Additional remarks Paclitaxel oplossing voor infusie 6mg/ml €1384,46 per flacon van 100 ml. Voor mammacarcinoom kost normale formulering paclitaxel €8.400 gemiddeld p.p.p.j..

Potential total cost per year

Total cost

3,470,000.00

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

Off label use No

Indication extension

Indication extension Yes
Indication extensions NSCLC, pancreas, ovarium (1L), borst.

Other information

There is currently no futher information available.