Paclitaxel

Active substance
Paclitaxel
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Ovarian cancer
Extended indication
Apealea in combination with carboplatin is indicated for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.

1. Product

Proprietary name
Apealea
Manufacturer
Oasmia
Mechanism of action
Cytostatic
Route of administration
Intravenous
Therapeutical formulation
Intravenous drip
Budgetting framework
Intermural (MSZ)
Additional comments
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.)

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Particularity
New therapeutical formulation
Submission date
February 2016
Expected Registration
November 2018
Orphan drug
No
Registration phase
Registered
Additional comments
Positieve CHMP-opinie september 2018. Geregistreerd in november 2018.

3. Therapeutic value

Therapeutic value
No judgement
Duration of treatment
Not found

4. Expected patient volume per year

Patient volume

< 347

Market share is generally not included unless otherwise stated.

References
NKR
Additional comments
Ovarium carcinoom NKR stadium 4: 347

5. Expected cost per patient per year

Cost
5,000 - 15,000
References
Medicijnkosten.nl
Additional comments
Paclitaxel oplossing voor infusie 6mg/ml €1.384,46 per flacon van 100 ml. Voor mammacarcinoom kost normale formulering paclitaxel €8.400,00 gemiddeld p.p.p.j..

6. Potential total cost per year

Total cost

3,470,000

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

Off label use
No

8. Indication extension

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

9. Other information

There is currently no futher information available.