Paclitaxel

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.
Therapeutic value	No judgement
Total cost	3,470,000.00
Registration phase	Registered

Product

Active substance	Paclitaxel
Domain	Oncology and Hematology
Reason of inclusion	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.
Proprietary name	Apealea
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
Particularity	New therapeutical formulation
Submission date	February 2016
Expected Registration	November 2018
Orphan drug	No
Registration phase	Registered
Additional remarks	Positieve CHMP-opinie september 2018. Geregistreerd in november 2018.

Therapeutic value

Therapeutic value	No judgement

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

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 €1.384,46 per flacon van 100 ml. Voor mammacarcinoom kost normale formulering paclitaxel €8.400,00 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.

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.