Abaloparatide

Extended indication	Treatment of osteoporosis in postmenopausal women at increased risk of fracture
Therapeutic value	No estimate possible yet
Total cost	22,500,000.00
Registration phase	Positive CHMP opinion

Product

Active substance	Abaloparatide
Domain	Metabolism and Endocrinology
Reason of inclusion	New medicine (specialité)
Main indication	Other metabolism and Endocrinology
Extended indication	Treatment of osteoporosis in postmenopausal women at increased risk of fracture
Proprietary name	Eladynos
Manufacturer	Radius
Route of administration	Subcutaneous
Therapeutical formulation	Injection
Budgetting framework	Extramural (GVS)

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
Submission date	January 2016
Expected Registration	December 2022
Orphan drug	No
Registration phase	Positive CHMP opinion
Additional remarks	Negatieve opinie CHMP maart 2018. Herbeoordeling gestart in april 2018. Negatieve opinie CHMP juli 2018. Positieve CHMP opinie ontvangen oktober 2022.

Therapeutic value

Current treatment options	teriparatide, denosumab
Therapeutic value	No estimate possible yet
Duration of treatment	continuous
Frequency of administration	1 times a day
Dosage per administration	80 ug

Expected patient volume per year

Patient volume	< 1,500 Market share is generally not included unless otherwise stated.
References	GIPdatabank
Additional remarks	Denosumab heeft momenteel ruim 20.000 gebruikers (voor alle indicaties) en teriparatide 1.500 gebruikers.

Patient volume

< 1,500

Market share is generally not included unless otherwise stated.

References

GIPdatabank

Additional remarks

Denosumab heeft momenteel ruim 20.000 gebruikers (voor alle indicaties) en teriparatide 1.500 gebruikers.

Expected cost per patient per year

Cost	10,000.00 - 20,000.00
References	FiercePharma
Additional remarks	In de Verenigde Staten wordt Tymlos ingezet op $19.500 per patiënt per jaar.

Potential total cost per year

Total cost	22,500,000.00 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

22,500,000.00

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	Transdermal patch in ontwikkeling

Other information

There is currently no futher information available.