Olopatadine / mometasone

Active substance
Olopatadine / mometasone
Domain
Chronic immune diseases
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Allergy
Extended indication
Allergic rhinitis

1. Product

Proprietary name
Ryaltris
Manufacturer
Glenmark
Mechanism of action
Combination therapy
Route of administration
Nasal
Therapeutical formulation
Nose spray
Budgetting framework
Extramural (GVS)
Additional comments
Antihistamine (oloparatide) en corticoteroid (mometasone). Scrip pipeline watch 18 dec 2017: Efficacy and safety endpoints met.

2. Registration

Registration route
Centralised (EMA)
Submission date
2020
Expected Registration
2021
Orphan drug
No
Registration phase
Clinical trials
Additional comments
FDA registratieaanvraag verwacht begin 2018

3. Therapeutic value

Current treatment options
Anti-histaminica, corticosteroiden.
Therapeutic value
Potential equal value
Duration of treatment
Average 120 day / days
Frequency of administration
2 times a day
Dosage per administration
665 μg / 25 μg
References
NCT02709538; GIPdatabank
Additional comments
Gebruik wanneer nodig. 2 maal sprayen per toediening dus 4 doses per dag. Gemiddeld aantal DDD voor antihistaminica in 2016 is 120.

4. Expected patient volume per year

References
NHG-Standaard Allergische en niet-allergische rhinitis
Additional comments
In huisartsenregistraties is de prevalentie van allergische en niet-allergische rhinitis 25 per 1.000 mannen en 31 per 1.000 vrouwen per jaar. Dit komt neer op 391.000 per 17 miljoen Nederlanders. Olopatadine/mometasone zal hier een klein deel van de markt van kunnen veroveren.

5. Expected cost per patient per year

Cost
700 - 800
References
Medicijnkosten.nl; GIPdatabank
Additional comments
1 flacon mometasone 140 doses, 50 μg/dosis kost €5,45; 1 flacon van 5 ml, 1mg/ml olopatadine oogdruppels kost €7,32; Mometason (Nosonex) wordt gemiddeld per gebruiker voor 90 DDD gebruikt.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
No

9. Other information

There is currently no futher information available.