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

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.

Registration

Registration route Centralised (EMA)
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials
Additional comments FDA registratieaanvraag verwacht begin 2018

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.

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.

Expected cost per patient per year

Cost 700.00 - 800.00
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.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No

Other information

There is currently no futher information available.