Olopatadine / mometasone Medicine 12 June 2018 Extended indication Allergic rhinitis Therapeutic value Possible equal value Total cost Registration phase Clinical trials Product Active substance Olopatadine / mometasone Domain Chronic immune diseases Reason of inclusion Main indication Allergy Extended indication Allergic rhinitis Current proprietary name Already available biosimilars / generics Proprietary name Ryaltris Manufacturer Glenmark Portfolio holder Mechanism of action Unknown Route of administration Nasal Therapeutical formulation Nose spray Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Antihistamine (oloparatide) en corticoteroid (mometasone). Scrip pipeline watch 18 dec 2017: Efficacy and safety endpoints met. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity New medicine ATMP Unknown Submission date 2018 Expected Registration 2019 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks FDA registratieaanvraag verwacht begin 2018 Therapeutic value Current treatment options Anti-histaminica, corticosteroiden. Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation 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 remarks 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 Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NHG-Standaard Allergische en niet-allergische rhinitis Additional remarks In huisartsenregistraties is de prevalentie van allergische en niet-allergische rhinitis 25 per 1000 mannen en 31 per 1000 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 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. References Medicijnkosten.nl; GIPdatabank Additional remarks 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 Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks