Olopatadine / mometasone Medicine 12 June 2018 Extended indication Ryaltris is indicated in adults and children 12 years of age and older for the treatment of nasal and ocular symptoms associated with allergic rhinitis and rhino-conjunctivitis Therapeutic value Possible equal value Total cost Registration phase Registered Product Active substance Olopatadine / mometasone Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Unknown Extended indication Ryaltris is indicated in adults and children 12 years of age and older for the treatment of nasal and ocular symptoms associated with allergic rhinitis and rhino-conjunctivitis Current proprietary name Already available biosimilars / generics Proprietary name Ryaltris Manufacturer Glenmark Portfolio holder Mechanism of action Combination therapy Route of administration Nasal Therapeutical formulation Nose spray Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Antihistamine (oloparatide) en corticosteroïd (mometasone). Scrip pipeline watch 18 dec 2017: Efficacy and safety endpoints met. Registration Registration route Decentralised Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date January 2020 Expected Registration August 2021 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Het geneesmiddel is ingediend bij de FDA, maar niet in behandeling genomen vanwege onbekende onvolkomenheden in de aanvraag. 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. Tweemaal sprayen per toediening dus 4 doses per dag. 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 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 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 5ml, 1mg/ml olopatadine oogdruppels kost €7,32; Mometason (Nosonex) wordt gemiddeld per gebruiker voor 90 DDD (Daily Defined Dose) 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