Budesonide modified released capsule Medicine 07 December 2021 Extended indication Treatment of primary immunoglobulin A (IgA) nephropathy Therapeutic value No estimate possible yet Total cost Registration phase Positive CHMP opinion Product Active substance Budesonide modified released capsule Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Other chronic immune diseases Extended indication Treatment of primary immunoglobulin A (IgA) nephropathy Current proprietary name Already available biosimilars / generics Proprietary name Nefecon Manufacturer Calliditas Therapeutics Portfolio holder Mechanism of action Immunosuppression Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Glucocorticoid receptor agonist Registration Registration route Centralised (EMA) Type of trajectory Accelerated assessment Particularity Unknown ATMP Unknown Submission date June 2021 Expected Registration July 2022 Orphan drug Yes Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie ontvangen in mei 2022. Therapeutic value Current treatment options Entocort Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De werking is hetzelfde als dat van normaal budesonide. Echter, is de afgifte van de stof mogelijk beter in deze nieuwe variant. Resultaten van de studie lieten zien dat Nefecon de primaire eindpunten behaald heeft. Statistisch significant op proteinuria reductie (as measured by urine protein to creatinine ratio; P =.0005), en ook op eGFR stabilisatie (P =.0029), vergeleken met placebo. Duration of treatment Frequency of administration 1 times a day Dosage per administration 16 mg References NCT03643965 Additional remarks Expected patient volume per year Patient volume 255 - 680 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Richtlijn Behandeling en Diagnostiek van IgA Nefropathie; Simon P, Ramee MP, Boulahrouz R et al: Epidemiologic data of primary glomerular diseases in western France. Kidney Int 66:905-908, 2004 Additional remarks De incidentie van IgA-nefropathie wordt geschat op 15-40 gevallen per miljoen inwoners. Dit zou voor Nederland betekenen dat er jaarlijks tussen de 255 en 680 patiënten in aanmerking zullen komen voor deze behandeling. Expected cost per patient per year Cost References Additional remarks Het is nog de vraag hoe groot het verschil in kosten zal zijn met Entocort. 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 Unknown Indication extensions References Additional remarks Other information Additional remarks