Neridronic Acid Medicine 13 December 2018 Extended indication Complex regional pain syndrome; type 1; also known as reflex sympathetic dystrophy Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Neridronic Acid Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Pain Extended indication Complex regional pain syndrome; type 1; also known as reflex sympathetic dystrophy Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Abiogen Portfolio holder Mechanism of action Other Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Potent osteoclast inhibitor - reduces osteoclast activity by inhibiting the farnesyl pyrophosphate synthase (FPPS) enzyme. Fabrikant: Abiogen Pharma. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2022 Expected Registration 2023 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Anti-inflammatoire therapieën (zoals dimethyl sulfoxide and N-acetylcysteine, biphosphonaten zoals clodronate en aledronate en corticosteroïden), farmacologische analgetische therapieën (zoals ketamine intraveneus, gabapentine), vasodilatoire therapie (calcium influx blokkade, ketanserine), spasmolytische therapie (orale spasmolytische therapie met benzodiazepines of baclofen, baclofen intrathecaal bij patiënten met bijkomende dyskinesie). (Universitair Pijn Centrum Maastricht (UPCM)) Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 4 times every 2 weeks Dosage per administration 100 mg References NCT03560986, NCT03530345, NCT02972359 Additional remarks 100mg 4 maal in 10 dagen. Expected patient volume per year Patient volume < 5,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References SPS, Universitair Pijn Centrum Maastricht (UPCM) Additional remarks SPS: "Incidence rates of Complex Regional Pain Syndrome (CRPS) are around 26 per 100,000 patient years in Europe. CRPS has a mean age of onset of 46 years." Universitair Pijn Centrum Maastricht (UPCM): De incidentie van CRPS is 26,2 per 100.000 persoonsjaren en komt vaker voor in de bovenste extremiteit. Een fractuur is de meest voorkomende initiërende gebeurtenis. Vrouwen krijgen 3,4 x vaker CRPS dan mannen. De hoogste incidentie wordt vastgesteld bij vrouwen in de leeftijdscategorie 61 tot 70 jaar. Meestal komt het voor aan 1 extremiteit maar CRPS is ook aan meerdere extremiteiten beschreven. Expected cost per patient per year Cost References Drugs.com Additional remarks In de Verenigde Staten een prijs van $49.40 4mg/100ml. 100mg 4 maal in 10 dagen. $197,60 = €163,15. De definitieve prijs in Nederland is nog niet bekend. 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