ALKS8700 Medicine 12 June 2018 Extended indication Relapsing remitting multiple sclerosis Therapeutic value No judgement Total cost € 4,750,000.00 Registration phase Clinical trials Product Active substance ALKS8700 Domain Neurological disorders Reason of inclusion Main indication Multiple sclerosis Extended indication Relapsing remitting multiple sclerosis Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Alkermes Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks EVOLVE-MS trial: well tolerated. Prodrug of monomethyl fumarate (MMF) in a controlled-release formulation that rapidly and efficiently convert to MMF in the body. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity New medicine ATMP Unknown Submission date 2021 Expected Registration 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Dimethylfumaraat of andere MS-middelen (zie farmacotherapeutisch kompas). Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 2 times a day Dosage per administration 462 mg References clinicaltrials.gov Additional remarks Expected patient volume per year Patient volume < 500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIP databank, hersenstichting, Nationaal MS fonds. Additional remarks Hersenstichting: In Nederland komt MS voor bij ongeveer 1 op de 1.000 inwoners. Nederland telt dus ongeveer 17.000 mensen met MS. Nationaal MS fonds: Relapsing Remitting MS komt bij ongeveer 40% van alle mensen met MS voor (6.800 personen). ALK8700 zal met Dimethylfumaraat moeten gaan concurreren binnen deze patiëntenpopulatie. Aantal gebruikers Dimethylfumaraat bedroeg in 2016: 2.174. De werkgroep schat in dat ALKS8700 hier een klein deel (maximaal 500) van zal over gaan nemen. Expected cost per patient per year Cost € 9,000.00 - 10,000.00 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 GIPdatabank Additional remarks Dimethylfumaraat kostte in 2016 €9.199 per patiënt per jaar. Potential total cost per year Total cost € 4,750,000.00 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