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Cladribine

Mavenclad

Extended indication Behandeling van volwassenen met recidiverende vormen van multipele sclerose.
Therapeutic value No judgement
Total cost 15,600,000.00

Product

Active substance Cladribine
Domain Neurological disorders
Main indication Multiple sclerosis
Extended indication Behandeling van volwassenen met recidiverende vormen van multipele sclerose.
Proprietary name Mavenclad
Manufacturer Merck
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date August 2016
Expected Registration August 2017
Orphan drug No
Additional remarks Vergoedingsdossier ingediend bij Zorginstituut Nederland.

Therapeutic value

Therapeutic value No judgement
Duration of treatment Average 2 year / years
Frequency of administration 10 times a year
Dosage per administration 12,25 mg/kg
Additional remarks De cumulatieve dosis is 1,75 mg/kg/jaar. Voor een patient van 70 kg: 122,5 mg/jaar.

Expected patient volume per year

Patient volume

400 - 800

Market share is generally not included unless otherwise stated.
Additional remarks Verwachting: minder patiënten dan Ocrevus.

Expected cost per patient per year

Cost 17,000.00 - 35,000.00
References Prescribing Outlook 2017, Fabrikant.
Additional remarks Prescribing Outlook 2017: 'Cost unknown but it will have to compete with other MS treatments. Annual cost of other disease-modifying therapies ranges from about £6,000 to £21,000.' Fabrikant geeft aan: 25% kostenbesparing tov fingolimod over 4 jaar. Fingolimod behandeling: 0,5 mg per dag, 4 jaar behandelduur: € 93.757,46 Mavenclad behandeling: 1,75 mg/kg cumulatieve dosis per jaar, hoeft maar 2 jaar gebruikt te worden voor een effect van 4 jaar: 3,5 mg/kg, dit zou 25% kostenbesparting opleveren over 4 jaar: €70.318,10. Mavenclad per jaar 1 en 2 zou dan zijn: €70.318,10/2 = € 35.159,05 p.p.p.j. per jaar 3 en 4 € 0,00.

Potential total cost per year

Total cost

15,600,000.00

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.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.