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Mogamulizumab

Poteligeo

Extended indication Poteligeo is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syn
Therapeutic value Possible added value
Total cost 900,000.00
Registration phase Registered

Product

Active substance Mogamulizumab
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Aggressive non-Hodgkin’s lymphoma
Extended indication Poteligeo is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.
Proprietary name Poteligeo
Manufacturer Kyowa
Mechanism of action Other
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Humanized monoclonal antibody targeting CC chemokine receptor 4 (CCR4).

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date November 2017
Expected Registration November 2018
Orphan drug Yes
Registration phase Registered
Additional remarks Indiening gebaseerd op de MAVORIC trial. Positieve CHMP-opinie september 2018. Geregistreerd in november 2018.

Therapeutic value

Current treatment options Systemische chemotherapie
Therapeutic value Possible added value
Substantiation Er bestaat een duidelijke unmet clinical need voor de systemische behandeling van patiënten met een CTCL. In Nederland zijn hiervoor nauwelijks behandelingen beschikbaar. Mogalizumab heeft in een gerandomiseerde fase 3 studie hogere ORR en langere PFS laten zien in verband met vorinostat (ASH 2017).
Frequency of administration 1 times a week
Dosage per administration 1 mg/kg
References NCT01728805
Additional remarks 1 mg/kg per week gedurende 4 weken in cyclus 1, daarna 1 maal per 2 weken.

Expected patient volume per year

Patient volume

< 10

Market share is generally not included unless otherwise stated.
References NKR
Additional remarks Incidentie CTCL in 2016 (NKR): 131. Expertopinie schat het aantal patiënten per jaar in op minder dan 10.

Expected cost per patient per year

Cost 60,000.00 - 120,000.00
References Scrip
Additional remarks ¥155,999 (ongeveer €1.200) per 20mg/5ml. Prijs minimaal/maximaal gebaseerd op 6-12 maanden behandeling van een patiënt van 70kg.

Potential total cost per year

Total cost

900,000.00

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

Indication extension Yes
Indication extensions HTLV-1 associated myelopathy (HAM), Adult T-cell Leukemia/Lymphoma.
References clinicaltrials.gov
Additional remarks Verwachting van patiëntaantal bij recidief ATLL betreft waarschijnlijk minder dan 5 patiënten per jaar.

Other information

There is currently no futher information available.