Extended indication

"Tysabri is indicated as single disease modifying therapy in adults with highly active relapsing rem

Therapeutic value

Possible equal value

Total cost

8,100,000.00

Registration phase

Clinical trials

Product

Active substance

Natalizumab

Domain

Neurological disorders

Reason of inclusion

New medicine (specialité)

Main indication

Multiple sclerosis

Extended indication

"Tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: •Patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods) •Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.

Manufacturer

Biogen

Mechanism of action

Immunosuppression

Route of administration

Subcutaneous

Therapeutical formulation

Injection

Budgetting framework

Extramural (GVS)

Additional comments
Natalizumab is een gehumaniseerd monoklonaal antilichaam gericht tegen het celadhesiemolecuul α4-integrine. Binding aan α4-integrine verhindert dat witte bloedcellen vanuit het bloed het centraal zenuwstelsel bereiken en dat de zenuwcellen en hun uitlopers door ontstekingen worden vernietigd.

Registration

Registration route

Centralised (EMA)

Type of trajectory

Normal trajectory

Particularity

New therapeutical formulation

Submission date

2021

Expected Registration

2022

Orphan drug

No

Registration phase

Clinical trials

Therapeutic value

Current treatment options

Alle huidige ziekte-modificerende behandelingen (DMT's, disease modifying therapies) voor de onderhoudsbehandeling van patiënten met 'relapsing' multipele sclerose (RMS).

Therapeutic value

Possible equal value

Substantiation

De verwachting is dat de effectiviteit van de subcutane variant van natalizumab vergelijkbaar zal zijn met ofatumumab. Voor natalizumab zullen enkel JCV negatieve patiënten in aanmerking komen.

Duration of treatment

continuous

Frequency of administration

1 times every 6 weeks

Dosage per administration

300 mg

References
NCT03689972

Expected patient volume per year

Patient volume

300 - 600

Market share is generally not included unless otherwise stated.

References
GIPdatabank
Additional comments
In 2019 waren er 1.077 gebruikers van de intraveneuze variant van natalizumab. De verwachting is dat er een afname zal plaatsvinden doordat patiënten in de toekomst zullen overstappen op ocrelizumab en ofatumumab. Er komen in Nederland vermoedelijk 300 tot 600 patiënten in aanmerking voor deze behandeling.

Expected cost per patient per year

Cost

18,000.00

References
GIPdatabank; https://www.ema.europa.eu/en/medicines/human/EPAR/tysabri#product-information-section
Additional comments
In 2019 werd er per gebruiker €17.916 vergoed voor natalizumab IV. De verwachting is dat natalizumab SC in dezelfde prijsrange zal worden ingezet.

Potential total cost per year

Total cost

8,100,000.00

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

No

References
Adis Insight
Additional comments
Momenteel geen lopende fase 3 studies naar andere indicaties.

Other information

There is currently no futher information available.