Extended indication

Extension of indication to include treatment, as monotherapy or in combination with conventional syn

Therapeutic value

No estimate possible yet

Total cost

213,440.00

Registration phase

Registered and reimbursed

Product

Active substance

Baricitinib

Domain

Chronic immune diseases

Reason of inclusion

Indication extension

Main indication

Rheumatism

Extended indication

Extension of indication to include treatment, as monotherapy or in combination with conventional synthetic disease modifying antirheumatic drugs (DMARDs), of active juvenile idiopathic arthritis (JIA) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic DMARDs.

Proprietary name

Olumiant

Manufacturer

Eli Lilly

Portfolio holder

Eli Lilly

Mechanism of action

JAK tyrosine kinase inhibitor

Route of administration

Oral

Therapeutical formulation

Tablet

Budgetting framework

Intermural (MSZ)

Registration

Registration route

Centralised (EMA)

Type of trajectory

Normal trajectory

ATMP

No

Submission date

September 2022

Expected Registration

October 2023

Orphan drug

No

Registration phase

Registered and reimbursed

Additional remarks
Positieve CHMP-opinie juli 2023

Therapeutic value

Current treatment options

Adalimumab, etanercept, tocilizumab, abatacept, tofacitinib.

Therapeutic value

No estimate possible yet

Substantiation

De fase 3 studie is gepubliceerd in de Lancet met goede resultaten. Substitutie met tofacitinib. Er is een betere toedieningsfrequentie (1 keer per dag) dan tofacitinib (2 keer per dag).

Frequency of administration

1 times a day

Dosage per administration

2-4 mg

References
NCT03773978; expertopinie

Expected patient volume per year

Patient volume

10 - 30

Market share is generally not included unless otherwise stated.

References
ReumaNederland(1); Expertopinie(2);
Additional remarks
JIA komt bij ongeveer 4.000 kinderen in Nederland voor; 30-40 nieuwe JIA diagnoses per jaar (1). Op basis van het gebruik van tofacitinib bij deze indicatie en het aantal patiënten in deze leeftijd dat gemiddeld behandeld wordt een patiëntvolume van maximaal 25-30 patiënten verwacht (2).

Expected cost per patient per year

Cost

10,672.00

References
Z-index mei 2023
Additional remarks
De prijs voor een verpakking van 28 tabletten Olumiant 4mg bedraagt €820,93. 1 tablet kost €29,32. Bij een behandelduur van een jaar (13 verpakkingen) zou dat €10.672,09 bedragen.

Potential total cost per year

Total cost

213,440.00

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

zie overige indicaties op de horizonscan

Other information

There is currently no futher information available.