Baricitinib

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.
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).

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.

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.