Expand all sections

Baricitinib

Olumiant

Extended indication Systemic lupus erythematosus
Therapeutic value No estimate possible yet
Total cost 3,809,904.00
Registration phase No registration expected

Product

Active substance Baricitinib
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Other chronic immune diseases
Extended indication Systemic lupus erythematosus
Proprietary name Olumiant
Manufacturer Eli Lilly
Mechanism of action JAK tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks JAK 1/2 remmer

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Orphan drug No
Registration phase No registration expected
Additional remarks Based on top-line efficacy results from two pivotal Phase 3 trials (SLE-BRAVE-I and II), Lilly has decided to discontinue the Phase 3 development program for OLUMIANT in lupus.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Unmet need. Groot effect verwacht bij zeldzame indicaties.
Duration of treatment continuous
Frequency of administration 1 times a day
Dosage per administration 4 mg
References Wallace et al. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet 2018; 392: 222–31

Expected patient volume per year

Patient volume

< 357

Market share is generally not included unless otherwise stated.
References Op basis van inschatting Forigerimod (Rigerimod) / Belimumab
Additional remarks In de beoordeling van belimumab heeft het Zorginstituut gerekend met: 'De prevalentie van SLE is 28-40 per 100.000 inwoners (ongeveer 4.470 patiënten in Nederland). Ongeveer 8% van de patiënten met SLE heeft een hoge mate van ziekteactiviteit, ondanks een standaardbehandeling (zo’n 357 patiënten).'

Expected cost per patient per year

Cost 10,672.00
References G-standaard november 2022.
Additional remarks De prijs voor een verpakking van 28 tabletten baricitinib 4mg bedraagt €820,93. 1 tablet kost €29,32. Bij een behandelduur van een jaar (13 verpakkingen) zou dat €10. 672,09 bedragen. Baricitinib studies voor SLE bevinden zich in fase 3. De definitieve dosering is nog niet vastgesteld.

Potential total cost per year

Total cost

3,809,904.00

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 Psoriasis; Conditioneel exzeem; Graft versus Host Disease; Arteritis, Giant Cell. Daarnaast geeft de fabrikant de volgende uitbreiding aan: Alopecia Areata.
References Clinicaltrial.gov

Other information

There is currently no futher information available.