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Part B - Final decisions on matters not referred to an expert advisory committee
5. New Chemical Entities - medicines for human therapeutic use
5.8 Baricitinib
Delegate's final decision
Final decision:
The delegate has made a final decision to create a new Schedule 4 entry for baricitinib in the Poisons Standard as follows:
Schedule 4 - New Entry
BARICITINIB.
Implementation date: 1 June 2018
Reasons:
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate include:
- the risks and benefits of the use of a substance
- Baricitinib is a new chemical entity with no previous marketing experience in Australia.
- The risks and benefits of baricitinib have been considered and are outlined in the Product Information, Delegate's Request for ACM's Advice and TGA evaluation reports.
- the purposes for which a substance is to be used and the extent of use of a substance
- Treatment should be initiated and monitored by a specialist medical practitioner with experience in the diagnosis and treatment of rheumatoid arthritis.
- Baricitinib has no previous experience of use in the community in Australia but is marketed in the European Union.
- It is proposed for use by patients in the community.
- Baricitinib is a JAK1/JAK2 inhibitor with weaker tyrosine kinase 2 inhibition.
- the toxicity of a substance
- Baricitinib has risks that require medical intervention, monitoring, evaluation, diagnosis and treatment by a medical professional.
- the dosage, formulation, labelling, packaging and presentation of a substance
- The dosage is outlined in the Product Information for baricitinib. The labelling, packaging and presentation of baricitinib need to comply with the requirements for a prescription only medicine.
- the potential for abuse of a substance
- Baricitinib does not appear to produce dependency and the potential for abuse is low.
- any other matters that the Secretary considers necessary to protect public health
- Nil.
Scheduling proposal
The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of baricitinib, a new chemical entity (NCE) for a human therapeutic medicine.
Substance summary
Baricitinib is an oral selective Janus kinase 1 (JAK1) and Janus kinase 2 (JAK2) inhibitor which function by inhibiting the activity of selective JAK1 and JAK2 enzymes, interfering with the JAK-STAT signalling pathway. This pathway is important in modulating the activity of inflammatory cytokines.
Baricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients. Baricitinib has been shown to improve physical function, reduce the signs and symptoms of RA. Baricitinib may be used as monotherapy or with conventional disease modifying anti-rheumatic drugs. Baricitinib should not be used with any other biological disease modifying anti-rheumatic drugs.
Scheduling status
Baricitinib is not specifically scheduled in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) - the Poisons Standard that was in effect at the time the decision was made (Poisons Standard March 2018 (SUSMP No. 20)).
International regulations
Baricitinib is not classified in New Zealand.
Delegate's considerations
The delegate considered the following in regards to this application for scheduling:
- Subsection 52E(1) of the Therapeutic Goods Act 1989;
- The Scheduling Policy Framework (2018) scheduling factors;
- The TGA evaluation report; and
- The new drug application.
The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.