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Scheduling delegate's final decisions, January 2018
Scheduling medicines and poisons
The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of bictegravir, a new chemical entity (NCE) for a human therapeutic medicine.
Bictegravir is an integrase strand-transfer inhibitor and will be presented in a single tablet fixed dose combination with emtricitabine and tenofovir alafenamide.
Bictegravir is indicated for the treatment of HIV-1 infection in adults without any known mutations associated with resistance to the individual components of the fixed dose combination and for the treatment of chronic hepatitis B in adults coinfected with HIV-1.
Bictegravir is not specifically scheduled and is not captured by any entry 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 October 2017 (SUSMP No. 18)).
Bictegravir not classified in New Zealand, Canada or the United States of America.
The delegate decided to make a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.
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 (2015) scheduling factors;
- The TGA clinical 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.
Delegate’s final decision
Schedule 4 – New Entry
The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are: (a) the risks and benefits of the use of a substance; (b) the purpose and the extent of use of a substance; (c) the toxicity of a substance; and (d) the dosage, formulation, labelling, packaging and presentation of a substance.
The delegate decided that the reasons for the final decision comprise the following:
- Bictegravir is an NCE with no clinical or marketing experience in Australia.
- Requires specialised clinical use.
- Presentation will be in compliance with the prescription medicines labelling requirements.