We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. Find out how to contact us during the holiday period.
Part B - Final decisions on matters not referred to an expert advisory committee
4. New Chemical Entities - medicines for human therapeutic use
4.2. Doravirine
Note
New text is shown as green, larger font, with a horizontal line above it.
Delegate's final decision
Final decision
The delegate's final decision is to amend the Poisons Standard to include doravirine in Schedule 4 as follows:
Schedule 4 - New Entry
DORAVIRINE
Index - New Entry
DORAVIRINE
Schedule 4
Implementation date
1 June 2019
Reasons
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate for the decision include:
- the risks and benefits of the use of a substance:
It is a New Chemical Entity with no clinical or marketing experience in Australia. The risk-benefit requires appropriate selection of patients by the treating physician.
- the purposes for which a substance is to be used and the extent of use of a substance:
Used in the treatment of a serious infection (HIV) requiring specialised medical oversight and monitoring.
- the toxicity of a substance:
Doravirine is a HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI). Toxicity typical of NNRTI agents is expected. Drug interactions are also a safety concern.
- the dosage, formulation, labelling, packaging and presentation of a substance:
Presentation and packaging consistent with the labelling requirements for prescription medicine.
- the potential for abuse of a substance:
Nil
- any other matters that the Secretary considers necessary to protect public health:
Nil
Scheduling proposal
The delegate of the Secretary proposed to amend the Poisons Standard with respect to doravirine, a new chemical entity (NCE) for a human therapeutic medicine.
Scheduling status
Doravirine is not specifically scheduled and is not captured by any entry in the Poisons Standard.
Delegate's considerations
- Section 52E(1) of the Therapeutic Goods Act 1989;
- Scheduling Policy Framework (SPF 2018); and
- Advice on the place in therapy of this NCE.