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Scheduling delegate's final decisions, June 2016
Scheduling of medicines and poisons
Part B - Final decisions on matters not referred to an expert advisory committee
5. New Chemical Entities - medicines for human therapeutic use
Delegate's Scheduling proposal
The delegate considered an application from the TGA for the scheduling of velpatasvir, a new chemical entity for a human therapeutic medicine.
Velpatasvir is a novel pan-genotypic HCV non-structural protein 5A (NS5A) inhibitor for use in combination with sofosbuvir for the treatment of HCV infection.
Velpatasvir, in a fixed combination with sofosbuvir, is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults.
Velpatasvir is not specifically scheduled and is not captured by any entry in the current Standard for the Uniform Scheduling of Medicines and Poisons.
Delegate's interim decision
The delegate decided to make a delegate-only decision to include this to Schedule 4. 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 scheduling factors;
- The TGA evaluation report;
- 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
The delegate has made a final decision to amend the Poisons Standard to include velpatasvir in Schedule 4, with an implementation date of 1 October 2016.
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:
- It is a new chemical entity with no clinical/marketing experience in Australia or overseas.
- Treatment of hepatitis C infection.
- Limited data from the clinical trials base.
- Needs to be consistent with the other direct acting antiviral drugs for use in the treatment of hepatitis C infection.
The delegate has decided that the wording for the schedule entry will be as follows:
Schedule 4 - New Entry