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Scheduling delegate's final decisions: NCEs, April 2016

Scheduling of medicines and poisons

28 April 2016

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1.7 Hexyl Aminolevulinate

Final decisions on matters not referred to an expert advisory committee

1. New Chemical Entities - medicines for human therapeutic use

1.7 Hexyl Aminolevulinate

Scheduling proposal

The proposal is to include hexaminolevulinate, a new chemical entity for a human therapeutic medicine, in Schedule 4 of the SUSMP.

Scheduling application

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of hexaminolevulinate.

The Advisory Committee on Medicines Scheduling was not consulted.

Substance summary

Hexyl aminolevulinate (as hydrochloride) is a hexyl ester of 5-aminolevulinic acid (5-ALA or ALA), which is the first specific intermediate of heme biosynthesis.

Hexyl aminolevulinate is indicated as adjunct to standard white light cystoscopy to contribute to the diagnosis and management of bladder cancer in patients with known or high suspicion of bladder cancer.

Scheduling status

Hexyl aminolevulinate is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons.

Hexyl aminolevulinate is not classified in New Zealand.

Delegate's consideration

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.

Delegates' final decision

The delegate has made a final decision to amend the SUSMP to include hexyl aminolevulinate (as hydrochloride) in Schedule 4, with an implementation date of 1 June 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.
  • Hexyl aminolevulinate hydrochloride is a blue light cystoscopy imaging agent.
  • Hexyl aminolevulinate is to be used for a medical condition that requires careful diagnosis and management by medical professionals.
  • There are limited data on the use of hexyl aminolevulinate in pregnant women.
  • There are adverse events, such as haematuria and urinary retention, reported with the use of cystoscopy.
  • Cystoscopy should only be performed by health care professionals who are trained specifically in cystoscopy.

The delegate has decided that the wording for the schedule entry will be as follows:

Schedule entry

Schedule 4 - New Entry

HEXYL AMINOLEVULINATE (AS HYDROCHLORIDE)

Implementation date: 1 June 2016.

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