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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 letermovir, a new chemical entity (NCE) for a human therapeutic medicine.
Letermovir is an inhibitor of cytomegalovirus viral terminase and will be presented as a concentrated injection solution for infusion.
Letermovir has been requested for the indication of "prophylaxis of cytomegalovirus (CMV) infection or disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT)".
Letermovir is not specifically scheduled but is captured by the Schedule 4 class entry for insulins 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)).
Letermovir is classified as a prescription only medicine in Canada and the United States of America, and is unclassified in New Zealand.
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; and
- 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 letermovir in Schedule 4, with an implementation date of 1 February 2018.
The delegate has decided that the wording for the schedule entry will be as follows:
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:
- Letermovir is an NCE with no clinical or marketing experience in Australia.
- Letermovir is for highly specialised clinical use.
- Requires use under specialised clinical supervision.
- Presentation will be in compliance with the prescription medicines labelling requirements.