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Scheduling delegates' final decisions: NCEs, May 2018
Scheduling medicines and poisons
New Chemical Entities - medicines for human therapeutic use
Delegate's final decision
The delegate's final decision is to amend the Poisons Standard to include blinatumomab in Schedule 4 as follows:
Schedule 4 - New Entry
Implementation date: 1 June 2018
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate include:
- the risks and benefits of the use of a substance
- The benefits are considered to outweigh risks at a population level when blinatumomab is used for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).
- the purposes for which a substance is to be used and the extent of use of a substance
- The use of blinatumomab as a treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL is approved based on phase II, non-randomised evidence. An improvement in clinical outcomes by direct prospective comparison in a randomised setting relative to other standard-of-care salvage therapies has not been established.
- the toxicity of a substance
- The toxicity of blinatumomab includes tumour lysis syndrome, infusion reactions, neutropaenia and febrile neutropaenia, thrombocytopaenia, sepsis, fungal bacterial & viral infections, elevated liver enzymes, pancreatitis, leukoencephalopathy.
- the dosage, formulation, labelling, packaging and presentation of a substance
- Blinatumomab has a significantly complex preparation and administration schedule - a prescriber/administrator education program must be completed prior to use.
The delegate of the Secretary proposed to amend the Poisons Standard with respect to blinatumomab.
Blinatumomab is not specifically scheduled in the Poisons Standard, but as a monoclonal antibody, it is captured by the Schedule 4 entry for monoclonal antibodies as follows:
MONOCLONAL ANTIBODIES for therapeutic use except:
- in diagnostic test kits; or
- when separately specified in these Schedules.
The delegate considered the following in regards to this scheduling:
- Advice on the place in therapy of this medicine;
- Scheduling Policy Framework (SPF 2018); and
- Section 52E(1) of the Therapeutic Goods Act 1989 in particular: (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used 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.