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Scheduling delegates' final decisions: NCEs, May 2018

Scheduling medicines and poisons

19 June 2018

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1.9 Lonoctocog alfa

New Chemical Entities - medicines for human therapeutic use

1.9 Lonoctocog alfa

Delegate's final decision
Final decision:

The delegate's final decision is that lonoctocog alfa is exempt from scheduling as it falls under Appendix A - General Exemptions under HUMAN BLOOD PRODUCTS.

Implementation date: 1 June 2018
Reasons:

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate include:

  1. the risks and benefits of the use of a substance
    • The risks and benefits have been considered with the view reached that benefits outweighed risks.
  2. the purposes for which a substance is to be used and the extent of use of a substance
    • Lonoctocog alfa is a recombinant single-chain coagulation Factor VIII for use in Haemophilia A
Scheduling proposal

The delegate of the Secretary proposed to amend the Poisons Standard with respect to lonoctocog alfa.

Scheduling status

Lonoctocog alfa is exempt from scheduling as it is captured by the Appendix A entry for HUMAN BLOOD PRODUCTS, (iv) clotting factors as follows:

Appendix A - General exemptions

HUMAN BLOOD PRODUCTS including:

  1. whole blood;
  2. blood components including red cells, white cells, platelets and plasma (including cryoprecipitate); and
  3. the following plasma-derived therapeutic proteins; and their equivalent recombinant alternatives:
    1. albumin;
    2. anticoagulation complex;
    3. C1 esterase inhibitors;
    4. clotting factors;
    5. fibrinogen;
    6. protein C;
    7. prothrombin complex concentrate (PCC); and
    8. thrombin.
Delegate's consideration

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; and (b) the purposes for which a substance is to be used and the extent of use of a substance.

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