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Scheduling delegate's final decisions: ACCS/ACMS, June 2013

Scheduling medicines and poisons

28 June 2013

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Part B: New chemical entities - medicines for human therapeutic use

5.1 Aclidinium Bromide

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of aclidinium bromide, a new chemical entity for a human therapeutic medicine.

Aclidinium bromide is a selective M3 muscarinic antagonist.

Aclidinium bromide is proposed for 'long-term maintenance of bronchodilator treatment to relieve symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD)'.

The delegate decided to make a delegate-only decision to include aclidinium bromide in Schedule 4. The Advisory Committee on Medicines Scheduling was not consulted.

Scheduling status

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

Aclidinium bromide is not classified in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application for scheduling.

  • The new drug application.
  • The TGA evaluation report.
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.

Delegates' final decision

The delegate has made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include aclidinium bromide in Schedule 4, with an implementation date of 1 September 2013.

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are (a) risks and benefits of aclidinium bromide.

The delegate decided that the reasons for the final decision comprise of the following.

  • Aclidinium bromide is a new chemical entity with no [clinical/marketing] experience in Australia.

Schedule entry

Schedule 4 - New entry

ACLIDINIUM BROMIDE.

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5.2 Crizotinib

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of crizotinib, a new chemical entity for a human therapeutic medicine.

Crizotinib is an inhibitor of receptor tyrosine kinases including ALK, Hepatocyte Growth Factor Receptor (HGFR, c-Met) and Recepteur d'Origine Nantais (RON). Translocations can affect the ALK gene resulting in the expression of oncogenic fusion proteins. The formation of ALK fusion proteins results in activation and dysregulation of the gene's expression and signalling which can contribute to increased cell proliferation and survival in tumors expressing these proteins.

Crizotinib is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

The delegate has made a delegate-only decision to include crizotinib in Schedule 4. The Advisory Committee on Medicines Scheduling (ACMS) was not consulted19.

Scheduling status

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

Crizotinib is not classified in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application for scheduling.

  • The new drug application.
  • The TGA evaluation report.
  • The advice of the Advisory Committee on Prescription Medicines.
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.
  • S60 decision and subsequent information.

Delegates' final decision

The delegate has made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include crizotinib in Schedule 4, with an implementation date of 1 September 2013.

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are (a) risks and benefits of crizotinib.

The delegate decided that the reasons for the final decision comprise of the following:

  • Crizotinib is a new chemical entity with no marketing experience in Australia.

Schedule entry

Schedule 4 - New entry

CRIZOTINIB.

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5.3 Lidocaine (Lignocaine) and Tetracaine (Amethocaine)

Scheduling proposal

The medicines scheduling delegate (the delegate) considered a proposal from the Therapeutic Goods Administration to cross-reference the International Nonproprietary Names (INNs) to the Australian Approved Names (AANs) in the index to the Standard for the Uniform Scheduling of Medicines and Poisons, for the Schedule entries for lignocaine and amethocaine.

Delegate's consideration

The delegate considered the following with regard to this proposal.

  • Lignocaine is the AAN and currently included in Schedules 2 and 4.
  • Lignocaine is a synonym of lidocaine, the INN.
  • Amethocaine is the AAN and currently included in Schedules 2 and 4.
  • Amethocaine is a synonym of tetracaine, the INN.
  • Poisons are scheduled using their approved names, as stated under 'Reading the Schedules' in the Introduction to the SUSMP.
  • The approved name for a poison that is for human therapeutic use, is the name approved for use by the TGA, as defined in Part 1, Interpretation to the SUSMP.
  • The name approved for use by the TGA is the AAN.

Delegate's final decision

The delegate has made a delegate-only decision to include new entries in the Index to the Standard for the Uniform Scheduling of Medicines and Poisons to cross-reference lidocaine (INN) to lignocaine (AAN) and to cross-reference tetracaine (INN) to amethocaine (AAN).

The reason for the delegate's decision is to achieve clarity.

The cross-references will be included in the next consolidation of the SUSMP.

Schedule entry

SUSMP Index - New cross-reference entries

LIDOCAINE

  • See LIGNOCAINE

TETRACAINE

  • See AMETHOCAINE

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5.4 Loteprednol etabonate

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of loteprednol etabonate, a new chemical entity for a human therapeutic medicine.

Loteprednol etabonate is a corticosteroid used in optometry and ophthalmology. The proposed indication is for:

  • the treatment of post-operative inflammation following ocular surgery; and
  • the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in oedema and inflammation.

Scheduling status

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

Loteprednol etabonate is not classified in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application for scheduling.

  • The new drug application.
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.

The delegate decided to make a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.

Delegates' final decision

The delegate has made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include loteprednol etabonate in Schedule 4, with an implementation date of 1 September 2013.

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are (a) risks and benefits and (b) purpose and the extent of use.

The delegate decided that the reasons for the final decision comprise of the following.

  • It is a new chemical entity with no clinical/marketing experience in Australia.
  • It is a topical steroid and requires professional supervision and monitoring for initiation and continuation of use.

Schedule entry

Schedule 4 - New entry

LOTEPREDNOL ETABONATE.

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5.5 Pertuzumab

Scheduling proposal

For the delegate to consider the scheduling of pertuzumab (Perjeta), a new chemical entity for a human therapeutic medicine.

Pertuzumab is a monoclonal antibody and is the first of its class in a line of agents called "HER dimerization inhibitors". By binding to HER2, it inhibits the dimerizationof HER2 with other HER receptors, which is hypothesized to result in slowed tumor growth.

It is indicated in combination with Herceptin and docetaxel for patients with HER2-positive metastatic (Stage IV) or unresectable locally recurrent breast cancer who have not received previous treatment or whose disease has relapsed after adjuvant therapy.

The delegate has made a delegate-only decision to include pertuzumab in Schedule 4. The Advisory Committee on Medicines Scheduling was not consulted.

Scheduling status

Pertuzumab is not specifically scheduled but it is captured by the Schedule 4 entry of MONOCLONAL ANTIBODIES for therapeutic use except:

  • (a) in diagnostic test kits; or
  • (b) when separately specified in these Schedules.

Pertuzumab is not classified in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application for scheduling.

  • The new drug application.
  • The TGA evaluation report.
  • The advice of the Advisory Committee on Prescription Medicines (ACPM).
  • Subsection 52E(1) of the
  • Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors for inclusion in Schedule 4.

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 Standard for the Uniform Scheduling of Medicines and Poisons to include pertuzumab in Schedule 4, with an implementation date of 1 September 2013.

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are (a) risks and benefits; (b) purpose and the extent of use; (c) toxicity and d) dosage, formulation, labelling, packaging and presentation of pertuzumab.

The delegate decided that the reasons for the final decision comprise of the following.

  • Pertuzumab is a new chemical entity with no [clinical/marketing] experience in Australia.
  • There is a small margin between the therapeutic and toxic dose.
  • The substance is to be used for the treatment of cancer which requires expert medical diagnosis and monitoring of response to treatment.
  • There is a high incidence and severity of adverse reactions.
  • A risk management plan and periodic safety update reports are conditions of registration.
  • The product information advises on the use of the substance.
  • The Pregnancy Category is D.

Schedule entry

Schedule 4 - New entry

PERTUZUMAB.

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5.6 Pralatrexate

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of pralatrexate, a new chemical entity for a human therapeutic medicine.

Pralatrexate is an antimetabolite and antineoplastic agent. It is a folate analog that inhibits folate metabolism by binding to and inhibiting the enzyme dihydrofolate reducatase with effect on the synethsis of DNA.

Pralatrexate is indicated for the treatment of adult patients with relapsed or refractoryperipheral T-cell lymphoma (nodal, extranodal and leukamic/disseminated).

The delegate decided to make a delegate-only decision to include pralatrexate in Schedule 4. The Advisory Committee on Medicines Scheduling was not consulted.

Scheduling status

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

Pralatrexate is not classified in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application for scheduling.

  • The new drug application.
  • The TGA evaluation report.
  • The advice of the Advisory Committee on Prescription Medicines.
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors for inclusion in Schedule 4.

Delegates' final decision

The delegate has made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include pralatrexate in Schedule 4, with an implementation date of 1 September 2013.

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are (a) risks and benefits of pralatrexate.

The delegate decided that the reasons for the final decision comprise of the following:

  • Pralatrexate is a new chemical entity with no marketing experience in Australia.

Schedule entry

Schedule 4 - New entry

PRALATREXATE.

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5.7 Regorafenib

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of regorafenib, a new chemical entity for a human therapeutic medicine.

Regorafenib is an oral kinase inhibitor acting on various membrane-bound and intracellular kinases involved in cellular functions and processes, including oncogenesis, tumor angiogenesis, and maintenance of the tumor microenvironment.

Regorafenib is proposed for the treatment of patients with metastatic colorectal cancer (CRC) irrespective of KRAS mutational status who have been previously treated with, or are not considered candidates for, fluoropyrimidine-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.

The delegate decided to make a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.

Scheduling status

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

Regorafenib is not classified in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application for scheduling.

  • The new drug application.
  • The TGA evaluation report.
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.

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 Standard for the Uniform Scheduling of Medicines and Poisons to include regorafenib in Schedule 4, with an implementation date of 1 September 2013.

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are (a) risks and benefits; (b) purpose and the extent of use, (c) toxicity and (d) dosage, packaging and presentation of regorafenib.

The delegate decided that the reasons for the final decision comprise of the following:

  • Regorafenib is a new chemical entity with no clinical experience in Australia.
  • There is a small margin between the therapeutic and toxic dose.
  • The substance is to be used for the treatment of cancer which requires expert medical diagnosis and monitoring of response to treatment.
  • There is a high incidence and severity of adverse reactions.
  • A risk management plan will be a condition of registration.
  • The product information will advise on the use of the substance.
  • The Pregnancy Category is D.

Schedule entry

Schedule 4 - New entry

REGORAFENIB.

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5.8 Ruxolitinib (Phosphate)

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of ruxolitinib phosphate, a new chemical entity for a human therapeutic medicine.

Ruxolitinib phosphate is an antineoplastic agent and tyrosine kinase inhibitor proposed for the treatment of patients with primary myelofibrosis, postpolycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.

The delegate decided to make a delegate-only decision to include ruxolitinib phosphate as ruxolitinib in Schedule 4.

The Advisory Committee on Medicines Scheduling was not consulted.

Scheduling status

Ruxolitinib phosphate or ruxolitinib are not specifically scheduled and are not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons.

Ruxolitinib is not classified in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application for scheduling.

  • The new drug application.
  • The TGA evaluation report.
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.

Delegates' final decision

The delegate has made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include ruxolitinib in Schedule 4, with an implementation date of 1 September 2013.

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are (a) risks and benefits; (b) purpose and the extent of use, (c) toxicity and (d) dosage, formulation, labelling, packaging and presentation of ruxolitinib.

The delegate decided that the reasons for the final decision comprise of the following.

  • It is a new chemical entity with no clinical experience in Australia.
  • There is a small margin between the therapeutic and toxic dose.
  • The substance is to be used for the treatment of cancer which requires expert medical diagnosis and monitoring of response to treatment.
  • There is a high incidence and severity of adverse reactions.
  • A risk management plan will be a condition of registration.
  • The product information will advise on the use of the substance.
  • The Pregnancy Category is C.

Schedule entry

Schedule 4 - New entry

RUXOLITINIB.

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5.9 Vandetanib

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of vandetanib, a new chemical entity for a human therapeutic medicine.

Vandetanib is an antineoplastic agent that inhibits the activity of tyrosine kinases including members of the epidermal growth factor receptor (EGFR) family, vascular endothelial cell growth factor (VEGF) receptors.

Vandetanib is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.

The delegate decided to make a delegate-only decision to include vandetanib in Schedule 4. The Advisory Committee on Medicines Scheduling was not consulted.

Scheduling status

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

Vandetanib is not classified in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application for scheduling:

  • The new drug application.
  • The TGA evaluation report.
  • The advice of the Advisory Committee on Prescription Medicines.
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.

Delegates' final decision

The delegate has made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include vandetanib in Schedule 4, with an implementation date of 1 September 2013.

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are (a) risks and benefits of vandetanib.

The delegate decided that the reasons for the final decision comprise of the following:

  • Vandetanib is a new chemical entity with no marketing experience in Australia.
  • Based on evidence provided by the sponsor in support of registration on the ARTG, the benefits of vandetanib outweigh the harms in the proposed target population.

Schedule entry

Schedule 4 - New entry

VANDETANIB.

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5.10 Vismodegib

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of vismodegib, a new chemical entity for a human therapeutic medicine.

Vismodegib is an inhibitor of the Hedgehog pathway. It binds to and inhibits Smoothened, a transmembrane protein involved in Hedgehog signal transduction.

The proposed indication is for the treatment of adult patients with advanced basal cell carcinoma for whom surgery is inappropriate.

The delegate has made a delegate-only decision to include vismodegib in Schedule 4. The Advisory Committee on Medicines Scheduling was not consulted.

Scheduling status

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

Vismodegib is not classified in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application for scheduling.

  • The new drug application.
  • The TGA evaluation report.
  • The advice of the Advisory Committee on Prescription Medicines.
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors for inclusion in Schedule 4.

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 include vismodegib in Schedule 4 of the Standard for the Uniform Scheduling of Medicines and Poisons, with an implementation date of 1 September 2013.

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are (a) risks and benefits and (f) any other matters that the Secretary considers necessary to protect public health of vismodegib.

The delegate decided that the reasons for the final decision comprise of the following:

  • Vismodegib is a new chemical entity with no clinical and marketing experience in Australia.
  • Vismodegib is Pregnancy Category X but its use is in a restricted population and likely to be under close supervision of appropriately specialised physicians, therefore label warnings are not considered necessary at this stage.

Schedule entry

Schedule 4 - New entry

VISMODEGIB.


Footnotes

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