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

Scheduling medicines and poisons

Book pagination

8 November 2013

Part B - Final decisions on matters not referred to an expert advisory committee

4. Chemicals

4.1 Tylosin

Scheduling proposal

The Chemicals Scheduling Delegate and the Medicines Scheduling Delegate (the delegates) considered a proposal to reschedule tylosin from Schedule 5 to Schedule 4 in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

This matter was referred to the joint ACCS & ACMS meetings held in June 2012 and March 2013. Based on the Committee's advice and available information the delegates decided to defer making any schedule change, pending receipt of further information.

Scheduling status

Tylosin is listed in Schedules 4 and 5.

Tylosin is a macrolide antimicrobial agent approved in Australia by the APVMA for use in poultry, pigs and cattle. As of March 2013, tylosin has been available as an injection, water-soluble antimicrobial preparation and as premix. While injectable and water-soluble formulations are in Schedule 4 (Prescription Animal Remedy), the feed premix formulations are, according to the concentration of tylosin in the marketed premix, either in Schedule 4 or in Schedule 5 (available over-the-counter without a prescription).

Scheduling history

In November 1968, the then Poisons Schedule Sub-Committee (PSSC) recommended that an entry group 'antibiotics' be included in Schedule 4 exceptwhen tylosin and other macrolides bacitracin, erythromycin and oleandomycin when added to animal feedstuffs for the purpose of growth promotion in concentrations not exceeding 50 ppm, which should be exempt from scheduling. Antibiotic premixes for growth promotion purposes containing the antibiotics above in concentrations greater than 50 ppm but not in excess of 20,000 ppm should be exempt from Schedule 4 when packed and labelled in accordance with Schedule 6 of the Uniform Poisons Schedules. Water soluble antibiotic preparations intended for addition to animals' drinking water should not be made available without prescription.

In May 1977, the then Poisons Schedule Committee (PSC) decided to amend the Schedule 4 entry for antibiotics to include animal feedstuffs containing bacitracin, erythromycin, oleandomycin, tylosin and virginiamycin in concentration of 50 ppm or less of the total active antibiotic principles. The PSC was of the opinion that the continued use of antibiotics as growth promotions in animal feedstuffs could lead to an impairment of their efficacy in the treatment of human disease.

In May 1978 specific entries for antibiotics including tylosin, bacitracin, erythromycin, oleandomycin and virginiamycin were included in Schedule 4, exceptin animal feedstuffs for growth promotion in concentrations of 50 mg / kg or less of the total active antibiotic principle (remained Schedule 6).

In November 1986, the then Drugs and Poisons Schedule Standing Committee (DPSSC) considered a submission to remove tylosin from Schedule 4 to Schedule 6. The review noted that if the concentration of tylosin in the premix was increased it would increase the chance of erythromycin resistance occurring in possible human pathogens. The DPSSC decided not to remove the Schedule 4 entry and recommended the Schedule 6 level of tylosin in premixes be increased from 2 to 5 per cent.

In November 1990, the DPSC considered an apparent anomaly in the scheduling of tylosin. The DPSC confirmed the current scheduling that the Schedule 4 entry related to uses involving therapeutic claims while Schedule 6 entry was solely for growth promotion purposes.

In May 1993, the DPSC decided to include Safety Directions for a Schedule 6 tylosin stockfeed premix.

In February 1996, the National Drugs and Poisons Schedule Committee (NDPSC) decided to reschedule tylosin from Schedule 6 to Schedule 5. The NDPSC considered that the registered products for oral use fell within the acute oral criteria of the new draft guidelines for Schedule 5 and recommended that tylosin when in veterinary products for oral use should be classified as Schedule 5.

In 1999, the Joint Expert Technical Advisory Committee on Antibiotic Resistance (JETACAR) recommended "that all antibiotics for use in humans and animals (including fish) be classified as Schedule 4 (prescription only)." The JETACAR report also recommended that a review of the macrolides (tylosin, kitasamycin, oleandomycin) be undertaken as a priority to assess efficacy and to ensure that continued use is "not likely to impair the efficacy of any other prescribed therapeutic antibiotic or antibiotics for animal or human infections through the development of resistant strains of organisms."

In February 2003, the NDPSC scheduled / rescheduled all antibiotics (except tylosin, kitasamycin, oleandomycin) for use in human and animals in Schedule 4: viginiamycin, bacitracin, cuprimyxin, erythromycin, hygromycin, nalidixic acid, nisin, spiramycin and avoparcin as part of its response to the recommendations (in 1999) of the JETACAR

The October 2003 NDPSC meeting considered a letter sent to feed mill sales representatives from XXXXX in which the company highlighted the Committee's decision regarding the rescheduling of virginiamycin to Schedule 4. XXXXX letter mentioned that XXXXX (containing tylosin) remained in Schedule 5 and was unaffected by the NDPSC decision. The NDPSC agreed to refer claims of inappropriate promotion of antibiotics that are yet to be reviewed under JETACAR to Expert Advisory Group on Antimicrobial Resistance (EAGAR) and the APVMA.

In June 2012, the joint Committee considered a referral from the medicines and chemicals scheduling delegates to consolidate the scheduling of all uses of tylosin in Schedule 4. The joint Committee agreed that they were unable to provide the scheduling delegates informed advice at that stage. The delegates noted that the APVMA review on macrolides was yet to be completed. The delegates therefore decided not to make a scheduling decision on this issue and referred this matter to the March 2013 joint Committee meeting for advice.

Public pre-meeting submissions

Not applicable.

ACCS & ACMS advice to the Delegate - March 2013 meeting

The ACCS & ACMS considered the referral from the scheduling delegates to reschedule tylosin from Schedule 5 to Schedule 4 in the Standard for the Uniform Scheduling of Medicines and Poisons. The Committees advised the delegates that it was unable to make a scheduling recommendation or to provide advice at this time due to lack of provision to the Committees of all of the available data in the form of the macrolide review or an alternative acceptable process.

Delegates' interim decision - June 2013

The delegates decided to defer making an interim decision on the consolidation of the scheduling of tylosin in to Schedule 4, pending receipt of further advice on the key issue of the risks of expanding antibiotic resistance associated with its use as an animal health feed additive (the current Schedule 5 and exempt uses).

Submissions on interim decision

A submission was received from a sponsor of a product containing tylosin and was considered by the delegates in making a scheduling decision. The redacted public submissions are available at Public submissions on scheduling matters.

Delegates' consideration

The delegates considered the following in regards to this proposal:

  • evaluation report (not publically available);
  • scheduling proposal;
  • ACCS & ACMS advice;
  • section 52E of the Therapeutic Goods Act 1989;
  • scheduling factors1;
  • public submissions (pre- and post-meeting); and
  • other relevant information.

  1. Scheduling policy framework for medicines and chemicals
Delegates' final decision

The delegates have reconsidered this matter and decided to delete the current entry for tylosin in Schedule 5 with an implementation date of 1 June 2014.

The relevant matters considered by the delegate under section 52E (1) of the Therapeutic Goods Act 1989 includes (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 and (f) any other matters that the Secretary considers necessary to protect public health.

The decision to revert all uses of tylosin to Schedule 4 incorporated the following reasons:

  • The scheduling decision addresses an anomaly that has existed since 2003, when the then NDPSC responded to Recommendation 6 of the JETACAR report and re-scheduled animal treatment antibiotics to Schedule 4.
  • At that time, consideration of the re-scheduling of animal feed pre-mixes containing up to 5% tylosin was deferred pending a review of macrolide antibiotic use in animal treatment.
  • This review has not been completed, but the delegates have sought expert advice on the potential for veterinary use of tylosin to contribute to antibiotic resistance development (a key issue in the JETACAR report). This input has included advice from the APVMA, joint meetings of the ACCS & ACMS, the sponsor of an affected product, and independent expert on antibiotic resistance, who was also a previous member of the JETACAR panel.
  • The decision to delete the current Schedule 5 entry for tylosin and the other exemptions in the current Schedule 4 entry is to finalise Recommendation 6 of the JETACAR report and to align tylosin scheduling with that of other antibiotics used in animal treatment to require veterinary prescription of their use.
Schedule entry
Schedule 4 - Amendment

Tylosin. except:

  1. when included in Schedule 5;
  2. in animal feeds containing 50 mg/kg or less of antibiotic substances:
    1. for growth promotion;
    2. for the prevention of liver abscesses in cattle; or
    3. for the prevention of ileitis in pigs; or
  3. in milk replacers for calves, or starter rations for pigs, containing 100 mg/kg or less of antibiotic substances.
Schedule 5 - Delete entry

Tylosin in animal feed premixes containing 5 per cent or less of antibiotic substances:

  1. for growth promotion;
  2. for the prevention of liver abscesses in cattle; or
  3. for the prevention of ileitis in pigs.

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5. New chemical entities - medicines for human therapeutic use

5.1 Afatinib Dimaleate

Scheduling proposal

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

Afatinib dimaleate is a tyrosine kinase inhibitor (TKI) that irreversibly inhibits human epidermal growth factor receptor 2 (Her2) and epidermal growth factor receptor (EGFR) kinases. The proposed indication is:

GIOTRIF® is indicated as monotherapy for treatment of patients with metastatic adenocarcinoma of the lung whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or L858R substitution mutations. In patients previously treated with EGFR tyrosine kinase inhibitors, GIOTRIF should only be used if clinical benefit was sustained for 12 or more weeks on such therapy

The indication approved at registration may differ from this.

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

Scheduling status

Afatinib dimaleate is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

Afatinib dimaleate 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 afatinib dimaleate in Schedule 4, with an implementation date of 1 February 2014.

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 and (c) toxicity, d) dosage, formulation, labelling, packaging and presentation, and (e) the potential for abuse of afatinib dimaleate.

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

  • Afatinib dimaleate is a new chemical entity with no marketing experience in Australia.
  • The proposed indication is: GIOTRIF® is indicated as monotherapy for treatment of patients with metastatic adenocarcinoma of the lung whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or L858R substitution mutations. In patients previously treated with EGFR tyrosine kinase inhibitors, GIOTRIF should only be used if clinical benefit was sustained for 12 or more weeks on such therapy
  • Toxicity has been taken into account in consideration of benefit- risk.
  • The aspects of dosage, formulation, labelling, packaging and presentation have been evaluated and found acceptable in the TGA evaluation process.
  • The potential for abuse of this Substance is limited.
Schedule entry
Schedule 4 - New entry

Afatinib dimaleate.

5.2 Dabrafenib mesilate

Scheduling proposal

For the delegate to consider the scheduling of the new chemical entity dabrafenib mesilate.

Dabrafenib mesilate is an antineoplastic agent that inhibits BRAF kinase. It selectively binds to and inhibits the activity of B-raf (BRAF), which may inhibit the proliferation of tumor cells which contain a mutated BRAF gene. B-raf belongs to the raf family of serine/threonine protein kinases and plays a role in regulating the MAP kinase/ERKs signaling pathway, which may be constitutively activated due to BRAF gene mutations.

Dabrafenib mesilate is indicated for the treatment of patients with BRAF V600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma.

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

Scheduling status
  • Dabrafenib mesilate is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).
  • Dabrafenib mesilate 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 dabrafenib mesilate in Schedule 4, with an implementation date of 1 Feb 2014.

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 and (c) toxicity, d) dosage, formulation, labelling, packaging and presentation, and (e) the potential for abuse of dabrafenib mesilate.

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

  • Dabrafenib mesilate is a new chemical entity with no marketing experience in Australia.
  • During the TGA evaluation process, the benefits have been found to outweigh the risks of use in the indicated population.
  • The indication is: treatment of patients with BRAF V600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma.
  • Toxicity has been taken into account in consideration of benefit - risk.
  • The aspects of dosage, formulation, labelling, packaging and presentation have been evaluated and found acceptable in the TGA evaluation process.
  • The potential for abuse of this Substance is limited.
Schedule entry
Schedule 4 - New entry

Dabrafenib mesilate.

5.3 Dolutegravir

Scheduling proposal

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

Dolutegravir is indicated for the treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in adults and children over 12 years of age.

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

Scheduling status
  • Dolutegravir is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).
  • Dolutegravir is not classified in New Zealand.
Delegate's consideration

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

  • 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.

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 xxxxx in Schedule 4, with an implementation date of 1 Feb 2014.

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 and (c) toxicity, d) dosage, formulation, labelling, packaging and presentation, and (e) the potential for abuse of dolutegravir.

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

  • Tivicay is a new chemical entity with no clinical experience in Australia.
  • TIVICAY is to be used for the treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in adults and children over 12 years of age.
  • Many toxic effects are associated with the use of this class of drug, such as Hypersensitivity reactions, Immune Reconstitution Syndrome
  • There is also possible interaction with other drugs.
  • TIVICAY are tablets to be taken orally.
  • Not aware of any potential for abuse.
Schedule entry
Schedule 4 - New entry

Dolutegravir.

5.4 Mirabegron

Scheduling proposal

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

Mirabegron is a beta3-adrenoceptor agonist which increases bladder capacity by relaxing the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle. It is indicated for symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in patients with overactive bladder (OAB) syndrome.

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

Scheduling status
  • Mirabegron is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).
  • Mirabegron 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 on 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 mirabegron in Schedule 4, with an implementation date of 1 Feb 2014.

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 and (c) toxicity, d) dosage, formulation, labelling, packaging and presentation, and (e) the potential for abuse of mirabegron.

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.
  • Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in patients with overactive bladder (OAB) syndrome.
  • Suitable for Schedule 4
  • Once daily, oral treatment, 25 mg or 50 mg, as prolonged-release film-coated tablets, which are packed in blisters in cartons
  • Does not appear to produce dependence
Schedule entry
Schedule 4 - New entry

Mirabegron.

5.5 Ocriplasmin

Scheduling proposal

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

Ocriplasmin is recombinant truncated form of human plasmin produced by recombinant DNA technology in a Pichia pastoris expression system. The finished drug product is a sterile, clear solution in a single-use glass vial containing 0.5 mg ocriplasmin in 0.2 mL fill volume to be diluted with an equal volume of 0.9% sodium chloride prior to use and is intended for intravitreal administration.

Ocriplasmin is proposed for "the treatment of symptomatic vitreomacular adhesion (sVMA) including those associated with macular hole in adults".

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

Scheduling status
  • Ocriplasmin is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons.
  • Ocriplasmin 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 ocriplasmin 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 ocriplasmin.

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.
Schedule entry
Schedule 4 - New entry

Ocriplasmin.

5.6 Romidepsin

Scheduling proposal

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

Romidepsin is an antineoplastic agent indicated for the treatment of peripheral T-cell lymphoma in patients who have received at least one prior systemic therapy.

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

Scheduling status
  • Romidepsin is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).
  • Romidepsin 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 romidepsin in Schedule 4, with an implementation date of 1 February 2014.

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 and (c) toxicity, d) dosage, formulation, labelling, packaging and presentation, and (e) the potential for abuse of romidepsin.

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

  • romidepsin is a new chemical entity with no marketing experience in Australia.
  • During the TGA evaluation process, the benefits have been found to outweigh the risks of use in the indicated population.
  • Romidepsin is indicated for the treatment of peripheral T-cell lymphoma in patients who have received at least one prior systemic therapy.
  • Toxicity has been taken into account in consideration of benefit - risk.
  • The aspects of dosage, formulation, labelling, packaging and presentation have been evaluated and found acceptable in the TGA evaluation process.
  • The potential for abuse of this substance is limited.
Schedule entry
Schedule 4 - New entry

Romidepsin

5.7 Trametinib dimethyl sulfoxide

Scheduling proposal

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

Trametinib dimethyl sulfoxide is a reversible allosteric inhibitor of MEK1 and MEK2 (mitogen-activated extracellular signal regulated kinases 1 and 2).

The sponsor's proposed indications for use of trametinib dimethyl sulfoxide are as follows:

MEKINIST as a monotherapy and in combination with dabrafenib is indicated for the treatment of patients with BRAFV600 mutation positive unresectable or metastatic (Stage IV) melanoma.

MEKINIST as monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy.

These indications are subject to review / potential modification prior to inclusion of trametinib dimethyl sulfoxide in the ARTG.

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

Scheduling status

Trametinib dimethyl sulfoxide is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

It is noted that the proposed formulation is a solvate using a relatively small amount of dimethyl sulfoxide (DMSO), which is included in the SUSMP in Schedule 4 when intended for therapeutic use. DMSO is considered an excipient in the context of trametinib dimethyl sulfoxide.

Trametinib dimethyl sulfoxide 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 trametinib dimethyl sulfoxide in Schedule 4, with an implementation date of 1 Feb 2014.

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 and (c) toxicity, d) dosage, formulation, labelling, packaging and presentation, and (e) the potential for abuse of trametinib dimethyl sulfoxide.

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

  • Trametinib dimethyl sulfoxide is a new chemical entity with no marketing experience in Australia.
  • Its proposed indication is: MEKINIST as a monotherapy and in combination with dabrafenib is indicated for the treatment of patients with BRAFV600 mutation positive unresectable or metastatic (Stage IV) melanoma.MEKINIST as monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy (see CLINICAL TRIALS). These indications are subject to review / potential modification prior to inclusion of trametinib dimethyl sulfoxide in the ARTG.
  • Toxicity has been taken into account in consideration of benefit - risk.
  • The aspects of dosage, formulation, labelling, packaging and presentation have been evaluated and found acceptable in the TGA evaluation process.
  • The potential for abuse of this Substance is limited.
Schedule entry
Schedule 4 - New entry

Trametinib dimethyl sulfoxide.

5.8 Trastuzumab emtansine

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the Trastuzumab emtansine is an antibody-drug conjugate consisting of the antibody trastuzumab (a prescription-only medicine) linked to the cytotoxic agent DM1 that is a derivative of maytansine.

Trastuzumab emtansine is indicated, as a single agent, for the treatment of patients with HER2-positive metastatic (Stage IV) breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: received prior therapy for metastatic disease; or developed disease recurrence during or within 6 months of completing adjuvant therapy.

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

Scheduling status
  • Trastuzumab emtansine is not specifically scheduled in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).
  • Trastuzumab emtansine 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 trastuzumab emtansine in Schedule 4, with an implementation date of 1 Feb 2014.

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 and (c) toxicity, d) dosage, formulation, labelling, packaging and presentation, and (e) the potential for abuse of trastuzumab emtansine.

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

  • Trastuzumab emtansine is a new chemical entity with no marketing experience in Australia.
  • During the TGA evaluation process, the benefits have been found to outweigh the risks of use in the indicated population.
  • Trastuzumab emtansine is indicated, as a single agent, for the treatment of patients with HER2-positive metastatic (Stage IV) breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: received prior therapy for metastatic disease; or developed disease recurrence during or within 6 months of completing adjuvant therapy.
  • Toxicity has been taken into account in consideration of benefit - risk.
  • The aspects of dosage, formulation, labelling, packaging and presentation have been evaluated and found acceptable in the TGA evaluation process.
  • The potential for abuse of this substance is limited.
Schedule entry
Schedule 4 - New entry

Trastuzumab emtansine.

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6. Editorials and errata

6.1 Bistrifluron

Scheduling proposal

The chemicals scheduling delegate (the delegate) considered a proposal from the Scheduling Secretariat to amend the incorrect 'area of use' 1.1.2 in Part3 of the Appendix B for bistrifluron in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) to correct area of use 1.2.2 as listed in Part 1 of the Appendix B.

The delegate has considered this application and made a delegate-only decision. The Advisory Committee on Chemicals Scheduling was not consulted.

Scheduling status
  • Bistrifluron is currently included in Appendix B of the SUSMP.
    • The reason of entry is low toxicity 'a'.
    • The area of use is Agricultural '1.1.2'.
Delegate's consideration
  • The delegate considered the following with regard to this proposal.
  • Delegate-only final decision on Bistrifluron dated on 17 April 2012.
  • The Amendment No 3.2 of the SUSMP.
  • The Appendix B, Part 1 of theSUSMP.
    • The area of use for termiticide is '1.2.2'
  • The Scheduling Policy Framework.
Delegate's final decision

The delegate has made a delegate-only decision to correct a typographical error in the entry for bistrifluron in the Part 3 of the Appendix B in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

The reason for the delegate's decision is to correct a typographical error.

The amendment will be included in the next amendment of the SUSMP, which implementation date is 1 February 2014.

Appendix Title Reason for listing Area of use
Bistrifluron - Amend entry to read:
B Bistrifluron a 1.2.2

6.2 Besifloxacine hydrochloride, Loteprednol etabonate, Pasireotide diaspartate and Vilanterol trifenatate

Scheduling proposal

The medicines scheduling delegate (the delegate) considered a proposal from the Scheduling Secretariat to amend besifloxacine hydrochloride, loteprednol etabonate, pasireotide diaspartate and vilanterol trifenatate to list the parent Substance rather than the individual salt (and esters). By scheduling the parent Substance, it avoids the necessity to reconsider the scheduling when another salt, ester, etc. appears.

The delegate has considered this application and made a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.

Scheduling status

Besifloxacine hydrochloride, loteprednol etabonate, pasireotide diaspartate and vilanterol trifenatate are all listed in Schedule 4.

Delegate's consideration

The delegate considered the following with regard to this proposal:

  • The proposal;
  • General scheduling policy.
Delegate's final decision

The delegate has made a delegate-only decision to list the parent Substance for the following substances:

  • besifloxacine hydrochloride;
  • loteprednol etabonate;
  • pasireotide diaspartate; and
  • vilanterol trifenatate.

The reason for the delegate's decision is to:

  • provide consistency in the scheduling of substances; and
  • avoiding the necessity to reconsider the scheduling entry should another salt or ester appears.

The implementation date is 1 February 2014.

Schedule entry
Schedule 4 - Amendment
  • Besifloxacine.
  • Loteprednol.
  • Pasireotide.
  • Vilanterol.

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