1

WELCOME

2

Apologies

3

Confirmation of the minutes of the 61^st meeting held on 2 november 2018

4

Declaration of conflicts of interest

5

Matters arising

5.1

Objections to recommendations made at the 61st meeting

No valid objections have been received

6

Submissions for reclassification

6.1

Ropivacaine up to 7.5 mg/mL, solution for injection – proposed reclassification from prescription medicine to prescription except classification
(Podiatrists Board of New Zealand )

This is a submission (PDF, 197 KB, 14 pages) from the Podiatrists Board of New Zealand proposing that ropivacaine be reclassified from a prescription medicine to a ‘prescription except’ classification for podiatrists with the extended scope of practice of podiatric surgeons.

6.2

Bupivacaine up to 0.5% w/v in combination with adrenaline – proposed reclassification from prescription medicine to prescription except classification
(Podiatrists Board of New Zealand)

This is a submission (PDF, 247 KB, 14 pages) from the Podiatrists Board of New Zealand proposing that Marcain Plain and Marcain with adrenaline, which contain the active ingredients bupivacaine and adrenaline, be reclassified from prescription medicines to ‘prescription except’ classification for podiatrists with the extended scope of practice of podiatric surgeons.

7

New medicines for classification

7.1

Tivozanib

Fotivda capsule, 890 and 1,340 micrograms (TT50-10460, a)

8

Harmonisation of the New Zealand and Australian schedules

8.1

New chemical entities which are not yet classified in New Zealand

December 2018 Scheduling Final Decisions Public Notice

8.1.1

Crisaborole

Crisaborole is a phosphodiesterase-4 (PDE-4) inhibitor and is developed for topical treatment of mild to moderate atopic dermatitis.

From 1 February 2019, crisaborole is classified as a prescription medicine in Australia.

8.1.2

Brigatinib

Brigatinib is an orphan drug used for the treatment of anaplastic lymphoma kinase-positive, r-cos 1 oncogene positive, or epidermal growth factor receptor positive non-small cell lung cancer.

From 1 February 2019, brigatinib is classified as prescription medicine in Australia.

8.1.3

Lanadelumab

Lanadelumab is indicated for the prophylaxis of hereditary angioedema.

From 1 February 2019, lanadelumab is classified as prescription medicine in Australia.

Lanadelumab is not specifically scheduled in the Medicines Regulations, but as a monoclonal antibody, it is captured by the entry for monoclonal antibodies as a prescription medicine.

8.1.4

Romosozumab

Romosozumab is indicated for the treatment of osetoporosis.

From 1 February 2019, romosozumab is classified as prescription medicine in Australia.

Romosozumab is not specifically scheduled in the Medicines Regulations, but as a monoclonal antibody, it is captured by the entry for monoclonal antibodies as a prescription medicine.

28 September 2018 Scheduling Final Decisions

8.1.5

Safinamide

Safinamide is indicated for the treatment of adult patients with idiopathic Parkinson's disease.

From 1 October 2018, safinamide has been classified as prescription medicine in Australia.

8.1.6

Tilmanocept

Tilmanocept is a diagnostic, receptor-targeted, radiopharmceutical developed for the detection of sentinel lymph nodes. It is indicated for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma, or localised squamous carcinoma of the oral cavity.

From 1 October 2018, tilmanocept has been classified as prescription medicine in Australia.

8.2

Decisions by the Secretary to the Department of Health and Aging in Australia (or the Secretary's Delegate)

8.2.1

Decisions by the Delegate – 29 November 2018

8.2.1a

Budesonide

The Schedule 2 entry (pharmacy-only) for budesonide should be amended to increase the dose per actuation from 50 to 64 micrograms and to remove the limit of 200 actuations per primary pack.

The implementation date for the delegate’s decision is 1 February 2019.

8.2.1b

Fluticasone

The Schedule 2 entry (pharmacy-only) for fluticasone should be amended to remove the limit of 200 actuations per primary pack.

This decision has been implemented in Australia since 1 October 2018.

9

Agenda items for the next meeting

10

General business

11

Date of next meeting