1

WELCOME

2

Apologies

3

Confirmation of the minutes of the 62^nd meeting held on 11 APRIL 2019

4

Declaration of conflicts of interest

5

Matters arising

5.1

Objections to recommendations made at the 62nd meeting

No valid objections have been received

5.2

Recommendations implemented from the 62nd meeting

5.3

Update on outstanding agenda items from the 62nd meeting

(6.1) Ropivacaine up to 7.5 mg/mL, solution for injection - proposed reclassification from prescription medicine to prescription except when classification

(6.2) Bupivacaine up to 0.5% w/v in combination with adrenaline - proposed reclassification from prescription medicine to prescription except classification

The Committee had requested further information from the applicant, the Podiatrists Board of New Zealand. This request for further information was sent on 4 June 2019.

No information has been received for this meeting. The Podiatrists Board of New Zealand has indicated that they intend to submit the requested information at a future meeting.

5.3a

Reclassification of codeine

An information paper on the classification of codeine (PDF, 592 KB, 24 pages) has been prepared. The purpose of this paper is to summarise the risks and benefits of harmonising the classification of codeine with Australia, and the alternative option recommended by the Committee at the 59th meeting.

6

Submissions for reclassification

6.1

Influenza vaccine – proposed change to the Prescription classification statement
(Pharmaceutical Society of New Zealand )

This is a submission (PDF, 100 KB, 8 pages) from the Pharmaceutical Society of New Zealand to change the Prescription classification statement for influenza vaccine to include registered intern pharmacists.

6.2

Bilastine - proposed change to the Pharmacy Only classification statement
(Menarini New Zealand Pty Ltd)

This is a submission (PDF, 247 KB, 14 pages) from Menarini New Zealand Pty Ltd to change the Pharmacy Only classification statement for bilastine by removing the maximum pack size.

The current classification of bilastine is:
Prescription; except when specified elsewhere in this schedule.
Pharmacy Only; in divided solid dosage forms for oral use containing 20 milligrams or less for the treatment of the symptoms of allergic rhinoconjuctivitis (seasonal and perennial) and urticaria when sold in a pack containing not more than 30 dosage units

There is currently one medicine that is approved in New Zealand containing the active ingredient bilastine, Labixten 20 mg tablets. The sponsor company of Labixten is Menarini New Zealand Pty Ltd.

7

New medicines for classification

7.1

New chemical entities

New medicine applications have been received for the following new chemical entities that require classification.

7.1a

Esketamine

Spravato nasal spray solution, 28 milligrams (TT50-10559)

7.1b

Upadacitnib

TRADENAME film coated tablet, 15 milligrams (TT50-10565)

7.1c

Avibactam sodium

Zavicefta powder for infusion, 2000 milligram / 500 milligram (TT50-10637)

7.1d

Polatuzumab vedotin

Polivy powder for injection, 140 milligram (TT50-10616)

7.1e

Entrectinib

TRADE NAME capsule, 100 milligram and 200 milligram (TT50-10652,a)

7.1f

Lanadelumab

TAKHZYRO solution for injection, 300 milligram/ 2 millilitre (TT50-10654)

7.2

New chemical entities identified by Medsafe

7.2a

Metamizole (aka dipyrone)

7.2b

Meldonium

7.2c

Octodrine (synonyms include 1,5 - dimethylhexylamine, DMHA and 2,-amino-6-methylheptane)

Medsafe has prepared an information paper on this New Chemical Entity (PDF, 530 KB, 3 pages)

7.2d

Voglibose

7.2e

Artemisia annua

Medsafe has prepared an information paper on this New Chemical Entity (PDF, 514 KB, 18 pages)

7.2f

Dipyrone

8

Harmonisation of the New Zealand and Australian schedules

8.1

New chemical entities which are not yet classified in New Zealand

8.1.1

Racetams

Racetams are a group of compounds that are associated with cognitive enhancing effects and nootropic claims.

The ACCS/ACMS considered a new group entry for racetams and new specific entries for aniracetam, coluracetam, dimiracetam, fasoracetam, methylphenylpiracetam, nebracetam, nefiracetam, omberacetam, oxiracetam, phenylpiracetam, pramiracetam, rolziracetam, seletracetam, sunifiram and unifiram.

From 1 June 2019, a group entry for racetams and the specific substances aniracetam, coluracetam, dimiracetam, fasoracetam, methylphenylpiracetam, nebracetam, nefiracetam, omberacetam, oxiracetam, phenylpiracetam, pramiracetam, rolziracetam, seletracetam, sunifiram and unifiram are classified as a prescription medicine in Australia.

Racetams were considered by the Committee at the 53rd meeting in May 2015 and the Committee recommended that they should be classified individually as prescription medicines and that a class entry for racetams would not be suitable.

8.1.2

Galcanezumab

Galcanezumab is indicated for migraine prophylaxis that requires medical assessment and monitoring.

From 1 June 2019, galcanezumab is classified as prescription medicine in Australia.

Galcanezumab 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.

8.1.3

Doravirine

Doravirine is a HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI). Doravirine is indicated for the treatment of a serious infection (HIV) requiring specialised medical oversight and monitoring.

From 1 June 2019, doravirine is classified as prescription medicine in Australia.

8.1.4

Abemaciclib

Abemaciclib is indicated for the treatment of women with hormone receptor positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy (MONARCH-2,3).

From 1 June 2019, abemaciclib is classified as prescription medicine in Australia.

8.1.5

Plitidepsin

Plitidepsin is used for the treatment of patients with relapsed or refractory multiple myeloma who have received at least three prior treatment regimens, including both a proteasome inhibitor and an immunomodulator.

From 1 June 2019, plitidepsin is classified as prescription medicine in Australia.

8.1.6

Isavuconazole

Isavuconazole is used for the treatment of invasive aspergillosis and mucormycosis in patients for whom amphotericin B is inappropriate.
From 1 June 2019, isavuconazole is classified as a prescription medicine in Australia.

8.1.7

Semaglutide

Semaglutide is used for the treatment of adults with insufficiently controlled type 2 diabetes mellitus. Semaglutide is a long-acting glucagon like peptide-1 (GLP-1) receptor agonist (GLP=1RA).

From 1 June 2019, semaglutide is classified as a prescription medicine in Australia.

8.1.8

Cenegermin

Cenegermin is a new biological medicine indicated for the treatment of neurotrophic keratitis. The diagnosis of neurotrophic keratitis requires a detailed clinical assessment and ongoing assessment by an opthamologist.

From 1 June 2019, cenegermin is classified as a 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 - 6 June 2019

8.2.1.a

Alkyl nitrites

A new group entry for alkyl nitrites was created in Schedule 4 (prescription) except when specified elsewhere in the schedules.

The Schedule 4 (prescription) entry for amyl nitrite was down-scheduled to Schedule 3 (Restricted) when in preparations for human therapeutic use and packaged in containers with child-resistant closures.

The Schedule 4 (prescription) entries for isoamyl nitrite, butyl nitrite, isobutyl nitrite and octyl nitrite remained unchanged.

New Schedule 10 (prohibited) entries were created for isopropyl nitrite and n-propyl nitrite.

The implementation date for the delegate's decision is 1 February 2020, in view of the fact that there are new Schedule 10 entries and the incorporation of a group alkyl nitrite entry in Schedule 4 which captures previously unscheduled substances.

Schedule 1 of the Medicines Regulations currently does not contain a group entry for alkyl nitrites.

Amyl nitrite is currently classified as a prescription medicine except when sold to a person who holds a controlled substances licence (issued under section 95B of the Hazardous Substances and New Organisms Act 1996) authorising the person to possess cyanide; except when sold to an exempt laboratory covered by a Hazardous Substances and New Organisms Act 1996 approved code of practice.
Isoamyl nitrite, butyl nitrite, isobutyl nitrite and octyl nitrite are currently classified as prescription medicines.

9

Agenda items for the next meeting

10

General business

11

Date of next meeting