Published: 6 September 2021

Committees


Agenda for the 67th meeting of the Medicines Classification Committee to be held in Wellington on 26 October 2021 at 9:30 am

 

1

Welcome  

2

Apologies  

3

Confirmation of the minutes of the 66th meeting held on 11 May 2021  

4

Declaration of conflicts of interest  

5

Matters arising  

5.1

Objections to recommendations made at the 66th meeting  

  No valid objections were received.  

5.2

Update on outstanding agenda items from the 66th meeting  

  (6.1) Allopurinol for review  
At the 66th meeting, the Committee deferred making a recommendation in order to engage with the Pharmacy Council process for medicines reclassification as outlined in the guidance. The Pharmacy Council have provided the following document. (PDF, 150KB, 2 pages) 

(7.2a) Cardarine  
The Committee requests that Medsafe write an information paper for the Committee on cardarine and other SARM-like substances.  

(8.2.1) Salbutamol
 
At the 66th meeting the Committee noted that under the current legislation (Section 44 of the Medicines Act 1981) a pharmacist can provide an emergency supply of a medicine however, this is limited to New Zealand citizens and residents that have previously had the medicine before. The Committee notes there is variable use of the emergency supply function under the Medicines Act and therefore that there would be benefit in the Pharmacy Council communicating guidance of the interpretation of emergency supply. Additionally, the Committee note that the reclassification does not align with current asthma guidelines.  

(8.2.2) Melatonin
 
At the 66th meeting the Committee requested clarity on the rationale behind the scheduling change made in Australia.  

(8.3.2.c) Calcifediol
 
At the 66th meeting the Committee requested Medsafe provide more information regarding the use of this substance in nutritional supplements.   (8.3.3.b) Arbutin   At the 66th meeting the Committee noted that this substance is found in topical cosmetics for reduction of the appearance of spots and hyper-pigmentation. They requested the rationale behind the change made in Australia.  

6

Submissions for reclassification  

6.1

Ibuprofen 300mg in powder form – proposed reclassification from prescription medicine to restricted medicine (AFT Pharmaceuticals Ltd)

  This submission (PDF, 7.19 MB, 34 pages) from AFT Pharmaceuticals Ltd proposes the reclassification of 300mg of ibuprofen in powder form to a restricted medicine for oral use in powder form containing 300 milligrams per dose form with a recommended daily dose of not more than 1.2 grams, and sold in the manufacturers original packs containing not more than 12 dose units, and labelled for use by adults and children over 12 years of age.  

Note - Larger pack sizes containing 13 to 50 dose units (sachets) are to remain as a prescription medicine and are not the subject of this application.  

7

New medicines for classification  

a.

Ripretinib

  Qinlock Tablet 50mg (TT50-10920)
  
Qinlock is a kinase inhibitor indicated for the treatment of adult patients with advanced gastrointestinal stromal tumours (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.  

b.

Faricimab

  Vabysmo Solution for injection 120mg/mL (TT50-10940)  

Vabysmo is a bispecific angiopoietin-2 (Ang-2) and vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of: • Neovascular (wet) age-related macular degeneration (nAMD) • Diabetic macular oedema (DME).  

8

Harmonisation of the New Zealand and Australian schedules  

8.1

New chemical entities which are not yet classified in New Zealand  

 

18 May 2021

a.

Deutetrabenzine

  Deutetrabenazine is the deuterated form of tetrabenazine. The precise mechanism by which deutetrabenazine and tetrabenazine exert their effects in the treatment of tardive dyskinesia and chorea in patients with Huntington's disease is unknown but is believed to be related to the reversible depletion of monoamines (such as dopamine, serotonin, norepinephrine, and histamine) from nerve terminals. The major circulating metabolites (α-dihydrotetrabenazine (HTBZ) and β-HTBZ) of deutetrabenazine, are reversible inhibitors of vesicular monoamine transporter 2 (VMAT2), resulting in decreased uptake of monoamines into synaptic vesicles and depletion of monoamine stores.  

Deutetrabenzine is indicated for the treatment of chorea associated with Huntington's disease; tardive dyskinesia in adult.  

From 1 June 2021, deutetrabenzine is classified as a prescription medicine in Australia.
 

b.

Eslicarbazepine Acetate

  The precise mechanisms of action of eslicarbazepine acetate are unknown. However, in vitro electrophysiological studies indicate that both eslicarbazepine acetate and its metabolites stabilise the inactivated state of voltage gated sodium channels, precluding their return to the activated state and thereby preventing repetitive neuronal firing.  

Eslicarbazepine acetate is indicated in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; adjunctive therapy in adults, adolescents and children aged above 6 years, with partial- onset seizures with or without secondary generalisation.  

From 1 June 2021, eslicarbazepine acetate is classified as a prescription medicine in Australia.
 

c.

Lemborexant

  Lemborexant is a competitive antagonist of both orexin receptors, orexin receptors type 1 (OX1R) and orexin receptors type 2 (OX2R), with a higher affinity for OX2R. It belongs to the pharmacologic class of orexin receptor antagonists. The orexin neuropeptide signalling system is a central promoter of wakefulness. Blocking the binding of wake promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive.  

Antagonism or orexin receptors may also underlie potential adverse effects such as signs of narcolepsy/cataplexy. Lemborexant administered to mice at oral doses greater than 10mg/kg resulted in behaviour characteristic of cataplexy when presented with chocolate. Chocolate is a stimulus that has been demonstrated to increase cataplexy occurrences in narcoleptic mice.  

Lemborexant is indicated for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance in accordance with latest DSM criteria  

From 1 June 2021, lemborexant is classified as a prescription medicine in Australia.
 

d.

Luspatercept

  Luspatercept-aamt is a recombinant fusion protein that induces erythroid maturation by binding several endogenous TGF-beta superfamily ligands, diminishing Smad2/3 signaling. In beta-thalassemia and myelodysplastic syndromes, by decreasing abnormally elevated Smad2/3 signaling, hematology parameters associated with ineffective erythropoiesis are improved in mice  

Luspatercept has Orphan drug designation for the treatment of myelofibrosis  

From 1 June 2021, luspatercept is classified as a prescription medicine in Australia.
 

e.

Trabectedin

  Trabectedin binds to the minor groove of deoxyribonucleic acid (DNA), bending the helix to the major groove. This binding to DNA triggers a cascade of events affecting several transcription factors, DNA binding proteins, and DNA repair pathways, resulting in perturbation of the cell cycle.  

Trabectedin is indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen.  

From 1 June 2021, trabectedin 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 – 19 July 2021  

 

Bilastine

  The Schedule 4 (prescription) entry was amended to except when included in Schedule 3.  

A new entry was created in Schedule 3 (restricted) for bilastine in divided oral preparations containing 20mg or less in adults and adolescents 12 years of age and older.  

The date of implementation is 1 June 2021.
 

8.2.2

Final decision 21 December 2021

 

Nicotine

  The Schedule 4 (prescription) entry was amended to include nicotine in liquid preparations when in Schedule 4.  

The date of implementation is 1 October 2021.
 

9

Agenda items for the next meeting  

10

General business  

11

Date of next meeting  

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