1

Welcome

The Chair opened the meeting at 9.32am with a karakia and welcomed members and guests.

2

Apologies

3

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

4

Declaration of conflicts of interest

The Conflict of Interest forms were returned to the Secretary.

The following conflicts of interest were declared:

1. Kerri Miedema declared she held shares in AFT Pharmaceuticals Ltd. It was determined this conflict would be managed by Mrs Miedema sitting out agenda items 6.1 Ibuprofen 300mg in powder form.

All other members declared they had no additional interests which would pose a conflict with any of the items on the agenda.

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

a.

(6.1) Allopurinol for review

At the 66^th 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.

Discussion

The Committee received a letter from the submitter requesting the decision for allopurinol to be deferred to a later date.

Recommendation

The submission for allopurinol will be considered by the Committee at a future meeting.

b.

(7.2a) Cardarine

Background

At the 66^th meeting the Committee requested that Medsafe write an information paper for the Committee on cardarine and other SARM-like substances.

Discussion

The Committee thanked the Medsafe Investigation and Enforcement Team for providing an informative paper on cardarine and agreed with the suggestion for harmonisation with the Australian Schedule, in line with the long-standing Trans-Tasman scheduling harmonisation agreement.

Cardarine has been classified as a Schedule 10 substance in Australia. The Committee acknowledges the scheduling system varies between countries and therefore agree that it is appropriate to schedule cardarine as a prescription medicine to harmonise.

The Committee expressed interest in the potential for a class entry for SARM-like substances and has requested that Medsafe investigate and provide a paper exploring the potential to create a class entry.

Recommendation

That cardarine should be added to the New Zealand Schedule as a prescription medicine.

c.

(8.2.1) Salbutamol

Background

At the 66^th meeting the Committee considered the change in classification of salbutamol in Australia. 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, supply is restricted to New Zealand citizens and residents that have previously been prescribed the medicine. The Committee notes in practice, use of the emergency supply function by pharmacists, and their understanding of the relevant provisions of the Medicines Act may not be consistent. They therefore advise that there would be benefit in the Pharmacy Council communicating guidance of the interpretation of emergency supply. Additionally, the Committee note that the Australian reclassification does not align with current New Zealand asthma guidelines.

Discussion

The Committee noted that this item appeared as a part of the standing harmonisation item on the 66^th meeting agenda.

The members revisited their discussion from the 66^th meeting and reaffirmed that the classification change does not align with current asthma guidelines. The Committee concluded that the provisions of the emergency supply clause in the Medicines Act 1981 provides the same pharmacist-level access of salbutamol without the risk of unintended consequences such as masking uncontrolled asthma.

The Committee note that the emergency supply clause is intended for New Zealand citizens and residents that have previously had the medicine before therefore restricts access to patients that do not meet these criteria such as travellers and tourists. The Committee suggested an extension to the emergency supply provisions would better address these specific accessibility issues.

The Committee would like to extend their thanks to the Pharmacy council for their commitment, following the 66^th meeting, to include information around emergency supply of salbutamol in their newsletter.

Recommendation

That there should be no change in classification to salbutamol.

d.

(8.2.2) Melatonin

Background

At the 66^th meeting the Committee requested clarity on the rationale behind the scheduling change made in Australia.

Discussion

The Committee noted that this item appeared as a part of the standing harmonisation item on the 66^th meeting agenda.

The Committee commented that melatonin had been recently reviewed at the 61^st meeting held on 2 November 2018 and that the changes to the Australian schedule were similar to the current scheduling of melatonin in New Zealand. The differences noted in the Australian classification were the reference to a monotherapy and duration of treatment.

The Committee reviewed the Australian decision and was not satisfied that the evidence supports a further change to New Zealand’s current scheduling therefore does not recommend harmonising.

Recommendation

That there should be no change in classification to melatonin. The Committee considered the current classification conditions to be satisfactory.

e.

(8.3.2.c) Calcifediol

Background

At the 66^th meeting the Committee requested Medsafe provide more information regarding the use of this substance in nutritional supplements.

Discussion

The Committee noted that this item appeared as a part of the standing harmonisation item on the 66^th meeting agenda.

The Committee reviewed the interim and final decision made by the Australian delegate and agreed to harmonise.

Recommendation

That calcifediol should be added to the New Zealand Schedule as a prescription medicine.

f.

(8.3.3.b) Arbutin

Background

At the 66^th 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.

Discussion

The Committee noted that this item appeared as a part of the standing harmonisation item on the 66^th meeting agenda.

The Committee reviewed the interim and final decision made by the Australian delegate. The members commented that the mild to moderate irreversible toxicity was associated with oral doses of arbutin rather than topical treatments commonly found in cosmetics. The Committee agreed to harmonise.

Recommendation

That arbutin should be added to the New Zealand Schedule as a prescription medicine in oral preparations except herbal preparations containing 500 mg or less beta-arbutin per recommended daily dose.

5.3

Record of out of session held in October 2021

The Chair noted the out of session that took place to address on the following agenda items that were not discussed at the 65^th meeting:

1. Classification of the new chemical entity Risdiplam
2. Classification of the new chemical entity Cemiplimab
3. Addition of warning statements required on packs of products containing choline salicylate:
   1. Do not use in babies under 4 months of age
   2. Do not exceed the maximum stated dose
   3. Prolonged or excessive use can be harmful
   4. Do not use in patients known to be allergic to salicylates.

The Committee agreed that the new chemical entities should be classified as prescription medicines and the warning and advisory statements for choline salicylate are added to the labelling statements database.

Recommendation

That risdiplam and cemiplimab should be classified as prescription medicines.

That the following warning and advisory statements are added to the labelling and statements database for products containing choline salicylate:

1. Do not use in babies under 4 months of age
2. Do not exceed the maximum stated dose
3. Prolonged or excessive use can be harmful
4. Do not use in patients known to be allergic to salicylates.

Secretary’s Note:

The classification changes to risdiplam and cemiplimab were implemented by way of notice in the New Zealand gazette on 2 November 2021.

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 proposed to remain as a prescription medicine and are not the subject of this application.

Discussion

The Committee reviewed and considered all of the information provided in the submission and acknowledged all of the comments received.

The Committee was satisfied that the current proposal to reclassify 300mg ibuprofen in powder form to a restricted medicine addressed the safety concerns raised by the Committee with the previous proposal to reclassify ibuprofen 300mg in powder form to pharmacy only. The members agreed that the revised restricted classification addresses concerns relating to the lack of market evidence of combination products presented in sachet for reconstitution as a hot drink through the interaction with a pharmacist. This would allow a consumer to be screened for risks and comorbidities, receive advice and understand the risks associated with this dosage form.

The Committee noted that there is a new medicine application for Maxigesic double strength currently under evaluation with Medsafe and raised concerns in relation to the wording on the product labels indicating “double strength” and “double action”. The Committee are concerned the wording may be confusing and unclear to consumers, therefore has suggested that Medsafe considers this wording during the evaluation of the products in question.

Recommendation

To change the classification of ibuprofen 300mg 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 thatn 12 dose units, and labelled for use by adults and children over 12 years of age.

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.

Recommendation

That ripretinib should be added to the New Zealand schedule as prescription medicine.

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:

1. Neovascular (wet) age-related macular degeneration (nAMD)
2. Diabetic macular oedema (DME).

Recommendation

That faricimab should be added to the New Zealand schedule as a prescription medicine.

8

Harmonisation of the New Zealand and Australian schedules

8.1

New chemical entities which are not yet classified in New Zealand

The Committee note that it is standard practice for new chemical entities to be classified as prescription medicines until they have been used widely in a country with an acceptable medicines evaluation process and a good adverse reaction reporting system.

18 May 2021

a.

Deutetrabenazine

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.

Recommendation

That deutetrabenazine should be added to the New Zealand schedule as a prescription medicine.

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.

Recommendation

That eslicarbazepine should be added to the New Zealand schedule as a prescription medicine.

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.

Recommendation

That lemborexant should be added to the New Zealand schedule as a prescription medicine.

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.

Recommendation

That luspatercept should be added to the New Zealand schedule as a prescription medicine.

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.

Recommendation

That trabectedin should be added to the New Zealand schedule as a prescription medicine.

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 was 1 June 2021.

Recommendation

That the New Zealand classification of bilastine should remain unchanged.

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 was 1 October 2021.

Discussion

The Committee reviewed the decision made by the Australian delegate and reflected on the different nicotine use in New Zealand.

The Committee acknowledges that there are a number of differences between Australia and New Zealand and it has requested further information to consider this classification change in New Zealand.

The Committee requests that Medsafe consults with the Vaping Regulatory Authority and provide advice on policy objectives relating to vaping, how nicotine in vaping products is regulated under the Medicines Act 1981, and any potential consequences of a reclassification of liquid nicotine for discussion at the next meeting.

Recommendation

That nicotine should be noted for a change in classification and be placed on the 68th meeting agenda to allow for consultation with the Vaping Regulatory Authority.

9

Agenda items for the next meeting

1. Nicotine

10

General business

No general business was discussed.

11

Date of next meeting