1

Welcome

2

Apologies

3

Confirmation of the minutes of the 67^th meeting held on 26 October 2021

4

Declaration of conflicts of interest

5

Matters arising

5.1

Objections to recommendations made at the 67^th meeting

No valid objections were received.

5.2

Update on outstanding agenda items from the 67^th meeting

5.3

(9.a) Nicotine

At the 67^th meeting, held on 26 October 2021, The Committee noted a classification change to the Australian schedule for liquid nicotine and requested 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.

6

Submissions for reclassification

6.1

Nitrofurantoin (modified release) – proposed change to prescription classification statement
(MACROBID, Te Arai BioFarma Limited)

This is a submission (PDF, 2.66MB, 46 pages) proposing an amendment to the prescription classification statement for nitrofurantoin modified release to prescription medicine except when supplied for oral use containing 100 mg per dose unit when sold in a pack of 10 solid dosage units to a woman aged 16-65 years for the first-line empiric treatment of an uncomplicated urinary tract infection by a registered pharmacist who has successfully completed the New Zealand College of Pharmacists' training in the treatment of urinary tract infections.

The current classification of nitrofurantoin is prescription.

6.2

Naloxone – proposed down-scheduling change to classification
(New Zealand Drug Foundation)

This submission (PDF, 335.19KB, 14 pages) proposing a down-scheduling amendment to the classification of naloxone.

The submission has two proposals:

1. Reclassification of naloxone to a general sale medicine.
2. Amendment to the prescription classification statement to:
   • Prescription; except when provided, or intended to be provided, for the reversal of opioid overdose, along with equipment and instructions

The current classification of naloxone is: Prescription; except when provided as part of an approved emergency kit for the treatment of opioid overdose.

7

New medicines for classification

7.1

Levomefolate

Elevit, Film coated tablet

Levomefolic acid, also known as 5-methyltetrahydrofolate (5-MTHF) is the biologically active form of folate and the form found in circulation. It does not require enzymatic conversion and can be utilised directly by the body.

7.2

Amivantamab

RYBREVANT, concentrate for solution for Infusion, 350 mg/7 mL

RYBREVANT as monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal-growth factor receptor (EGFR) Exon 20 insertion mutations as determined by a validated test, whose disease has progressed on or after platinum-based chemotherapy.

7.3

Glu-urea-Lys(ahx)-hbed-CC

Illuccix, Powder for Injection, 25mcg

Illuccix, after radiolabelling with Ga-68, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) imaging combined with Computerised Tomography (CT) in patients with prostate cancer:

• who are at risk of metastasis and who are suitable for initial definitive therapy.
• who have suspected recurrence based on elevated serum prostate specific antigen (PSA) level.

7.4

Icosapent ethyl

Vazkepa, Soft Capsules, 998mg

Vazkepa is indicated to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥ 150 mg/dL [≥ 1.7 mmol/L]) and

• established cardiovascular disease, or
• diabetes, and at least one other cardiovascular risk factor.

7.5

Zanubrutinib

Brukinsa, Capsules, 80 mg

Brukinsa is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.

Brukinsa is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Note: also listed on the agenda under 8.1.k.

7.6

Faricimab

Vabysmo, solution for injection, 120 mg/mL

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).

7.7

Damoctocog alfa pegol

Jivi, powder for injection, 250IU, 500IU, 1000IU, 2000IU, 3000IU

Jivi is indicated for the treatment and prophylaxis of bleeding in previously treated patients (PTPs) ≥ 12 years of age with haemophilia A (congenital factor VIII deficiency).

7.8

Ciltacabtagene autoleucel

Carvykti, Solution for Injection

Carvykti is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.

8

Harmonisation of the New Zealand and Australian schedules

8.1

New chemical entities which are not yet classified in New Zealand

21 September 2021 Scheduling Final Decisions Public Notice

a.

Belumosudil

Belumosudil is indicated for the treatment of adults and paediatric patients 12 years or older with chronic graft-versus-host disease (chronic GVHD) after failure of at least 2 prior lines of systemic therapy.

From 1 October 2021, belumosudil is classified as a prescription medicine in Australia.

b.

Estetrol Monohydrate

Estetrol is a weak estrogen steroid hormone. Estetrol used in combination with drospirenone is indicated for use by women of reproductive potential to prevent pregnancy.

From 1 October 2021, estetrol monohydrate is classified as a prescription medicine in Australia.

c.

Finerenone

Finerenone is indicated to reduce the risk of sustained estimated GFR decline, ESRD, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adults with chronic kidney disease (CKD) associated with type 2 diabetes.

From 1 October 2021, finerenone is classified as a prescription medicine in Australia.

d.

Fostemsavir

Fostemsavir is indicated in combination with other antiretroviral agents for the treatment of heavily treatment-experienced adults with multidrug-resistant human immunodeficiency virus-1 (HIV-1) infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen due to resistance, intolerance or safety considerations.

From 1 October 2021, fostemsavir is classified as a prescription medicine in Australia.

e.

Inclisiran

Inclisiran is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolaemia, atherosclerotic cardiovascular disease, or at high risk of a cardiovascular event:

• in combination with a statin or statin with other lipid‐lowering therapies in patients unable to reach LDL‐C goals with the maximum tolerated dose of a statin or,
• alone or in combination with other lipid‐lowering therapies in patients who are statin-intolerant

From 1 October 2021, inclisiran is classified as a prescription medicine in Australia.

f.

Pegcetacoplan

Pegcetacoplan is indicated for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) in adults.

From 1 October 2021, pegcetacoplan is classified as a prescription medicine in Australia.

g.

Pegvaliase

Pegvaliase is indicated for the treatment of patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control despite prior management with available treatment options.

From 1 October 2021, pegvaliase is classified as a prescription medicine in Australia.

h.

Sacituzumab govitecan

Sacituzumab govitecan is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received at least two prior systemic therapies, including at least one prior therapy for locally advanced or metastatic disease.

From 1 October 2021, Sacituzumab govitecan is classified as a prescription medicine in Australia.

i.

Trastuzumab deruxtecan

Trastuzumab deruxtecan is indicated for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti HER2-based regimens.

From 1 October 2021, trastuzumab deruxtecan is classified as a prescription medicine in Australia.

j.

Vericiguat

Vericiguat is indicated in addition to standard of care therapy for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction less than 45% who are stabilised after a recent heart failure decompensation event requiring admission and/or IV diuretic therapy.

From 1 October 2021, vericiguat is classified as a prescription medicine in Australia.

k.

Zanubrutinib

From 1 October 2021, zanubrutinib is classified as prescription medicines in Australia.

Note: also listed on the agenda under 7.5.

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 – December 2021

8.2.1a

Bufexamac

The Schedule 4 entry was amended to remove all classification statements.

Bufexamac is now classified as a schedule 4 substance in Australia.

The date of implementation was 1 February 2022.

9

Agenda items for the next meeting

10

General business

11

Date of next meeting