The deadline for intentions to object to a recommendation made at the 70^th Medicines Classification Committee (MCC) meeting, together with a statement of the grounds on which the objection would be made, was 18 July 2023. No valid objections were received.

6.Submissions for reclassification

6.1 Phenol – proposed change to prescription classification statement to include provision by podiatrists under certain conditions (Podiatrist Board of New Zealand and Podiatry New Zealand)

High concentration phenol can be used for nail chemical matrixectomy.

Phenol is currently classified as:

Prescription: for injection

Pharmacy-only: in medicines other than for injection containing more than 3%

General sale: in medicines other than for injection containing 3% or less.

This submission (PDF, 10 pages, 269KB) by the Podiatrist Board of New Zealand and Podiatry New Zealand proposes the reclassification of phenol to allow provision by podiatrists for chemical matrixectomy under certain conditions.

New medicines for classification

The following new chemical entities were submitted to the Committee for classification.

7. New chemical entities

7.1a Tezepelumab

Tezspire, solution for injection in pre-filled syringe (210 mg Tezepelumab).

Tezspire contains 210 mg Tezelumab is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

7.1b Clascoterone

Winlevi, clascoterone 1% cream.

Winlevi is a cream containing 1% clascoterone and is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

7.1c AOH1996

Medsafe has received inquiry as to the availability of AOH1996 in Aotearoa New Zealand. Medsafe has not received any medicine applications for medicines containing AOH1996.

AOH1996 is an experimental anticancer medicine. Medsafe recommends that AOH1996 be classified 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

3 May 2023 Scheduling Final Decisions Public Notice

8.1a Andexanet alfa

Andexanet alfa is a coagulation factor Xa recombinant, inactivated-zhzo. Andexant alfa is indicated for patients treated with rivaroxaban and apixaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

From the 1 June 2023 andexanet alfa was classified as a prescription medicine in Australia.

8.1b Avatrombopag

Avatrombopag is indicated for treatment of thrombocytopenia in adult patients with chronic liver disease under certain conditions or for treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia under certain conditions.

From the 1 June 2023 avatrombopag was classified as a prescription medicine in Australia.

8.1c Difelikefalin

Difelikefalin is indicated for the treatment of moderate to severe pruritus associated with chronic kidney disease in patients undergoing haemolysis.
From the 1 June 2023 difelikefalin was classified as a prescription medicine in Australia.

8.1d Ivosidenib

Ivosidenib is indicated for treatment of patients with cholangiocarcinoma under certain conditions or treatment of patients with acute myeloid leukemia under certain conditions.

From the 1 June 2023 ivosidenib was classified as a prescription medicine in Australia.

8.1e Pralsetinib

Pralsetinib is indicated for treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer under certain conditions and treatment of patients with advanced or metastatic RET fusion-positive thyroid cancer under certain conditions.

From the 1 June 2023 pralsetinib was classified as a prescription medicine in Australia.

8.2 Decisions by the Secretary to Department of Health and Ageing in Australia (or the Secretary’s Delegate).

3 May 2023 Scheduling Final Decisions Public Notice

8.2.1. Paracetamol

Paracetamol is a widely used analgesic and antipyretic. In Australia the Therapeutic Goods Administration (TGA) announced on 3 May 2023 that there would be scheduling changes for paracetamol. The proposed scheduling changes will affect the maximum size of packs of immediate release paracetamol from:

20 tablets or capsules to 16 for unscheduled (general sales) products (8 grams per pack)
100 tablets or capsules to 50 for schedule 2 (pharmacy-only) products (25 grams per pack)

The TGA has also announced a limit of 100 tablets/ capsules for schedule 3 (restricted/ pharmacist-only) products (50 grams per pack).

Equivalent and proportionate changes will also apply to preparations of wrapped powders and sachets of granules that contain paracetamol. The date of implementation for scheduling changes for paracetamol is 1 February 2025.

In Aotearoa New Zealand the maximum pack sizes of immediate release paracetamol in solid dose form available over the counter are currently as follows:

10 grams for general sales medicines (equivalent 20 x 500 mg tablets)
50 grams for pharmacy-only medicines (equivalent 100 x 500 mg tablets)

There is a limit of three months’ supply for prescription medicines (which could consist of 720 x 500 mg tablets, if prescribed at the maximum daily dose).

8.2.2. Brimonidine

Brimonidine is a medicine which may be used to lower intraocular pressure in patients under certain conditions or may be used to relieve redness of the eye due to minor eye irritations. In Australia the TGA has re-scheduled brimonidine to:

Schedule 4 (prescription); except when included in schedule 2.
Schedule 2 (pharmacy-only); in ophthalmic preparations for adult use containing not more than 0.025% brimonidine.

The implementation date was the 1 June 2023.

In Aotearoa New Zealand brimonidine is currently classified as a prescription medicine.

8.2.3 Fexofenadine

Fexofenadine is a non-sedating antihistamine. The TGA has rescheduled fexofenadine to increase the pack size available for general sale from five dosage units to 10 dosage units under certain conditions. The conditions are as follows:

For the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:

in a primary pack containing 10 dosage units or less and not more than 10 days supply; and
labelled with a recommended daily dose not exceeding 180 mg of fexofenadine

The implementation date was the 1 June 2023.

In Aotearoa New Zealand the pack size limit for fexofenadine for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when in tablets containing 180 mg or less of fexofenadine hydrochloride with a maximum daily dose of 180 mg when sold in the manufacturer’s original pack available general sale is five dosage units or less and not more than five days’ supply.

The MCC last considered the classification of fexofenadine at the 65^th MCC meeting (27 October 2020) following a submission from Sanofi-Aventis New Zealand Limited which led to a number of recommendations including that tablets containing 180 mg or less of fexofenadine hydrochloride be available general sales under the aforementioned conditions.

8.2.4 Melatonin

The TGA has rescheduled immediate release melatonin to allow for pharmacist only provision when containing 5 mg or less of melatonin for the treatment of jet lag in adults aged 18 or over, in a primary pack containing no more than 10 dosage units.

The implementation date was 1 June 2023.

In Aotearoa New Zealand melatonin is currently classified as:

Prescription except when supplied in medicines for oral use containing 3mg or less per immediate release dose unit, or 2mg or less per modified release dose unit, when sold in the manufacturers original pack that has received consent from the Minister of Health or the Director General for the treatment of primary insomnia for adults aged 55 years or older for up to 13 weeks by a registered pharmacist.

20 January 2023 Scheduling Final Decisions Public Notice

8.2.5 Cetirizine

Cetirizine is a non-sedating antihistamine. The TGA has rescheduled cetirizine to allow general sale supply for oral use for the treatment of seasonal allergic rhinitis in adults and children 6 years of age and over when: in a primary pack containing not more than 10 days’ supply; and labelled with a recommended daily dose not exceeding 10 mg of cetirizine.

The implementation date was 1 February 2023.

In Aotearoa New Zealand cetirizine at general sale is classified as: in divided solid dosage forms for oral use containing 10 milligrams or less of cetirizine hydrochloride per dose form for the treatment of seasonal allergic rhinitis when sold in the manufacturer's original pack containing not more than 5 days' supply.

The MCC last considered the classification of cetirizine at the 64^th MCC meeting (9 July 2020) following a submission from AFT Pharmaceuticals proposing to increase the pack size limit for cetirizine available general sale from 5 days’ supply to 10 days’ supply. At this time the MCC recommended that the pack size available general sale remain at 5 tablets.

9. Agenda items for the next meeting

10. General business

11. Date of the next meeting

MEDSAFE

New Zealand Medicines and Medical Devices Safety Authority

Committees

Agenda for the 71st meeting of the Medicines Classification Committee to be held by Videoconference on 14 December 2023

1. Welcome

2. Apologies

3. Confirmation of the minutes of the 70^th meeting held on 25 May 2023

4. Declaration of conflicts of interest

5. Matters arising

5.1 Objections to recommendations made at the 70^th meeting.

6.Submissions for reclassification

6.1 Phenol – proposed change to prescription classification statement to include provision by podiatrists under certain conditions (Podiatrist Board of New Zealand and Podiatry New Zealand)

New medicines for classification