Published: 18 November 2024
Committees
Agenda for the 73rd meeting of the Medicines Classification Committee to be held Q1 2025, date to be confirmed.
- Welcome
- Apologies
- Confirmation of the minutes of the 72nd meeting held on 12 June 2024.
- Declaration of conflicts of interest
- Matters arising
- Submissions for reclassification
- New medicines for classification
- Harmonisation of the New Zealand and Australian schedules
- Agenda items for the next meeting
- General business
- Date of the next meeting
1. Welcome
2. Apologies
3. Confirmation of the minutes of the 72nd meeting held on 20 June 2024
4. Declaration of conflicts of interest
5. Matters arising
5.1 Objections to recommendations made at the 72nd meeting
The objection period for the 72nd meeting closed on the 29th July 2024.
6. Submissions for reclassification
6.1 Lidocaine (lignocaine) – proposed up-scheduling of oromucosal lidocaine containing products (Medsafe)
This submission (PDF, 878KB, 48 pages) , from Medsafe proposes that the classification of lidocaine changes to include a restricted (pharmacist only) entry specific to oromucosal dose forms. This follows a review and recommendation from the Medicines Adverse Reactions Committee.
The current classification of lidocaine is:
|
Ingredient |
Conditions (if any) |
Classification |
|
Lignocaine |
for injection except when used as a local anaesthetic in practice by a nurse whose
scope of practice permits the performance of general nursing functions or by a podiatrist registered with the
Podiatry Board or by a dental therapist, oral health therapist or dental hygienist (without local anaesthetic
exclusion on their scope of practice) registered with the Dental Council; |
Prescription |
|
Lignocaine |
for urethral use; |
Pharmacy Only |
|
Lignocaine |
in throat lozenges in medicines containing 30 milligrams or less per dose form; |
General Sale |
6.2 Tenofovir disoproxil and emtricitabine (Burnett Foundation)
The submission (PDF, 11.91MB, 324 pages) proposes that the classification of tenofovir disoproxil and emtricitabine is changed to:
Prescription medicine: except when supplied for HIV prophylaxis to people who are over 18, are HIV negative, and meet the clinical and eligibility criteria of an approved training programme, when provided by a pharmacist who meets the requirements of the Pharmacy Council
Tenofovir disoproxil, and emtricitabine are used for the treatment of HIV, and also used as pre-exposure prophylaxis, with other safer sex practices, to reduce the risk of sexually acquired HIV.
6.3 Travel vaccines (Green Cross Health Limited)
The submission (PDF, 857KB, 35 pages) is a proposal for the classification of travel vaccines:
- Hepatitis A Vaccine
- Hepatitis B Vaccine
- Hepatitis A and Hepatitis B vaccine
- Hepatitis A and Typhoid
- Japanese Encephalitis Vaccine
- Poliomyelitis Vaccine
- Typhoid Vaccine
- Yellow Fever Vaccine
The proposal is to classify as:
Yellow fever vaccine: except when administered by registered pharmacists who have successfully completed the Vaccinator Foundation Course (or any equivalent training course approved by the Ministry of Health), and who is authorised by the Director-General or a Medical Officer of Health in accordance with this regulation to administer, for the purposes of an approved immunisation programme, a vaccine that is a prescription medicine, may, in carrying out that immunisation programme, administer that prescription medicine otherwise than pursuant to a prescription.
All other vaccines: except when administered by vaccinators or registered pharmacists, who have successfully completed the Vaccinator Foundation Course (or any equivalent training course approved by the Ministry of Health), hold the relevant travel medicine qualifications from an approved facility and who comply with the immunisation standards of the Ministry of Health (but excluding vaccinators who have completed the Provisional Vaccinator Foundation Course.
The committee last considered these vaccines at the 69th meeting on 25 October 2022.
6.4 Recombinant Varicella Zoster Virus Vaccine (GSK New Zealand)
The submission (PDF, 682KB, 26 pages) is a proposal for the classification of Recombinant Varicella Zoster Virus vaccines to be:
Prescription only except when administered for the prevention of herpes zoster (shingles) to a person 18 years or over who has successfully completed the Vaccinator Foundation Course (or any equivalent training course approved by the Ministry of Health) and who complies with the immunisation standards of the Ministry of Health (but excluding a vaccinator who has completed the Provisional Vaccinator Foundation Course).
The submission is to enable a wider range of vaccinators for these vaccines.
6.5 Allopurinol (Arthritis New Zealand Mateponapona Aotearoa, Green Cross Health, Dr Natalie Gauld, Associate Professor Peter Gow).
The submission (PDF,352 KB, 31 pages) is a proposal to change the classification of allopurinol to:
Prescription medicine except when supplied for prophylaxis of gout to people who meet the clinical and eligibility criteria of an approved training programme, when provided by pharmacists who meet the requirements of the Pharmacy Council
Allopurinol, is a xanthine oxidase inhibitor, used to prevent gout. The submission is to enable supply by a pharmacist.
The MCC last considered classification of allopurinol at the 66th meeting in August 2021.
New medicines for classification;
The following new chemical entities are submitted to the Committee for classification.
7.New chemical entities
7.1 Foslevodopa
Foslevodopa is a prodrug of levodopa monophosphate and when combined with foscarbidopa is indicated for the treatment of Parkinson’s disease under conditions.
7.2 Foscarbidopa
Foscarbidopa is a prodrug of carbidopa monophosphate and when combined with foslevodopa is indicated for the treatment of Parkinson’s disease under conditions.
7.3 Cytisine
Cytisine, also known as baptitoxine, cytisinicline, or sophorine, is an alkaloid that occurs naturally in several plant genera. Cytisine is schedule in Australia as:
Pharmacist only: in divided oral and oromucosal preparations with a recommended daily dose of 9 mg or less of cysteine as an aid in withdrawal from tobacco smoking in adults.
7.3 Inavolisib
Inavolisib is an anti-cancer medicine used for the treatment of breast cancer.
7.4 Rimegepant
Rimegepant is a medication used for the acute treatment of migraine with or without aura in adults and the prophylactic/ preventive treatment of episodic migraine in adults.
7.5 Empagliflozin
Empagliflozin is an antidiabetic medicine used to improve glucose control in people with type 2 diabetes. Empagliflozin is an inhibitor of the sodium glucose co-transporter-2 (SGLT-2),
7.6 Glucagon-like peptide-1 receptor agonists (GLP-1 agonists)
GLP-1 agonists are a class of anorectic substances that reduce blood sugar and energy intake by activating the GLP-1 receptor. They mimic the actions of the endogenous incretin hormone GLP-1 that is released by the gut. They include Dulaglutide, Danuglipron, and Retratrutide, which are also on the agenda for this meeting. Semaglutide (a prescription medicine with products approved in New Zealand) is also a GLP-1 agonist. As further GLP-1 agonists will be developed over time, Medsafe proposes a group entry for GLP-1 agonists, as well as listing individual compounds as they arise, for clarity:
- Dulaglutide is used for the treatment of type 2 diabetes in combination with diet and exercise. It is a glucagon-like peptide-1 inhibitor.
- Danuglipron is being developed by Pfizer, for is type 2 diabetes in combination with diet and exercise. It is a glucagon-like peptide-1 inhibitor.
- Retratrutide is being developed by Eli Lili, for type 2 diabetes in combination with diet and exercise. It is a glucagon-like peptide-1 inhibitor.
7.7 Momelotinib dihydrochloride
Momelotinib dihydrochloride is used for the treatment of disease-related splenomegaly. It is an inhibitor of wild type Janus Kinase 1 and 2 (JAK1/JAK2) and mutant JAK2.
7.8 Epcoritamab
Epcoritamab is used for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. It is a humanised IgG1-bispecific antibody that binds to a specific extracellular epitope of CD20 on B cells and to CD3 on T cells.
8. Harmonisation of the New Zealand and Australian schedules
Recent scheduling changes made to the Poisons Standard in Australia are to be considered by the Medicines Classification Committee for their implementation in New Zealand.
Public consultation is an important part of the Medicines Classification Committee process, stakeholders are welcome to provide comment on all agenda items including those being considered for harmonisation.
The Medsafe Medicines Classification Committee- Public Consultation on Agenda Items webpage provides information on how to comment on agenda items.
8.1 New chemical entities which are not yet classified in New Zealand
22 May 2024 Scheduling Final Decisions Public Notice
8.1a Abrocitinib
Abrocitinib is a Janus kinase (JAK) inhibitor which is indicated for treatment of adults and paediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis under certain conditions.
From 1 June 2024 abrocitinib was classified as a Schedule 4 (prescription medicine) in Australia.
8.1b Bulevirtide
Bulevirtide is an antiviral medicine used for the treatment of chronic hepatitis D.
From 1 June 2024 bulevirtude was classified as a Schedule 4 (prescription medicine) in Australia.
8.1c Erlanatamab
Erlanatamab-bcmm is a bispecific B cell maturation antigen (BCMA)-directed T-cell engaging antibody indicated for multiple myeloma under certain conditions.
From 1 June 2024 erlanatamab was classified as a Schedule 4 (prescription medicine) in Australia.
8.1d Etranacogene dezaparvovec
Eyranacogene dezaparavovec-drlb indicated to treat adults with haemophilia B under certain conditions.
From 1 June 2024 estranacogene dezaparvovec was classified as a Schedule 4 (prescription medicine) in Australia.
8.1e Etrasimod
Etrasimod is a sphinosine 1-phosphate receptor modulator indicated for treatment of moderately to severely active ulcerative colitis in adults.
From 1 June 2024 etrasimod was classified as a Schedule 4 (prescription medicine) in Australia.
8.1f Fezolinetant
Fezolinetant is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
From 1 June 2024 fezolinetant was classified as a Schedule 4 (prescription medicine) in Australia.
8.1g Lebrikizumab
Lebrikizumab is a humanized monoclonal antibody used for the treatment of atopic dermatitis.
From 1 June 2024 lebrikizumab was classified as a Schedule 4 (prescription medicine) in Australia.
8.1f Lecanemab
Lecanemab-irmb is indicated for the treatment of Alzheimer’s disease.
From 1 June 2024 lecanemab was classified as a Schedule 4 (prescription medicine) in Australia.
8.1h Maribavir
Maribavir is indicated for the treatment of adults and specified paediatric patients with post-transplant cytomegalovirus infection/ disease under certain conditions.
From 1 June 2024 maribavir was classified as a Schedule 4 (prescription medicine) in Australia.
8.1i Nelarabine
Nelarabine is a nucleoside prodrug of 9-beta-D-arabinofuranosylguanine (ara-G). It is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) under certain conditions.
From 1 June 2024 nelarabine was classified as a Schedule 4 (prescription medicine) in Australia.
8.1j Tebentafusp
Tebentafusp-tebn is indicated for the treatment of adult patients with HLA-A*02:01-positive unresectable or metastatic uveal melanoma.
From 1 June 2024 tebentafusp was classified as a Schedule 4 (prescription medicine) in Australia
8.1k Zilucoplan
Zilucoplan is indicated for the treatment of generalised myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive.
From 1 June 2024 tebentafusp was classified as a Schedule 4 (prescription medicine) in Australia
8.2 Decisions by the Secretary to Department of Health and Aged Care Australia (or the Secretary’s Delegate).
8.2a Naratriptan
Naratriptan is serotonin-1 (5HT1) agonist indicated for the treatment of migraine headache with or without aura.
The TGA rescheduled naratriptan from schedule 4 (prescription only) to the following:
Schedule 4 (prescription); except when included in schedule 3 (restricted)
Schedule 3 (restricted); when in divided oral preparations containing 2.5 mg or less of naratriptan per dosage unit and when sold in a pack containing not more than 2 dosage units for the acute relief of migraine in patients who have a stable, well-established pattern of symptoms.
This scheduling change was implemented on the 1 June 2024.
In New Zealand naratriptan is currently classified as a prescription only medicine. The MCC will consider at the 73rd meeting whether it would be appropriate to reclassify in New Zealand to harmonise with Australia.
9. Agenda items for the next meeting
10. General business
11. Date of the next meeting
