Published: 15 March 2023
Committees
Agenda for the 70th meeting of the Medicines Classification Committee to be held in Wellington on 25 May 2023 at 9:30 am
- 1. Welcome
- 2. Apologies
- 3. Confirmation of the minutes of the 69th meeting held on 25 October 2022
- 4. Declaration of conflicts of interests
- 5. Matters arising
- 6. Submissions for reclassification
- 7. New chemical entities
- 8. Harmonisation of the New Zealand and Australian schedules
- 9. Agenda items for the next meeting
- 10. General business
- 11. Date of the next meeting
1. Welcome
2. Apologies
3. Confirmation of the minutes of the 69th meeting held on 25 October 2022
4. Declaration of conflicts of interest
5. Matters arising
5.1 Objections to recommendations made at the 69th meeting.
The deadline for intentions to object to a recommendation made at the 69th Medicines Classification Committee (MCC) meeting, together with a statement of the grounds on which the objection would be made, was 27 January 2023.
5.1a. Low-dose cannabidiol (CBD)
Seven objections were received regarding the MCC recommendation for low-dose CBD made at the 69th meeting.
Low-dose CBD was considered as a harmonisation item at the 69th MCC meeting. In December 2020 the Therapeutic Goods Administration (TGA) of Australia changed the scheduling for low-dose CBD (≤150 mg per day) from schedule 4 (prescription medicine) to schedule 3 (restricted medicine) under certain conditions.
The MCC made a recommendation at the 69th meeting, based on the information available to them, that the classification of CBD remain unchanged. The Minister of Health’s delegate has requested low-dose CBD be returned to the Committee with additional information (PDF 135KB, 2 pages) to provide regulatory context, for a further recommendation.
There are currently no CBD-only products approved under the Medicines Act 1981 that would meet the definition of a low-dose CBD medicine. CBD products approved under the Misuse of Drugs (Medicinal Cannabis) Regulations 2019 do not have approval under the Medicines Act 1981. Medsafe is aware that there are now products being developed, with the intent of being supplied over the counter. Medsafe expects that there may be new medicine applications in Australia and New Zealand shortly.
5.2 Body Protective Compound-157(BPC-157)- proposed classification change to prescription medicine (Medsafe)
Body protective compound-157 (BPC-157) is a synthetically produced peptide. The safety and efficacy of BPC-157 in humans remains to be fully elucidated as there is very little clinical data available.
Unproven claims regarding the use of BPC-157 for bone or joint healing, stomach ulcers, organ damage, and a number of other purposes, including athletic performance enhancement have been made on various online platforms.
The World Anti-Doping Agency (WADA) listed BPC-157 as a prohibited substance on 1 January 2022.
There are currently no approved products or pending applications for medicines containing BPC-157 in New Zealand.
Medsafe has now encountered instances of importation of BPC-157 for personal use and enquiries regarding the legality of importation.
Medsafe proposes that BPC-157 is classified as a prescription medicine.
5.3 Teneligliptin- proposed classification change to prescription medicine (Medsafe)
Teneligliptin was developed as an oral treatment for type 2 diabetes mellitus.
There are currently no approved products or pending applications for medicines containing teneligliptin in New Zealand.
Medsafe has encountered instances of importation of teneligliptin for personal use.
Medsafe proposes that teneligliptin is classified as a prescription medicine.
5.4 Ganaxolone- proposed classification change to prescription medicine (Medsafe)
Ganaxolone is an anticonvulsant indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder under certain conditions.
There are currently no approved products or pending applications for medicines containing ganaxolone in New Zealand.
Medsafe has received an enquiry regarding sourcing of ganaxolone containing products in New Zealand.
Medsafe proposes that ganaxolone is classified as a prescription medicine.
5.5 Fruquintinib- proposed classification change to prescription medicine (Medsafe)
Fruquintinib is indicated for patients with metastatic colorectal cancer (mCRC) under certain conditions.
There are currently no approved products or pending applications for medicines containing fruquintinib in New Zealand.
Medsafe has received an enquiry regarding importation of fruquinitinib containing products in New Zealand.
Medsafe proposes that fruquinitib is classified as prescription medicine.
5.6 Paracetamol (liquid formulations)- referred from Medicines Classification Committee 66th meeting
Paracetamol liquid formulations was considered as a harmonisation item with Australia at the MCC 66th meeting on the 11 May 2021.
On 1 June 2020 the TGA changed the scheduling for paracetamol in liquid preparations to be:
Schedule 3 (restricted): liquid preparations for oral use except when in schedule 2 (pharmacy-only).
Schedule 2 (pharmacy-only): liquid preparations for oral use containing a maximum of 10 g of paracetamol per container.
All paracetamol liquid preparations are currently classified as pharmacy-only in New Zealand. At the MCC 66th meeting the MCC discussed the current liquid paracetamol product pack sizes available in New Zealand and suggested a maximum limit of 5 g per paracetamol container could reflect currently available products on the New Zealand market. A formal recommendation was referred to a later meeting. This is now submitted under that referral to the MCC for their consideration.
5.7 Zinc- amendment to classification statements (Medsafe)
The MCC is asked to amend the classification statements for zinc.
The current prescription classification for zinc contains the statement “except for external use when in medicines containing 5% or less”.
The above classification for zinc would mean products for external use containing over 5% zinc would be a prescription medicine. This classification statement unintentionally captures products such as barrier creams which may contain zinc oxide at concentrations over 5%. These products are intended to be general sales even when containing zinc oxide at concentrations over 5%.
The aforementioned classification statement for zinc has likely been a result of the selective scheduling of zinc chloride which is pharmacy-only for dermal use in medicines containing more than 5% as was the MCC’s intentions.
Medsafe requests for the MCC to recommend that the classification statements of zinc be amended so that barrier creams containing more than 5% of zinc are clearly unscheduled and so that zinc chloride clearly remains as pharmacy-onlyfor dermal use in medicines containing more than 5%.
5.8 Pholcodine
Pholcodine was reclassified as a restricted (pharmacist only) medicine on the 1 December 2022 following advice from both the Medicines Adverse Reactions Committee and the MCC. The Therapeutic Goods Administration (TGA) of Australia have since recalled 55 pholcodine containing products and the European Medicines Agency (EMA) have recommended the withdrawal of marketing authorisations for pholcodine containing medicines in Europe.
Medsafe is monitoring action taken by overseas regulators and does not require a further recommendation from the MCC at this time.
5.9 National Immunisation Schedule
A number of recommendations were made regarding item 6.1e of the 69th meeting, National Immunisation Schedule – proposed change to prescription vaccine classification statements. Medsafe is working with the Ministry of Health policy team, and Te Whatu Ora (Health New) Zealand to identify to identify how to best meet the intent of these recommendations, should they be accepted as appropriate.
6. Submissions for reclassification
6.1a. Ibuprofen 400 mg – proposed classification change from restricted (pharmacist only) medicine to pharmacy-only medicine under specified conditions (Reckitt Benckiser (New Zealand) Pty Limited)
Ibuprofen 400 mg dose forms are a ‘double strength’ formulation of the standard 200 mg dose forms and are currently classified as:
Restricted; ‘for oral use in tablets or capsules containing up to 400 milligrams per dose form and in packs containing not more than 50 dose units and that have received the consent of the Minister or the Director-General to their distribution as restricted medicines and that are sold in the manufacturer’s original pack labelled for use by adults and children over 12 years of age’
On 25 November 2020 Australia down-scheduled ibuprofen 400 mg to:
Schedule 2 (pharmacy-only); ‘in divided immediate release preparations, each containing 400 mg or less of ibuprofen in a primary pack containing no more than 12 dosage units, when labelled: not for the treatment of children under 12 years of age”.
This submission (PDF, 1180KB, 52 pages) by Reckitt Benckiser (New Zealand) Pty Limited proposes that Ibuprofen 400 mg dose form in packs not containing more than 12 dose units, when sold in the manufacturer’s original pack labelled for use by adults and children over 12 years of age is reclassified from a restricted (pharmacist only) medicine to a pharmacy-only medicine.
6.1b. Trimethoprim- proposed classification change to prescription with no exceptions (Te Arai BioFarma Limited, Auckland New Zealand)
Trimethoprim is indicated for the treatment of acute urinary tract infections and is currently classified as:
Prescription: ‘except in medicines for oral use containing 300 milligrams or less per dose unit when sold in a pack of 3 solid dosage units to a woman aged 16-65 years for the 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.’
This submission (PDF, 248KB, 7 pages) by Te Arai BioFarma Limited, Auckland New Zealand proposes that trimethoprim is reclassified as prescription medicine.
6.1c. Flurbiprofen- proposed classification change from pharmacy-only to general sales under specified conditions (Reckitt Benckiser (New Zealand) Pty Limited)
Flurbiprofen is a non-steroidal anti-inflammatory drug (NSAID) indicated for pain and inflammation and is currently classified as:
Prescription; except in locally acting oromucosal preparations containing 10 milligrams or less per dosage unit.
Pharmacy-only; in locally acting oromucosal preparations containing 10 milligrams or less per dosage unit.
This submission (PDF, 878KB, 44 pages) by Reckitt Benckiser (New Zealand) Pty Limited proposes the reclassification of flurbiprofen in locally acting oromucosal preparations containing 10 mg or less per dosage unit, when sold in the manufacturer’s original pack containing not more than 16 dosage units and when labelled only for the treatment of adults and children over 12 years from pharmacy-only to general sales.
6.1d. Glecaprevir and Pibrentasvir (Maviret) – proposed change to prescription classification statement to include provision by pharmacists under certain circumstances (Te Whatu Ora).
Glecaprevir and pibrentasvir are the 2 main active ingredients in Maviret. Maviret is a medicine indicated for the treatment of adults and adolescents 12 years and older with chronic hepatitis C virus (HCV).
Glecaprevir is currently classified as a prescription medicine.
Pibrentasvir is currently classified as a prescription medicine.
At the 69th MCC meeting glecaprevir and pibrentasivr were considered by the MCC for reclassification to include provision by nurses under certain conditions. The MCC recommended that:
Glecaprevir be reclassified as:
Prescription; except when supplied in combination with pibrentasvir for treatment of chronic hepatitis C virus infection to people who meet the clinical and eligibility criteria of the approved training programme, when provided by nurses who meet the requirements of the Nursing Council.
Pibrentasvir be classified as:
Prescription; except when supplied in combination with glecaprevir for treatment of chronic hepatitis C virus infection to people who meet the clinical and eligibility criteria of the approved training programme, when provided by nurses who meet the requirements of the Nursing Council.
As per appropriate MCC process the Minister’s delegate will consider the classification recommendations made by the MCC and make the final decision as to the classification of these medicines.
This submission (PDF, 462KB, 20 pages) by Te Whatu Ora (Health New Zealand), Long Term Conditions proposes that glecaprevir and pibrentasvir be reclassified to include provision by pharmacists under certain conditions.
6.1e. Naproxen- proposed up-scheduling change to classification (Medsafe)
Naproxen is an NSAID currently classified as:
Prescription: except when specified elsewhere in this schedule.
Pharmacy-only: in solid dose form containing 250 milligrams or less per dose form in packs of not more than 30 tablets or capsules.
This submission (PDF, 226KB, 16 pages) by Medsafe proposes the MCC consider the appropriateness of the current classification of naproxen in New Zealand.
6.1f. Bilastine – proposed change to pharmacy-only classification statement (Menarini New Zealand Pty Ltd).
Bilastine is a non-sedating antihistamine used in adults and children from 6 years (minimum 20 kg weight). It has the licensed indications of symptomatic treatment of allergic-rhinoconjunctivitis (seasonal and perennial) and urticaria.
Bilastine is currently classified as:
Prescription: except when specified elsewhere in this schedule.
Pharmacy-only: in divided solid dosage forms for oral use containing 20 milligrams or less of the symptoms of allergic rhinoconjuctivitis (seasonal and perennial) an urticaria.
This submission (PDF, 709KB, 16 pages) proposes the pharmacy-only classification statement is changed to Pharmacy-only: for oral use.
New medicines for classification
The following new chemical entities were submitted to the Committee for classification.
7. New chemical entities
7.1a Atogepant
Qulipta, tablets (10 mg, 60 mg)
Atogepant is an orally administered, small molecule, selective calcitonin gene-related peptide (CGRP) receptor antagonist that blocks the binding of the CGRP to the receptor and antagonizes CGRP receptor function.
Qulipta is a tablet containing either 10 mg atogepant or 60 mg atogepant. Qulipta is indicated for prophylaxis of migraine in adults under certain conditions.
7.1b Glofitamab
[TRADENAME] Glofitamab, concentrate for solution for infusion (2.5 mg, 10 mg)
Glofitamab is a bispecific monoclonal antibody that binds bivalently to CD20 expressed on the surface of B cells and monovalently to CD3 in the T cell receptor complex expressed on the surface of T cells.
Glofitamab as a monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
7.1c Avalglucosidase alfa
Nexviazyme, powder for injection, (100 mg/ 10 mL)
Avaglucosidase alfa is a recombinant human acid α-glucosidase (rhGAA) that provides an exogenous source of GAA.
Nexviazyme is a powder for injection containing 100 mg avaglucosidase alfa indicated for long-term enzyme replacement therapy for the treatment of patients one year of age and older with Pompe disease.
7.1d Relugolix
RYEQO, film-coated tablet, (40 mg relugolix, 1 mg estradiol, 0.5 mg norethisterone acetate)
Relugolix is a non-peptide GnRH receptor antagonist that binds to and inhibits GnRH receptors in the anterior pituitary gland.
RYEQO is a film-coated tablet containing 40 mg relugolix, 1 mg estradiol and 0.5 mg norethisterone acetate. RYEQO is indicated for treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
7.1e Tislelizumab
TEVIMBRA tislelizumab, concentrated injection (100mg/10mL)
Tislelizumab is a humanised immunoglobulin G4 (IgG4) variant monoclonal antibody against PD-1, binding to the extracellular domain of human PD-1 with high specificity and affinity.
Tevimbra is a concentrate for solution for infusion containing 100 mg tislelizumab in 10 mL solution. Tevimbra is indicated for treatment in patients with oesophageal squamous cell carcinoma (OSCC) under certain conditions and non-small cell lung cancer (NSCLC) under certain conditions.
7.1f Asciminib hydrochloride
SCEMBLIX, film-coated tablets (20 mg and 40 mg).
Asciminib is an oral and potent inhibitor of ABL/BCR::ABL1 tyrosine kinases.
SCEMBLIX contains the active ingredient asciminib hydrochloride indicated for the treatment of patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase under certain conditions.
Also listed in section 8.1a as a harmonisation item.
8 Harmonisation of the New Zealand and Australian schedules
8.1 New chemical entities which are not yet classified in New Zealand
14 September 2022 Scheduling Final Decisions Public Notice
8.1a Asciminib
Refer to section 7.1f
From the 1 October 2022, asciminib was classified as a prescription only medicine in Australia.
8.1b Mobocertinib
Mobocertinib is indicated for treatment in those with non-small cell lung cancer under certain conditions.
From the 1 October 2022, mobocertinib was classified as a prescription only medicine in Australia.
8.1c Osilodrostat
Osilodrostat is indicated to treat adult patients with Cushing disease under certain conditions.
From the 1 October 2022, osilodrostat was classified as a prescription only medicine in Australia.
8.1d Pemigatinib
Pemigatinib is indicated to treat adult patients with cholangiocarcinoma under certain conditions or myeloid/ lymphoid neoplasms under certain conditions.
From the 1 October 2022, pemigatinib was classified as a prescription only medicine in Australia.
8.1e Vosoritide
Vosoritide is indicated to increase linear growth in paediatric patients 5 years and older with achondroplasia and open epiphyses.
From the 1 October 2022, vosoritide was classified as a prescription only medicine in Australia.
20 January 2023 Schedule Final Decisions Public Notice
8.1f Avacopan
Avacopan is indicated for adjunctive treatment of adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)).
From the 1 February 2023, avacopan was classified as a prescription only medicine in Australia.
8.1g Deucravacitinib
Deucravacitinib is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
From the 1 February 2023, deucravacitinib was classified as a prescription only medicine in Australia.
8.1h Edaravone
Edaravone is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
From the 1 February 2023, edaravone was classified as a prescription only medicine in Australia.
8.1i Lenacapavir
Lenacapavir, an HIV-1 capsid inhibitor, is indicated in combination with other antiretroviral(s) for the treatment of HIV-1 infection in heavily treatment experienced adults with multidrug resistant HIV-1 infection who are failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.
From the 1 February 2023, lenacapavir was classified as a prescription only medicine in Australia.
8.1j Patisiran
Patisiran is an RNA interference (RNAi) therapeutic agent. Patisiran is indicated for treatment of polyneuropathy in patients with hereditary transthyretin amyloidosis.
From the 1 February 2023, patisiran was classified as a prescription only medicine in Australia.
8.1k Tirzepatide
Tirzepatide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
From the 1 February 2023, tirzepatide was classified as a prescription only medicine in Australia.
9. Agenda items for the next meeting
10. General business
11. Date of the next meeting
