Published: 4 July 2023
Committees
Minutes for the 70th meeting of the Medicines Classification Committee held in Wellington on 25 May 2023 at 9:30 am
Contents
- Welcome
- Apologies
- Confirmation of the minutes of the 69thmeeting held on 25 October 2022
- Declaration of conflicts of interests
- Matters arising
- Submissions for reclassification
- New chemical entities
- Harmonisation of the New Zealand and Australian schedules
- Agenda items for the next meeting
- General business
- Date of the next meeting
Present:
Andi Shirtcliffe (Chair)
Dr Ben Hudson
Dr Marcia Walker
Megan Peters
Bronwen Shepherd
Jessica Crockett (Secretariat)
In attendance (from Medsafe):
Matthew Spencer (Manager, Product Regulation)
Susan Kenyon (Manager, Clinical Risk)
Leah Russell (Team Leader, Product Regulation)
Scott Read (Senior Investigator, Investigations and Enforcement)
Sou Mieng Tran (Advisor, Pharmacovigilance)
Lizzie Collings (Advisor, Pharmacovigilance)
In attendance (from Te Whatu Ora):
Dr Natasha White (Regional Director Te Manawa Taki, National Public
Health Service)
Harry Zheng (Advisor, Pharmacy)
Observing (from Medsafe)
Tracey O’Flynn (Medical Advisor, Clinical Risk)
Karin Van Bart (Medical Advisor, Clinical Risk)
Joanna Tomlin (Advisor, Regulatory Practice and Analysis)
Nahid Khalajiassadi (Advisor (Science), Product Regulation)
Theodore Keats (Advisor (Science), Product Regulation)
Bri Mitchell (Assistant Advisor, Product Regulation)
1. WELCOME
The Chair opened the 70th Medicines Classification Committee (the Committee) meeting at ~9.30am and welcomed members and guests. The Chair began the meeting with a karakia.
The Secretariat provided health and safety information.
2. APOLOGIES
No apologies were received.
3. CONFIRMATION OF MINUTES OF THE 69th MEETING HELD ON 25 MAY 2023
The minutes of the 69th meeting were accepted as a true and accurate record. The minutes had been signed digitally prior to this meeting.
4. DECLARATION OF CONFLICTS OF INTEREST
The conflict of interest forms were returned to the Secretariat.
One member had a potential conflict of interest pertaining to agenda item 5.1a, low-dose cannabidiol, and removed themselves from the discussion and decision relating to this item.
All other members confirmed 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 69th meeting.
The deadline for intentions to object to a recommendation made at the 69th meeting, together with a statement of the grounds on which the objection would be made, was 27 January 2023. Objections received for the 69th Medicines Classification Committee meeting did not meet the formal criteria for a ‘valid’ objection (page 13, https://www.medsafe.govt.nz/downloads/how_to_change_medicine_classification.pdf).
A request was received regarding the recommendation for methenamine hippurate, a general sales medicine, to be classified as a restricted (pharmacist-only) medicine, to delay implementation.
The Minister of Health’s delegate for medicine classification (Minister’s delegate) has decided to delay implementation for the classification of methenamine hippurate as a restricted medicine until 1 December 2023, to allow time for products containing methenamine hippurate to make regulatory changes to comply with the new classification, and to allow for manufacturing and distribution lead time.
Seven objections were received regarding the recommendation for the classification of low-dose cannabidiol (low-dose CBD) to remain as a prescription medicine.
The Minister’s delegate referred low-dose CBD to the Committee with additional information, to provide regulatory context for a further recommendation.
5.1a Low-dose cannabidiol (CBD)
Background
Low-dose CBD was considered as a harmonisation item at the 69th Medicines Classification Committee 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.
CBD is classified as a prescription medicine, at any concentration or dose. The Committee made a recommendation at the 69th meeting, based on the information available to them, that the classification of CBD should remain unchanged.
There are no CBD-only products approved under the Medicines Act 1981 that would meet the definition of a low-dose CBD medicine. CBD products verified to meet the minimum quality standard 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 Aotearoa (New Zealand) shortly.
Discussion
The Committee reflected on the recommendation for low-dose CBD from the 69th Medicines Classification Committee meeting.
The Committee acknowledged the six comments received regarding low-dose CBD. The Committee noted these comments were largely supportive of a reclassification for low-dose CBD to a restricted medicine.
The Committee considered whether there would be an increased opportunity for clinical research should low-dose CBD be down-scheduled. The Committee noted that low-dose CBD has been a restricted medicine in Australia since December 2020. The Committee noted that there are currently no low-dose CBD medicines that meet the definition of ‘low-dose’ CBD in Australia.
The Committee acknowledged that many pharmacists would be familiar with CBD containing products, given they currently dispense these products, though these are at higher doses and often in combination with THC.
The Committee considered the regulatory context for prescription and restricted medicines in New Zealand. They acknowledged that the medicine application fees are lower for over-the-counter medicines compared to prescription medicines, and that there are some differences in quality assessment and labelling requirements. The Committee noted that for both prescription and restricted medicines, clinical data is required to support any given indication, however literature-based submissions are possible. They also noted that clinical data required would be commensurate with the indication proposed, with ‘lower level’ indications, such as ‘alleviation of minor pain’, requiring less clinical data, for example.
Medsafe’s Clinical Risk Branch provided some background information on what is currently known about some drug-drug interactions, and safety risks for CBD. Medsafe referred to a published report detailing CBD potential drug-drug interactions with systemic mTOR and calcineurin inhibitors. Medsafe noted that the mechanism behind potential drug-drug interactions remains to be fully elucidated, however, serious adverse reactions as a result of a drug-drug interaction have been reported. Medsafe also presented a summary of the European Union (EU) Risk Management Plan (RMP) for Epidyolex. The RMP identifies the important risks of Epidyolex, how these risks can be minimized, and how more information will be obtained. Epidyolex is an approved CBD containing medicine indicated for use as an adjunctive therapy of seizures associated with Lennox Gastraut syndrome (LGS) or Dravet syndrome (DS) under certain conditions. Epidyolex is not a low-dose CBD product. Important risks of Epidyolex outlined in the RMP include hepatocellular injury, somnolence and sedation. The data sheet for Epidyolex specifies the important risks associated with Epidyolex and provides essential information to healthcare professionals on how Epidyolex should be used.
The Committee acknowledged these potential drug-drug interactions, and safety risks associated with higher-dose CBD. The Committee noted they are reviewing the classification of low-dose CBD and acknowledged that further information is needed to determine whether the aforementioned safety signals for high-dose CBD could also be relevant for low-dose CBD, and therefore would require prescriber oversight to manage this risk. The Committee had considered all information provided as submissions to this agenda item.
The Committee considered that there are no current applications, or approved products containing low-dose CBD. They acknowledged that indications from an OTC product would need to be appropriate for that level of access, and that this would be evaluated via Medsafe’s usual medicine assessment process. The Committee however noted that there is difficulty in determining the overall benefit-risk of access to low-dose CBD products, when there are no products (and therefore indications and safety data available for context). Their opinion was that this was a key consideration when determining whether ‘restricted’ was an appropriate level of access. The Committee’s view was that a conservative approach for these products to remain as prescription medicines, until Medsafe received an application would be most appropriate. The level of access could then be considered in the context of the proposed indication(s) for the product(s) under evaluation.
Availability of published literature supporting the use of low-dose CBD for given indications could also support down-scheduling.
The Committee concluded that there is not currently enough evidence for a robust evaluation of the benefit-risk of access to low-dose CBD to determine the appropriate classification. The Committee noted they would welcome further review of low-dose CBD should an application for a low-dose CBD containing medicine be submitted to Medsafe for approval. The Committee agreed that they would be prepared to expedite further review of low-dose CBD upon a new medicine application being submitted to Medsafe.
Recommendation
The Committee recommended that the classification for low-dose CBD should remain unchanged.
5.2 Body Protective Compound-157 (BPC-157)- proposed classification change to prescription medicine (Medsafe)
Background
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 encountered instances of importation of BPC-157 for personal use, and receives enquiries regarding the legality of importation.
Medsafe proposes that BPC-157 is classified as a prescription medicine.
Discussion
The Committee noted that BPC-157 is not currently scheduled in New Zealand.
The Committee agreed to Medsafe’s proposal to classify BPC-157 as a prescription medicine.
Recommendation
The Committee recommended that BPC-157 should be added to the New Zealand schedule as a prescription medicine.
5.3 Teneligliptin - proposed classification change to prescription medicine (Medsafe)
Background
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.
Discussion
The Committee noted that teneligliptin is not currently scheduled in New Zealand.
The Committee noted that dipeptidyl peptidase-4 (DDP-4) inhibitors or ‘gliptins’ are a class of drugs largely indicated for high blood sugar associated with diabetes. The Committee noted they would welcome a submission for an appropriate group classification to capture medicines such as ‘gliptins’ in future.
The Committee agreed with Medsafe’s proposal to classify teneligliptin as a prescription medicine.
Recommendation
The Committee recommended that teneligliptin should be added to the New Zealand schedule as a prescription medicine.
5.4 Ganaxolone - proposed classification change to prescription medicine (Medsafe)
Background
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.
Discussion
The Committee noted that ganaxolone is not currently scheduled in New Zealand.
The Committee agreed with Medsafe’s proposal to classify teneligliptin as a prescription medicine.
Recommendation
The Committee recommended that ganaxolone should be added to the New Zealand schedule as a prescription medicine.
5.5 Fruquintinib – proposed classification change to prescription medicine (Medsafe)
Background
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.
Discussion
The Committee noted that fruquitinib is not currently scheduled in New Zealand.
The Committee agreed with Medsafe’s proposal to classify fruquintinib as a prescription medicine.
Recommendation
The Committee recommended that frunquintinib should be added to the New Zealand schedule as a prescription medicine.
5.6 Paracetamol (liquid formulations)- referred from Medicines Classification Committee 66th meeting
Background
Paracetamol liquid formulations were 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 grams 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.
Discussion
The Committee reflected on the recommendation made at the Medicines Classification Committee’s 66th meeting. The Committee noted that Australia has a maximum of 10 grams of paracetamol in liquid preparations per container available pharmacy-only. The Committee noted that they had previously considered a maximum of 5 grams paracetamol in liquid preparations per container available pharmacy-only.
The Committee acknowledged the two comments made regarding paracetamol (liquid dose form). The Committee noted that one comment was opposed to the reclassification of paracetamol liquid formulations on the basis of paracetamol liquid formulations already requiring warning statements regarding patient safety on the labelling, and due to concerns of disrupting paracetamol supply because of a classification change.
The Committee considered the benefits and risks of access to liquid paracetamol being restricted to a maximum paracetamol content, available as pharmacy-only medicines.
The Committee noted the importance for patients to have access to liquid paracetamol products as over-the-counter medicines.
The Committee noted that there are two strengths of liquid paracetamol supplied in New Zealand: 120 mg/ 5mL and 250 mg/ 5 mL, with both commonly available for sale in 100 mL and 200 mL bottles. The Committee noted if they were to recommend a maximum of 5 grams paracetamol in liquid preparations per container, this would mean a 200 mL container containing 250 mg/ 5mL, which contains 10 grams of paracetamol, would no longer be classified a pharmacy-only medicine.
Medsafe also noted that while only 100 ml and 200 ml pack sizes are commonly supplied as pharmacy only packs, larger packs are approved, and that the current classification does not in itself prevent larger pack sizes from being supplied pharmacy-only. Medsafe advised that a classification change to a maximum content of 10 grams of paracetamol per pack, would mean that both the 100 mL and 200 mL presentations of both the 120 mg/5 mL and 250 mg/5 mL strengths would remain pharmacy-only. The Committee was concerned that a maximum pack size could impact availability, particularly as there have been national and global paracetamol supply issues over the last few years.
The Committee noted the severity of paracetamol poisoning as a result of either unintentional or intentional overdose.
The Committee concluded that they agreed in principle to the establishing of a formal maximum limit to the pack size of paracetamol available in liquid preparations. However, the Committee’s opinion was that there was not enough information available to recommend a specific limit that would be appropriate for the New Zealand context. They also noted Medsafe’s advice regarding the potential impact of a classification change to introduce a maximum content of 10 grams per paracetamol pack, on those products commonly sold in pharmacies.
The Committee requested that Medsafe provide further information, regarding paracetamol toxicity and the risk of unintentional or intentional overdose with regard to liquid formulations, for their consideration before they form a recommendation.
Recommendation
The Committee recommended that consideration of the classification of paracetamol (liquid formulations) be deferred to a future meeting.
Secretariat’s Note: Medsafe has since gathered data on the presentations of approved liquid paracetamol products marketed in New Zealand. On review, Medsafe is considering recommending to the Minister’s delegate that a limit per pack of liquid paracetamol is put in place and welcomes feedback on the following:
- 10 grams per pack for pharmacy-only presentations
- 50 grams per pack for restricted
Feedback on the above pack size limits for liquid paracetamol is due 10 working days following the publication of the minutes. Contact the MCC Secretariat with any feedback (committees@health.govt.nz).
5.7 Zinc - amendment to classification statements (Medsafe)
Background
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 prescription medicines. 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-only for dermal use in medicines containing more than 5%.
Discussion
The Committee acknowledged the comments regarding the amendment to the classification of zinc. The Committee noted these comments were in support of amending this classification with one comment requesting zinc be available general sale when for external use (not just dermal use).
The Committee supported an amendment to the classification conditions for zinc to allow zinc for external use to be available general sale, with the exception of zinc chloride which is scheduled separately.
Recommendation
The classification of zinc should be amended to:
Prescription: except for internal use in medicines containing 25 milligrams or less per recommended daily dose; except for internal use in medicines containing 50 milligrams or less and more than 25 milligrams per recommended daily dose in packs that have received the consent of the Minister or the Director-General to their distribution as general sale medicines, when sold in the manufacturer’s original pack and when labelled with a statement that the product may be dangerous if taken in large amounts or for long periods; except for external use except when specified elsewhere in this schedule; except in parenteral nutrition replacement preparations
General Sale: for external use except zinc
chloride in medicines containing more than 5%;
for internal use in medicines containing 25 milligrams or less per recommended
daily dose;
for internal use in medicines containing 50 milligrams or less and more
than 25 milligrams per recommended daily dose and in packs which have
received the consent of the Minister or the Director-General to their
distribution as general sale medicines and that are sold in the manufacturer's
original pack and when labelled with a statement that the product may
be dangerous if taken in large amounts or for long periods;
except in parenteral nutrition replacement preparations
5.8 Pholcodine
Update from Medsafe
Medsafe updated the Committee on pholcodine containing medicines noting that pholcodine was reclassified as a restricted medicine on 1 December 2022 in New Zealand.
Medsafe noted that some international regulators have made decisions to withdraw products from the market. The Therapeutic Goods Administration (TGA) of Australia has cancelled the registration of these products and have since required the recall of 55 pholcodine containing products. The European Medicines Agency (EMA) has recommended the withdrawal of marketing authorisations for pholcodine containing medicines in Europe.
Medsafe noted this agenda item is to update the Committee on actions pertaining to pholcodine and does not currently require a classification decision.
5.9 National Immunisation Schedule
Update from Medsafe
Medsafe updated the Committee on actions regarding the classification of vaccines on the National Immunisation Schedule. Medsafe noted the Committee’s recommendations from the 69th Medicines Classification Committee meeting, which had a purpose to enable a wider group of vaccinators to administer vaccines.
Since the 69th meeting, Medsafe and the Ministry of Health have identified a more appropriate means of enabling wider access to these vaccines, this work is currently underway. The Minister’s delegate has therefore decided not to implement the committee’s recommendation of the 69th meeting.
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).
Background
Over-the-counter Ibuprofen 400 mg medicines approved in New Zealand are largely marketed as a ‘double strength’ formulation of the standard 200 mg dose forms. Ibuprofen is 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 for oral use in tablets or capsules containing up to 400 milligrams per dose form with a recommended daily dose of not more than 1.2 grams and in packs containing not 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.
Discussion
The Committee discussed the submission from Reckitt Benckiser and noted this item was also considered at the 65th Medicines Classification Committee meeting and the 66th Medicines Classification Committee meeting where ibuprofen 400 mg was last considered.
The Committee acknowledged the four comments made regarding ibuprofen 400 mg. The Committee noted Consumer Health Products (CHP) Australia and CHP New Zealand were in support of the reclassification proposal. The Committee noted the Pharmacy Guild and Pharmaceutical Society and were largely opposed to the reclassification proposal.
The Committee noted that Australia had rescheduled 400 mg ibuprofen under the aforementioned conditions.
The Committee noted the proposed classification statement is for preparations containing ‘up to 400 mg or less ibuprofen’ which may unintentionally capture modified-release preparations of ibuprofen.
The Committee noted that a 200 mg dose of ibuprofen is currently the only dose available at pharmacy-only or general sales. The Committee noted that a 200 mg presentation of ibuprofen is what most consumers are familiar with at a pharmacy-only level, and that introduction of a second dose (400 mg) available pharmacy-only may cause confusion for consumers. The Committee acknowledged the submission’s statement that there is a clinical need for ibuprofen products for patients with difficulty swallowing tablets/ capsules but noted that there are other products available such as chewable dose forms and liquid formulations which can meet this need.
The Committee considered the safety risks associated with NSAIDs.
The Committee considered the overall benefits and risks of the reclassification of ibuprofen 400 mg from restricted to pharmacy-only and concluded that it was not suitable to reclassify ibuprofen 400 mg.
Recommendation
The Committee recommended that the classification of ibuprofen 400 mg remain unchanged.
6.1b Trimethoprim - proposed classification change to prescription with no exceptions (Te Arai BioFarma Limited, Auckland New Zealand).
Background
Trimethoprim is indicated for the treatment of acute urinary tract infections (UTI) 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 a prescription medicine.
Discussion
The Committee discussed the trimethoprim submission, noting that the proposed classification conditions would remove pharmacist ability to supply trimethoprim without prescription.
The Committee noted the five comments made regarding trimethoprim. The Committee noted that all five comments were opposed to the reclassification of trimethoprim.
The Committee noted that trimethoprim is no longer considered as a first-line empiric treatment for UTI. However, the Committee noted trimethoprim is still used as an alternative treatment option for patients unable to take nitrofurantoin.
The Committee commented on the problems related to trimethoprim antibiotic resistance. They noted that antibiotic resistance can evolve and that future strains may be more respondent to trimethoprim and less respondent to other antibiotics. The Committee considered that there may be risk in removing pharmacist ability to supply trimethoprim or in restricting pharmacist supply to only ‘second-line’ treatment of uncomplicated UTI, as best practice guidance regarding the role of antibiotics for UTI treatment may change.
The Committee noted that pharmacists are required to maintain current training in order to supply trimethoprim without a prescription. The Committee noted that pharmacist training sets clear requirements for which situations trimethoprim can be supplied. The MCC appreciated the work done by the Pharmaceutical Society of New Zealand (PSNZ) in maintaining their guidance regarding pharmacist treatment of UTIs. They would encourage the PSNZ to ensure their training continues to be up to date following any classification change to trimethoprim.
The Committee noted the importance of having pharmacists as a touch point in the primary healthcare system for diagnosis and treatment of UTI.
The Committee commented that it would be beneficial to keep records of trimethoprim supplied by pharmacists but noted that there are mechanisms by which New Zealand total supply of trimethoprim could be obtained.
The Committee considered the overall benefits and risks of reclassifying trimethoprim as prescription without exception and concluded that many of the risks are mitigated by pharmacist training and therefore the classification of trimethoprim should remain unchanged.
Recommendation
The Committee recommended that the classification of trimethoprim remain unchanged.
6.1c Flurbiprofen - proposed classification change from pharmacy-only to general sales under specified conditions (Reckitt Benckiser (New Zealand) Pty Limited).
Background
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.
Discussion
The Committee gave a summary of the submission from Reckitt Benckiser and noted the Committee’s comments from the 65th Medicines Classification Committee meeting where flurbiprofen was last considered.
The Committee noted the three comments regarding flurbiprofen. The Committee noted one comment from CHP Australia was in support of the proposed reclassification of flurbiprofen and that the two comments from the Pharmacy Guild and the Pharmaceutical Society were opposed to the proposed reclassification of flurbiprofen.
The Committee noted that the submission has referred to the use of oromucosal preparations of flurbiprofen in Australia following a reclassification to general sales (under certain conditions) in 2020. The submission highlighted safe use of flurbiprofen lozenges in Australia. The Committee acknowledged the points made in the submission but noted the risks regarding the down-scheduling of flurbiprofen oromucosal preparations in a New Zealand context.
The Committee expressed specific concerns regarding inequitable rates of rheumatic fever in New Zealand and the risk of flurbiprofen, an NSAID, masking symptoms of group A streptococcal (GAS) positive throat infections. The Committee noted that the inequitable rates of rheumatic fever largely affect Māori and Pacific children and young people. The Committee noted that the comments opposing the proposed reclassification of oromucosal preparations of flurbiprofen largely expressed concerns, specifically related to rheumatic fever. The Committee noted one comment which referenced the New Zealand Guidelines for Rheumatic Fever’s recommendation that “If a diagnosis of rheumatic fever is being considered, NSAIDs should be avoided until a diagnosis is secure as NSAIDs can mask symptoms and test results’.
The Committee noted that the submission did acknowledge rheumatic fever in New Zealand. However, the Committee found that overall the benefit-risk of reclassification had not shifted and that flurbiprofen oral mucosal preparations (under the specified conditions) are most appropriate as pharmacy-only medicines. The Committee saw it to be beneficial for patients with sore throat to be able to have contact with a pharmacist so they may receive or be directed to the most appropriate care. The Committee also saw that there may be risk of worsened patient outcome due to self-management should flurbiprofen be down-scheduled.
The Committee noted that benzydamine, an NSAID, is available as general sales ‘for oromucosal or topical use’. However, the Committee noted that this classification came into effect in 2015 and that public health strategies for sore throats have evolved since this time, including the introduction of sore throat triage at pharmacy level to enable the diagnosis and early intervention of GAS positive throat infections with a high equity focus. The Committee noted that they would welcome a submission for benzydamine oromucosal and topical preparations.
Recommendation
The Committee recommended that the classification of flurbiprofen remain unchanged.
6.1d Glecaprevir and Pibrentasvir (Maviret)
Background
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.
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.
Discussion
The Committee discussed the submission from Te Whatu Ora and noted the Committee’s comments from the 69th Medicines Classification Committee meeting where Maviret was last considered.
The Committee noted the three comments made regarding Maviret. The Committee noted that all three comments were largely in support of the reclassification of Maviret to allow supply by pharmacists.
A representative of Te Whatu Ora, as submitter for this item, noted that there has been support for pharmacist and nurse provision of Maviret from the Pharmacy Council, Nursing Council and Pharmaceutical Society and communication with these entities regarding training. They explained the proposed training programmes for Maviret noting there will be customised differences between the training programme for nurses and for pharmacists which cater to the professional roles of each group.
The Committee reaffirmed the need for the classification of Maviret (glecaprevir and pibrentasvir) and noted this supports the World Health Organisation (WHO) goal to eliminate hepatitis C. The Committee noted that glecaprevir and pibrentasvir were reclassified by New Zealand Gazette on the 24 May 2023 to allow provision by Nurses under certain conditions. The Committee noted that under some circumstances where isolated provision by pharmacists and nurses is required but in others there may be greater ability for collaborative work between these two groups. The Committee noted that both situations of provision (isolated and collaborative) could be built into the training programmes.
The Te Whatu Ora representative highlighted the complex medical history of some patients with hepatitis C. The Committee acknowledged this and noted that the training programmes should be sufficient at guiding pharmacists on the most appropriate care for patients, when it is appropriate to provide Maviret directly, and when patients should be referred.
The Committee considered the overall benefits and risks of pharmacist provision of Maviret under certain conditions and found that this favoured reclassification.
Recommendation
The Committee recommended that the classification of glecaprevir be reclassified to ‘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 an approved training programme, when provided by nurses who meet the requirements of the Nursing Council or pharmacists who meet the requirements of the Pharmacy Council.
The Committee recommended that the classification of pibrentasvir be reclassified to ‘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 an approved training programme, when provided by nurses who meet the requirements of the Nursing Council or pharmacists who meet the requirements of the Pharmacy Council.
6.1e Naproxen - proposed up-scheduling change to classification (Medsafe)
Background
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.
Discussion
The Committee discussed the naproxen report submitted by Medsafe and the considerations for the naproxen classification as noted in the submission.
The Committee noted the four comments made regarding naproxen. The Committee noted that two comments were opposed to a reclassification of naproxen, and that two comments were in support of a reclassification of naproxen.
Medsafe, as the submitter, highlighted to the Committee the current classification of other NSAIDs sold OTC, ibuprofen and diclofenac. A maximum daily dose specified for these medicines sold as pharmacy only. The Committee discussed whether a similar statement should also be included for naproxen.
The Committee discussed the current naproxen products available in New Zealand, including pharmacy-only and prescription medicines, and their indications for use. The Committee considered the appropriateness of the indications of the pharmacy-only medicines available for self-selection. The Committee discussed that for some conditions such as gout and musculoskeletal disorders, input of a health professional is necessary. The Committee acknowledged the safety risks associated with NSAIDs, including naproxen.
The Committee considered that it would be appropriate to have a maximum recommended daily dose for naproxen available pharmacy-only. Medsafe recommended to the Committee a maximum daily dose of 750 mg naproxen (equiv. 825 mg naproxen sodium) could be considered for inclusion in the pharmacy-only classification. This is on the basis that there are products approved for minor therapeutic indications (headache, minor acute pain or inflammation), with a maximum daily dose of 750 mg. Medsafe noted that the recommended daily doses in the pharmacy-only classification for ibuprofen and diclofenac are lower than maximum recommended daily doses in the prescription products data sheets. They also noted that the maximum daily dose of naproxen in overseas naproxen OTC products is lower than that of prescription presentations.
The Committee noted Medsafe’s recommendations and considered that lower doses of naproxen are appropriate for the relief of minor acute pain and/or inflammation managed by a pharmacy-only medicine. Use of higher doses and/or in some conditions should require input from a health professional. The Committee recommended naproxen also be classified as a restricted medicine.
Recommendations
The Committee recommended that naproxen be reclassified to:
Prescription: except when specified elsewhere in this schedule.
Restricted: in solid dose forms in medicines containing 250 milligrams or less per dose form in packs containing not more than 30 tablets or capsules.
Pharmacy-only: in solid dose forms in medicines containing 250 milligrams or less per dose form in packs containing not more than 30 tablets or capsules and with a recommended daily dose of not more than 750 milligrams per day.
6.1f Bilastine - proposed change to pharmacy-only classification statement (Menarini New Zealand Pty Ltd.)
Background
Bilastine is a non-sedating antihistamine used in adults and children from 6 years (minimum 20 kg weight). Approved products are indicated for 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.
Discussion
The Committee discussed the submission from Menarini New Zealand Pty Ltd and noted the Committee’s comments from the 69th Medicines Classification Committee meeting where Maviret was last considered.
The Committee noted that bilastine is still a relatively new active pharmaceutical ingredient in New Zealand. The first bilastine containing medicine was granted consent for distribution in New Zealand in February 2018.
The Committee noted that having consistent classifications across a class of medicines (such as non-sedating antihistamines) can be beneficial, when appropriate.
The Committee noted that there is no maximum dose for other non-sedating antihistamines (such as loratadine, desloratadine and cetirizine) and the pharmacy-only classification only specifies for oral use and does not have other conditions regarding the dose form or indications.
The Committee noted that if the classification conditions of bilastine available pharmacy-only were to change to “for oral use” this could include liquids. The Committee noted that this would be consistent with other non-sedating antihistamines available pharmacy-only and so is acceptable.
The Committee considered whether there should be a maximum daily dose of bilastine for oral use available pharmacy-only. The Committee decided this was not necessary at this time as it would not align with other non-sedating antihistamines and would be complicated by dosing differences in children and adults.
The Committee concluded the benefits and risks favoured a reclassification of bilastine to pharmacy-only: for oral use.
Recommendation
The Committee recommended that the classification for bilastine be reclassified to:
Prescription: except when specified elsewhere in this schedule.
Pharmacy-only: for oral use.
7 NEW CHEMICAL ENTITIES
7.1a Atogepant
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.
Recommendation
The Committee recommended that atogepant be added to the New Zealand Medicines Schedule as a prescription medicine.
7.1b Glofitamab
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.
Recommendation
The Committee recommended that glofitamab be added to the New Zealand Medicines Schedule as a prescription medicine.
7.1c Avalglucosidase alfa
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.
Recommendation
The Committee recommended that avalglucosidase alfa be added to the New Zealand Medicines Schedule as a prescription medicine.
7.1d Relugolix
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.
Recommendation
The Committee recommended that relugolix be added to the New Zealand Medicines Schedule as a prescription medicine.
7.1e Tislelizumab
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.
Recommendation
The Committee recommended that tislelizumab be added to the New Zealand Medicines Schedule as a prescription medicine.
7.1f Asciminib hyrochloride
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.
Recommendation
The Committee recommended that asciminib hydrochloride be added to the New Zealand Medicines 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.
14 September 2022 Scheduling Final Decisions Public Notice
8.1a Asciminib
Refer to section 7.1f
Recommendation
The Committee recommended that asciminib be added to the New Zealand Medicines Schedule as a prescription medicine.
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.
Recommendation
The Committee recommended that mobocertinib be added to the New Zealand Medicines Schedule as a prescription medicine.
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.
Recommendation
The Committee recommended that osilodrostat be added to the New Zealand Medicines Schedule as a prescription medicine.
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.
Recommendation
The Committee recommended that pemigatinib be added to the New Zealand Medicines Schedule as a prescription medicine.
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.
Recommendation
The Committee recommended that vosoritide be added to the New Zealand Medicines Schedule as a prescription medicine.
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.
Recommendation
The Committee recommended that avacopan be added to the New Zealand Medicines Schedule as a prescription medicine.
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.
Recommendation
The Committee recommended that deucravacitinib be added to the New Zealand Medicines Schedule as a prescription medicine.
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.
Recommendation
The Committee recommended that deucravacitinib be added to the New Zealand Medicines Schedule as a prescription medicine.
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.
Recommendation
The Committee recommended that lenacapavir be added to the New Zealand Medicines Schedule as a prescription medicine.
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.
Recommendation
The Committee recommended that patisiran be added to the New Zealand Medicines Schedule as a prescription medicine.
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.
Recommendation
The Committee recommended that tirzepatide be added to the New Zealand Medicines Schedule as a prescription medicine.
9. AGENDA ITEMS FOR THE NEXT MEETING
The following item will be added to the agenda of the next meeting:
- Paracetamol: as a harmonisation item with Australia following TGA final decision to reduce the maximum size of packs for various paracetamol products.
10. GENERAL BUSINESS
10.1 Phenol
Medsafe updated the Committee that they have been in correspondence with Podiatry New Zealand and the Podiatrists Board, and individual practitioners, regarding the reclassification of phenol to allow use by podiatrists in their clinical practice. Phenol is a medicine used for nail ablation as a treatment for ingrown toenails; currently there are no approved medicines containing phenol for this indication. The current classification of phenol would not allow for use by podiatrists in their clinical practice for the aforementioned indication should a phenol containing medicine for this indication be approved. This would pose an access issue for podiatrists, whose patients would need a prescription before an approved medicine may be used by a podiatrist for their patient. The Committee agreed as soon as an application is received by Medsafe for an appropriate medicine for use by podiatrists, that they would expedite their review for reclassification.
11. DATES OF THE NEXT MEETING
The next Medicines Classification Committee meeting will take place in October or November 2023.
The Chair closed the meeting at 2.43 pm with a karakia.
This document was prepared by
Jessica Crockett
as the Medicines Classification Committee Secretariat.
