Published: 1 May 2025

Committees

Minutes for the 73rd meeting of the Medicines Classification Committee held at 133 Molesworth Street, Wellington on 26 February 2025

  1. Welcome
  2. Apologies
  3. Confirmation of the minutes of the 72st meeting held on 12 June 2024.
  4. Declaration of conflicts of interest
  5. Matters arising
  6. Submissions for reclassification
  7. New Chemical Entities
  8. Harmonisation of New Zealand and Australian schedule
  9. Agenda items for the next meeting
  10. General business
  11. Date of the next meeting

Present

Alison Cossar (Chair)
Dr Ben Hudson (via Teams)
Dr Marcia Walker
Megan Peters
Bronwen Shepherd
Holly Wilson (Secretariat)

In attendance from Medsafe:

Matthew Spencer (Manager, Product Regulation)
Lizzie Collings (Senior Advisor, Pharmacovigilance)

Observing:

Susan Kenyon (Manager, Clinical Risk Management)
Jessy Park (Advisor, Pharmacovigilance)
Leah Russell (Team Leader Medicines Assessment, Product Regulation)
Karen Fu (Advisor – Science, Product Regulation)
Billy Allan (Clinical Chief Advisor, Medicines)

1. Welcome

The Chair opened the 73rd Medicines Classification Committee (MCC) meeting at 9:35am with a karakia.

The Chair introduced the new MCC secretariat, Holly Wilson, to the Committee.

2. Apologies

One apology was received from Dr Tim Hanlon.

3. Confirmation of the minutes of the 72nd meeting held on 12 June 2024

The minutes of the 72nd 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

Conflict of interest forms were returned to the Secretariat.

One member declared a potential or perceived conflict of interest pertaining to agenda item 6.3, travel vaccines. The Committee agreed that this member could participate in the discussion of this agenda item, but should abstain from voting.

All other members confirmed they had no additional interests that would pose a conflict with any of the items on the agenda.

5. Matters arising

5.1 Objections to recommendations made at the 72nd meeting

The closing date for objections to recommendations made at the 72nd MCC meeting, together with a statement of the grounds on which the objection would be made, was 27 July 2024. Information on how to submit an objection to an MCC recommendation can be found on page 11 of the ‘How to change the legal classification of a medicine in New Zealand’ (PDF, 542KB, 19 pages) guidance document.

There were two valid objections received regarding the Committee’s recommendation to change the restricted classification for sedating antihistamines from children over 2 years of age, to children over 6 years of age.

These objections have been accepted as valid on the basis that the Committee made recommendations of a broader scope than the submission which was consulted on. As such, the consultation process was not fully complete.

As such, a decision on age limits in the restricted classification for sedating antihistamines will take into account the submission, MCC recommendation, and objections. The item may be referred to a future MCC meeting.

This was a submission from Medsafe based on the recommendations from the 182nd Medicines Adverse Reactions Committee (MARC) meeting.

5.2 Respiratory syncytial virus vaccine, adjuvanted – proposed classification to enable administration without prescription (GlaxoSmithKline Australia Pty Ltd)

Background

The classification of the respiratory syncytial virus (RSV) vaccine was considered at the 72nd MCC meeting. The RSV vaccine was classified as a prescription medicine, by way of the ‘vaccine’ class classification. The submission considered at the 72nd MCC meeting proposed this classification be changed to:

Prescription except when injected by a vaccinator who has successfully completed the Vaccinator Foundation Course (or equivalent course) approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health, but excluding COVID-19 Vaccinators Working Under Supervision, Provisional Vaccinators, Provisional Pharmacist Vaccinators, and Vaccinating Health Workers, or when specified elsewhere in this schedule.

The Committee made a recommendation at the 72nd meeting, based on the information available to them, that the classification of the RSV vaccine should remain unchanged.

Minister’s delegate decision

Medsafe updated the Committee on the status of this recommendation. Following the MCC recommendation of the MCC 72nd meeting, the submitter made an objection. Medsafe did not consider the objection to be valid, however agreed to accept further information from the sponsor, GSK, which would support reclassification. This was to enable certainty of classification of RSV vaccines before the 2025 cold and flu season. Based on additional information received from the submitters, Medsafe recommended the classification of the RSV vaccine be reclassified to:

Prescription except when administered for the prevention of lower respiratory tract disease caused by respiratory syncytial virus RSV-A and RSV-B subtypes to a person 60 years of age or older by registered pharmacists, who have successfully completed the Vaccinator Foundation Course (or any equivalent training course approved by Te Whatu Ora) and who complies with the immunisation standards of Health NZ/Te Whatu Ora.

The Group Manager of Medsafe, Ministry of Health, acting under delegated authority, changed RSV vaccine classification, by gazette, on 18 December 2024.

6. Submissions for reclassification

6.1 Lidocaine (lignocaine) – proposed up-scheduling of oromucosal lidocaine containing products (Medsafe)

Purpose

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 of the risks associated with these products and recommendations from the Medicines Adverse Reactions Committee (MARC).

The intent of the reclassification would be to restrict availability of lidocaine products for children, to manage the risk of overuse.

The current classification for 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;
except when containing 2.5% or less and used topically as a local anaesthetic in practice by a dental therapist, oral health therapist or dental hygienist (without local anaesthetic exclusion on their scope of practice) registered with the Dental Council;
for ophthalmic use except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board;
for oral use except in throat lozenges in medicines containing 30 milligrams or less per dose form;
for external use in medicines containing more than 10%;
except in throat sprays in medicines containing 2% or less;
except when specified elsewhere in this schedule. 		Prescription
Lignocaine for urethral use;
for external use in medicines containing 10% or less and more than 2% 		Pharmacy Only
Lignocaine in throat lozenges in medicines containing 30 milligrams or less per dose form;
for external use in medicines containing 2% or less;
in throat sprays in medicines containing 2% or less 		General Sale
Background

The MCC noted that the submission for reclassification from Medsafe is in response to the 195th Medicines Adverse Reactions Committee meeting, which found a dose-related risk of toxicity from oromucosal lidocaine products in younger children and infants.

The MCC noted that the submission provides two options for lidocaine reclassification that could satisfy the concerns raised at the 195th MARC meeting:

Option 1

To add a new restricted classification: for external use in medicines containing 10% or less for oromucosal use, except for use in adults and children 12 years of age and over, (except throat lozenges, except throat sprays 2% or less).

Option 2

To add a new pharmacy only classification: for external use in medicines containing 10% or less for oromucosal use, except in adults and children over 12 years of age, (except throat lozenges, except throat sprays 2% or less).

The MCC noted that there are currently six approved external use medicines containing lidocaine that are for oromucosal use and are indicated in children under 12 years of age (or have no age limit on the package label), and therefore could be impacted by this proposal. Throat lozenges and throat sprays that contain lidocaine 2% or less are not intended to be captured by this proposal.

The MCC noted that option 2 shares more similarities with the Australian classification than option 1, and that Medsafe have asked the MCC to consider whether any changes to lidocaine classification for oromucosal use should harmonise with that of Australia.

The MCC acknowledged that in Australia, most of the products potentially impacted by this reclassification are pharmacy-only products. In the United Kingdom, these products tend to be general sales or pharmacy-only (equivalent to New Zealand’s restricted classification).

The MCC noted that the submitters have also asked the MCC to consider warning statements in addition to the proposed classification change.

The MCC acknowledged that there have been cases of medication error and accidental exposure in children, and noted that the dose calculation and administration of these products can be unclear for consumers.

Comments

The MCC acknowledged that there were four comments received on this agenda item. There was overall support for the proposed restricted classification of lidocaine, however some concerns were raised regarding maintaining access of these products for adult patients.

Discussion

The MCC acknowledged the risk of toxicity from oromucosal lidocaine products in younger children and infants.

Option 1: new restricted classification

The MCC considered the impact of a new restricted (pharmacist-only) classification (option 1) for these products and discussed concerns regarding barriers to access that this could introduce for people 12 years of age and older. Because the affected products can be used in both children and adults, the options for sponsors (companies) following reclassification would be:

  1. Change the presentation of the product to restricted, to ensure they are still able to be indicated for use in children.
  2. Introduce two presentations;
    1. a restricted medicine for use including children, and
    2. a second pharmacy only presentation for use in adults and children 12 years of age and older.

Both scenarios require regulatory approval. The MCC noted that, if companies changed the presentation of these medicines to restricted (scenario 1 above), adults using these products would be required to have a discussion with a pharmacist each time they wished to make a purchase, presenting a possible barrier for access. However, the MCC also considered this as a benefit, promoting pharmacist engagement and facilitating discussions around safe product use. The MCC also noted that patients regularly using such medicines would likely have a prescription to access funded products. The MCC therefore agreed that it is unlikely access would be impacted to a significant degree.

The MCC acknowledged that the introduction of two presentations of lidocaine products (scenario 2 above) could cause confusion for consumers.

Option 2: new pharmacy-only classification

The MCC considered the impact of a new pharmacy-only classification (option 2) for these products. This change would only impact two products marketed in New Zealand; Lidocaine gel 2%, and Medijel Gel, for which the classification would change from general sales to pharmacy only.

The MCC noted that this approach would be less likely to result in access issues (particularly as only two products would be impacted), and still provides an opportunity for the education of consumers through more detailed labelling and mandatory warning statements. However, the MCC acknowledged it could be difficult to convey a meaningful dose through labelling for some of the product preparations.

The MCC noted that for both options, labelling will differentiate products from prescription medicines (as is the case for these products as currently scheduled), and that option 1 (restricted) will also require compulsory data sheets to be included.

The MCC acknowledged that the affected products contain appropriate labelling and that there may be limited benefit of additional labelling and information with regards to toxicity in children. The MCC acknowledged that the submission is specifically targeting the increased risk of toxicity in the paediatric population. The MCC agreed that labelling changes will be unlikely to prevent inadvertent or accidental overdose in children, and noted that most adverse reactions associated with oromucosal lidocaine products in New Zealand are in children under the age of 3 due to accidental consumption, rather than misuse. However, the MCC agreed that the inclusion of labelling stating that these products are not recommended for use in those under 12 years of age could be helpful.

The MCC agreed that whilst there were merits to both approaches, up-scheduling to restricted (pharmacist-only) would be the most effective change. The MCC agreed that this reclassification would help to mitigate the risks associated with using these products in children through facilitation of conversations between pharmacists and parents/caregivers.

The MCC therefore recommended to introduce a new restricted (pharmacist-only) classification for use of oromucosal lidocaine products in children aged under 12 years of age. The MCC recommended that mandatory warning statements be included on these products, as proposed in the submission:

Do not exceed the maximum stated dose.

Prolonged or excessive use can be harmful.

The effect of the recommended classification is that products containing 10% or less of lignocaine, and indicated for children under 12, are restricted medicines. However, additional presentations could be marketed as pharmacy only medicines for use in adults and children aged 12 years and over.

Recommendation

That the classification of lidocaine should be amended to:

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;
except when containing 2.5% or less and used topically as a local anaesthetic in practice by a dental therapist, oral health therapist or dental hygienist (without local anaesthetic exclusion on their scope of practice) registered with the Dental Council;
for ophthalmic use except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board;
for oral use except in throat lozenges in medicines containing 30 milligrams or less per dose form;
for external use in medicines containing more than 10%;
except in throat sprays in medicines containing 2% or less;
except when specified elsewhere in this schedule. 		Prescription
Lignocaine For external use in medicines containing 10% or less for oromucosal use, except for use in adults and children 12 years of age and over, (except throat lozenges, except throat sprays 2% or less) Restricted
Lignocaine for urethral use;
for external use in medicines containing 10% or less and more than 2% 		Pharmacy Only
Lignocaine in throat lozenges in medicines containing 30 milligrams or less per dose form;
for external use in medicines containing 2% or less;
in throat sprays in medicines containing 2% or less 		General Sale

6.2 Tenofovir disoproxil and emtricitabine (Burnett Foundation)

Purpose

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.

Background

The MCC acknowledged the submission received from the Burnett Foundation. The MCC noted that the submission was very thorough.

The MCC acknowledged the research outlined in the submission conducted by researchers at the University of Auckland, which has revealed a strong desire for new pathways of access for tenofovir disoproxil and emtricitabine.

The MCC noted the expression of interest from nurses to be included in the proposed classification, although this falls outside of the scope of the submission.

Comments

The MCC acknowledged that 19 comments were received on this submission, and noted that only one comment was against the proposal. The MCC acknowledged that all other comments expressed support for the submission. However, the MCC acknowledged that a major concern raised by many commenters related to implementation, particularly with regards to the management of blood tests for patients not enrolled with a GP.

Discussion

The MCC reviewed and considered all the information provided in the submission and the many comments received.

The MCC acknowledged that one of the key target patient groups impacted by this submission are people not enrolled with a GP. The MCC agreed that the proposal would widen access to HIV prophylaxis medication in New Zealand, and could improve uptake by those not enrolled with a GP. The MCC agreed that the proposal has the potential to improve access and continuity of care for this group of people.

The MCC considered the two proposed supply models presented in the submission: a pharmacy-initiated model and a collaborative GP/pharmacist model.

The MCC noted that for individuals not enrolled with a GP, it is unclear who is responsible for ordering blood tests and managing these results, as this would typically be the person’s GP. This introduces risk regarding the access, interpretation and responsibility associated with blood tests from individuals not enrolled with a GP. The MCC discussed the management of abnormal lab results, and agreed that the proposal to have laboratory pathologists inform patients of their results and refer them to a GP would be difficult to implement and manage. The MCC agreed that this approach presents a risk of missing patients who have tested positive for HIV, creating risks to patients and their sexual partners.

The MCC discussed that these issues may be exacerbated if patients were able to order their own lab tests. This could worsen access issues due to financial cost, particularly given the frequency of testing. Self-ordering of lab tests also introduces a risk of self-interpretation of these tests. The MCC agreed that self-ordering of laboratory tests should not be encouraged.

The MCC discussed that issues with pharmacy management systems for receiving and storing blood test results could also present a major barrier to this approach, and that proposed processes for unenrolled patients could be too labour intensive.

The MCC emphasised that they had a positive view of the submission, which was comprehensive, and agreed that the proposal has potential to improve access to HIV prophylaxis medication. However, the MCC acknowledged that there are issues surrounding the management of blood tests for unenrolled patients, and the implementation and management in the health sectors, that need to be addressed.

The MCC will provide additional feedback directly to the Burnett Foundation.

Recommendation

The MCC is deferring the decision pending additional information from the submitters.

6.3 Travel vaccines (Green Cross Health Limited)

Purpose

The submission (PDF, 857KB, 35 pages) is a proposal for the classification of travel vaccines:

  1. Hepatitis A Vaccine
  2. Hepatitis B Vaccine
  3. Hepatitis A and Hepatitis B Vaccine
  4. Hepatitis A and Typhoid Vaccine
  5. Japanese Encephalitis Vaccine
  6. Poliomyelitis Vaccine
  7. Typhoid Vaccine
  8. 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 has previously considered these vaccines at the 69th MCC meeting on 25 October 2022.

Background

The MCC acknowledged the submission by Green Cross Health Limited. The MCC noted that the current classification of the proposed vaccines is prescription-only and acknowledged the proposed classification changes. The MCC agreed that the yellow fever vaccine should be discussed separately due to the additional risks and management associated with this product.

The MCC noted that travel vaccines were previously considered at the 69th MCC meeting and the MCC recommendation at that time was not to reclassify.

The MCC acknowledged the classification status of these vaccines in the United Kingdom, United States, and Australia, and noted that classification varies across these countries.

The MCC noted that this submission aims to improve access to these vaccines.

Comments

The MCC acknowledged the 9 comments that were received regarding this agenda item. The MCC noted that four comments expressed support for the proposed changes, whilst five comments expressed major concerns and are strongly against the submission.

Discussion

The MCC noted that many of the comments not supportive of the proposed classification changes were concerned about the lack of specialist travel medicine advice provided when accessing these vaccinations through current providers. The MCC acknowledged that a thorough, in-depth travel medicine consultation is important and noted that travel healthcare specialists are best suited to provide this care.

The MCC considered the benefits of the proposed reclassification of travel vaccines. The MCC noted that the submission did not provide significant evidence of clinical, public health, economic or communal benefits for the proposed reclassification. The MCC noted that the patient population accessing travel vaccines is very small and that the purported benefits of the proposal were overstated. They did not consider that there were significant access concerns for travel vaccines and noted the lack of evidence provided by the submitters in this regard.

The MCC noted that vaccine-preventable diseases make up a small proportion of travel-associated diseases.

The MCC considered the risks of the proposed reclassification of travel vaccines. The MCC noted that removing vaccinations from the broader travel medicine consultation carries the potential for unnecessary vaccination and the worsening of outcomes due to self-management by patients. The MCC acknowledged the complexities surrounding a comprehensive travel medicine consultation and noted that patients would likely miss out on important medical advice should these services be fragmented. The MCC noted that travel consultations are longer and more in-depth than traditional consultations, and that GPs often refer travelling patients to travel medicine providers who are better suited to provide this care.

The MCC considered the requirement of a postgraduate qualification in travel medicine outlined in the proposal. The MCC acknowledged that travel medicine is a dynamic field and noted that the proposal did not provide any detail as to how this knowledge would be maintained in the long term.

The MCC noted that some pharmacies may have standing orders from GPs to administer these vaccines. The MCC noted that there was some risk involved with issuing standing orders, but did not believe it outweighed the potential risk of the proposed classification changes.

The MCC agreed that the current proposal did not provide enough evidence on the need and benefits of travel vaccine reclassification, and that the risks associated with reclassification were not adequately addressed. The MCC agreed that, based on the information provided, travel vaccines are best kept as a component of broader travel medicine consultations provided by travel medicine experts. The MCC emphasised that they do not believe pharmacists to be incapable of providing high quality vaccine care, rather that travel vaccines are a small component of larger, complex travel consultations and should not be fragmented from this service at this time.

The MCC considered the yellow fever vaccine separately due to its additional international regulations. The MCC noted that the same concerns expressed for other vaccines in this submission also apply for the yellow fever vaccine. The MCC agreed that the yellow fever vaccine should not be reclassified.

Recommendation

The MCC agreed that the classifications for the hepatitis A vaccine, hepatitis B vaccine, hepatitis A & B vaccine, hepatitis A & typhoid vaccine, Japanese encephalitis vaccine, poliomyelitis vaccine, typhoid vaccine, and yellow fever vaccine remain prescription only.

6.4 Recombinant Varicella Zoster Virus Vaccine (GSK New Zealand)

Purpose

The submission (PDF, 682KB, 26 pages) is a proposal for the classification of Recombinant Varicella Zoster Virus vaccines to be changed to:

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).

Background

The MCC acknowledged the submission from GSK to reclassify the recombinant varicella zoster virus vaccine (Shingrix). The MCC discussed whether the proposed classification was for all patients aged 18 years and over, or only patients aged 18 years and over who are immunocompromised. The MCC noted that the submission is not clear in this regard, with several points in the submission independently stating both options.

The MCC agreed to interpret the submission as proposing reclassification to include patients aged 18 years and over who are immunocompromised.

Comments

The MCC acknowledged that 5 comments were received regarding the recombinant varicella zoster virus vaccine. The MCC noted that there was overall support for the proposed changes, but that concern was expressed regarding the inclusion of all authorised vaccinators in the scope of the classification.

Discussion

The MCC acknowledged the comments received, and noted concerns raised regarding the inclusion of all authorised vaccinators in the classification. The MCC considered the risks associated with the vaccine, and acknowledged that this is a newer vaccine with risks in immunocompromised individuals, particularly those who may have had ocular zoster in the past.

The MCC noted that most people who are indicated to receive the vaccine are covered by the current classification, i.e. over 50 years of age. The MCC therefore questioned whether there would be any significant improvements in equity and access.

The MCC noted the evidence linking an increased risk of cardiovascular disease with shingles. The MCC acknowledged that scientific understanding of shingles is dynamic and frequently being updated. The MCC noted that as more complications and risks associated with shingles are discovered, the potential benefits of reclassification could be greater.

The MCC agreed that reclassification of the vaccine to allow registered pharmacists to administer the vaccine for the prevention of shingles to immunocompromised individuals aged 18 years and over would improve access to the vaccine for this group of people, and promote alignment between Medsafe and PHARMAC following PHARMAC’s recent decision to expand the funding of the vaccine to include immunocompromised individuals aged 18 years and over.

Recommendation

To change the classification of the recombinant varicella zoster virus vaccine from:

Prescription except when administered for the prevention of herpes zoster (shingles) to a person 50 years of age or over by a registered pharmacist 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).

To:

Prescription except when administered for the prevention of herpes zoster (shingles) to a person 50 years of age or over, or a person aged 18 to 49 years at increased risk of herpes zoster, by a registered pharmacist who has successfully completed the Vaccinator Foundation Course (or any equivalent training course approved by the Ministry of Health) and who comply with the immunisation standards of the Ministry of Health.

6.5 Allopurinol (Arthritis New Zealand Mateponapona Aotearoa, Green Cross Health, Dr Natalie Gauld, Associate Professor Peter Gow)

Purpose

The submission (PDF, 352KB, 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 MCC meeting in August 2021.

Background

The MCC acknowledged the submission and noted the proposed classification.

The MCC acknowledged that the submission follows a previous submission discussed at the 66th MCC meeting in 2021. The MCC noted that at the time they recommended to defer the decision until further information was provided and engagement with the Pharmacy Council was carried out.

Comments

The MCC acknowledged that 17 comments were received regarding this agenda item. The MCC noted that all comments were in support of the proposed reclassification, with most providing no additional recommendations. The MCC noted that some comments raised concerns regarding inequitable access for those not enrolled with a GP.

Discussion

The MCC agreed that the submitters have provided the evidence that was missing at the last MCC review of allopurinol. The MCC agreed that the submission has significant potential benefits in terms of improving both the quality and equity of gout treatment in New Zealand. The MCC noted the rheumatological, metabolic, and cardiovascular risks associated with gout, and agreed that the proposed reclassification has the potential to significantly improve access to treatment, continuity of care, and clinical outcomes for these patients, as well as to promote wider public health improvements.

The MCC acknowledged comments that raised concerns regarding access issues for unenrolled patients. The MCC considered that the submitters have appropriately addressed this issue, and noted that a patient presenting with gout symptoms must have other potential causes of hyperuricaemia excluded before a gout diagnosis can be made and allopurinol be prescribed. The MCC noted that unenrolled patients presenting to pharmacies with gout concerns opens an opportunity for pharmacists to aid these patients in finding a GP.

The MCC acknowledged a comment questioning the necessity of annual eGFR testing and whether this would present a barrier to access. However, the MCC agreed that annual eGFR testing is necessary when considering gout patients often have significant comorbidities that can affect kidney function.

The MCC noted that pharmacists will have sufficient training and support to implement this program.

The MCC agreed to recommend that allopurinol be reclassified to enable pharmacists to provide allopurinol for the prophylaxis of gout.

Recommendation

That the classification of allopurinol should be amended to:

Prescription except when provided for the prophylaxis of gout to people who meet the clinical and eligibility criteria of an approved training program, when provided by pharmacists who meet the requirements of the Pharmacy Council and the Pharmaceutical Society of New Zealand Incorporated training programme.

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.

Recommendation

The MCC recommended that foslevodopa be added to the New Zealand Medicines Schedule as a prescription medicine.

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.

Recommendation

The MCC recommended that foscarbidopa be added to the New Zealand Medicines Schedule as a prescription medicine.

7.3 Cytisine

Cytisine, also known as baptitoxine, cytisinicline, or sophorine, is an alkaloid that occurs naturally in several plant genera. Cytisine is scheduled in Australia as:

Pharmacist only: in divided oral and oromucosal preparations with a recommended daily dose of 9 mg or less of cytisine as an aid in withdrawal from tobacco smoking in adults.

Discussion

The MCC noted cytisine’s mechanism of action and indication.

The MCC acknowledged that 7 comments were received regarding this agenda item and noted that most comments were in support of cytisine having a pharmacist-only classification in New Zealand.

The MCC acknowledged comments suggesting cytisine should be classified as prescription-only until efficacy is proven in New Zealand. The MCC noted that smoking cessation advice is one of pharmacist’s core skills. The MCC agreed that pharmacists would be well-equipped to deliver advice regarding cytisine use in appropriate patients.

The MCC considered the TGA decision regarding cytisine, and their view on the associated side effects and risks. The MCC agreed that pharmacist oversight would mitigate potential risks, and noted that it has been used in many European countries for years as an OTC medicine.

The MCC acknowledged research from the University of Auckland, noting that cytisine presents a new option for those wishing to stop smoking, and could be considered more culturally appropriate for Māori.

The MCC acknowledged a recent Cochrane systematic review assessing the effectiveness of nicotine receptor partial agonists for smoking cessation, and noted that cytisine was more effective in helping people to quit smoking than placebo or nicotine replacement therapy, and may be as effective as varenicline. The MCC noted that all techniques have a low rate of smoking cessation as a whole, but agreed that having options is important.

The MCC considered the expansion of the classification to include nicotine dependence, rather than restricting the classification to tobacco smoking alone. The MCC agreed that classifying cytisine for those with nicotine dependence would allow patients who vape to benefit from this medication also.

The MCC noted the dosing schedule of cytisine, and discussed whether to include dose specifications in the classification. Medsafe noted that there are currently no approved cytisine products in New Zealand. The MCC agreed including dose specifications in the classification could be unnecessarily restrictive.

Recommendation

The MCC recommended that cytisine be added to the New Zealand Medicines Schedule as a pharmacist-only (restricted) medicine, in divided oral and oromucosal preparations as an aid in withdrawal from nicotine dependence in adults.

7.4 Inavolisib

Inavolisib is an anti-cancer medicine used for the treatment of breast cancer.

Recommendation

The MCC recommended that inavolisib be added to the New Zealand Medicines Schedule as a prescription medicine.

7.5 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.

Recommendation

The MCC recommended that rimegepant be added to the New Zealand Medicines Schedule as a prescription medicine.

7.6 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).

Recommendation

The MCC recommended that empagliflozin be added to the New Zealand Medicines Schedule as a prescription medicine.

7.7 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 the treatment of 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 the treatment of type 2 diabetes in combination with diet and exercise. It is a glucagon-like peptide-1 inhibitor.
Recommendation

The MCC recommended that GLP-1 agonists be added to the New Zealand Medicines Schedule as a prescription medicine, as a class entry.

7.8 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.

Recommendation

The MCC recommended that momelotinib dihydrochloride be added to the New Zealand Medicines Schedule as a prescription medicine.

7.9 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 CD3 on T cells.

Recommendation

The MCC recommended that epcoritamab 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

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.

Recommendation

The MCC recommended that abrocitinib be added to the New Zealand Medicines Schedule as a prescription medicine.

8.1b Bulevirtide

Bulevirtide is an anti-viral medicine used for the treatment of chronic hepatitis D.

From June 1 2024 bulevirtide was classified as a Schedule 4 (prescription medicine) in Australia.

Recommendation

The MCC recommended that bulevirtide be added to the New Zealand Medicines Schedule as a prescription medicine.

8.1c Elranatamab

Elranatamab-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 elranatamab was classified as Schedule 4 (prescription medicine) in Australia.

Recommendation

The MCC recommended that elranatamab be added to the New Zealand Medicines Schedule as a prescription medicine.

8.1d Etranacogene dezaparvovec

Etranacogene dezaparvovec-drlb is 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.

Recommendation

The MCC recommended that etranacogene dezaparvovec be added to the New Zealand Medicines Schedule as a prescription medicine.

8.1e Etrasimod

Etrasimod is a sphinosine 1-phosphate receptor modulator indicated for treatment of moderate to severe active ulcerative colitis in adults.

From 1 June 2024 etrasimod was classified as a Schedule 4 (prescription medicine) in Australia.

Recommendation

The MCC recommended that etrasimod be added to the New Zealand Medicines Schedule as a prescription medicine.

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.

Recommendation

The MCC recommended that fezolinetant be added to the New Zealand Medicines Schedule as a prescription medicine.

8.1g Lebrikizumab

Lebrikizumab is a humanised monoclonal antibody used for the treatment of atopic dermatitis.

From 1 June 2024 lebrikizumab was classified as a Schedule 4 (prescription medicine) in Australia.

Recommendation

The MCC recommended that lebrikizumab be added to the New Zealand Medicines Schedule as a prescription medicine.

8.1h 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.

Note: In the published 73rd MCC meeting agenda, this agenda item was labelled 8.1f. This, and the subsequent agenda item labels, have been rectified.

Recommendation

The MCC recommended that lecanemab be added to the New Zealand Medicines Schedule as a prescription medicine.

8.1i 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.

Recommendation

The MCC recommended that maribavir be added to the New Zealand Medicines Schedule as a prescription medicine.

8.1j 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.

Recommendation

The MCC recommended that nelarabine be added to the New Zealand Medicines Schedule as a prescription medicine.

8.1k 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.

Recommendation

The MCC recommended that tebentafusp be added to the New Zealand Medicines Schedule as a prescription medicine.

8.1l Zilucoplan

Zilucoplan is indicated for the treatment of generalised myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive.

From 1 June 2024 zilucoplan was classified as a Schedule 4 (prescription medicine) in Australia.

Recommendation

The MCC recommended that zilucoplan be added to the New Zealand Medicines Schedule as a prescription medicine.

8.2 Decisions by the Secretary to Department of Health and Aged Care Australia (or the Secretary’s Delegate)

8.2a Naratriptan

Purpose

Naratriptan is a serotonin-1 (5HT-1) 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 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 1 June 2024.

In New Zealand naratriptan is currently classified as a prescription only medicine.

Comments

The MCC acknowledged the two comments received regarding naratriptan. Both comments were in support of harmonising with Australia.

Recommendation

The MCC recommended that the classification statement of naratriptan be updated to the following:

Prescription; except when included elsewhere in this schedule.

Restricted (pharmacist-only); when divided in 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.

9. Agenda items for the next meeting

The agenda items for the 74th MCC meeting are yet to be determined.

10. General business

11. Date of the next meeting

The date of the 74th MCC meeting is scheduled for 23 July 2025.

The Chair closed the meeting at 2:05pm.

This document was prepared and written by Holly Wilson as the Medicines Classification Committee Secretariat

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