Published: 5 December 2022

Committees

MINUTES FOR THE 69thMEETING OF THE MEDICINES CLASSIFICATION COMMITTEE HELD IN WELLINGTON ON 25 OCTOBER 2022 AT 9:32 AM

Present:

Andi Shirtcliffe (Chair)
Dr Ben Hudson
Dr Marcia Walker
Megan Peters
Angela Renall
Bronwen Shepherd
Jessica Crockett (Secretariat)

In attendance (from Medsafe):

Susan Kenyon (Manager, Clinical Risk)
Leah Russell (Team Leader, Product Regulation)
Matthew Spencer (Manager, Product Regulation)
Tegan Coventry (Senior Advisor, Clinical Risk)
Alice Weil (Senior Advisor, Compliance)

In attendance (from Te Whatu Ora)

Harry Zheng (Pharmacy Team, Te Whatu Ora)

1

WELCOME

The Chair opened the meeting at 9.32am with a karakia and welcomed members and observers.

2

APOLOGIES

Apologies were received from Dr Natasha Murray

A meeting was held on the 17 October 2022 between Dr Natasha Murray, the Secretariat and Chair to discuss agenda item 6.1e National Immunisation Schedule

3

CONFIRMATION OF THE MINUTES OF THE 68TH MEETING HELD ON 26 April 2022

The minutes of the 68th meeting were accepted as a true and accurate record.

4

DECLARATION OF CONFLICTS OF INTEREST

The Conflict of Interest forms were returned to the Secretariat of the Medicine Classification Committee.

One member had a potential conflict of interest pertaining to item 8.2a, low dose cannabidiol, and removed themselves from discussion and decisions relating to this item.

The MCC Chair had a potential conflict of interest pertaining to item 6.1e, vaccine reclassification. In consultation with the Committee Secretariat, the Committee agreed it would be appropriate for the Chair to step down from chairing this item, but was still able to participate in the discussion and decisions. Item 6.1e was chaired by Angela Renall. 

5

MATTERS ARISING

5.1

Objections to recommendations made at the 68th meeting

The Committee discussed reasons for a valid objection, descriptions of which can be found on the following link: How_to_change_medicine_classification.pdf (medsafe.govt.nz).

No valid objections were received for the 68th meeting.

Secretariat’s note:  

In New Zealand the medicine classification process includes an opportunity for comments on agenda items. There is also an opportunity to object to MCC recommendations that are published following the MCC meeting. Given the complexity of this agenda, those objecting to MCC recommendations are requested to please specify clearly which recommendations their objection relates to.

Please be aware that the Medicine Classification Committee (MCC) is an expert advisory group whose function is outlined in the Medicines Act 1981 (the Act). The role of the MCC is to make recommendations to the Minister in respect of the classification of any medicine as prescription medicines or restricted medicines or pharmacy-only medicines under the Act. The MCC is not responsible for making recommendations relating to medicine funding and operational / service delivery models.

5.2

Bilastine- proposed change to classification statements (Medsafe)

Background

Medsafe received a New Medicine Application for a bilastine 10 mg tablet, with the proposed indication:

for the treatment of rhinoconjunctivitis and urticaria in children aged 6 to 11 years with a body weight of at least 20 kg.

At the 53rd meeting held on 5 May 2015 the Committee recommended the current classifications for bilastine. Bilastine is currently classified as:

  • Prescription: except when specified elsewhere in the schedule
  • Pharmacy only: in divided solid dosage forms for oral use containing 20 milligrams or less for the treatment of the symptoms of allergic rhinoconjunctivitis (seasonal and perennial) and urticaria.

The current pharmacy-only classification of bilastine does not include any age range restrictions. The only bilastine-containing medicine currently approved in New Zealand is a 20 mg tablet that is not approved for use in individuals under 12 years of age.

At, 22 April 2021 the Australian Therapeutic Goods Administration (TGA) rescheduled bilastine to:

  • Schedule 4 (Prescription): except when included in Schedule 3.
  • Schedule 3 (Restricted/ Pharmacist Only): bilastine in divided oral preparations containing 20 mg or less in adults and adolescents 12 years and older

The MCC was requested to review the classification of bilastine made at the 53rd meeting taking into account a New Medicine Application received for a product with an indication for use in children aged 6 to 11 years with a body weight of at least 20 kg.

Discussion

The Committee received and considered all of the submissions and comment material relevant to this agenda item.

The Committee thanked Medsafe for submitting this agenda item for MCC consideration, noting the caution taken when considering bilastine for use in paediatric populations.

The Committee acknowledged that the Australian classification of bilastine differs to the New Zealand classification, with products only being classed as pharmacist only for those 12 years of age and older in Australia.

The Committee considered current use of bilastine in New Zealand in those over 12 years of age. The Committee also considered the use of bilastine containing drug products in those under 12 years of age internationally, noting that classifications of bilastine in this age group in other countries such as the United Kingdom (UK) and Australia is prescription only. The Committee noted that bilastine is widely used in paediatric populations internationally.

The Committee acknowledged the current classifications of other second-generation antihistamines, noting for example that fexofenadine has an age restriction of 12 years and older in New Zealand.

The Committee noted that the New Zealand label statement requirements for bilastine, when used in cough and cold medicines, is consistent with that of other non-sedating antihistamines, with a statement requirement of ‘do not use in children under 6 years old’.

The Committee noted that there is no additional risk of unintended misuse due to incorrect self-diagnosis of allergies as there are already other second-generation antihistamines for this indication available over the counter (OTC).

The Committee noted the selective properties of bilastine and considered the drug substance to carry a low risk for adverse events. 

The Committee did not recommend any additional label statements for bilastine when provided at pharmacy-only for those 6 to 11 years with a body weight of at least 20 kg.

Recommendation

The Committee recommended that the classification of bilastine remain unchanged.

5.3

Fenbendazole- proposed classification change to prescription medicine (Medsafe)

Background

Fenbendazole is a broad-spectrum antiparasitic substance approved for use in numerous animal species. The safety and efficacy of fenbendazole in humans remains to be fully elucidated as there is very little clinical data available.

Fenbendazole is currently not scheduled in New Zealand.

There has been a growing interest in the use of fenbendazole in humans for a therapeutic purpose as an anti-cancer agent, which can be seen on a number of online platforms. There has also been an increased interest in the repurposing of other anti-parasitic and antibacterial agents (e.g., ivermectin, doxycycline and azithromycin) as a treatment for COVID-19. This raises a risk that individuals may self-administer fenbendazole without adequate oversight from a healthcare professional.

Medsafe has received enquiries about the importation of fenbendazole medicines for human cancer treatment, and there have been instances of importation for personal use.

Medsafe proposes fenbendazole is classified as a prescription medicine.

Discussion

The Committee noted that fenbendazole is an antiparasitic agent not currently scheduled in New Zealand.

The Committee agreed to the Medsafe proposal to classify fenbendazole as a prescription medicine.

Recommendation

That fenbendazole should be added to the New Zealand schedule as a prescription medicine.

6

SUBMISSIONS FOR RECLASSIFICATION

6.1a

Methenamine Hippurate- proposed up-scheduling change to classification (Medsafe)

Background

Methenamine hippurate is indicated for suppression or elimination of urinary tract infections. Methenamine hippurate is a prodrug that converts to the active:  formaldehyde, in an acidic environment.

Methenamine hippurate is unscheduled in New Zealand, therefore available as a ‘general sales’ medicine. There are currently two approved medicines in New Zealand that contain methenamine hippurate. 

Methenamine hippurate was previously considered at the 47th MCC meeting in May 2012 following Medsafe investigation into the marketing of a methenamine hippurate product. At the 47th meeting, the Committee concluded that there was insufficient evidence of a safety issue to warrant classifying methenamine hippurate. However, the Committee recommended that Medsafe should continue to monitor the marketing of the product in question.

At the 190th Medicines Adverse Reactions Committee (MARC) meeting on 9 June 2022 the MARC reviewed the benefit-risk profile of methenamine hippurate. The MARC considered that, on balance, the benefit-risk profile for methenamine hippurate is favourable but expressed concern that the general sale classification may not be appropriate for the approved indication.

This is a submission from Medsafe for the MCC to consider the classification of methenamine hippurate to a more restrictive classification.

Discussion

Medsafe introduced the submission for reclassification. Medsafe highlighted that this substance is a grandfathered medicine, meaning that it had never been assessed. The MARC had reviewed the benefits but this was difficult as the majority of studies were old and therefore less robust than required now. Medsafe summarised the clinical effectiveness of methenamine hippurate as considered by the MARC. Medsafe noted that the efficacy studies did not provide any information on long-term use and that there was missing information for use in those with renal tract abnormalities. Similarly, there is no long-term safety data. 

The Committee received and considered all of the submissions and comments relevant to this agenda item. The Committee acknowledged the four comments received regarding methenamine hippurate, noting that three of these comments were largely against any up-scheduling of this substance and one comment was in favour of up-scheduling this substance.

The Committee noted the role of methenamine hippurate in antimicrobial stewardship, specifically that this substance is used as a preventive and antibiotic sparing treatment. The Committee also considered the rates of antibiotic resistance in those with urinary tract infections (UTIs).

The Committee noted that methenamine hippurate remains unscheduled in Australia.

The Committee considered that consultation with a Health Professional prior to using this product for prophylaxis of recurrent UTI important, noting as a matter of current best practice, pharmacists should refer patients to their general practitioner when they present with recurrent UTIs. The Committee also expressed concern regarding consumer self-diagnosis as symptoms of other diseases could be mistaken as a UTI.  

The Committee noted that methenamine hippurate has recently become a funded product in New Zealand and is commonly accessed via a prescription. The Committee also noted that the product is currently only marketed through pharmacies, although the current classification could enable general sales accessibility e.g. through supermarkets and dairies. The Committee also noted that the current general sales classification means there is no legal requirement for methenamine hippurate products to provide a data sheet.  The Committee’s opinion was that up-scheduling methenamine hippurate would not impact appropriate access to the medicine.

The Committee considered the benefits and risks of this medicine and concluded that methenamine hippurate is not appropriate for self-selection without interaction with a healthcare processional. They concluded that up-scheduling methenamine hippurate is appropriate and would allow for appropriate use.

The Committee discussed whether additional training for pharmacists to distribute methenamine hippurate would be valuable. The Committee recommended that Medsafe ask the Pharmaceutical Society of New Zealand and Pharmacy Council of New Zealand to consider whether additional training materials should be made available to pharmacists.

Recommendation

That methenamine hippurate should be added to the New Zealand schedule as a restricted (pharmacist only) medicine. 

6.1b

Glecaprevir and Pibrentasvir- proposed change to prescription classification statement (Health New Zealand, Long Term Conditions)

Background

This is a submission from Health New Zealand, which seeks to widen access to glecaprevir and pibrentasvir. The only currently approved medicine containing these substances is Maviret, which contains both substances for the treatment for chronic hepatitis C infection. Reclassification would allow nurses with appropriate knowledge and experience to supply Maviret without a prescription.

The current classifications of both glecaprevir and pibrentasvir are prescription.

Discussion

The Committee received and considered all of the submissions and comments relevant to this agenda item. The Committee acknowledged the 11 comments received regarding this agenda item, noting support for widening the classification of Maviret to include nurses with special knowledge of hepatitis C.

The Committee discussed the prevalence of hepatitis C in New Zealand, noting that the disease burden disproportionately affects the Māori population. The Committee discussed the potential benefits of providing equitable access to Maviret.

The Committee highlighted the World Health Organisation (WHO) goal to eliminate hepatitis C by 2030, which is supported by the National Hepatitis C Actional Plan for Aotearoa New Zealand. The Committee noted this action plan includes increased accessibility to anti-viral treatment.

The Committee noted that there are few serious adverse effects associated with use of Maviret and that this medicine is generally well-tolerated. The Committee considered the different contraindications and drug-drug interactions of Maviret. The Committee considered that nurses, especially those working from mobile clinics are unlikely to have patient records of other conditions and current medicines which could introduce risk when distributing Maviret. The Committee considered the population groups at risk of hepatitis C.

The Committee also queried how the supply of Maviret would occur, for example the storage and recording of Maviret supply. The Committee considered concerns that patients may be supplied Maviret, which if not recorded could lead Health Professionals to later prescribe medicines which could interact with Maviret.

The Committee noted that some of the comments have supported reclassification of Maviret to include nurses but suggested that patients should be referred for a general practitioner consultation to ensure that the patient has an appropriate level of primary healthcare.

The Committee commented that the nurses suggested in this proposal are specialised in terms of diagnosis of hepatitis C and would be well equipped to supply Maviret to the appropriate populations. The Committee noted an additional option to improve access for Maviret would be to include these substances as specified prescription medicines for designated registered nurse prescribers, however consideration of this option is outside the scope of the MCC. 

The Committee noted that some comments suggested development of a distribution model whereby nurses refer eligible/ suitable patients to pharmacists, who could be enabled (by scheduling) to provide Maviret.  The Committee noted the important role pharmacists play in patient follow-up. Specifically, the model proposed by the Pharmacy Guild of New Zealand was noted however outside the current classification request. The Committee noted that they would be open to considering a separate submission to enable pharmacists to supply Maviret.

The Committee noted that as the regulatory body, the Nursing Council of New Zealand would be responsible for ensuring that nurses supplying Maviret under an ’except when’ statement have appropriate training. The Committee considered the benefits and risks of nurses being able to supply Maviret and concluded that it is favourable to reclassify Maviret to a ‘prescription except when’ statement to allow nurses to distribute.

Recommendation

The Committee recommended 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 the approved training programme, when provided by nurses who meet the requirements of the Nursing Council.

The Committee recommended 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 the approved training programme, when provided by nurses who meet the requirements of the Nursing Council.

6.1c

Topical and injected local anaesthetics – proposed change to prescription classification statements (Dental Council)

Background

At the 58th meeting held on 16 May 2017 changes were made to the classification of articaine, lignocaine (lidocaine) and prilocaine with or without felypressin to enable dental therapists and oral therapists to administer them in their practice. In addition, at the 66th meeting held on 11 May 2021 changes were made to the classification of topical oral tetracaine hydrochloride, benzocaine, lidocaine and prilocaine to enable dental therapists and oral therapists to administer them in their practice.

This is a submission from the Dental Council New Zealand proposing to change the classification for topical oral benzocaine, tetracaine hydrochloride, lidocaine and prilocaine, and injected articaine, lidocaine and prilocaine with or without felypressin, to enable dental hygienists to use them in their practice without a prescription.

Discussion

The Committee received and considered all of the submissions and comments relevant to this agenda item. The Committee acknowledged the two comments regarding the agenda item, which were both in support of reclassification.

The Committee noted that this was an extension of the successful applications from May 2017 and May 2021 which widened the classification of articaine, lignocaine (lidocaine) and prilocaine with or without felypressin along with topical oral tetracaine hydrochloride, benzocaine, lidocaine and prilocaine to enable dental therapists and oral therapists to administer them in their practice.

The Committee noted that dental hygienists are educated and trained in the proper use of the proposed topical and injected local anaesthetics. The Committee noted that dental hygienists already access and use these medicines through Standing Order. The Committee noted the benefit in providing anaesthetics to avoid pain during certain dental procedures, highlighting perceived pain can be a barrier to access.

The Committee considered the safety risks to be low.

Feedback from the National Clinical Director of Oral Health was supportive of this reclassification.

The Committee considered the benefit-risk profile to be favourable for reclassification.

Recommendation

The Committee recommended that the prescription classification statements for benzocaine, prilocaine, lidocaine (lignocaine), tetracaine (amethocaine), articaine, felypressin should be amended to the following statements:

Benzocaine:

Prescription except when specified elsewhere in this schedule; except in dermal preparations containing 2% or less of total anaesthetic substances; except in lozenges containing 30milligrams or less of total anaesthetic substances per dosage unit; except when containing 20% 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

Prilocaine:

Prescription for injection except when used as a local anaesthetic in practice by a dental therapist, or oral health therapist or dental hygienist (without local anaesthetic exclusion on their scope of practice) registered with the Dental Council; except when specified elsewhere in this schedule 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

Lidocaine (lignocaine):

Prescription 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 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

Tetracaine (amethocaine):

Prescription for internal use; for external use in medicines containing more than 10%; for ophthalmic use except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board; except when containing 2% 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

Articaine:

Prescription except when used 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

Felypressin:

Prescription except when combined with a local anaesthetic and used 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

6.1d

Adrenaline- proposed change to prescription classification statement (Dental Council)

Background

This is a submission from the Dental Council New Zealand proposing to change the classification of adrenaline to enable oral health therapists, dental therapists and dental hygienists registered with the dental council to use adrenaline in emergency situations in their practice without a prescription.

Discussion

The Committee noted that these groups have a professional obligation to have current training in resuscitation and are currently able to use adrenaline under a Standing Order.

The Committee noted that adrenaline has a well-established safety profile and that this submission is proposing the reclassification for the use of adrenaline in emergency situations, in particular anaphylaxis.

The Committee found the benefit-risk profile to be in favour of changing the classification statement for adrenaline to include oral health therapists, dental therapists and dental hygienists.

Recommendation

The Committee recommended that the restricted classification statements for adrenaline be amended to the following statement:

Restricted medicine in medicines containing 1% or less except in medicines for injection containing 0.02% or less, except in medicines for injection containing 0.1% for use in practice in an emergency by a dental therapist, an oral health therapist or a dental hygienist registered with the Dental Council

6.1e

National Immunisation Schedule – proposed change to prescription vaccine classification statements (Ministry of Health)

Background

This is a submission from the Ministry of Health proposing to widen the classification for a number of vaccines to allow vaccinators who have successfully completed the Vaccinator Foundation Course (or equivalent course) approved by the Ministry of Health and who comply with the immunisation standards of the Ministry of Health to both distribute and administer vaccines.

COVID-19 Vaccinators Working Under Supervision, Provisional Vaccinators, Provisional Pharmacist Vaccinators, and Vaccinating Health Workers are excluded from this submission.

Discussion

The MCC Chair had a potential conflict of interest pertaining to this item 6.1e. In consultation with the Committee Secretariat, the Committee agreed it would be appropriate for the Chair to step down from chairing this item, but still participate in the discussion and decisions. This item was chaired by Angela Renall.  The author, Harry Zheng, was invited to present a brief introduction on the submission. Differences between proposed classifications among the vaccines included in the submission were highlighted. Cholera vaccine, haemophilus influenza vaccine, pneumococcal vaccine, staphylococcus aureus, streptococcus vaccine in oral dose form were not included in this submission. The reclassification or the rotavirus vaccine and typhoid vaccine covered both the oral dose form and any injectable dose form that may be approved in the future. It was highlighted that COVID-19 vaccine, tuberculosis vaccine and yellow fever vaccine had additional requirements for the vaccinator to have completed the relevant training programmes.

The Committee considered all submission information and comments for this agenda item. The Committee also considered the classification of vaccines internationally. The Committee noted that this agenda item was of high public interest and acknowledged the 17 comments regarding this item.

The Committee noted that many comments which were not in support of bulk reclassification of vaccines, were due to concerns around the reclassification of travel vaccines. The Committee considered the comments made regarding reclassification of travel vaccines and acknowledged the value of expert advice being available for consumers when they have a consultation and subsequent vaccination from a travel health service provider. The Committee considered the additional authorisation and training required for vaccination of the yellow fever vaccine and tuberculosis/Bacillus Calmette-Guerin (BCG) vaccine. The Committee noted that the existing requirements for training for authorisation to use these vaccines would apply regardless of classification. Compared to other vaccines considered in this submission, the Committee did not see a compelling argument for rescheduling travel vaccines to improve equity and accessibility.

The Committee noted the benefit of increased access to childhood vaccines, given their current low uptake in some populations. The Committee considered equity to be a primary driver for widening the classifications of childhood vaccinations. The Committee viewed wider access to distributing and administering childhood vaccines and other non-travel vaccines as favourable. The Committee also considered harmonising the vaccination classification statements within New Zealand to be favourable.

For the purposes of considering this submission the Committee considered ‘travel’ and ‘non-travel vaccines’ separately. The Committee classed the following vaccines as being ‘travel vaccines’, which they considered separately: cholera vaccine, Japanese encephalitis vaccine, rabies vaccine, typhoid vaccine, and yellow fever vaccine. The Committee agreed the current proposal did not provide enough information on the benefits and risks to make a recommendation for reclassification of these ‘travel’ vaccines. The Committee noted they would welcome any future submissions which more specifically focussed on the benefit-risk profile of reclassifying these ‘travel’ vaccines.

The Committee considered other vaccines in the proposal and viewed that the benefits of reclassifying these were positive.

The hepatitis A vaccine and tuberculosis (BCG) vaccine were noted as having indications for travel and non-travel purposes in New Zealand. The Committee considered equitable access to be of high importance for both of these vaccines when indicated for non-travel purposes. The benefit-risk profile for both of these vaccines was viewed as favourable for reclassification.

The staphylococcus aureus vaccine and streptococcus beta-haemolyticus vaccine were noted as not having any currently approved injectable vaccines in New Zealand. The Committee has therefore decided not to make a recommendation regarding these substances.

The ‘triple antigen vaccine’ in the submission was noted to be a drug product rather than a drug substance, as only drug substances are classified by the Committee this was not considered for reclassification.

The Committee noted that it will be important for any vaccinator to keep a record of a patient’s vaccine schedule. It’s acknowledged that this is the intent of the new Aotearoa Immunisation Register, that all vaccinators will have access to.

Recommendation

The Committee unanimously agreed to recommend the following classification changes for the non-travel vaccines:

COVID-19 vaccine: ‘Prescription except when administered, by a vaccinator who has successfully completed a Vaccinator Foundation Course and a COVID-19 Vaccinator Education Course (or any equivalent training course on COVID-19 vaccination 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 Worker’

Diphtheria, tetanus and pertussis (acellular, component) vaccine (Tdap): ‘Prescription except when administered 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’

Diphtheria toxoid: ‘Prescription except when administered 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’

Diphtheria vaccine: ‘Prescription except when administered 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’

Haemophilus influenzae vaccine: ‘Prescription except when administered 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’

Hepatitis B vaccine: ‘Prescription except when administered 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’

Human papillomavirus vaccine (HPV): ‘Prescription except when administered 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’

Influenza vaccine: ‘Prescription except when administered 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’

Measles vaccine: ‘Prescription except when administered 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’

Meningococcal vaccine: ‘Prescription except when administered 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’

Mumps vaccine: ‘Prescription except when administered 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’

Pertussis (whooping cough) vaccine: ‘Prescription 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’

Pneumococcal vaccine: ‘Prescription except when administered 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’

Poliomyelitis vaccine (polio): ‘Prescription except when administered 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’

Recombinant varicella zoster virus glycoprotein E antigen: ‘Prescription except when administered 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’

Rotavirus vaccine: ‘Prescription except when by administered 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’

Rubella vaccine: ‘Prescription except when administered 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’

Tetanus toxoid: ‘Prescription except when administered 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’

Vaccinia virus vaccine: ‘Prescription except when administered 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’

Varicella vaccine: Prescription except when administered 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’

Hepatitis A vaccine: ‘Prescription except when administered 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-19Vaccinators Working Under Supervision, Provisional Vaccinators, Provisional Pharmacist Vaccinators, and Vaccinating Health Workers’

Tuberculosis vaccine: ‘Prescription except when administered, by a vaccinator who has successfully completed a Vaccinator Foundation Course (or equivalent course) approved by the Ministry of Health, and who is complying with the immunisation standards and any other requirements of the Ministry of Health, but excluding COVID-19 Vaccinators Working Under Supervision, Provisional Vaccinators, Provisional Pharmacist Vaccinators, and Vaccinating Health Workers’

The Committee recommended that the classifications for staphylococcus aureus vaccine, streptococcus beta-haemolyticus vaccine, triple antigen vaccine, cholera vaccine, Japanese encephalitis vaccine, rabies vaccine, typhoid vaccine, and yellow fever vaccine remain unchanged.

7

NEW MEDICINES FOR CLASSIFICATION

7.1a

Dostarlimab

Jemperli concentrate for solution for infusion 50 mg/mL

Dostarlimab is an anti-programmed cell death protein-1 (PD-1) immunoglobulin G4 (IgG4) humanised monoclonal antibody (mAb). Dostarlimab is indicated for adults with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.

Recommendation

That dostarlimab should be added to the New Zealand schedule as a prescription medicine.

7.1b

Diroximel fumarate

Vumerity capsule 231 mg

Diroximel fumarate is indicated in adults for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Also listed in section 8.1h as a harmonisation item.

Recommendation

That diroximel fumarate should be added to the New Zealand 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

 

Therapeutic Goods Administration 24 January 2022

Scheduling Final Decisions Public Notice

8.1a.

Infigratinib

Infigratinib is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. 

From 1 February 2022, infigratinib is classified as a prescription only medicine in Australia

Recommendation.

That infigratinib should be added to the New Zealand schedule as a prescription medicine.

8.1b

Ponesimod

Ponesimod is indicated to treat adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

From 1 February 2022, ponesimod is classified as a prescription only medicine in Australia.

Recommendation.

That ponesimod should be added to the New Zealand schedule as a prescription medicine.

8.1c

Selinexor

Selinexor is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. 

From 1 February 2022, selinexor is classified as a prescription only medicine in Australia.

Recommendation

That selinexor should be added to the New Zealand schedule as a prescription medicine.

8.1d

Selumetinib

Selumetinib is indicated for the treatment of paediatric patients 2 years of age or older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas.

From 1 February 2022, selumetinib is classified as a prescription only medicine in Australia.

Recommendation

That selumetinib should be added to the New Zealand schedule as a prescription medicine.

8.1e

Sotorasib

Sotorasib is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least 1 prior systemic therapy. 

From 1 February 2022, sotorasib is classified as a prescription only medicine in Australia.

Recommendation

That sotorasib should be added to the New Zealand schedule as a prescription medicine.

8.1f

Tepotinib

Tepotinib is indicated for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.

From 1 February 2022, tepotinib is classified as a prescription only medicine in Australia.

Recommendation

That tepotinib should be added to the New Zealand schedule as a prescription medicine.

 

Therapeutic Goods Administration 13 April 2022

Scheduling Final Decisions Public Notice

8.1g

Belzutifan

Belzutifan is indicated for treatment of adults with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, CNS hemangioblastomas, or pancreatic neuroendocrine tumours, not requiring immediate surgery.

From 1 June 2022, belzutifan is classified as a prescription only medicine in Australia.

Recommendation

That belzutifan should be added to the New Zealand schedule as a prescription medicine.

8.1h

Diroximel fumarate

Refer to section 7.1.

Diroximel fumarate is indicated in adults for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

From 1 June 2022, diroximel fumarate is classified as a prescription only medicine in Australia.

Recommendation

That diroximel fumarate should be added to the New Zealand schedule as a prescription medicine.

8.1i

Enfortumab vedotin

Enfortumab vedotin-ejfv is indicated for the treatment of adults with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy.

From 1 June 2022, enfortumab vedotin is classified as a prescription only medicine in Australia.

Recommendation

That enfortumab vedotin should be added to the New Zealand schedule as a prescription medicine.

8.1j

Lurbinectedin

Lurbinectedin is indicated for the treatment of adults with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.

From 1 June 2022, lurbinectedin is classified as a prescription only medicine in Australia.

Recommendation

That lurbinectedin should be added to the New Zealand schedule as a prescription medicine.

8.1k

Mavacamten

Mavacamten is indicated to treat adults with symptomatic NYHA class II or III obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms.

From 1 June 2022, mavacamten is classified as a prescription only medicine in Australia.

Recommendation

That mavacamten should be added to the New Zealand schedule as a prescription medicine.

8.1l

Somapacitan

Somapacitan-beco is indicated for replacement of endogenous growth hormone in adults with growth hormone (GH) deficiency.

From 1 June 2022, somapacitan is classified as a prescription only medicine in Australia.

Recommendation

That sompacitan should be added to the New Zealand schedule as a prescription medicine.

8.2

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

8.2.1

Decisions by the Delegate – December 2021

8.2.1a

Low-dose Cannabidiol (CBD)
Background

‘Low-dose’ cannabidiol (CBD) has been down-scheduled from schedule 4 (Prescription Only) to schedule 3 (Pharmacist Only), when certain conditions are met, by the TGA in Australia. The TGA considers ‘low-dose’ cannabidiol to mean a maximum daily dose of <150 mg.

Medsafe and the Medicinal Cannabis Agency have provided some regulatory advice, for submitters on the item, and the MCC to consider

Specifically, Medsafe noted that any classification change would only apply to products that are granted consent under the Medicines Act 1981. At the time of this meeting there were no low-dose (<150 mg) products with consent under the Medicines Act 1981 and no applications under evaluation.

Discussion

One Committee member declared a conflict of interest pertaining to this agenda item and excluded themselves from the discussion and decisions of this item.

The MCC considered the Australian rationale for rescheduling low-dose CBD. This appeared to be focussed on the Therapeutic Good’s Administration (TGA) safety review of low-dose CBD products, and on advice from their Joint Committee of the Advisory Committees for Medicines Scheduling and Chemicals Scheduling.  The MCC also considered the classification conditions attached to the Australian scheduling of low-dose CBD.

The Committee considered the five comments pertaining to the low-dose CBD agenda item. In general, these were supportive of down-scheduling low-dose CDB.

The Committee noted that CBD medicines did not have an established long-term safety profile, when used as medicines, which would usually be expected to support down-scheduling of a substance. They also noted that there are currently no approved products in New Zealand that have a daily dose of <150 mg, it was not clear what indications this dose would cover, and therefore there was no clear access issue for these specific medicines.

The Committee noted that there are potential safety issues pertaining to drug-drug interactions with CBD. 

The Committee concluded that it was not necessary to harmonise with Australia’s scheduling of low-dose CBD

Recommendation

The Committee recommended that the classification of low-dose CBD remain unchanged.

9

AGENDA ITEMS FOR THE NEXT MEETING

Medsafe updated the Committee on any potential agenda items for the following meeting.

10

GENERAL BUSINESS.

The Chair reminded the Committee that Medsafe will be in contact with those members whose membership is expiring shortly.

11

DATE OF NEXT MEETING

 The Committee agreed the next scheduled MCC meeting will be in April/ May 2023.

This document was prepared by
Jessica Crockett
as the Medicines Classification Committee Secretariat 

0 1 2 4 5 6 7 9 [ /