1
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Welcome
The Chair opened the meeting at 10.02am with a karakia and
welcomed members and observers.
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2
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Apologies
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3
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Confirmation of the minutes of the
67th meeting held on 26 October 2021
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4
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Declaration of conflicts of interest
The Conflict of Interest forms were returned to the Manager of
Product Regulation, Medsafe.
All members declared they had no interests which would pose a conflict
with any of the items on the agenda.
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5
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Matters arising
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5.1
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Objections to recommendations made
at the 67th meeting
No valid objections were received.
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5.2
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Update on outstanding agenda items
from the 67th meeting
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5.2.1
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(9.a) NIcotine
At the 67th meeting, held on 26 October 2021, the
Committee noted a change to the Australian schedule for liquid
nicotine, where Schedule 4 of the Poison Standard (the SUSMP) has
been updated to include nicotine. This is equivalent to the
prescription classification in New Zealand. The Committee requested
Medsafe consults with the Vaping Regulatory Authority and provide
advice on policy objectives relating to vaping, how nicotine in
vaping products is regulated under the Medicines Act 1981, and any
potential consequences of a reclassification of liquid nicotine for
discussion at the next meeting.
A response from the Vaping Authority was provided.
Discussion
The Committee noted that the intent of vaping policy between
Australia and New Zealand is materially different. The New Zealand
Ministry of Health considers vaping to be primarily recreational and
that its use as a cessation aid for smokers is secondary in New
Zealand. Vaping products containing liquid nicotine supplied under
the provisions of the Smokefree Environments and Regulated Products
Act 1990 are therefore not medicines.
Whereas in Australia, liquid nicotine for use in vaping is
considered to be an aid for smoking cessation. It therefore has a
therapeutic purpose and is a medicine. Taking this difference into
consideration, the Committee decided there would be no benefit to
changing the classification of nicotine in New Zealand and that
scheduling would not achieve better harmonisation with Australia.
There are no approved medicines in New Zealand that contain liquid
nicotine.
Recommendation
That there should be no change in classification to nicotine.
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6
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Submissions for reclassification
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6.1
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Nitrofurantoin (modified release) –
proposed change to prescription classification statement
(MACROBID, Te Arai BioFarma Limited)
This
submission (PDF, 2.66MB, 46 pages) proposes an amendment to the
prescription classification statement for nitrofurantoin modified
release to ‘prescription medicine except when supplied for oral use
containing 100 mg per dose unit when sold in a pack of 10 solid dosage
units to a woman aged 16-65 years for the first-line empiric treatment
of an uncomplicated urinary tract infection by a registered pharmacist
who has successfully completed the New Zealand College of Pharmacists'
training in the treatment of urinary tract infections.’
The current classification of nitrofurantoin is prescription.
Discussion
The Committee reviewed and considered all of the information
provided in the submission and acknowledged each of the comments
received.
It was noted that a proposal was made for the reclassification of
nitrofurantoin in 2015 at the 53rd Medicines Classification Committee
(MCC) meeting for immediate release nitrofurantoin. Nitrofurantoin was
not reclassified at that time. The submission in the current meeting is
for the reclassification of nitrofurantoin as a modified release dose
form.
The Committee noted that nitrofurantoin is now considered the first
line empiric treatment of uncomplicated urinary tract infections, whereas
it was not the first-line treatment at the point in time of the previous
submission at the 53rd MCC meeting. Trimethoprim is currently supplied to
the same group of females but resistance to trimethoprim has increased
with time. Reclassification could therefore assist in enabling pharmacy
practice to align with clinical best practice.
The concerns regarding the adverse event risk of hypersensitivity and
the increased risk with renal impairment from nitrofurantoin administration
were discussed. The trimethoprim treatment algorithm was referred to which
highlighted the means of minimising these risks. The committee agreed a
similar approach should be taken with nitrofurantoin. The concerns for
hypersensitivity and renal impairment should be highlighted to the Pharmacy
Council and Pharmacy Society to be incorporated into the nitrofurantoin
training package.
The comments from the Royal New Zealand College of General Practitioners
were acknowledged and discussed.
Ensuring appropriate reporting of antimicrobial usage in New Zealand was
considered to be an issue by some stakeholders. The Committee expressed
support for the sharing of data between pharmacies and general practice
teams to facilitate collaborative care and to allow for aggregated
population data on antimicrobial usage.
The Committee encourages any part of the sector to approach the Health
Research Council of New Zealand to highlight the fact that antimicrobial
resistance and prescribing of empirically treated infections in pharmacies
and general practice teams would be a valuable area for on-going research.
The submission stated that the training would be carried out by the New
Zealand College of Pharmacists. However, this organisation no longer exists
and was merged into The Pharmaceutical Society of New Zealand. The
Pharmaceutical Society of New Zealand now carries out additional
accreditation training for pharmacists.
The Committee would welcome submissions for consideration of the
reclassification of trimethoprim.
Recommendation
To change the classification for nitrofurantoin to ‘prescription
medicine except when supplied for oral use containing 100 mg per dose unit
when sold in a pack of 10 solid dosage units to a woman aged 16-65 years for
the first-line empiric treatment of an uncomplicated urinary tract infection
by a registered pharmacist who has successfully completed the Pharmaceutical
Society of New Zealand training in the treatment of urinary tract infections.’
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6.2 |
Naloxone – proposed down-scheduling change to
classification
(New Zealand Drug Foundation)
This submission (PDF,
335.19KB, 14 pages) proposed an amendment to the classification of naloxone.
The submission proposed two options:
- Reclassification of all presentations of naloxone to a general sale
medicine,
or
- Amendment to the prescription classification statement to:
- Prescription; except when provided, or intended to be provided,
for the reversal of opioid overdose, along with equipment and
instructions
The current classification of naloxone is: Prescription; except when
provided as part of an approved emergency kit for the treatment of opioid
overdose.
Discussion
The Committee acknowledged the community benefit of the down scheduling of
naloxone and the intent of previous reclassifications to increase access to
this medicine for immediate first aid. The Committee acknowledged the cost and
funding of these medicines as being a factor that was of concern and a barrier
to access, although noted cost and funding considerations fall outside of the
remit of the Committee.
The Committee discussed the two proposed options for reclassification and
some of the implications associated with each classification statement.
General sales classification
Two key issues with this proposal were considered; labelling, and access to
the needles and syringes needed to administer the product. While the safety of
naloxone as a substance was not considered an issue, the change would only
affect product currently supplied as ampoules as the only other presentation
was already supplied as a general sales medicine. The ampoules meet the
labelling requirements for a prescription medicine but would not meet the
labelling requirements for a general sales medicine. As naloxone in ampoules
is a prescription medicine in most other markets it is unlikely a company
would label a product just for the New Zealand market.
The Committee noted that a general sale classification could enable access
to medicines containing naloxone. However, there would be an issue with
obtaining product that meets New Zealand general sales labelling requirements.
The only approved and available products being:
- Nasal spray emergency kit (general sales)
- Ampoules (prescription), labelled to prescription medicine
requirements.
The Committee discussed the requirement for equipment (needles and syringes),
and instructions for use to administer naloxone from ampoules and the issues
associated with this method of supply. The committee noted that the Health
(Needles and Syringes) Regulations 1998 places restrictions on who may supply
these devices.
Prescription except when classification
The Committee noted that the proposed amendment to the prescription
‘except when for the reversal of opioid overdose, along with equipment and
instructions’ did not factor in the restrictions on who could supply needles
and syringes, and how any advice might be provided. The committee agreed that any
classification statement should be specific to include health care providers that
are competent and able to provide naloxone, needles, and advice. This was to allow
for appropriate access from trained healthcare professionals.
The potential issue of current pack sizes of approved naloxone ampoules in New
Zealand was discussed; the smallest pack size approved in New Zealand contains
five ampoules. It’s likely healthcare providers would prefer to supply this as a
single ampoule pack size, the consequential requirement for new medicine
applications was discussed. It was acknowledged that if supplied in ‘except when’
circumstances, the approved five pack of ampoules may need to be supplied.
Secretariat's note:
Following the 68th MCC meeting, Medsafe staff and the Committee
Chair met with Ministry of Health staff knowledgeable in New Zealand’s harm
reduction and needle exchange program. This helped to refine the Committee’s
recommendation for a change to the classification statement. Committee members
have subsequently reviewed and agreed the below recommendation. This
classification statement would enable supply of any approved prescription medicine
(e.g. ampoules) by appropriate health care providers that are also able to provide
appropriate equipment and instructions on use.
Recommendation
The committee recommended that a change to the classification of naloxone
be made, to further enable access (note that this is in addition to the current
classification statement):
Prescription: except when supplied with needles and syringes by an
authorised representative as approved under the provisions of the Health (Needles
and Syringes) Regulations 1998, and when supplied with instructions for use. |
7
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New medicines for classification
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7.1 |
Levomefolate
Elevit, Film coated tablet
Levomefolic acid, also known as 5-methyltetrahydrofolate (5-MTHF) is the
biologically active form of folate and the form found in circulation in the
human body. It does not require enzymatic conversion and can be utilised
directly by the body.
Folates refer to a class of biologically active compounds related to and
including folic acid. Of these compounds, currently folic acid and folinic acid
are scheduled.
The committee noted that in addition to being scheduled under the Medicines
Regulations 1984, that the Dietary Supplement regulations specify maximum limits
of folic acid allowed in products that are dietary supplements. There are
products containing folic acid, folinic acid, and levomefolate that are marketed
as dietary supplements in New Zealand.
The committee noted the comments from Natural Health Products New Zealand,
and stakeholders from the associated industry such as naturopaths. They noted
the concern that these groups perceived that scheduling levomefolate at any
level would mean that all products containing levomefolate would ‘automatically’
be considered medicines. Medsafe staff described the regulation of medicines,
dietary supplements, and products marketed as natural health products in New
Zealand.
Medicine is defined in section 4 of the Medicines Act 1981 and are products
which are used for a therapeutic purpose as defined in section 3 of the Act.
Scheduling of levomefolate would not necessarily indicate that all products
containing this substance are medicines, just as not all products containing
folic acid are medicines. Other examples such as potassium, which is scheduled
and can be a medicine but is also an ingredient of many sports drinks, were
discussed.
However, Medsafe’s view is that some products containing levomefolate
currently marketed in New Zealand are for a therapeutic purpose and are
therefore considered to be medicines, regardless of any classification. The
committee noted that at least in some instances, levomefolate would be
considered to have a therapeutic purpose, for example reducing the risk of
neural tube defects in pregnancy. In addition, products containing levomefolate
above any pharmacy-only or prescription levels would be more likely to be
considered medicines due to their purpose and mode of action.
The committee considered products which may contain multiple forms of folate,
for example levomefolate and folic acid, and whether cumulative limits should be
placed on these. They noted the Australian TGA has taken this approach.
Recommendation
That the Folic acid pharmacy only statement is updated to:
For oral use in medicines containing more than 500 micrograms per
recommended daily dose. When the medicine contains a combination of folic acid,
folinic acid or levomefolic acid, the medicine must not provide more than a
combined total of 500 micrograms of folic acid, folinic acid and levomefolic
acid per maximum recommended daily dose
That the Folinic acid pharmacy-only statement is updated to:
For oral use in medicines containing more than 500 micrograms per
recommended daily dose. When the medicine contains a combination of folic acid,
folinic acid or levomefolic acid, the medicine must not provide more than a
combined total of 500 micrograms of folic acid, folinic acid and levomefolic
acid per maximum recommended daily dose
That Levomefolate prescription statement is:
For injection
That Levomefolate pharmacy-only statement is:
For oral use in medicines containing more than 500 micrograms per
recommended daily dose. When the medicine contains a combination of folic
acid, folinic acid or levomefolic acid, the medicine must not provide more
than a combined total of 500 micrograms of folic acid, folinic acid and
levomefolic acid per maximum recommended daily dose |
7.2 |
Amivantamab
RYBREVANT, concentrate for solution for Infusion, 350 mg/7 mL
RYBREVANT as monotherapy is indicated for the treatment of patients with
locally advanced or metastatic non-small cell lung cancer (NSCLC) with
activating epidermal-growth factor receptor (EGFR) Exon 20 insertion mutations
as determined by a validated test, whose disease has progressed on or after
platinum-based chemotherapy.
Recommendation
That amivantamab should be added to the New Zealand schedule as a
prescription medicine. |
7.3 |
Glu-urea-Lys(ahx)-hbed-CC
Illuccix, Powder for Injection, 25mcg
Illuccix, after radiolabelling with Ga-68, is a radioactive diagnostic agent
indicated for use with positron emission tomography (PET) imaging combined with
Computerised Tomography (CT) in patients with prostate cancer:
- who are at risk of metastasis and who are suitable for initial
definitive therapy,
- who have suspected recurrence based on elevated serum prostate specific
antigen (PSA) level.
Recommendation
That Glu-urea-Lys(ahx)-hbed-CC should be added to the New Zealand schedule
as a prescription medicine. |
7.4 |
Icosapent ethyl
Vazkepa, Soft Capsules, 998mg
Vazkepa is indicated to reduce the risk of cardiovascular events in adult
statin-treated patients at high cardiovascular risk with elevated triglycerides
(≥ 150 mg/dL [≥ 1.7 mmol/L]) and
- established cardiovascular disease, or
- diabetes, and at least one other cardiovascular risk factor.
Recommendation
That icosapent ethyl should be added to the New Zealand schedule as a
prescription medicine. |
7.5 |
Zanubrutinib
Brukinsa, Capsules, 80 mg
Brukinsa is indicated for the treatment of adult patients with Waldenström’s
macroglobulinaemia (WM) who have received at least one prior therapy, or in
first line treatment for patients unsuitable for chemo-immunotherapy.
Brukinsa is indicated for the treatment of adult patients with mantle cell
lymphoma (MCL) who have received at least one prior therapy.
Note: also listed on the agenda under 8.1.k.
Recommendation
That zanubrutinib should be added to the New Zealand schedule as a
prescription medicine. |
7.6 |
Faricimab
Vabysmo, solution for injection, 120 mg/mL
Vabysmo is a bispecific angiopoietin-2 (Ang-2) and vascular endothelial growth
factor (VEGF) inhibitor indicated for the treatment of:
- Neovascular (wet) age-related macular degeneration (nAMD)
- Diabetic macular oedema (DME).
Recommendation
That faricimab should be added to the New Zealand schedule as a
prescription medicine. |
7.7 |
Damoctocog alfa pegol
Jivi, powder for injection, 250IU, 500IU, 1000IU, 2000IU, 3000IU
Jivi is indicated for the treatment and prophylaxis of bleeding in previously
treated patients (PTPs) ≥ 12 years of age with haemophilia A (congenital factor
VIII deficiency).
The committee noted that similar Factor VIII products available in New
Zealand are currently unscheduled, that is are considered general sales medicines.
Recommendation
That damoctocog alfa pegol should not be added to the New Zealand schedule,
and therefore be available as a general sale medicine. |
7.8 |
Ciltacabtagene autoleucel
Carvykti, Solution for Injection
Carvykti is indicated for the treatment of adult patients with relapsed or
refractory multiple myeloma, who have received at least three prior lines of
therapy, including a proteasome inhibitor, an immunomodulatory agent and an
anti-CD38 antibody.
Recommendation
That ciltacabtagene autoleucel should be added to the New Zealand schedule
as a prescription medicine. |
8
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Harmonisation of the New Zealand
and Australian schedules
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8.1
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New chemical entities which are not
yet classified in New Zealand
21 September 2021 Scheduling Final Decisions Public Notice
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a.
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Belumosudil
Belumosudil is indicated for the treatment of adults and paediatric
patients 12 years or older with chronic graft-versus-host disease (chronic
GVHD) after failure of at least 2 prior lines of systemic therapy.
From 1 October 2021, belumosudil has been classified as a prescription
medicine in Australia.
Recommendation
That belumosudil should be added to the New Zealand
schedule as a prescription medicine.
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b.
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Estetrol Monohydrate
Estetrol is a weak estrogen steroid hormone. Estetrol used in combination
with drospirenone is indicated for use by women of reproductive potential to
prevent pregnancy.
From 1 October 2021, estetrol monohydrate has been classified as a
prescription medicine in Australia.
Discussion
The Committee noted that this oral contraceptive is not on the list of
specified oral contraceptives classified as pharmacist only medicines.
Recommendation
That estetrol monohydrate should be added to the New Zealand
schedule as a prescription medicine.
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c.
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Finerenone
Finerenone is indicated to reduce the risk of sustained estimated GFR
decline, ESRD, cardiovascular death, non-fatal myocardial infarction, and
hospitalization for heart failure in adults with chronic kidney disease (CKD)
associated with type 2 diabetes.
From 1 October 2021, finerenone has been classified as a prescription
medicine in Australia.
Recommendation
That finerenone should be added to the New Zealand schedule
as a prescription medicine.
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d.
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Fostemsavir
Fostemsavir is indicated in combination with other antiretroviral agents
for the treatment of heavily treatment-experienced adults with
multidrug-resistant human immunodeficiency virus-1 (HIV-1) infection for whom
it is otherwise not possible to construct a suppressive anti-viral regimen due
to resistance, intolerance or safety considerations.
From 1 October 2021, fostemsavir has been classified as a prescription
medicine in Australia.
Recommendation
That fostemsavir should be added to the New Zealand
schedule as a prescription medicine.
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e.
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Inclisiran
Inclisiran is indicated as an adjunct to diet and exercise to reduce
low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous
familial hypercholesterolaemia, atherosclerotic cardiovascular disease, or at
high risk of a cardiovascular event:
- in combination with a statin or statin with other lipid‐lowering
therapies in patients unable to reach LDL‐C goals with the maximum
tolerated dose of a statin or,
- alone or in combination with other lipid‐lowering therapies in
patients who are statin-intolerant.
From 1 October 2021, inclisiran has been classified as a prescription
medicine in Australia.
Recommendation
That inclisiran should be added to the New Zealand schedule
as a prescription medicine.
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f.
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Pegcetacoplan
Pegcetacoplan is indicated for the treatment of paroxysmal nocturnal
haemoglobinuria (PNH) in adults.
From 1 October 2021, pegcetacoplan has been classified as a prescription
medicine in Australia.
Recommendation
That pegcetacoplan should be added to the New Zealand schedule
as a prescription medicine.
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g.
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Pegvaliase
Pegvaliase is indicated for the treatment of patients with phenylketonuria
(PKU) aged 16 years and older who have inadequate blood phenylalanine control
despite prior management with available treatment options.
From 1 October 2021, pegvaliase has been classified as a prescription
medicine in Australia.
Recommendation
That pegvaliase should be added to the New Zealand schedule
as a prescription medicine.
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h.
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Sacituzumab govitecan
Sacituzumab govitecan is indicated for the treatment of adult patients with
unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC)
who have received at least two prior systemic therapies, including at least one
prior therapy for locally advanced or metastatic disease.
From 1 October 2021, sacituzumab govitecan has been classified as a prescription
medicine in Australia.
Recommendation
That sacituzumab govitecan should be added to the New Zealand schedule
as a prescription medicine.
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i.
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Trastuzumab deruxtecan
Trastuzumab deruxtecan is indicated for the treatment of adult patients with
unresectable or metastatic HER2 positive breast cancer who have received two or
more prior anti HER2-based regimens.
From 1 October 2021, trastuzumab deruxtecan has been classified as a prescription
medicine in Australia.
Recommendation
That trastuzumab deruxtecan should be added to the New Zealand schedule
as a prescription medicine.
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j.
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Vericiguat
Vericiguat is indicated in addition to standard of care therapy for the
treatment of symptomatic chronic heart failure in adult patients with reduced
ejection fraction less than 45% who are stabilised after a recent heart failure
decompensation event requiring admission and/or IV diuretic therapy.
From 1 October 2021, vericiguat has been classified as a prescription
medicine in Australia.
Recommendation
That vericiguat should be added to the New Zealand schedule
as a prescription medicine.
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k.
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Zanubrutinib
Zanubrutinib is a kinase inhibitor used to treat mantle cell lymphoma, a
type of B-cell non-Hodgkin lymphoma, in adults who previously received therapy.
From 1 October 2021, zanubrutinib has been classified as a prescription
medicine in Australia.
Note: also listed on the agenda under 7.5.
Recommendation
That zanubrutinib should be added to the New Zealand schedule
as a prescription medicine (as stated in the minutes under 7.5).
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8.2
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Decisions by the Secretary to the
Department of Health and Aging in Australia (or the Secretary’s
Delegate)
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8.2.1
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Decisions by the Delegate – December
2021
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8.2.1a
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Bufexamac
The Schedule 4 entry was amended to remove all classification statements.
Bufexamac is now classified as a schedule 4 substance in Australia.
The committee noted that the Medicines Adverse Reactions Committee (MARC)
recommended revocation of the consent for products currently approved in New
Zealand, at the 186th MARC meeting on 10 June 2021.
The date of implementation was 1 June 2021.
Recommendation
That the classification of bufexamac should be changed to prescription,
removing the statement except in suppositories or for dermal use in medicines
containing 5% or less.
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9
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Agenda items for the next meeting
None raised.
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10
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General business
None raised.
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11
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Date of next meeting
The committee agreed the next scheduled MCC meeting will be in October 2022.
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