Published: 15 February 2022
Committees
Agenda for the 68th meeting of the Medicines Classification Committee to be held in Wellington on 26 April 2022 at 9:30 am
1 |
Welcome |
2 |
Apologies |
3 |
Confirmation of the minutes of the 67th meeting held on 26 October 2021 |
4 |
Declaration of conflicts of interest |
5 |
Matters arising |
5.1 |
Objections to recommendations made at the 67th meetingNo valid objections were received. |
5.2 |
Update on outstanding agenda items from the 67th meeting |
5.3 |
(9.a) NicotineAt the 67th meeting, held on 26 October 2021, The Committee noted a classification change to the Australian schedule for liquid nicotine and 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. |
6 |
Submissions for reclassification |
6.1 |
Nitrofurantoin (modified release)
– proposed change to prescription classification statement
|
6.2 |
Naloxone – proposed down-scheduling
change to classification
|
7 |
New medicines for classification |
7.1 |
LevomefolateElevit, 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. It does not require enzymatic conversion and can be utilised directly by the body. |
7.2 |
AmivantamabRYBREVANT, 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. |
7.3 |
Glu-urea-Lys(ahx)-hbed-CCIlluccix, 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:
|
7.4 |
Icosapent ethylVazkepa, 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
|
7.5 |
ZanubrutinibBrukinsa, 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. |
7.6 |
FaricimabVabysmo, 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:
|
7.7 |
Damoctocog alfa pegolJivi, 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). |
7.8 |
Ciltacabtagene autoleucelCarvykti, 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. |
8 |
Harmonisation of the New Zealand and Australian schedules |
8.1 |
New chemical entities which are not yet classified in New Zealand |
|
21 September 2021 Scheduling Final Decisions Public Notice |
a. |
BelumosudilBelumosudil 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 is classified as a prescription medicine in Australia. |
b. |
Estetrol MonohydrateEstetrol 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 is classified as a prescription medicine in Australia. |
c. |
FinerenoneFinerenone 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 is classified as a prescription medicine in Australia. |
d. |
FostemsavirFostemsavir 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 is classified as a prescription medicine in Australia. |
e. |
InclisiranInclisiran 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:
From 1 October 2021, inclisiran is classified as a prescription medicine in Australia. |
f. |
PegcetacoplanPegcetacoplan is indicated for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) in adults. From 1 October 2021, pegcetacoplan is classified as a prescription medicine in Australia. |
g. |
PegvaliasePegvaliase 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 is classified as a prescription medicine in Australia. |
h. |
Sacituzumab govitecanSacituzumab 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 is classified as a prescription medicine in Australia. |
i. |
Trastuzumab deruxtecanTrastuzumab 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 is classified as a prescription medicine in Australia. |
j. |
VericiguatVericiguat 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 is classified as a prescription medicine in Australia. |
k. |
ZanubrutinibFrom 1 October 2021, zanubrutinib is classified as prescription medicines in Australia. Note: also listed on the agenda under 7.5. |
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 |
BufexamacThe Schedule 4 entry was amended to remove all classification statements. Bufexamac is now classified as a schedule 4 substance in Australia. The date of implementation was 1 February 2022. |
9 |
Agenda items for the next meeting |
10 |
General business |
11 |
Date of next meeting |