Published: 22 August 2022
Committees
Agenda for the 69th meeting of the Medicines Classification Committee to be held by Videoconference on TBC at 9:30 am
1. Welcome
2. Apologies
3. Confirmation of the minutes of the 68th meeting held on 26 April 2022
4. Declaration of conflicts of interest
The chair has declared a potential perceived conflict of interest relating to item 6.1e. This is detailed in a paper prepared for the Committee’s review.
5. Matters arising
5.1 Objections to recommendations made at the 68th meeting.
No valid objections were received.
5.2 Bilastine – proposed change to classification statements (Medsafe)
Medsafe received a New Medicine Application for a bilastine 10 mg tablet, with 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 is 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.
5.3 Fenbendazole – proposed classification to prescription medicine (Medsafe)
Fenbendazole is a broad-spectrum benzimdazole antiparasitic drug 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 agents (e.g. ivermectin, doxycycline and azithromycin) as a treatment for COVID-19, raising concerns that there will be attempted self-administration of fenbendazole for this indication.
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.
6. Submissions for reclassification
6.1a Methenamine hippurate – proposed up-scheduling change to classification (Medsafe)
Methenamine hippurate is a urinary antibacterial agent indicated for suppression or elimination of urinary tract bacteria. Methenamine hippurate is a prodrug that converts to formaldehyde in an acidic environment.
Methenamine hippurate is unscheduled in New Zealand, therefore available as a general sale 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. At this meeting, the MCC considered a report from Medsafe on action taken an investigation into a complaint regarding the promotion of a medicine containing methenamine as the active ingredient. The committee concluded that there was insufficient evidence of a safety issue to warrant classifying methenamine hippurate. However, it was 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 (PDF 405B, 6 pages), from Medsafe for the MCC to consider the classification of methenamine hippurate to a more restrictive classification.
6.1b Glecaprevir and Pibrentasvir – proposed change to prescription classification statement (Health New Zealand, Long Term Conditions)
This is a submission (PDF 445KB, 18 pages) from Health New Zealand, which seeks to widen access to glecaprevir and pibrentasvir (Maviret), a treatment for chronic hepatitis C infection, by allowing nurses with appropriate knowledge and experience to administer Maviret without a prescription.
6.1c Topical and injected local anaesthetics - proposed change to prescription classification statement (Dental Council)
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 (PDF 345KB, 31 pages) 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.
6.1d Adrenaline - proposed change to prescription classification statement (Dental Council)
This is a submission (PDF 221KB, 16 pages) 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 them in emergency situations in their practice without a prescription.
6.1e National Immunisation Schedule - proposed change to prescription vaccine classification statements (Ministry of Health)
This is a submission (PDF 256KB, 27 pages) 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.
The vaccines proposed for reclassification are:
Cholera vaccine
COVID-19 vaccine
Diphtheria, tetanus and pertussis (acellular, component) vaccine (Tdap)
Diphtheria toxoid
Diphtheria vaccine
Haemophilus influenzae vaccine
Hepatitis A vaccine
Hepatitis B vaccine
Human papillomavirus vaccine (HPV)
Influenza vaccine
Japanese encephalitis vaccine
Measles vaccine
Meningococcal vaccine
Mumps vaccine
Pertussis (whooping cough) vaccine
Pneumococcal vaccine
Poliomyelitis vaccine (polio)
Rabies vaccine
Recombinant varicella zoster virus glycoprotein E antigen
Rotavirus vaccine
Rubella vaccine
Staphylococcus aureus vaccine
Streptococcus beta-haemolyticus vaccine
Tetanus toxoid
Tetanus vaccine
Triple antigen vaccine
Tuberculosis vaccine
Typhoid vaccine
Vaccinia virus vaccine
Varicella vaccine
Yellow fever vaccine
7. New medicines for classification
The following new chemical entities were submitted to the Committee for classification.
7.1 New chemical entities
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.
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.
8. Harmonisation of the New Zealand and Australian schedules
8.1 New chemical entities which are not yet classified in New Zealand
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
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.
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.
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.
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.
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.
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 tumors, not requiring immediate surgery.
From 1 June 2022, belzutifan is classified as a prescription only medicine in Australia.
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.
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.
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.
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.
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.
8.2 Decisions by the Secretary to the Department of Health and Aging in Australia (or the Secretary’s Delegate)
Decisions by the Delegate- Date 2022
8.2a Low dose cannabidiol
Low dose cannabidiol (CBD) has been down-scheduled from schedule 4 (Prescription Only) to schedule 3 (Pharmacist Only) under certain conditions by the TGA in Australia. Low dose cannabidiol refers to daily dose of <150 mg.
Medsafe and the Medicinal Cannabis Agency have provided some regulatory advice (PDF document 305KB, 21 pages).
9. Agenda items for the next meeting
10. General business
11. Date of the next meeting
