Committees

Published: 23 February 2018
Revised: 3 April 2018

Agenda for the 60th meeting of the Medicines Classification Committee to be held in Wellington on Thursday 26 April 2018 at 9:30 am

1

Welcome

2

Apologies

3

Confirmation of the minutes of the 59th meeting held on 7 November 2017

4

Declaration of conflicts of interest

5

Matters arising

5.1

Objections to recommendations made at the 59th meeting

The deadline for intentions to object to a recommendation made at the 59th meeting, together with a statement of the grounds on which the objection would be made, was 2 February 2018. 

5.1.1

Reclassification of influenza vaccine – Objection to the proposed recommendation to amend the current classification of influenza vaccine to include registered nurses

Secretary’s note
This submission on the reclassification of influenza vaccine has been withdrawn by the submitter on 23 March 2018.

A valid objection (PDF, 228 KB, 3 pages) was received regarding the Committee’s recommendation to amend the current classification for influenza vaccine to include registered nurses.

This objection has been accepted as valid on the basis that there was a breach of appropriate process. In consideration of the upcoming influenza season, an out-of-session meeting will be held by the MCC to reconsider the classification of influenza vaccine. A four week consultation period will begin from the date this agenda is published.

This is a submission (PDF, 2135 KB, 2 pages) from the Director of Public Health, Ministry of Health to propose extending the current classification to include registered nurses. Currently registered nurses can only administer the influenza vaccine if a medical practitioner has either written a prescription or has a standing order in place. Alternatively, section 44A of the Medicines Regulations 1984 enables registered nurses to administer vaccines as an authorised vaccinator without the need for a prescription if this is given as part of an approved immunisation programme by a medical officer of health, for example influenza vaccination in workplace settings.

The aim of extending the current classification to include registered nurses is to increase access and convenience of obtaining an influenza vaccination, in order to increase uptake by the general population and reduce the burden of influenza. This extension would remove the need to use of section 44A of the Medicines Regulations 1984, and will enable registered nurses with the appropriate vaccinator training to provide influenza vaccine in an agile and responsive manner. This rationale aligns with the Pharmacists Vaccinator reclassification and also reduces the administrative burden associated with section 44A on health professionals.

5.2

Report on standing agenda items from the 59th meeting

5.3

Trimethoprim – usage and resistance following reclassification

This is a Medsafe investigative paper (PDF, 129 KB, 5 pages).

At the 47th meeting the MCC recommended that trimethoprim should be reclassified from prescription medicine to prescription medicine except when supplied in packs of three tablets to women aged 16 to 65 years for uncomplicated urinary tract infection by a pharmacist who has successfully completed the New Zealand College of Pharmacists' training in the treatment of urinary tract infections.

The MCC Chair has requested that Medsafe investigate the use of and resistance to trimethoprim following the reclassification in 2012.

5.4

Manufacturers original pack – information paper

This is a Medsafe information paper (PDF, 397 KB, 9 pages) summarising all medicines in Schedule 1 to the Medicine Regulations 1984 that reference the manufacturer’s original pack and the Committee deliberations behind each reference. This information paper presents the list of medicines in Appendix 1 (PDF, 387 KB, 62 pages).

5.5

Phenibut – proposed classification as a prescription medicine

This is a Medsafe submission (PDF, 303 KB, 14 pages) proposing the classification of phenibut as a prescription medicine.

5.6

Rilmazafone - proposed classification as a prescription medicine

This is a Medsafe submission (PDF, 125 KB, 8 pages) proposing the classification of reilmazafone as a prescription medicine.

6

Submissions for reclassification

6.1

Clotrimazole and hydrocortisone - proposed reclassification from restricted medicine to pharmacy-only medicine
(Canesten Plus, Bayer New Zealand Limited)

This is a company submission (PDF, 449 KB, 34 pages) proposing the reclassification of Canesten Plus topical cream from restricted medicine to pharmacy-only medicine.

6.2

Loratadine – proposed reclassification from pharmacy-only medicine to general sale medicine
(Claratyne, Bayer New Zealand Limited)

This is a company submission (PDF, 720 KB, 38 pages) proposing an amendment to the Label Statements Database to change the general sales restriction on age from 12 years and older to six years and older.

6.3

Influenza vaccine – proposed amendment to prescription except when classification
(Pharmaceutical Society of New Zealand)

This is a submission (PDF, 96 KB, 9 pages) proposing an amendment to the ‘prescription except when’ classification of influenza vaccine to include registered intern pharmacists who have successfully completed a vaccinator training course approved by the Ministry of Health and who are complying with the immunization standards of the Ministry of Health.

6.4

Melatonin – proposed reclassification from prescription medicine
(Individual submission)

This is a submission (PDF, 911 KB, 17 pages) proposing the reclassification of melatonin to permit sale as a dietary supplement.

6.5

Modified-release paracetamol – proposed reclassification from pharmacy-only medicine to restricted medicine
(Medsafe)

This is a Medsafe submission (PDF, 916 KB, 9 pages) proposing the reclassification of modified-release paracetamol from pharmacy-only medicine to restricted medicine.

6.6

Sedating antihistamines – proposed amendment to restricted medicine classification
(Medsafe)

This is a Medsafe submission (PDF, 155 KB, 14 pages) proposing that ‘for the treatment of anxiety’ should be removed from the restricted medicine classification statements of sedating antihistamines.

7

New medicines for classification

7.1

Spinraza – nusinersen solution for injection 12 mg/5 mL (TT50-10323)

7.2

Etomidate – proposed classification as prescription medicine (section 29)

8

Harmonisation of the New Zealand and Australian schedules

8.1

New chemical entities which are not yet classified in New Zealand

8.1.1

Guselkumab (October 2017)


Guselkumab is indicated for the treatment of moderate to severe plaque psoriasis, scalp, nail, and hand and foot psoriasis and improvement of health related quality of life in adult patients who are candidates for systemic therapy or phototherapy.
From 1 October 2017, guselkumab is classified as a prescription medicine in Australia.

8.1.2

Apalutamide (January 2018)


Apalutamide is intended to be indicated for the treatment of patients with castration-resistant prostate cancer at risk of developing metastases.
From 1 February 2018, apalutamide is classified as a prescription medicine in Australia.

8.1.3

Bictegravir (January 2018)


Bictegravir is indicated for the treatment of HIV-1 infection in adults without any known mutations associated with resistance to the individual components of the fixed dose combination and for the treatment of chronic hepatitis B in adults coinfected with HIV-1.
From 1 February 2018, bictegravir is classified as a prescription medicine in Australia.

8.1.4

Binimetinib (January 2018)


Binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma, with NRAS Q61 mutation.
From 1 February 2018, binimetinib is classified as a prescription medicine in Australia.

8.1.5

Cabozantinib (January 2018)


Cabozantinib is indicated for the treatment of advanced renal cell carcinoma in adults following prior therapy.
From 1 February 2018, cabozantinib is classified as a prescription medicine in Australia.

8.1.6

Cinnarizine (January 2018)


Cinnarizine is used in a fixed dose combination product with dimenhydrinate and is intended for the short term treatment of vertigo in adults.
From 1 February 2018, cinnarizine is classified as a prescription medicine in Australia.

8.1.7

Encorafenib (January 2018)


Encorafenib is indicated for use in combination with binimetinib for the treatment of adult patients with unresectable or metastatic melanoma, with BRAF V600 mutation.
From 1 February 2018, encorafenib is classified as a prescription medicine in Australia.

8.1.8

Erenumab (January 2018)


Erenumab is indicated for the prophylaxis of migraine in adults.
From 1 February 2018, erenumab is classified as a prescription medicine in Australia.

8.1.9

Ertugliflozin (January 2018)


Ertugliflozin is indicated for the treatment of type 2 diabetes.
From 1 February 2018, ertugliflozin is classified as a prescription medicine in Australia.

8.1.10

Ferric derisomaltose (January 2018)


Ferric derisomaltose is indicated for the treatment of iron deficiency in adults, under the following conditions:
  • when oral preparations are ineffective or cannot be used; and
  • when there is a clinical need to deliver iron rapidly.
From 1 February 2018, ferric derisomaltose is classified as a prescription medicine in Australia.

8.1.11

Insulin deglude (January 2018)


Insulin degludec is indicated to improve glycaemic control in adult patients with diabetes mellitus.
From 1 February 2018, insulin deglude is classified as a prescription medicine in Australia.

8.1.12

Letermovir (January 2018)


Letermovir has been requested for the indication of prophylaxis of cytomegalovirus (CMV) infection or disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant.
From 1 February 2018, letermovir is classified as a prescription medicine in Australia

8.1.13

Patiromer sorbitex calcium (January 2018)


Patiromer sorbitex calcium is indicated for the treatment of hyperkalaemia in adults.
From 1 February 2018, patiromer sorbitex calcium is classified as a prescription medicine in Australia.

8.1.14

Peramivir (January 2018)


Peramivir is indicated for the treatment of infections due to influenza A and B viruses in adults and children 2 years and older. Treatment should commence as soon as possible, but no later than 2 days after the onset of the initial symptoms of infection.
From 1 February 2018, peramivir is classified as a prescription medicine in Australia.

8.1.15

Recombinant varicella zoster virus glycoprotein E antigen (January 2018)


Recombinant varicella zoster virus glycoprotein E antigen is a varicella zoster virus antigen based on recombinant technology. Recombinant varicella zoster virus glycoprotein E antigen is indicated for the prevention of herpes zoster and herpes zoster-related complications, such as post-herpetic neuralgia, in adults 50 years of age or older.  
From 1 February 2018, recombinant varicella zoster virus glycoprotein E antigen is classified as a prescription medicine in Australia.

8.1.16

Reslizumab (January 2018)


Reslizumab is indicated as an add-on treatment in adult patients with severe eosinophilic asthma.
From 1 February 2018, reslizumab is classified as a prescription medicine in Australia.

8.1.17

Ribociclib (January 2018)


Ribociclib is indicated for advanced breast cancer.
From 1 February 2018, ribociclib is classified as a prescription medicine in Australia.

8.1.18

Tafenoquine succinate (January 2018)


Tafenoquine succinate is indicated for radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older.
From 1 February 2018, tafenoquine succinate is classified as a prescription medicine in Australia.

8.1.19

Telotristat ethyl (January 2018)


Through inhibition of peripheral TPH1, telotristat reduces the production of serotonin, thus alleviating symptoms associated with carcinoid syndrome.
From 1 February 2018, telotristat ethyl is classified as a prescription medicine in Australia.

8.1.20

Tipiracil (January 2018)


Tipiracil (as tipiracil hydrochloride), in combination with trifluridine, is indicated for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vascular endothelial growth factor agents, and anti-epidermal growth factor receptor agents.
From 1 February 2018, tipiracil is classified as a prescription medicine in Australia.

8.1.21

Trifluridine (January 2018)


Trifluridine, in combination with tipiracil hydrochloride, is indicated for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vascular endothelial growth factor agents, and anti-epidermal growth factor receptor agents.
From 1 February 2018, trifluridine is classified as a prescription medicine in Australia.

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 – October 2017

8.2.1a

Esomeprazole


Esomeprazole in oral preparations containing 20 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply should be reclassified from Schedule 3 (Restricted medicine) to Schedule 2 (Pharmacy-only medicine).

9

Agenda items for the next meeting

10

General business

10.1

The function of the MCC under the future therapeutic products regime

The Committee will discuss the future of the MCC and how it will function under the new therapeutic products regulatory regime. The following points were raised at the 59th meeting:

  • continuing with the transparency of the Committee
  • increasing engagement with the health sector
  • concerns that the number of submissions will reduce due to the commercial sensitivity of publishing training tools and references.

11

Date of next meeting