1

WELCOME

2

Apologies

3

Confirmation of the minutes of the 63rd meeting held on 10 October 2019

4

Declaration of conflicts of interest

5

Matters arising

5.1

Objections to recommendations made at the 63rd meeting

No valid objections have been received

5.2

Gazette notice to implement recommendations made at the 63rd meeting

5.3

Update on outstanding agenda items from the 63rd meeting

(9) Agenda items for the next meeting

The following items will be added to the agenda of the next meeting:

1. explore opportunities to optimise access to vaccines (as discussed in agenda item 6.1)
2. alkyl nitrites (as discussed in agenda item 8.2.1.a.)
3. an information paper to update the Committee on CBD products and the medicinal cannabis scheme

These reports are currently in progress. These reports are intended as supporting information papers and are not proposals.

6

Submissions for reclassification

6.1

Human Papillomavirus (HPV) vaccine – proposed change to the prescription classification statement (Pharmaceutical Society of New Zealand, the Pharmacy Guild of New Zealand and Green Cross Health)

This is a submission (PDF, 569 KB, 35 pages) from the applicants proposing changes to the classification statement for human papillomavirus vaccine.

The current classification of human papillomavirus vaccine is: prescription.

6.2

Cetirizine - proposed change to the pack size limit
(AFT Pharmaceuticals Limited)

This is a submission (PDF, 1443 KB, 24 pages) from the applicant proposing to increase the pack size limit of cetirizine hydrochloride for general sale from five days' supply to ten tablets.

The current classification of cetirizine is:
Prescription; except for oral use
Pharmacy Only; for oral use except in divided solid dosage forms for oral use containing 10 milligrams or less of cetirizine hydrochloride per dose form for the treatment of seasonal allergic rhinitis when sold in the manufacturer's original pack containing not more than 5 days' supply
General Sale in divided solid dosage forms for oral use containing 10 milligrams or less of cetirizine hydrochloride per dose form for the treatment of seasonal allergic rhinitis when sold in the manufacturer's original pack containing not more than 5 days' supply

6.3

Pholcodine - reclassification from a pharmacy medicine to a restricted medicine
(Medsafe)

This is a submission (PDF, 1051 KB, 62 pages) from the applicant proposing to change the classification of pholcodine from a pharmacy medicine to a restricted medicine.

The current classification of pholcodine is:
Prescription; except when specified elsewhere in this schedule
Pharmacy only; in medicines for oral use containing not more than 15 milligrams of pholcodine per solid dosage unit or per dose of liquid with a maximum daily dose not exceeding 100 milligrams of pholcodine, when combined with 1 or more active ingredients in such a way that the substance cannot be recovered by readily applicable means, or in a yield that would constitute a risk to health, when sold in a pack approved by the Minister or the Director-General for distribution as a pharmacy-only medicine

7

New medicines for classification

7.1

New chemical entities

New medicine applications have been received for the following new chemical entities that require classification.

7.1a

Galcanezumab

Emgality prefilled pen, solution for injection (TT50-10685)

7.1b

Plitidepsin

7.1c

Baloxavir marboxil

7.2

New chemical entities identified by Medsafe

7.2a

Cilnidipine

8

Harmonisation of the New Zealand and Australian schedules

8.1

New chemical entities which are not yet classified in New Zealand

Final decisions for new chemical entities and medicines (25 September 2019)

8.1.1

Lorlatinib

Lorlatinib is indicated for: anaplastic lymphoma kinase positive non-small cell lung cancer, metastatic, progressed on alectinib or ceritinib as first ALK inhibitor therapy or crizotinib and a least 1 other ALK inhibitor for metastatic disease.

From 1 October 2019, lorlatinib is classified as a prescription medicine in Australia.

8.1.2

Niraparib

Niraparib is indicated for: treatment of ovarian cancer.

From 1 October 2019, niraparib is classified as a prescription medicine in Australia.

8.1.3

Darolutamide

Darolutamide is indicated for: prostate cancer, nonmetastatic, castration resistant

From 1 October 2019, darolutamide is classified as a prescription medicine in Australia.

8.1.4

Alpelisib

Alpelisib is indicated for: breast cancer, advanced or metastatic, hormone receptor-positive, HER2-negative disease, PIK3CA-mutated, in combination with fulvestrant in postmenopausal women, and men following progression on or after endocrine therapy

From 1 October 2019, alpelisib is classified as a prescription medicine in Australia.

Final decisions for new chemical entities and medicines (November 2019)

8.1.5

Talazoparib

Talazoparib is indicated for: metastatic breast cancer, or locally advanced, HER2-negative, germline BRCA-mutated disease

From 1 December 2019, talazoparib is classified as a prescription medicine in Australia.

9

Agenda items for the next meeting

10

General business

11

Date of next meeting