1

Welcome

2

Apologies

3

Confirmation of the minutes of the 105th meeting held on 27 June 2017

4

Declaration of conflicts of interest

5

Applications for consent to distribute a new medicine under section 20 of the Medicines Act 1981 (referred by the Minister of Health under section 22(2))

5.1

Liposomal Doxorubicin SUN, 2 mg/mL concentrate for infusion (TT50-9159) Pharmacy Retailing (NZ) Ltd

Liposomal Doxorubicin SUN contains 2 mg/mL of the active ingredient liposomal doxorubicin hydrochloride, and is presented as 10 mL and 25 mL suspensions for further dilution and intravenous infusion. The proposed indications are as follows:

•  metastatic breast cancer in women for whom an anthracycline would be considered or who have failed a taxane-containing regimen
•  advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen
• in combination with bortezomib, for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant
•  AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (<200 lymphocytes/mm3) and extensive mucocutaneous or visceral disease; as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents:
  •  a vinca alkaloid
  •  bleomycin
  •  doxorubicin (or other anthracycline).

The application underwent two rounds of ‘Requests for Information’ in accordance with Medsafe’s standard evaluation processes and was referred to the MAAC for consideration at the 102nd meeting on 29 September 2015.

At the 102nd meeting, the MAAC recommended that the Minister of Health should defer making a decision to grant consent to the distribution of the medicine Liposomal Doxorubicin SUN 2 mg/mL concentrate for infusion under section 20 of the Medicines Act 1981 as further studies were being carried out and Medsafe should evaluate these when the data became available.

Medsafe has completed the evaluation of the company responses to the request for further information made by the MAAC, and is presenting its findings to the Committee for their advice as to whether the Minister of Health should grant consent.

5.2

Nasovac-S Influenza Vaccine (TT50-9244) Te Arai Bioframa Limited

Nasovac-S is a trivalent, live attenuated influenza vaccine. The proposed indication is for active immunisation for the prevention of influenza disease in individuals above two years of age.

The application has undergone two rounds of ‘Requests for Information’ in accordance with Medsafe’s standard evaluation processes and issues remain unresolved.

The application is being referred to the Committee for independent advice as to whether the Minister of Health should grant consent.

6

Review of evaluation reports

6.1

List of medicines for potential review in 2018

The Committee will be provided with a list of all medicines for which evaluations were conducted in 2017.

The Committee will discuss which medicines should be reviewed (a maximum of eight will be chosen) and by which members of the Committee. Completed reviews will be brought back to the subsequent meetings in 2018.

6.2

Gardasil 9 (human papillomavirus) 0.5 mL suspension for injection (TT50-7571/1)
Merck, Sharpe & Dohme (New Zealand) Limited

6.3

Heberprot-P (recombinant human epidermal growth factor) 75 mcg powder for injection (TT50-9730)
Te Arai Biofarma Limited

6.4

Sirturo (bedaquiline fumarate) 100 mg tablet (TT50-9759)
Janssen-Cilag (New Zealand) Limited

6.5

Feedback from Medsafe on any process changes made following the expert advice provided by the Committee on the quality of the risk-benefit assessments that have been completed

7

General business

7.1

Observers

The public consultation regarding observers at Ministerial advisory committees closed 15 January 2018. The Committee will be provided an update on the progress of the consultation outcome.

7.2

Publication of MAAC Outcomes

At the 99th meeting on 1 July 2014, the Committee recommended that meeting dates, agendas and a summary of recommendations with reasons for that recommendation should be published on the Medsafe website. The Committee will review the format of the agenda and minute publication.

7.3

Any other business

8

Date of next meeting

The date of the next meeting will take place in June 2018