1

Welcome and Introductions

2

Apologies

3

Confirmation of the minutes of the 101st meeting held on Tuesday 10 march 2015

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

Ketum Gel 2.5%w/w topical gel (TT50-9546) Te Arai BioFarma Limited

Ketum Gel is a topical gel containing 2.5%w/w ketoprofen. Ketum Gel is indicated for the temporary relief of local pain and inflammation in muscles and joints, acute lower back pain, soft tissue injuries including:

• sprains
• strains
• contusions
• bursitis
• tendonitis
• sport injuries
• rheumatic pain.

The application has undergone two rounds of ‘Requests for Information’ in accordance with Medsafe’s standard evaluation processes and issues remain unresolved. Medsafe is unable to recommend that the benefits of using the medicine Ketum Gel outweigh the risks presented by the unresolved issues.

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

The application has now been withdrawn.

5.2

Liposomal Doxorubicin SUN 2 mg/mL concentrate for infusion Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

Liposomal Doxorubicin SUN is a concentrate for infusion containing 2 mg/mL doxorubicin hydrochloride. Liposomal Doxorubicin SUN is indicated for:

• 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 has undergone two rounds of ‘Requests for Information’ in accordance with Medsafe’s standard evaluation processes and issues remain unresolved. Medsafe is unable to recommend that the benefits of using the medicine Liposomal Doxorubicin SUN outweigh the risks presented by the unresolved issues.

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

Adenosine (adenosine) 3 mg/mL and 30 mg/10 mL solution for infusion (TT50-9063, -/1)
Max Health Limited

Associate Professor Fawcett

6.2

Clonidine Transdermal System (clonidine) 0.1 mg/24 h, 0.2 mg/24 h and 0.3 mg/24 h USP transdermal patches (TT50-8963, a, b)
Mylan New Zealand Ltd

Associate Professor Robson

6.3

Invokana (canagliflozin hemihydrate) 100 mg and 300 mg film coated tablets (TT50-9218, a)
Janssen-Cilag (New Zealand ) Ltd

Dr Woolner

6.4

Jakavi (ruxolitinib phosphate) 5 mg, 15 mg and 20 mg tablets (TT50-9462, a, b)
Novartis New Zealand Ltd

Dr Rayner

6.5

OxyContin (oxycodone hydrochloride) 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg modified release tablets (TT50-6493/1, -/1a, -/1b, -/1c, -/1d, -/1e, -/1f)
Mundipharma New Zealand Ltd

Associate Professor Frampton and Professor Glue

6.6

Sovaldi (sofosbuvir) 400 mg film coated tablet (TT50-9356)
Gilead Sciences (NZ)

Dr Handy

6.7

Tafinlar (dabrafenib) 50 mg and 75 mg capsules (TT50-9398, a)
Novartis New Zealand Ltd

Dr Jeffery

6.8

Vitekta (elvitegravir) 85 mg and 150 mg film coated tablets (TT50-9425, a)
Gilead Sciences (NZ)

Dr Tomlinson

7

general business

7.1

Review of piloting observers for applications referred to the Committee

Medsafe will provide a summary of the feedback received from those that have been involved in piloting observers for applications referred to the Committee.

8

Date of next meeting