1

Welcome

2

Apologies

3

Confirmation of the minutes of the 104th meeting held on Thursday 23 February 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

Azmasol HFA (salbutamol sulfate) aerosol inhaler, 100 mcg metered dose (TT50-9392)
Beximco Pharmaceuticals New Zealand Limited

Azmasol is an aerosol inhaler containing a metered dose of 100 mcg salbutamol sulfate. The proposed indication is for the short-acting bronchodilation in reversible airway obstruction due to asthma, chronic bronchitis and emphysema in both adults and children.

The application has undergone three rounds of ‘Requests for Information’ and issues remain unresolved. Medsafe is unable to recommend that the benefits of using the medicine Azmasol 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.

5.2

Diclofenac Mylan (sodium diclofenac) 20 mg and 50 mg enteric coated tablets (TT50-9469, a)
Mylan New Zealand Limited

Diclofenac Mylan enteric coated tablets contain 20 mg and 50 mg sodium diclofenac. The proposed indications are for the treatment of:

• inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis, painful syndromes of the vertebral column, non-articular rheumatism
• acute attacks of gout
• post-traumatic and post-operative pain, inflammation and swelling (eg, following dental or orthopaedic surgery)
• painful and / or inflammatory conditions in gynaecology (eg, primary dysmenorrhoea or adnexitis)
• as an adjuvant in severe painful inflammatory infections of the ear, nose or throat (eg, pharyngotonsillitis, otitis).

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 Diclofenac Mylan 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.

This application was withdrawn on 25 May 2017.

6

Review of evaluation reports

6.1

Bemfola (follitropin alfa) 600 IU/mL 75 IU/0.125 mL, 600 IU/mL 150 IU/0.25 mL, 600 IU/mL 225 IU/0.375 mL, 600 IU/mL 300 IU/0.5 mL, 600 IU/mL 450 IU/0.75 mL solution for injection (TT50-9937, a, b, c, d)
Pharmbio Pty Limited

6.2

Entresto (sacubitril / valsartan) 24.3 mg/25.7 mg, 48.6 mg/51.4 mg, 97.2 mg, 102.8 mg film coated tablet (TT50-9938, a, b)
Novartis New Zealand Limited

6.3

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

6.4

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

6.5

Lynparza (olaparib) 50 mg capsule (TT50-9989)
AstraZeneca Limited

6.6

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

6.7

Tamiflu (oseltamivir phosphate) 30 mg, 45 mg, 75 mg capsule, and 6 mg/mL powder for oral suspension (TT50-6401, a, b, -/2a)
Roche Products (New Zealand) Limited

6.8

Uptravi (selexipag) 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1000 mcg, 1200 mcg, 1400 mcg, 1600 mcg film coated tablet (TT50-9698, a-g)
Pharmacy Retailing (New Zealand) Limited

7

General business

7.1

Observers

At the 96th meeting on 26 March 2013, the Committee recommended that a pilot for observers attending committee meetings should go ahead. A draft proposal was finalised out of session and agreement was sought from the Minister’s delegate.

At the 102nd meeting on 29 September 2015, following a survey on applicants’ views of the observer process, the Committee agreed to continue piloting observers for applications referred to the Committee and to review the outcome in 12 months or after four more referrals (whichever is the longer period).

Medsafe provides secretarial support for three additional advisory committees established under Section 8 of the Medicines Act 1981. One other committee, the Medicines Classification Committee, also has observers attend its meetings.

A consultation document has been drafted by Medsafe regarding observers at Ministerial advisory committees. The Committee will consider the draft document before it is published on the Medsafe website for public consultation.

7.2

Any Other Business

8

Date of next meeting