1

Welcome

2

Apologies

3

Confirmation of the minutes of the 103rd meeting held on Thursday 4 August 2016

4

Declaration of conflicts of interest

5

Applications for consent to distribute a new medicine under section 20 / 23 / 24 of the Medicines Act 1981 (referred by the Minister of Health under section 22(2))

5.1

Bortezomib, 3.5 mg, powder for injection (TT50-9579) Dr Reddy's New Zealand Limited

The indications of bortezomib are:

1. in combination with melphalan and prednisone, for the treatment of patients with previously untreated multiple myeloma, who are not suitable for high dose chemotherapy
2. as part of combination therapy, for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma
3. for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.

The applicant has been afforded opportunities to address issues and concerns raised during the assessment in accordance with Medsafe's standard evaluation processes. However, the applicant has not satisfactorily addressed all the issues and concerns. Medsafe is unable to recommend that the benefits of using the medicine Bortezomib (Dr Reddy's) 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

Lidocaine, 1% & 2%, Solution for Injection (TT50-9609, a) B. Braun New Zealand Limited

Lidocaine is a solution for injection containing 1% or 2% of lidocaine hydrochloride monohydrate. Lidocaine is indicated for local, spinal, epidural and infiltration anaesthesia.

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 Lidocaine (B.Braun) 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.

6.0

Review of evaluation reports

Members of the Committee will conduct an independent review of medicine evaluations completed by Medsafe in the year ending 2015.

1. Actemra (tocilizumab) 162 mg/0.9 mL solution for injection (TT50-8074/2)

   D Wright

2. Avastin (bevacizumab) 25 mg/ml concentrate for infusion (TT50-6781/1)

   M Jeffery

3. Jardiance (empagliflozin) 10 mg and 25 mg film coated tablets (TT50-9580, a)

   D Woolner

4. Mekinist (trametinib), 0.5 mg, 1 mg and 2 mg film coated tablets (TT50-9526, a & b)

   P Tomlinson

5. Pomalyst (pomalidomide) 1 mg, 2 mg, 3 mg and 4 mg capsules (TT50-9621, a, b, c & d)

   A Rayner

6. Ribomustin (bendamustine) 25 mg and 100 mg powder for infusion (TT50-9353, a)

   R Handy

7. Spedra (avanafil) 50 mg, 100 mg, 200 mg tablets (TT50-9575, a, b)

   R Robson

8. Viekira Pak-RVB (ombitasvir, paritaprevir and ritonavir) film coated tablet combination product: Viekira Pak + Ribavirin 200 mg (TT50-9599/1, -/1a, -/1b, -/1c)

   P Glue

9. Xalkori (crizotinib) 200 mg, 250 mg capsules (TT50-9572, a)

   P Fawcett

6.1

List of medicines for potential review in 2017

The Committee will be provided with a list of all medicines for which evaluations were conducted in 2016.

The Committee will discuss which medicines should be reviewed (a maximum of eight will be chosen) and by which member of the Committee. Completed reviews will be brought back to the subsequent meetings in 2017.

6.2

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

8

Date of next meeting

The date of the next meeting will take place in June 2017.