Decision to list new brands of zoledronic acid Mylan and Vecure in the community and in DHB hospitals

Medicines

Decision

PHARMAC is pleased to announce that the approval of an agreement with Mylan New Zealand Limited (Mylan) for zoledronic acid injection 4 mg per ml and vecuronium bromide 10 mg vial.

This was the subject of a consultation letter dated 12 July 2016. The decision is as consulted on. In summary, the effect of the decision is that:

  • Zoledronic acid injection 4 mg per 5 ml vial (Zoledronic acid Mylan) will be funded from 1 September 2016 subject to the same Special Authority criteria and DHB hospital restrictions as the Zometa brand for patients with hypercalcaemia of malignancy or bone metastases.
  • Vecuronium bromide injection 10 mg vial (Vecure) will be listed in Part II of Section H of the Pharmaceutical Schedule for use as an adjunct to general anaesthesia, as soon as possible following Medsafe approval.
  • Vecuronium bromide injection 4 mg ampoule will be delisted from Part II of Section H of the Pharmaceutical Schedule from 1 September 2016.

Details of the decision

Zoledronic acid

  • Mylan’s brand of Zoledronic acid injection 4 mg per 5 ml vial (Zoledronic acid Mylan) will be listed in Section B (the Community) and Part II of Section H (the Hospital Medicines List) of the Pharmaceutical Schedule from 1 September 2016 as follows:

Chemical

Presentation

Brand

Pack size

Price and subsidy

Zoledronic acid

Inj 4 mg per 5 ml, vial

Zoledronic acid Mylan

1

$84.50

  • Zoledronic acid Mylan will have subsidy and delisting protection until 31 January 2018.
  • Zoledronic acid Mylan will be listed on the Pharmaceutical Schedule subject to the same Special Authority criteria and hospital restrictions that apply to the current listing of zoledronic acid injection 4 mg per 5 ml vial (Zometa brand).

 Vecuronium bromide 

  • Following Medsafe approval, Mylan’s brand of vecuronium bromide injection 10 mg vial (Vecure) will be listed in Part II of Section H (the Hospital Medicines List) of the Pharmaceutical Schedule as follows:

Chemical

Presentation

Product

Pack size

Price

Vecuronium bromide

Inj 10 mg vial

Vecure

10

$184.30

  •  Vecure will be listed as soon as practicable following Mylan’s notification to PHARMAC that Medsafe has granted registration.
  • Vecure will have delisting protection until 31 January 2018. 
  • Vecuronium bromide inj 4 mg ampoule will be delisted from Part II of Section H of the Pharmaceutical Schedule from 1 September 2016.

Note that Mylan has advised that it is willing to supply its brand of vecuronium bromide to DHB hospitals prior to registration, under section 29 of the Medicines Act 1981. However, the brand will not be listed on the Hospital Medicines List prior to registration.

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses were considered in their entirety in making a decision on the proposed changes. Most responses were supportive of the proposal. One responder had a question about access to the other funded presentation of zoledronic acid (0.05 mg per ml, 100 ml) which we have responded to separately.

More information

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.