Proposal to list new brands of zoledronic acid and vecuronium bromide

Medicines

Consultation Closed

PHARMAC is seeking feedback on a provisional agreement with Mylan New Zealand Limited for the listing of Mylan’s brands of zoledronic acid injection 4 mg per 5 ml vial and vecuronim bromide injection 10 mg vial.

In summary, this proposal would result in:

  • Zoledronic acid injection 4 mg per 5 ml vial (Zoledronic Alphapharm) being 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 (Vecuronium Bromide Alphapharm) being 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 being delisted from Part II of Section H of the Pharmaceutical Schedule from 1 September 2016.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 5pm Tuesday, 26 July 2016 to:

Nikki Swift
Contract Manager
PHARMAC

Email: nikki.swift@pharmac.govt.nz

Fax:     04 460 4995
Post:     PO Box 10 254, Wellington 6143

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld.  PHARMAC will give due consideration to any such request.

Details of the proposal

Zoledronic acid

  • Zoledronic acid (Zoledronic Alphapharm) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 September 2016 at the following price and subsidy (ex-manufacturer and excluding GST):

Chemical

Presentation

Brand

Pack size

Proposed price and subsidy

Zoledronic acid

Inj 4 mg per 5 ml, vial

Zoledronic Alphapharm

1

$84.50

  • Zoledronic Alphapharm would have subsidy and delisting protection until 31 January 2018.
  • Zoledronic Alphapharm would 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 inj 4 mg per 5 ml vial (Zometa brand).

Vecuronium bromide

  • Vecuronium bromide injection 10 mg vial (Vecuronium Bromide Alphapharm) would be listed in Part II of Section H of the Pharmaceutical Schedule at the following price (ex-manufacturer and excluding GST):

Chemical

Presentation

Brand

Pack size

Proposed price

Vecuronium bromide

Inj 10 mg vial

Vecuronium Bromide Alphapharm

10

$184.30

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

Background

Zoledronic acid

Zoledronic acid injection 4 mg per 5 ml vial (Zometa brand) is currently listed in Section B and Part II of Section H of the Pharmaceutical Schedule subject to Special Authority and hospital restrictions for hypercalaemia of malignancy or for patients with bone metastases who have severe treatment-resistant bone pain or are at risk of skeletal-related events.

The Zometa brand is listed at a price and subsidy of $550.00 per vial and a confidential rebate applies.

This proposal is to fund a second brand of zoledronic acid injection 4 mg per 5 ml in addition to Zometa.

There would be no change in funded access criteria that currently apply to zoledronic acid injection as a result of this proposal.

Vecuronium bromide

Vecuronium bromide injection 10 mg vial and 4 mg ampoule are listed in Part II of Section H of the Pharmaceutical Schedule, with no brand specified. Vecuronium bromide is indicated as an adjunct to general anaesthesia to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery.

PHARMAC has been notified that the current supplier to DHB hospitals, Merck Sharpe and Dohme, has discontinued supply of its brand of vecuronium bromide 10 mg (Norcuron).

The proposal to list Mylan’s brand of vecuronium bromide injection 10 mg, subject to Medsafe approval, would help ensure continuity of supply of this pharmaceutical.

We have also been advised that the 4 mg ampoule presentation of vecuronium bromide is no longer used or available; therefore, it is proposed that this presentation be delisted.