Proposal to widen access to zoledronic acid for early breast cancer

Medicines

Consultation Closed

We propose to widen funded access to zoledronic acid (injection 4 mg per 5 ml, vial) to include adjuvant use in postmenopausal women with early breast cancer.

Consultation on this proposal closes at 5 pm on Tuesday, 14 November 2017 and feedback can be emailed to alexander.rodgers@pharmac.govt.nz.

What would the effect be?

Certain patients with early breast cancer would be eligible for a funded course of zoledronic acid. This treatment has been shown to reduce the risk of bone metastases and improve survival rates in post-menopausal early breast cancer patients.

The treatment requires an infusion once every six months for a maximum of two years.

Who we think will be interested

Oncologists, doctors in general practice, patients who have or may develop early breast cancer, pharmacists, and organisations with an interest in cancer treatment.

About zoledronic acid

Zoledronic acid is a bisphosphonate, a class of medicines which reduce bone turnover. Bisphosphonates are used to treat osteoporosis and to prevent or treat bone metastases.

Zoledronic acid is currently listed on the Pharmaceutical Schedule in two forms; this proposal relates to the 4 mg per 5 ml vial form. Two brands of this form are funded, Zoledronic acid Mylan, and Zometa.

The relevant Medsafe datasheets can be found at:

http://www.medsafe.govt.nz/profs/Datasheet/z/Zometaconcinf.pdf(external link) and http://www.medsafe.govt.nz/profs/Datasheet/z/ZoledronicAcidinf.pdf(external link)

Why we’re proposing this

PHARMAC received an application to widen access to zoledronic acid for postmenopausal women with early breast cancer from the New Zealand Breast Cancer Special Interest Group. The application has been reviewed by the Pharmacology and Therapeutics Advisory Committee (PTAC) as well as by PTAC’s Cancer Subcommittee, CaTSoP.

PTAC and CaTSoP considered there is evidence of a modest but significant effect from treatment with bisphosphonates, in terms of reduced risk of disease recurrence and improved survival, although only in post-menopausal women. While the currently published evidence is from trials using multiple regimens and various bisphosphonates, the majority of published evidence was for use of zoledronic acid.

For more information on the history of the proposal and to read the minutes of these clinical reviews, please go to: https://www.pharmac.govt.nz/ApplicationTracker?ProposalId=1328 [link no longer available]

Details about our proposal

If approved, the Special Authority for zoledronic acid (Zoledronic acid Mylan and Zometa) inj 4 mg per 5 ml, vial would be amended to include adjuvant use in postmenopausal women with early breast cancer from 1 January 2018 as follows (additions in bold):

Special Authority for Subsidy

Initial application — (bone metastases) only from an oncologist, haematologist or palliative care specialist. Approvals valid without further renewal unless notified for applications meeting the following criteria:

Any of the following:

Initial application — (early breast cancer) only from an oncologist. Approvals valid for 2 years for applications meeting the following criteria:

All of the following:

  1. Treatment to be used as adjuvant therapy for early breast cancer; and
  2. Patient has been amenorrhoeic for 12 months or greater with endocrine levels consistent with a post-menopausal state; and
  3. Treatment to be administered at a minimum interval of 6-monthly for a maximum of 2 years.

The hospital restrictions for zoledronic acid (Zoledronic acid Mylan and Zometa) inj 4 mg per 5 ml, vial would be amended in the same way.

To provide feedback

Send us an email: alexander.rodgers@pharmac.govt.nz by 5 pm Tuesday 14 November 2017.

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.