Decision to widen access to zoledronic acid for early breast cancer

Medicines Decision

We’re pleased to announce our decision to widen funded access to zoledronic acid (injection 4 mg per 5 ml, vial) for the adjuvant treatment of early breast cancer in postmenopausal patients from 1 January 2018.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 31 October 2017.

The funding criteria differ from those consulted on in two ways:

  • applications can also be made by a medical practitioner on the recommendation of an oncologist, and
  • clarification to make it explicit that patients with induced amenorrhoea due to ovarian-suppression treatment or oophorectomy can access funding.

Who we think will be most interested

Groups such as oncologists, doctors in general practice, patients who have or may develop early breast cancer, pharmacists, and organisations with an interest in cancer treatments may be interested in this decision.

Details about this decision

The following changes will occur in Section B and Part II of Section H of the Pharmaceutical Schedule.

Section B changes

From 1 January 2018, the Special Authority for zoledronic acid (Zoledronic acid Mylan and Zometa) inj 4 mg per 5 ml, vial will be amended in Section B of the Pharmaceutical Schedule as follows (additions in bold):

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:

1. Patient has hypercalcaemia of malignancy; or

2. Both:

2.1   Patient has bone metastases or involvement; and
2.2   Patient has severe bone pain resistant to standard first-line treatments; or

3. Both:

3.1   Patient has bone metastases or involvement; and
3.2   Patient is at risk of skeletal-related events pathological fracture, spinal cord compression, radiation to bone or surgery to bone).

Initial application — (early breast cancer) only from an oncologist or medical practitioner on the recommendation of 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, either naturally or induced, with endocrine levels consistent with a postmenopausal state; and
  3. Treatment to be administered at a minimum interval of 6-monthly for a maximum of 2 years.

Section H (Hospital Medicines List) changes

From 1 January 2018, the restrictions for zoledronic acid (Zoledronic acid Mylan and Zometa) inj 4 mg per 5 ml, vial in Part II of Section H of the Pharmaceutical Schedule will be widened as follows (additions in bold): 

Restricted

Initiation – bone metastases

Oncologist, haematologist or palliative care specialist

Any of the following:

1. Patient has hypercalcaemia of malignancy; or

2. Both:

2.1   Patient has bone metastases or involvement; and
2.2   Patient has severe bone pain resistant to standard first-line treatments; or

3. Both:

3.1   Patient has bone metastases or involvement; and
3.2   Patient is at risk of skeletal-related events (pathological fracture, spinal cord compression, radiation to bone or surgery to bone).

Initiation – early breast cancer

Oncologist

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, either naturally or induced, with endocrine levels consistent with a postmenopausal state; and

3. Treatment to be administered at a minimum interval of 6-monthly for a maximum of 2 years.

Our response to what you told us

We’re really grateful for the time people spent responding to our consultation. The table below summarises the main themes raised in feedback, any changes we have made after listening to you, and other responses to the feedback received.

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.
 

Feedback theme

PHARMAC response

Special Authority application from other clinician groups should be allowed.

The proposed funding criteria were amended following consideration of this feedback to include practitioners who are applying on the recommendation of an oncologist. 

Zoledronic acid should be available for administration in GP clinics.

Administration costs in primary care should be funded by the government.

The listings in Schedule B and H will allow for funded drug product no matter where the service is delivered.

Funding for service delivery is determined by DHBs and we are aware that an increasing number of DHBs have systems in place to enable general practices to provide funded infusions for patients. Those DHBs that are not able to offer funded community based infusions are not required to be ready on 1 January 2018. They can continue to provide patients with zoledronic acid in a hospital outpatient setting, or as alternatively arranged, as they are currently doing.

Access should be widened to include patients whose postmenopausal state has been induced by ovarian function suppressing treatments such as gonadotrophin releasing hormone agonists or oophorectomy.

The funding criteria have been amended following consideration of this feedback to make explicit that they are intended to include these patients.

Adjuvant zoledronic acid treatment should be for up to 5 years as the majority of evidence is from studies where administration was 3-5 years.

The 2 year duration of treatment is in line with advice received from our clinical advisors which takes into account all currently available published evidence. We note that this was recommendation was primarily based on the Coleman et al 2015 meta-analysis, which reported no better rates of annual events for patients taking more than two years treatment compared with those taking only two years.

Our clinical advisors considered that the greatest benefit from bisphosphonate treatment was derived from the initial doses and that the incremental benefit of subsequent doses was uncertain.

We would welcome a funding application should new published evidence become available which supports extending the treatment duration of zoledronic acid treatment in this population.

Requirement for a dental assessment prior to initiation treatment with bisphosphonates and the impact on public dental services or personal patient costs.

Dental assessments would be a barrier to accessing zoledronic acid.

The costs of dental treatment should be funded.

We considered the impact (costs and savings to the health sector and to patients) of dental assessments when assessing the proposal. Despite these, we consider the widening of funding to be a good investment in health outcomes.

Funding for services such as dental assessments is provided by DHB hospitals. PHARMAC is not able to fund dental assessments.

This proposal would have a significant impact on infusion services.

We note the impact of extra infusions on the health system. Despite these costs and resourcing impacts, we consider the widening of funding to be a good investment in health outcomes.

There would be significant health service costs for patients who develop osteonecrosis.

We acknowledge the costs and health impacts of osteonecrosis.

Early specialist involvement should be a part of development for all new funding applications of significance to the sector rather than restricted to subcommittees and brief sector consultation.

We are keen to hear from interested stakeholders as their inputs are important contributions to our decision-making.

PHARMAC publishes the receipt of all funding applications on its website including the minutes of our clinical advisor’s assessments.  Our application tracker(external link) is searchable by therapeutic group, chemical name, brand name, applicant and condition. We regularly meet with people working in the health sector (including with specialists) and talk about the funding proposals we have received.

We note that the wider clinical community and consumer groups can submit funding applications and/or provide information (face to face or in writing) regarding funding proposals that PHARMAC has under assessment at any time. 

We are grateful for the specific suggestions from the respondent on how we could do better in our engagement.