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Bone metastases: utilisation analysis

Drug utilisation sub-committee (DUSC)

June 2014

Abstract

Purpose

To examine utilisation of medicines for bone metastases.  In particular, the effect of the PBS listing of denosumab and recent changes to restrictions for denosumab and zoledronic acid.

Background

The DUSC has not previously reviewed utilisation of medicines for the treatment of bone metastases.

The wording of the restriction for bone metastases from prostate cancer has been changed several times.  The condition that progression of the disease must be shown was removed, and then ‘hormone resistant’ was changed to ‘castration resistant’.

Date of listing on PBS

Bone metastases from breast cancer and hormone resistant prostate:

  • Zoledronic acid: 1 November 2003;
  • Denosumab: 1 December 2011.

Bone metastases from breast cancer:

  • Clodronate: 1 May 2001;
  • Pamidronate: 1 November 2000;
  • Ibandronic acid: 1 February 2009.

Current PBS listing details are available from the PBS website.

Data Source / methodology

Data was extracted from the Department of Human Services (DHS) Medicare Pharmacy Claims database and the Highly Specialised Drugs (HSD) database for the period January 2001 to September 2013, inclusive.  Supplemental data was extracted from the DHS Medicare Authority Approvals database for the period August 2003 to September 2013, inclusive.

Key Findings and discussion

In the first year of listing of denosumab (1 December 2011 to 30 November 2012):

  • 92,323 prescriptions were dispensed for the total market (clodronate, denosumab, ibandronic acid, pamidronate and zoledronic acid).  This includes use for bone metastases in breast and prostate cancer, and some use for hypercalcaemia of malignancy and multiple myeloma.
  • The approximate cost to the Government for these prescriptions was just over $40 million.
  • 20,406 prescriptions were dispensed for denosumab (for bone metastases in breast and prostate cancer), at a cost of approximately $10.5 million.

During the period 1 July 2013 to 30 September 2013:

  • There were 3,938 patients treated with denosumab.
  • The proportion of use by indication for denosumab was 60% for bone metastases in breast cancer, and 40% for bone metastases in prostate cancer (blank codes excluded).

There are several limitations in the data available for denosumab and zoledronic acid for bone metastases.  It is difficult to analyse the utilisation without including use for other indications.  During the period 1 July 2013 to 30 September 2013, 20% of the prescriptions dispensed for denosumab did not have an indication recorded at the time of dispensing.

The PBS listing of denosumab appears to have increased the bone metastases market.  Denosumab also substituted within the existing market for zoledronic acid, and the most recent data shows the number of prescriptions per month for the two drugs is approximately equal.

DUSC actions

Nil requested.

Context for analysis

The DUSC is a Sub Committee of the Pharmaceutical Benefits Advisory Committee (PBAC). The DUSC assesses estimates on projected usage and financial cost of medicines.

The DUSC also analyses data on actual use of medicines, including the utilisation of PBS listed medicines, and provides advice to the PBAC on these matters. This may include outlining how the current utilisation of PBS medicines compares with the use as recommended by the PBAC.

The DUSC operates in accordance with the quality use of medicines objective of the National Medicines Policy and considers that the DUSC utilisation analyses will assist consumers and health professionals to better understand the costs, benefits and risks of medicines.

The utilisation analysis report was provided to the pharmaceutical sponsors of each drug and comments on the report were provided to DUSC prior to its consideration of the analysis.

Sponsors’ comments

Amgen Australia Pty Limited:  Amgen's PBAC submission predicted a modest increase in the bone metastases market with the introduction of denosumab, as noted in the DUSC analysis.  The sponsor considers this to be due to a different safety profile to the bisphosphonates and a different administration route.

Novartis Pharmaceuticals Australia Pty Limited:  The sponsor has no comment.

Disclaimer

The information provided in this report does not constitute medical advice and is not intended to take the place of professional medical advice or care.  It is not intended to define what constitutes reasonable, appropriate or best care for any individual for any given health issue.  The information should not be used as a substitute for the judgement and skill of a medical practitioner.

The Department of Health (DoH) has made all reasonable efforts to ensure that information provided in this report is accurate. The information provided in this report was up-to-date when it was considered by the Drug Utilisation Sub-committee of the Pharmaceutical Benefits Advisory Committee.  The context for that information may have changed since publication.

To the extent provided by law, DoH makes no warranties or representations as to accuracy or completeness of information contained in this report.

To the fullest extent permitted by law, neither the DoH nor any DoH employee is liable for any liability, loss, claim, damage, expense, injury or personal injury (including death), whether direct or indirect (including consequential loss and loss of profits) and however incurred (including in tort), caused or contributed to by any person’s use or misuse of the information available from this report or contained on any third party website referred to in this report.