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16 Apr 2015

Parliamentary inquiry into availability of new cancer drugs

BCNA has made a submission to an inquiry being conducted by The Senate Community Affairs Committee into the availability of new, innovative and specialist cancer drugs in Australia.

In recent years, there have been a number of new breast cancer drugs approved for use by the Therapeutic Goods Administration (TGA) for treatment of secondary breast cancer. BCNA has strongly advocated for these drugs to be listed under the Pharmaceutical Benefits Scheme (PBS) so that women who may benefit from them can access them at minimal financial cost.

We are concerned at the length of time it can take for new innovative drugs to be listed on the PBS. A review undertaken in 2013 for Medicines Australia[1] found that the time period between a new cancer drug receiving approval for use in Australia by the TGA and the listing of the drug on the PBS was at least 14 months.

Some breast cancer drugs are taking much longer however. Two new breast cancer drugs listed on the PBS in 2014 took 30 months and 25 months respectively from TGA approval to PBS listing. Another two drugs, not yet listed, have been 22 months and 18 months since TGA approval.

This leaves women with secondary breast cancer, and their families, in the very difficult situation of having to either find large amounts of money to pay for new drugs or accept that there is a new drug that may benefit them, but that they are not able to afford.

BCNA’s recommendations

BCNA made a number of recommendations in our submission.

We strongly support more timely access to government subsidised breast cancer drugs to ensure that women and men who can benefit from these treatments have equitable access to them. We support:

  • improvements to drug approval processes to ensure timely listing of new cancer drugs on the PBS
  • consideration of an accelerated approvals program for cancer drugs, similar to that provided by the US Food and Drug Administration
  • examination of drug approvals processes in other countries to determine if there are any learnings for Australia
  • improvements to PBAC pre-application processes to reduce the number of applications required to be submitted for a positive recommendation
  • pharmaceutical companies pricing new drugs more realistically to reduce the length of time taken over pricing negotiations
  • pharmaceutical companies reviewing their patient access program schemes to make them more widely available and at a price point people with advanced cancer can reasonably afford
  • a review of the way clinical trials are designed, and PBAC requirements for clinical trial data
  • collection of consistent, national data on the incidence of secondary (metastatic) breast cancer
  • the establishment of a breast cancer clinical registry to collect treatment regimens and outcomes, including both patient reported and medically reported disease outcomes.

The Committee is due to report its findings to The Senate on 22 May 2015. We will update this webpage with the outcomes when they are available.

Acknowledgements

BCNA thanks the following Consumer Representatives who reviewed our submission and provided feedback:

  • Avis Macphee
  • Geraldine Robertson
  • Jennifer Muller
  • Margaret Tassell
  • Pat Hancock

We also thank members of our Strategic Advisory Group for their assistance in producing this submission.

More Information

 

[1] Deloitte Access Economics, Access to cancer medicines in Australia, Medicines Australia Oncology Industry Taskforce, July 2013