COMMITTEES;Community Affairs References Committee;Report – 12 Nov 2015

I rise tonight to add some comments on the Community Affairs References Committee’s report from its inquiry into the availability of new, innovative and specialist cancer drugs in Australia. As a member of this committee, a brain tumour survivor and the co-convenor of the brain tumour and brain cancer parliamentary group, I obviously have a particular interest in this subject. And it is an extremely complicated subject area, where treatments are changing rapidly as a result of recent advances in medical research. As such, it is vital that this place and this parliament as a whole ensures that our bureaucratic frameworks keep up with scientific developments to provide the best outcomes for Australian citizens.

I am pleased to say that this report reached a consensus regarding recommendations. The committee included senators from Labor, Liberal and the Greens as well as Senator Xenophon, a participating member of the committee who proposed this reference in the beginning, and I would like to thank him for that. I would also like to thank my fellow committee members and the ever-hardworking secretariat for their work on this issue. The report was over 100 pages, so it is a very significant report. I would also like to thank all those people who gave evidence at the inquiry. I know at least one of them had had the experience of their own child dying, from brain cancer, in fact. I thank, most specifically, all those people who gave evidence of a personal nature.

Sadly, Australia is often described as the cancer capital of the world, with the highest age-standardised incidence of cancer. Half of all Australians will develop cancer in their lifetime and one in five will die from it. It is estimated that 45,780 people will die from cancer in 2015. That is an average of 125 deaths every day. This figure represents approximately three out of every 10 deaths registered in Australia. Unfortunately, it is 84 per cent higher than the number of deaths reported in 1982. Cancer is one of nine national health priority areas, NHPAs, and accounts for 19 per cent of the total disease related burden, making it the highest disease related burden on Australian society.

On a positive note, Australia also has cancer survival outcomes that are equivalent to the best in the world. Australia’s one-year survival rate for all cancers combined is 81 per cent, and overall five-year relative cancer survival rates are more than 66 per cent. But I am sure everyone in this place will agree with me that we would like to see these survival rates increase further.

Cancer poses a complex challenge for the Australian healthcare system because cancer is not one disease. It is many hundreds of diseases, each of which can manifest differently in each cancer patient. Just five cancers—prostate cancer, colorectal cancer, breast cancer, melanoma of the skin and lung cancer—comprise approximately 60 per cent of all expected diagnosed cancers. Consequently, there are hundreds of cancers where there are only dozens, or fewer, cases in Australia each year.

Brain cancers, in particular, have a large number of different types, which makes it difficult and expensive for drugs to be developed or to gain approval in Australia. The overall incidence of brain tumours is low, but the tumours are most likely to be lethal. I am one of the very rare exceptions to the rule, I am very pleased to say. It is the equivalent of a car crash each day somewhere in Australia that involves almost four fatalities—that is just for brain tumours. Brain tumours and cancers are also the only cancer to directly affect both the mental and physical capability of a patient. In Australia, more children die from brain cancer than any other disease and more people under 40 die from brain cancer than from any other cancer.

The committee heard that advances in the treatment of cancers are frequently incremental and increasingly targeted at small patient populations. Cure Brain Cancer, in their submission to the inquiry, refer to a ‘personalised medicine’ approach, whereby tumour genetics are established early on and high-throughput screening of existing medications occurs, and, if any of the screened drugs show activity against an individual tumour, this information is conveyed to the treating oncologist to be used for treatment. More targeted medicines and therapies have the ability to increase the range of treatment options for cancer patients, resulting in improved quality of life and survival for many patients.

At the same time, cancer is an area of high clinical need, meaning that, even with access to subsidised medicines, many cancer patients face significant financial hardship. These challenges are exacerbated for patients with rare or less common cancers, particularly children and young people and those who live in rural and remote communities. These factors pose a significant challenge for all governments as they seek to facilitate affordable cancer care while maintaining the sustainability of the overall health budget.

Current trends in cancer research can be expected to continue, meaning that there will be more drugs to treat additional types of cancer which will need regulatory approval. Currently, the Australian government employs a range of processes and mechanisms to assess the quality, safety, efficacy, effectiveness and cost-effectiveness of health technologies and procedures. Collectively, these processes and mechanisms are referred to as health technology assessment—HTA. Through its HTA system, the Australian government seeks to ensure the sustainability of the Australian government’s health-financing arrangements. In order to gain approval and reimbursement of medicines in Australia, sponsors are required to demonstrate the merit of the medicines against five critical requirements: quality, safety and efficacy, as assessed by the TGA; clinical and cost effectiveness, as assessed by the PBAC; and financial feasibility and acceptability as assessed by the Minister for Health and the cabinet. The committee noted that the processes for assessing applications for registrations and listing are appropriately rigorous and are based on clear cyclical time lines. At the same time, though, the committee notes the concerns raised by sponsors and other stakeholders regarding the potential for inefficiency and uncertainty in the system.

The committee considers that Australia should strive to achieve world’s best practice in the approval of medicines and should, therefore, maintain a commitment to continuous improvement of its assessment processes. The committee also noted that the pharmaceutical industry has a significant role to play in achieving timely listing of cancer medicines. The committee received evidence pointing to fast-track processes used by overseas regulators and notes that key features of such processes are early and frequent interactions between the regulator and the sponsor and a process of rolling review. These mechanisms ensure collaboration in the design of trials to collect data that will support registration, together with the flexibility to submit sections of the application for review as they are ready.

The committee considers that some of the suggested avenues for streamlining the assessment process, particularly in the case of resubmitted applications, merit further consideration—for example, pre-application planning meetings to assist sponsors and other stakeholders to better tailor their applications to the requirements of the PBAC. Consequently, the committee made three recommendations to improve access to cancer drugs for Australians. Firstly, the committee recommends that the Australian government initiate a comprehensive review of the system for the registration and subsidisation of medicines. Secondly, the committee recommends that the Australian government commission a review of current data collection mechanisms for cancer medicines, including identification of obstacles to the integration of existing databases and potential avenues for addressing these; opportunities to incorporate data from post-market evaluations; and avenues for capturing data relating to the off-label use of cancer medicines. Finally, the committee recommended that the Australian government establish a steering committee to examine the feasibility of establishing a national register of cancer medicines.

The committee hopes that this report will go some way to improve access to new and innovative cancer drugs to improve outcomes for all Australians. We hope to see a comprehensive and timely response to this report by the government. I seek leave to continue my remarks later.

Leave granted; debate adjourned.