ASIA NEEDS A LEGAL FRAMEWORK TO COMBAT RARE DISEASES
Australia's way of addressing cancer burden
Cancer continues to be the greatest cause of health burden in Australia, accounting for around one-fifth (19%) of the total disease burden in 2011. It is estimated that 134,174 new cases of cancer will be diagnosed in Australia in 2017, an average of 367 diagnoses each day. Five-year relative survival from all cancers combined increased from 48% in 1984–1988 to 68% in 2009–2013. According to World Health Organization comparisons, people living in Australia generally had better cancer survival than those living in other countries and regions.
Cancer, a generic term describing a large group of diseases, is among the leading causes of morbidity and mortality worldwide. Australia has among the highest incidence of cancer in the world but it also has one of the world’s best survival outcomes. This is because of its comprehensive health care system which delivers access to skilled health professionals, effective and appropriate treatments, high quality care, affordable medicines and ongoing education. In Australia, over the period 2009-2013, people diagnosed with cancer had a 68% chance of surviving for at least 5 years, a significant improvement from 48% over the period 1984-1988.
In December 2014, the Senate referred the matter of the availability of new, innovative and specialist cancer drugs in Australia to its Community Affairs References Committee. The Committee reported on September 17, 2015, noting that over 45,000 people would die from cancer in 2015, representing three out of every 10 deaths registered in Australia. The Committee recommended a comprehensive review of Australia’s medicine registration and reimbursement systems, a review of current data collection mechanisms for cancer medicines and an examination of the feasibility of establishing a national register of cancer medicines.
Reacting to the Senate Committee Report, the Australian government noted that currently it spends an estimated $4-5 billion per annum on the treatment of cancer. With an ageing population and the prevalence of cancer trending upwards, the health and economic impacts on individuals and the health system can be expected to continue to increase. A key driver of Australian government expenditure is the growth in the number and cost of medicines subsidised through the Pharmaceutical Benefits Scheme (PBS) for the treatment of cancer.
In 2015-16, the Australian government spent over $11 billion on PBS and Repatriation Pharmaceutical Benefits Scheme (RPBS) medicines, of which $1.9 billion was for cancer medicines, that is, around one in every six dollars of PBS expenditure subsidises cancer medicines. The average reimbursement price for cancer medicines increased 133 per cent in real terms from 1999-2000 to 2011-2012. In contrast, the price
of non-cancer prescription medicines increased 37 per cent in the same period.
There are approximately 110 cancer medicines available on the PBS. From October 2013 to August 2017, the Australian government has approved over 60 new cancer medicines (or amended listings) at a total cost to government (estimated for the relevant budget period at the time of each listing) of around $4 billion. This includes new treatments for advanced pancreatic cancer, melanoma, rare giant cell bone tumours, advanced breast cancer, and ovarian, fallopian tube, and primary peritoneal cancer.
The Australian government has also invested in cancer prevention through successful measures such as immunisation and screening programs. The human papillomavirus (HPV) vaccine is provided in schools to all males and females aged 12-13 years through the National Immunisation Program (NIP). Free HPV vaccines have been made available through school based programs for girls since 2007 and boys since 2013. A 2015 independent evaluation of the Australian HPV Vaccination Program (conducted by the National Centre for Immunisation Research and Surveillance at the University of Sydney) found that the Program had been successful in reducing the incidence of cervical abnormalities in young women and anogenital warts in men and women. These reductions are expected to significantly reduce the prevalence of cervical cancer among women. According to a report “The Burden of Cancer in Australia: Australian Burden of Disease Study 2011” released by the Australian Institute of Health and Welfare (AIHW) in June last year, cancer continues to be the greatest cause of health burden in Australia, accounting for around one-fifth (19%) of the total disease burden in 2011.
The report finds that in 2017, it is estimated that 134,174 new cases of cancer (excluding basal and squamous cell carcinoma of the skin) will be diagnosed in Australia, an average of 367 diagnoses each day. It is expected that more than half (54%) of these diagnosed cases will be for males and 71% for those aged 60 and over. The age-standardised rate of new cancer cases increased from 383 per 100,000 persons in 1982 to a peak of 504 per 100,000 in 2008, before an expected decrease to 470 per 100,000 in 2017. The decrease has mainly been observed in males and is strongly influenced by changes in the incidence rate of prostate cancer. In 2017, breast cancer in females is expected to be the most common cancer in Australia, followed by colorectal (bowel) cancer, prostate cancer and melanoma of the skin.
In 2017, it is estimated that 47,753 people will die from cancer in Australia, an average of 131 deaths each day. It is expected that more than half (57%) of these deaths will be in males and 87% among people aged 60 and over. Males are estimated to have a higher age-standardised mortality rate than females (200 compared with 129 per 100,000). It is estimated that the age-standardised mortality rate from all cancers combined will decrease from 209 per 100,000 in 1982 to 161 per 100,000 in 2017. In 2014, cancer accounted for about 3 of every 10 deaths registered in Australia. In 2017, lung cancer is expected to be the leading cause of cancer death, followed by colorectal cancer, prostate cancer, breast cancer in females and pancreatic cancer.
Survival rate improves, but not for all cancers
Five-year relative survival from all cancers combined increased from 48% in 1984–1988 to 68% in 2009– 2013. Cancers that had the largest increase in survival were prostate cancer, non-Hodgkin lymphoma, kidney cancer and multiple myeloma. Pancreatic cancer and lung cancer showed only small improvements; bladder cancer and cancer of the larynx had a decrease in survival; and lip cancer and mesothelioma had no change. The report notes that, according to World Health Organization comparisons, people living in Australia generally had better cancer survival than those living in other countries and regions.
In 2011, cancer was the leading cause of disease burden in Australia. Australians lost 833,250 disability-adjusted life years (DALY) due to premature death from cancer or from living with cancer (19% of total DALY). Lung cancer was associated with the highest proportion of the cancer burden, followed by colorectal cancer, breast cancer, prostate cancer and pancreatic cancer.
Reacting to the report by AIHW, Dr Helen Zorbas, CEO, Cancer Australia - a national government agency working to reduce the impact of cancer on all Australians and provides information on the disease, research and clinical trials said that the cancer burden is primarily due to people dying earlier due to cancer.
“Ninety four per cent of the burden of cancer is due to dying prematurely, however it is likely that this will decrease into the future, as overall cancer mortality rates are predicted to fall,” Dr Zorbas said. “Of concern, indigenous Australians experienced 1.7 times the cancer burden of non-indigenous Australians, and people in the lowest socio-economic group experienced 1.4 times the cancer burden of those in the highest socio-economic group. Lung cancer was responsible for a large proportion of these differences.
“The report also found that almost one-quarter (22%) of the total cancer burden can be attributed to tobacco use,” said Dr Zorbas. “The 17 risk factors analysed in the study accounted for 44% of the cancer burden. In addition to the burden attributable to tobacco use, a further 7.2% was due to high body mass, 7.0% due to diet and 6.4% due to physical inactivity.”
“The report gives us valuable insights across cancer types and into the future to the year 2020. These insights will inform our efforts not only to reduce cancer mortality but also improve the quality of life for survivors of cancer,” Dr Zorbas said.
Public, Private Partnership
Hailing the Australian government response to the
Senate Committee Report, Medicines Australia (MA), which represents the discovery-driven pharmaceutical industry in Australia, in last November, noted that it is committed to working together with the government to ensure that access to new innovative medicines remains the highest priority.
Medicines Australia further noted that it’s encouraging that the government agrees that improving and streamlining existing regulatory and assessment processes for new medicines are key strategies to ensure Australians have even better access to breakthrough medicines.
As the government notes in their response, some of the Senate inquiry’s recommendations are currently being addressed through reforms of the Therapeutic Goods Administration (TGA).
In particular, Medicines Australia looks forward to the passage of legislation currently before Parliament that includes provisions for another expedited pathway called Provisional Approval that aims to speed up access to new medicines.
The government’s response also highlights the importance of the Strategic Agreement, signed with Medicines Australia, to address some of the recommendations of the Senate inquiry.
Not only does the Agreement provide $1.8 billion in savings on PBS listed medicines that will be used to pay for new treatments, the government has committed to reform that will improve and accelerate processes that lead to a medicine being made available on the PBS.
Medicines Australia believes that the government’s commitment in the Strategic Agreement will make a real difference to access to medicines for Australians.
Medicines Australia members discover, develop and manufacture the latest medicines that are made available to those who need them on the Pharmaceutical Benefits Scheme (PBS). They also undertake around one thousand clinical trials locally that support the development of new medicines and provide 34 thousand Australians with early access to the latest treatments, including for cancers.
More funds to boost cancer research projects
The Australian Government has announced on December 19, 2017 more support for cancer research with $8 million in grants. Through Cancer Australia, the government is investing $6.5 million combined with $2.1 million from Cancer Australia’s funding partners, Cure Cancer Australia, National Breast Cancer Foundation and Cancer Council NSW. This brings the total funding for the 2017 round of Cancer Australia’s Priority-driven Collaborative Cancer Research Scheme (PdCCRS) to $8.6 million.
The 24 successful grant recipients lead projects focusing on prevention, diagnosis and treatment of a range of cancer types. These include cancers of the breast, colon, head and neck, kidney, liver, lung, ovary, pancreas and prostate, as well as acute lymphoblastic leukaemia, leukaemia, melanoma and uveal (a part of the eye) melanoma, multiple myeloma and sarcoma. There is also a strong focus on defeating and improving the outcomes of childhood brain cancers and other cancers like neuroblastoma, a cancer of the nervous system common in children.
Sixty per cent of the grant funding will go to projects that focus on rare and less common cancers and cancers with low survival rates. The assessment process for the 2017 PdCCRS grants was done in collaboration with the National Health and Medical Research Council.
Cancer Australia’s PdCCRS has provided $124 million for priority-based cancer research since its inception in 2007. This latest round of grant funding complements existing programs like the Australian Brain Cancer Mission which was announced in October 2017. The Australian government announced a $100 million fund to defeat brain cancer and provide better outcomes for people suffering from the terrible disease.
Early December the government has announced a $640 million investment to support Australia’s world-leading health and medical researchers as they continue their work to find the next major medical breakthrough.
On December 18 2017, the mid-year budget update confirmed over half a billion dollars extra for the fight against cancer with additional funding for new medicines, screening and testing.
Medicines Australia hailed the ongoing commitment of the government to list medicines recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) in a timely manner which will benefit thousands of Australians who need access to the latest developments in medicine.
If Australia with its ageing and growing population is to continue to enjoy world-class access to the latest innovations in medicines into the future, Medicines Australia noted that there needs to be a discussion about how to appropriately invest additional money into the PBS. Medicines Australia believes this is a challenge that needs to be addressed by all sides of politics to ensure long-term predictability and sustainability of the PBS which is so cherished by the Australian people.
Notes: 1. Hospitalisation for which the care type was reported as Newborn with no qualified days and records for ‘Hospital boarders’ and ‘Posthumous organ procurement’ have been excluded from the analysis. 2. The rates were age-standardised to the 2001 Australian Standard Population and are expressed per 10,000 population.
Notes: 1. Cancers coded in the ICD-10 as C00–C97, D45, D46, D47.1 and D47.3–D47.5 with the exception of those C44 codes that indicate a BCC or SCC. 2. The number of new cases are rounded to the nearest whole. Therefore, male and female counts may not equal total persons.
3. The age-specific rates are expressed per 100,000.
4. The all ages rates were age-standardised to the Australian Standard Population and are expressed per 100,000 population.