The Availability of New, Innovative and Specialist Cancer Drugs in Australia

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The Availability of New, Innovative and Specialist Cancer Drugs in Australia Senate Community Affairs References Committee The availability of new, innovative and specialist cancer drugs in Australia. 2015 AUSTRALIAN MELANOMA RESEARCH FOUNDATION www.melanomaresearch.com.au SUMMARY COMMENTS Brendon Coventry & Martin Ashdown Brendon J Coventry, BMBS PhD FRACS FACS FRSM Research Director, Australian Melanoma Research Foundation & Discipline of Surgery & Immunotherapy Laboratory, University of Adelaide, Royal Adelaide Hospital. Martin L Ashdown, BApplSci, Research Fellow, University of Melbourne The Terms of Reference: a. the timing and affordability of access for patients; b. the operation of the Pharmaceutical Benefits Advisory Committee and the Pharmaceutical Benefits Scheme in relation to such drugs, including the impact of delays in the approvals process for Australian patients; c. the impact on the quality of care available to cancer patients; and d. any related matters. 1 EXECUTIVE SUMMARY COSTS • Cancer drug costs threaten to break our federal and state budgets across Australia. • Drug costs in Australia (and internationally) are currently unsustainable, and will become unaffordable to the Australian Government, taxpayers and the public within a decade or so if measures are not taken urgently to contain costs by improving clinical outcomes. • The highest rate of cost growth occurred in the PBS Chemotherapy (s100) program, at 62.61%. From 2011-12 to 2012-13, expenditure on this program more than doubled, from $222.5 million to $478.9 million. [1] This arises from newer high-cost agents. • Active lobbying by desperate individuals, patient advocacy groups, medical oncology groups and pharmaceutical groups for funding by the PBS for easier availability of expensive drugs is understandable, but is not solving the critical problems of poor clinical responses and costs. • A 1 percent reduction in cancer mortality would be worth US$500 billion per annum [2,3]. SURVIVAL & CLINICAL RESPONSES • Globally, about 160,000 patients per week die of advanced cancer. Some 800 patients per week die of advanced cancer in Australia. • Many cancer drugs show only marginal effectiveness, because only unpredictable low rates of complete responses and 5-year survival are demonstrated. • The clinical improvement in survival from advanced cancer has remained essentially static for 50 years, making the amount of money that has been spent on drugs wasteful. • Most cancer patients still Do Not Survive despite treatment (often with multiple courses) using expensive drugs. • A Cure for Cancer would Benefit Patients - (or even substantial improvement in clinical response rates), but would remove the need for multiple expensive, less-effective drugs, and the need for numerous expensive institutions attempting to solve cancer - representing a problem for the cancer associated industries. 2 SOLUTIONS & RECOMMENDATIONS • Removing the Conflict of Interest problem within hospitals, which is holding back quicker resolution of the issue of the low effectiveness of cancer drugs. • Cancer Clinical Improvement Research Fund needs to be set up by government. Drug companies would contribute to this fund when receiving PBS listing, and this would remain at "arms-length" from research centres to preserve proper independent investigation. • Exploring Different Approaches Several tertiary research institutions should be actively encouraged and adequately funded to explore different approaches, for example, using novel dosages, combinations and timing of therapies in an effort to more rapidly improve clinical outcome results (CR rates and survival). Drug companies are often reluctant to reduce dosage, or to explore side-effects/ combinations, chiefly on commercial grounds. • Independent Australian Clinical Institutions Setting up several institutions with complete independence from drug company sponsorship through full Government funding to permit unbiased independent investigation into ways to improve the clinical efficacy of drugs for the Australian public. • Reform of Drug Investigation Over-reliance on drug company approaches within Australian hospitals is seriously limiting new and innovative investigator-driven and cheaper research approaches; and this needs urgent reform to find better solutions. • Improving Complete Response (CR) Rates (where all cancer disappears) The CR phenomenon can be induced by multiple divergent agents/ approaches, but is random/ unpredictable in nature, however, when it occurs 5-year survival is usual. [4] Urgent and adequate funding is required to achieve higher CR rates to contain budgets through cost savings measures. • Active Exploration of Ways to Improve Cancer Survival is required to significantly improve health budgets and cancer patient survival. • Success of Clinical Outcomes/ Results must be Linked with Reimbursement to achieve better professional practice, industry responsibility and improve cost. [5] Currently, payment is not linked to successful outcomes. • Documentation of Clinical Outcome Results should be linked with PBS Reimbursement - these results need to be documented for each drug therapy in order to properly evaluate the true efficacy of drugs/ combinations occurring in actual clinical practice. This has seldom been done by medical oncologists outside of the initial clinical trials, but is essential to evaluate drug costs & benefits adequately. 3 • Exploration of Off-Patent Drugs Many current off-patent drugs demonstrate clinical efficacy against cancer, but these are not being adequately explored because of the distraction arising from newer expensive agents. • The key objectives must Improve Clinical Outcomes (CR & Survival). • Near-Immediate Solution Evidence shows that the problem can be solved in a near-immediate fashion with relatively small funding levels. [8-18] • Substantially Improving Costs & Benefits Evidence shows that if many current drugs were used more accurately, there would be a significant reduction in cost while increasing clinical effectiveness. The solution is potentially close at hand, but is not being adequately explored. [8-19] BACKGROUND DETAIL The Extent of the Problem: Every week, some 160,000 people die of advanced cancer around the world, despite our best attempts at cancer treatment globally. About $32 billion is being spent on oncology drugs and the USA National Cancer Institute/ NIH spends about $5.2 billion on cancer research, per annum. In Australia, the NHMRC funded $181M on cancer research grants in 2014, and almost 800 cancer patients per week still die of cancer, or over 40,000 Australians per annum. Sadly, cancer has remained a tremendously costly public health problem of major proportions for over 5 decades, and our progress has been puzzlingly slow towards solving this using standard methods. Progress in cancer treatment is often claimed. However, most of the real progress has been made through earlier detection and treatment of earlier stage cancers, and these figures are masking the major problem of disappointingly very marginal (or non-existent) gains in survival for most forms of advanced metastatic cancer. Cancer death rates arise predominantly from advanced metastatic cancer which has spread to organs, and these death rates have remained essentially unchanged for most common cancers for over 50 years.[21-26] This prompted Professor Laurence Baker, Chair of the South West Oncology Group in the USA, to state recently on the Journal of the National Cancer Institute “I am trying to get people to stop saying how successful the cancer research enterprise is. It is not true. It is just not true”. [21] Cost Expenditure & Economics: The cost of medications and equipment is rapidly becoming unsustainable and will be unaffordable to the Australian Governments, taxpayers and public within a decade or so, if measures are not taken to contain costs. Health will quickly become a principal Federal Government issue of major importance requiring urgent central coordinated administration to solve. Rational balancing of budgets must be achieved by developing sustainable patterns of healthcare delivery through appropriate cost-benefit analysis and sensible, equitable 4 expenditure. Innovative research approaches that offer global solutions to several or many problems in healthcare must be funded and supported to create better cost- benefit returns for the Australian public and economy. Australia has an enviable track-record of such innovative discoveries and approaches. The highest rate of cost growth occurred in the PBS Chemotherapy (s100) program, at 62.61%. [1] From 2011-12 to 2012-13, expenditure on this program more than doubled, from $222.5 million to $478.9 million. Chemotherapy drug costs rose from $84 million in 2009-10 to $586 million last financial year. In detail these figures were: Chemotherapy 83.8M (2009-10) 94.8M (2010-11) 222.5M (2011-12) 478.9M (2012-13) 585.9M (2013-14). Average annual growth (%) was 62.61. Taxpayers currently pay at least 3 times over for many new drug therapies, namely: (i) the initial drug cost for each drug used; (ii) the cost of side-effects and hospitalisations; (ii) the cost of premature death from cancer due to failure of the therapies. If several drugs are utilised, as is being increasingly proposed [27-28], then these costs will be repeated. Relevant History: The field of cancer treatments has evolved historically from the days of alchemy (pre-1800), through the chemical synthetic industry (1800-present), and into the highly commercially successful pharmaceutical, scientific and medical oncology industries (1950-present).
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