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AMA wants to recruit pharmacists to primary health team

Patients would suffer fewer adverse reactions to medicine and be almost $50 million better off while governments would save more than $500 million under an AMA plan to integrate pharmacists into general practice.

In a major pitch to improve patient care, reduce unnecessary hospitalisations, and boost cost-effective GP-led primary care, the AMA has developed a proposal to employ non-dispensing pharmacists in medical practices.

It is estimated that a quarter of a million hospital admissions each year are related to the use of prescription drugs, costing the country $1.2 billion, while around a third of patients fail to comply with directions for taking their medicines, undermining their health, causing adverse reactions and wasting taxpayer dollars.

AMA President Associate Professor Brian Owler said that integrating non-dispensing pharmacists within general practices as part of a GP-led multidisciplinary health team could go a long way to addressing these problems, improving patient health and cutting costs.

“Under this program, pharmacists within general practice would assist with things such as medication management, providing patient education on their medications, and supporting GP prescribing with advice on medication interactions and newly available medications,” A/Professor Owler said. “Evidence shows that the AMA plan would reduce fragmentation of patient care, improve prescribing and use of medicines, reduce hospital admissions from adverse drug events, and deliver better health outcomes for patients.”

The proposal, developed in consultation with the Pharmaceutical Society of Australia, could prove a game-changer in fostering closer collaboration between GPs and pharmacists.

It has come amid a concerted push by some in the pharmaceutical sector to encroach upon areas of medical practice in an effort to offset declining revenues from dispensing medicines, including authorising pharmacists to administer vaccines and conduct health checks.

The AMA has warned governments that allowing pharmacists to practise outside their field of expertise could put patients at risk, undermine continuity of care and increase health costs.

The AMA stressed that under its new proposal, pharmacists working within general practices would not dispense or prescribe drugs, nor issue repeat prescriptions, and would instead focus solely on medication management, including advising GPs on prescribing, drug interaction and new medicines, reviewing patient medications and monitoring compliance, improving coordination of care for patients being discharged from hospital with complex medication regimes, and ensuring the safe use and handling of drugs.

The proposal calls for medical practices to be awarded Pharmacist in General Practice Incentive Program (PGPIP) payments similar to those to support the employment of practice nurses.

The AMA has proposed that practices receive an incentive payment of $25,000 a year for each pharmacist employed for at least 12 hours 40 minutes a week, capped at no more than five pharmacists, meaning practices can receive no more than $125,000 a year – except those in rural and remote areas, which would be eligible for a loading of up to 50 per cent.

An independent analysis of the proposal commissioned by the AMA and conducted by consultancy Deloitte Access Economics estimated that if 3100 general practices joined the PGPIP program it would cost the Federal Government $969.5 million over four years.

The consultancy said that the average annual pharmacist salary was $67,000 plus on-costs, meaning only clinics treating 3000 or more standardised whole patient equivalents (an age-weighted measure based on GP and other non-referred consultation items in the MBS) would be likely to participate.

But the Deloitte report said the outlay would be more than offset by substantial savings in other areas of the health system, calculating that for every $1 invested in the PGPIP, taxpayers would save $1.56 in other areas of the health system.

In particular, Deloitte estimated that, as a result of the program:

  • a drop in the number of patients hospitalised because of adverse reactions to medications would save $1.266 billion;
  • fewer prescriptions subsidised through the PBS because of better use of medicines would save $180.6 million;
  • patients would save $49.8 million because of fewer prescriptions and the attached co-payments; and
  • Medicare would save $18.1 million because fewer patients would see their GP as a result of an adverse reaction to their medicine.

In all, Deloitte said the initiative would deliver a net saving of $544.8 million over four years for the health system, and the benefit-cost ratio improves with each year the scheme is in operation.

“The policy will likely to lead to improved compliance and persistence with medication regimens, which will result in improved health outcomes for patients,” the Deloitte report said. “This will result in significant avoided financial and economic costs for both the patient and the health system, as well as avoided broader economic costs such as lost productivity that arise when a health condition is treated and managed sub-optimally.”

The Deloitte report can be found at article/general-practice-pharmacists-improving-patient-care

Adrian Rollins

The use of financial incentives in Australian general practice

There is considerable interest in how to improve the quality and outcomes of health care by providing better incentives, including “pay-for-performance” arrangements.1 In Australia, financial incentives in primary care were first introduced in 1996, through the Better Practice Program, which was superseded by the Practice Incentives Program (PIP) in 1998.2 The PIP offers 10 practice-level incentives, currently for: quality prescribing; early diagnosis and effective management of diabetes; cervical screening of under-screened women; continuing care for patients with asthma; encouraging better health care of Aboriginal and Torres Strait Islander patients; adopting new eHealth technologies; operating after hours; providing teaching sessions for medical students; practising in a rural location; and performing certain non-referred services in rural locations. Within the PIP framework, the Service Incentives Payment (SIP) was introduced in 2001; this is an additional payment that is paid directly to general practitioners for completing cycles of care for patients with diabetes and asthma, as well as for cervical screening of under-screened women.3

Medicare data for 2011 showed that 68% of eligible practices were registered for the PIP. Various factors can influence the response to incentives, including the size of the payment, and the financial and time costs of claiming payments. A survey of 315 GPs in five Divisions of General Practice (DGPs) in metropolitan Sydney found that the perceived administrative burden was a barrier to uptake.4 Findings were similar in a series of semistructured interviews in one DGP in Melbourne, which suggested that any risk that patients might perceive over-servicing discouraged services that required further visits.5 Doctors also argued that they provide “cycles of care” in a range of ways, and that a systematic approach to care was more important to them than government incentives. A study that used a survey of DGPs combined with data on SIP claims by DGP, found that there was higher uptake of incentives in more disadvantaged areas, and that larger practices are associated with a higher SIP coverage (and solo practices with a lower SIP coverage).6

Here, we extend what is known about the use of financial incentives by Australian GPs by analysing a larger, nationally representative survey of GPs. We also investigate changes in use over the 4 years, 2008 to 2011. In addition, we explore the characteristics that predict uptake of incentives among GPs and whether this has changed in the same period.

Methods

We used data from the Medicine in Australia: Balancing Employment and Life (MABEL) longitudinal panel survey of medical practitioners in Australia, which started in 2008. Participants in the survey were drawn from the national database of doctors; all doctors undertaking clinical work were invited to participate. MABEL includes four categories of doctors: GPs and GP registrars, specialists, specialists-in-training, and hospital non-specialists. In this study, we included GPs and GP registrars, as our focus was on primary care. The baseline 2008 cohort included 10 498 doctors, of whom 3906 were GPs; in each subsequent wave of doctors added to the MABEL longitudinal panel, a new cohort was invited to participate, and a top-up sample was added.

In MABEL, respondents were asked: “In the last year, approximately what percentage of your total gross earning did you receive from . . . government incentive schemes and grants?”

As incentive payments are expected to account for a small proportion of total income,3 we treated this as a binary variable (ie, any versus no income from government incentive schemes and grants). The MABEL questionnaire also collects data on practice and GP characteristics; we used the variables that indicate the practice size (the number of GPs and the number of administrative staff in the practice), the GP’s business relationship with the practice, the geographic location of the practice and the sex of the GP.

First, we established the trend in the use of incentive payments, and disaggregated this to show entry to and exit from receiving incentive payment income. To describe the factors that influence incentive use by GPs, we estimated a probit regression model with incentive use as the outcome variable and a number of practice- and GP-level explanatory variables (eg, practice size, relationship with practice, location). We used multivariate methods to control for these multiple factors simultaneously in determining what influences incentive use by GPs. We derived average marginal effects to estimate the difference in probability that a GP with a specific characteristic (eg, inner regional practice location) will participate in the incentive scheme compared with the reference characteristic (city location). We estimated the model in each of the 4 years of the survey, 2008–2011, to determine whether these changed over time. Analyses were conducted with Stata, version 12.0 (StataCorp).

The study was part of a research program approved by the University of Technology Sydney Human Research Ethics Committee (UTS HREC REF NO. 2009-143P).

Results

Almost all GPs (90%) reported receiving 10% or less of their income from government incentive and grant schemes. Around half (47%) reported receiving some incentive or grant income in 2008, and this number fell to 43% by 2011, with most of the decline occurring between 2008 and 2009. This small change does not tell us about stability in the individuals participating in these schemes. Box 1 shows the transitions in participation in grant and incentive programs for each 2-year period. Overall, around a third of doctors changed their participation in any year, but as the rate of exit from the schemes was higher than the rate of entry, overall participation fell.

Box 2 shows the results of the regression models for each of the years. Overall, there was little change in which characteristics were significant from year to year, so we focus here on 2008 and 2011. GPs working in larger practices, particularly those with more than 10 GPs, were more likely to be using incentives. Doctors working in such practices (relative to those in solo practice) were 13.6% (95% CI, 6.9%–20.3%) and 10.8% (95% CI, 3.4%–18.2%) more likely to use incentive schemes in 2008 and 2011, respectively. The number of administrative staff in the practice was another indication of practice size. In 2008, GPs working in a practice with more than 10 administrative staff (relative to practices with no administrative staff) were 10.8% (95% CI, − 0.4%–22.0%) more likely to use incentive schemes. In 2011, this effect was much larger and statistically more significant at 27.1% (95% CI, 15.8%–38.4%) more likely to use incentive schemes.

The GP’s relationship with the practice was also significant. Compared with associates, principals and partners were more likely, and salaried employees, contracted employees and locums were all less likely to be using incentive schemes.

By far the largest predictor of incentive scheme use was the location of the GP’s practice. Relative to GPs in city practices, those in inner regional practices were 20.2% (95% CI, 16.6%–23.7%) and 22.2% (95% CI, 18.6%–25.7%) more likely to be using incentives in 2008 and 2011, respectively. This effect was even larger for GPs in outer regional practices, who (relative to GPs in city practices) were 33.6% (95% CI, 29.4%–37.7%) more likely to use incentive schemes in 2008 and 37.2% (95% CI, 33.2%–41.2%) more likely to do so in 2011. Finally, the sex of GPs does not appear to be a significant predictor of incentive use.

Discussion

Financial incentives other than Medicare Benefits Schedule-based fees for service were first introduced in Australia in 1996. Although the program has undergone many changes since its inception, it has been stable since 2006. Our results confirm previous findings that the proportion of income derived from incentive schemes and grants in Australian primary care has not been large.3 In the MABEL longitudinal sample, less than half of the GPs received any income from incentives in 2008 and, 3 years later, this proportion had decreased by several percentage points. This is consistent with the observed fall in PIP payments3 although we acknowledge that these are paid to practices while our data show use of incentive and grant schemes by individual GPs. More in-depth analysis of changes across the 4 years of our study shows a more surprising trend — that there was a high rate of turnover among GPs who used these schemes, with some starting to use them, but a larger number ceasing to do so. There have been a number of changes to grants and incentives since the introduction of the Better Practice Program in 1996. However, the most recent changes — such as the Enhanced Primary Care Package, the SIPs, the increase in the GP attendance rebate to 100%, higher rebates for after-hours attendances, and new items for mental health services — had been introduced before 2008. Therefore, for the period of this study, entry and exit to the schemes would be expected to be stable.

It is not surprising that GPs’ practice location was associated with incentive use, as a number of additional incentives are available for GPs in rural areas. Two PIPs are aimed exclusively at rural practices; one for practising in a rural location and one for performing certain non-referred services in rural locations. The effect of rural (this includes both inner and outer regional) locations did not change very much over the 4 years, which again is in line with the fact that the relevant policies have largely remained unchanged over this period, but in contrast to the retention of urban GPs.

Practice size, measured both by the number of GPs and the number of administrative staff in the practice, was a significant factor in incentive use in both 2008 and 2011. However, the effect of having more than 10 GPs in the practice diminished in magnitude from 2008 to 2011 while the effect of having a large number of administrative staff increased about 2.5 times in this period. This is consistent with there being a large administrative burden associated with claiming incentives.

The relationship of the GP with the practice was also important. Principals were more likely to claim incentive payments, and this may be due largely to payments being made to the practice. The Australian National Audit Office estimated that about two-thirds of general practices participated in the PIP,3 a somewhat larger proportion than of individual practitioners. The effects of GPs’ different relationships with the practice seemed to increase in magnitude over the 4 years, but the MABEL data had no further information on the conditions of contract and salaried GPs, so we were unable to explore this further. Although these GPs may claim incentives, these may be paid to the practice rather than the individual practitioners, and thus do not affect individual income.

Although the MABEL dataset covers many aspects of medical practice, there is a lack of detail on aspects of employment and income. The data simply do not distinguish different types of payments, such as PIPs, from service-related payments, such as SIPs. A major potential limitation of our study is the representativeness of the MABEL sample. Generalisability in terms of age, sex and location is ensured. However, it is much more difficult to understand and compare sizes and styles of practice (including the effects of increasing corporatisation), which are likely to be relevant in our analysis.

Nonetheless there are several implications for continuing or extending the use of financial incentives in Australian general practice. It is important to consider the administrative cost of claiming any incentive, as well as the cost of providing the service relative to the reward. The decreasing participation of urban GPs may reflect some blunting of the incentive effects of relatively small payments, as they become less effective over time. The higher retention of rural practitioners in claiming incentives may reflect a higher reward relative to effort for rural incentives, or the characteristics of rural practice. The response to incentives depends not just on the design of the incentive, but also on other conditions, such as levels of demand for, or changes in approaches to treatment. For example, faced with increasing demand. it may involve less effort to increase the number of consultations than to claim additional payments. This also applies to disincentives, such as reduced rebates and/or higher patient copayments. For these reasons, financial incentives should be reviewed and evaluated regularly. Finally, this and similar studies only show the use of incentives by providers. The impact on patients, their care and their health also warrants investigation in any evaluation of the role of financial incentives.

1 Transitions in the proportion of doctors receiving payments from government incentive schemes and grants, 2008–2011

 

Year 1/Year 2


Payments

2008/2009

2009/2010

2010/2011

2008/2011


Received payments in Year 1

47.7%

43.8%

44.0%

43.8%*

Received payments in Year 1, did not participate in Year 2

38.4%

34.5%

34.7%

41.1%

Did not participate in Year 1, received payments in Year 2

27.5%

25.2%

26.0%

29.4%

Changes in participation as a percentage of total participation

32.7%

29.2%

29.9%

35.0%


* Received payments in 2011.

2 Marginal effects (standard errors and 95% confidence intervals) of factors associated with an increased likelihood of general practitioners claiming any government incentive schemes and grants

 

Year


Factors

2008

2009

2010

2011


Total observations

3906

3662

3664

3436

No. of GPs in practice
(reference, 1)

       

2–5

0.061* (SE, 0.028;
95% CI, 0.006 to 0.116)

0.079 (SE, 0.030;
95% CI, 0.020 to 0.138)

0.096 (SE, 0.032;
95% CI, 0.033 to 0.159)

0.086 (SE, 0.032;
95% CI, 0.023 to 0.150)

6–10

0.083 (SE, 0.030;
95% CI, 0.024 to 0.142)

0.038 (SE, 0.033;
95% CI, − 0.026 to 0.102)

0.088* (SE, 0.034;
95% CI, 0.020 to 0.155)

0.053 (SE, 0.034;
95% CI, − 0.014 to 0.121)

> 10

0.136 (SE, 0.034;
95% CI, 0.069 to 0.203)

0.067 (SE, 0.037;
95% CI, − 0.005 to 0.138)

0.093* (SE, 0.038;
95% CI, 0.019 to 0.166)

0.108 (SE, 0.038;
95% CI, 0.034 to 0.182)

No. of administrative staff
in practice (reference, 0)

       

1–5

0.062 (SE, 0.053;
95% CI, − 0.042 to 0.165)

0.044 (SE, 0.058;
95% CI, − 0.069 to 0.157)

0.042 (SE, 0.058;
95% CI, − 0.073 to 0.156)

0.086 (SE, 0.053;
95% CI, − 0.018 to 0.191)

6–10

0.052 (SE, 0.056;
95% CI, − 0.057 to 0.162)

0.066 (SE, 0.060;
95% CI, − 0.053 to 0.184)

0.064 (SE, 0.061;
95% CI, − 0.055 to 0.184)

0.121* (SE, 0.056;
95% CI, 0.012 to 0.231)

> 10

0.108 (SE, 0.057;
95% CI, − 0.004 to 0.220)

0.144* (SE, 0.062;
95% CI, 0.021 to 0.266)

0.157* (SE, 0.063;
95% CI, 0.035 to 0.280)

0.271 (SE, 0.058;
95% CI, 0.158 to 0.384)

GP’s relationship with practice
(reference, associate)

       

Principal or partner

0.099 (SE, 0.023;
95% CI, 0.054 to 0.144)

0.058* (SE, 0.023;
95% CI, 0.012 to 0.103)

0.029 (SE, 0.024;
95% CI, − 0.018 to 0.075)

− 0.015 (SE, 0.025;
95% CI, − 0.064 to 0.034)

Salaried employee

− 0.109 (SE, 0.032;
95% CI, − 0.171 to − 0.047)

− 0.164 (SE, 0.031;
95% CI, − 0.225 to − 0.103)

− 0.206 (SE, 0.030;
95% CI, − 0.265 to − 0.147)

− 0.192 (SE, 0.031;
95% CI, − 0.254 to − 0.131)

Contracted employee

− 0.142 (SE, 0.022;
95% CI, − 0.184 to − 0.099)

− 0.188 (SE, 0.020;
95% CI, − 0.228 to − 0.148)

− 0.243 (SE, 0.020;
95% CI, − 0.282 to − 0.203)

− 0.216 (SE, 0.021;
95% CI, − 0.257 to − 0.174)

Locum

− 0.132* (SE, 0.053;
95% CI, − 0.236 to − 0.027)

− 0.215 (SE, 0.059;
95% CI, − 0.330 to − 0.100)

− 0.277 (SE, 0.055;
95% CI, − 0.385 to − 0.168)

− 0.147 (SE, 0.057;
95% CI, − 0.258 to − 0.036)

Practice location
(reference, city)

       

Inner regional

0.202 (SE, 0.018;
95% CI, 0.166 to 0.237)

0.228 (SE, 0.018;
95% CI, 0.194 to 0.263)

0.161 (SE, 0.018;
95% CI, 0.125 to 0.196)

0.222 (SE, 0.018;
95% CI, 0.186 to 0.257)

Outer regional

0.336 (SE, 0.021;
95% CI, 0.294 to 0.377)

0.288 (SE, 0.021;
95% CI, 0.247 to 0.329)

0.288 (SE, 0.020;
95% CI, 0.247 to 0.328)

0.372 (SE, 0.020;
95% CI, 0.332 to 0.412)

Sex of GP (reference, female)

       

Male

0.007 (SE, 0.016;
95% CI, − 0.024 to 0.037)

0.015 (SE, 0.016;
95% CI, − 0.016 to − 0.046)

0.005 (SE, 0.016;
95% CI, − 0.025 to 0.036)

0.015 (SE, 0.016;
95% CI, − 0.016 to 0.047)


* Significant at P ≤ 0.05. † Significant at P ≤ 0.01.

Health at the core of closing the gap

AMA President Associate Professor Brian Owler has warned that governments need to increase their investment in health in order to close the yawning gap in life expectancy and wellbeing between Indigenous people and other Australians.

In a veiled swipe at the Federal Government’s policy focus on school attendance and employment in Indigenous communities, A/Professor Owler told a major international conference on the social determinants of health that too often the importance of wellbeing was overlooked.

“Health is the cornerstone on which education and economics are built,” the AMA President said. “If you can’t go to school because you or your family are sick, truancy officers won’t work. If you can’t hear because of otitis media, you won’t learn. If you miss training opportunities because of depression or ill health, you won’t progress to employment. You can’t hold down a job if you keep having sick days.”

His remarks to a British Medical Association symposium on the role of physicians in addressing the social determinants of health came a month after Prime Minister Tony Abbott admitted that the nation had fallen behind on meeting most of its Closing the Gap targets.

While there has been some improvement in the life expectancy of Aboriginal and Torres Strait Islander people, Indigenous men still on average 10.6 years earlier than other Australian males, and the gap for women is 9.5 years.

In his speech, A/Professor Owler said that in many respects the term ‘social determinants of health’ was misconstrued, because health was in fact a determinant of social and other outcomes.

He said the fact that chronic and non-communicable diseases and other preventable occurrences such as suicide, trauma and injury accounted for a major proportion of the gap in life expectancy underlined the need for greater investment in health care, particularly Aboriginal community controlled health services.

“While those with chronic disease need to be cared for, prevention, particularly in the early part of life, is the key if we are going to see a generational change in health outcomes,” A/Professor Owler said.

He said hard-earned experience showed that health was fundamental to closing the gap, as was the need to work in partnership with Indigenous communities themselves.

“There have been many examples of governments trying to address the social determinants of health – but often they have failed,” he said, referring to policies including building inappropriate housing and taking children from their families.

The AMA President said any attempt to improve Indigenous health needed to acknowledge the fundamental importance for Aboriginal and Torres Strait Islander people of their connection with the land, and understand that in many Aboriginal languages health was a concept of social and emotional wellbeing rather than a physical attribute.

He told the London conference that this was one of reasons why the AMA was a foundation member of the campaign to achieve constitutional recognition for Indigenous Australians.

“Constitutional recognition is a vital step towards making Aboriginal and Torres Strait Islander people feel historically and integrally part of the modern Australian nation,” A/Professor Owler said. “Recognising Indigenous people in the Constitution will improve their self-esteem, their wellbeing, and their physical and mental health.”

Prime Minister Tony Abbott has taken a personal interest in Indigenous affairs, concentrating responsibility for many Indigenous policy areas within the Department of Prime Minister and Cabinet and overseeing the development of the Indigenous Advancement Strategy.

Priorities for the Strategy include improving school attendance, boosting Indigenous employment and improving community safety.

A/Professor Owler said these were all worthy aims, but the Strategy overlooked the central importance of health.

“What is missing from the core of the IAS is a focus on health,” the AMA President said. “Health underpins many of these outcomes. We need to get the balance right and we, the AMA, need to ensure that health is seen as a foundation to these outcomes.”

He said that “spending on health is an investment. Investing in health must underpin our future policies to Close the Gap, and to address what is, for Australia, a prominent blight on our nation”.

Adrian Rollins

 

 

Health at the core of closing the gap

AMA President Associate Professor Brian Owler has warned that governments need to increase their investment in health in order to close the yawning gap in life expectancy and wellbeing between Indigenous people and other Australians.

In a veiled swipe at the Federal Government’s policy focus on school attendance and employment in Indigenous communities, A/Professor Owler told a major international conference on the social determinants of health that too often the importance of wellbeing was overlooked.

“Health is the cornerstone on which education and economics are built,” the AMA President said. “If you can’t go to school because you or your family are sick, truancy officers won’t work. If you can’t hear because of otitis media, you won’t learn. If you miss training opportunities because of depression or ill health, you won’t progress to employment. You can’t hold down a job if you keep having sick days.”

His remarks to a British Medical Association symposium on the role of physicians in addressing the social determinants of health came a month after Prime Minister Tony Abbott admitted that the nation had fallen behind on meeting most of its Closing the Gap targets.

While there has been some improvement in the life expectancy of Aboriginal and Torres Strait Islander people, Indigenous men still on average 10.6 years earlier than other Australian males, and the gap for women is 9.5 years.

In his speech, A/Professor Owler said that in many respects the term ‘social determinants of health’ was misconstrued, because health was in fact a determinant of social and other outcomes.

He said the fact that chronic and non-communicable diseases and other preventable occurrences such as suicide, trauma and injury accounted for a major proportion of the gap in life expectancy underlined the need for greater investment in health care, particularly Aboriginal community controlled health services.

“While those with chronic disease need to be cared for, prevention, particularly in the early part of life, is the key if we are going to see a generational change in health outcomes,” A/Professor Owler said.

He said hard-earned experience showed that health was fundamental to closing the gap, as was the need to work in partnership with Indigenous communities themselves.

“There have been many examples of governments trying to address the social determinants of health – but often they have failed,” he said, referring to policies including building inappropriate housing and taking children from their families.

The AMA President said any attempt to improve Indigenous health needed to acknowledge the fundamental importance for Aboriginal and Torres Strait Islander people of their connection with the land, and understand that in many Aboriginal languages health was a concept of social and emotional wellbeing rather than a physical attribute.

He told the London conference that this was one of reasons why the AMA was a foundation member of the campaign to achieve constitutional recognition for Indigenous Australians.

“Constitutional recognition is a vital step towards making Aboriginal and Torres Strait Islander people feel historically and integrally part of the modern Australian nation,” A/Professor Owler said. “Recognising Indigenous people in the Constitution will improve their self-esteem, their wellbeing, and their physical and mental health.”

Prime Minister Tony Abbott has taken a personal interest in Indigenous affairs, concentrating responsibility for many Indigenous policy areas within the Department of Prime Minister and Cabinet and overseeing the development of the Indigenous Advancement Strategy.

Priorities for the Strategy include improving school attendance, boosting Indigenous employment and improving community safety.

A/Professor Owler said these were all worthy aims, but the Strategy overlooked the central importance of health.

“What is missing from the core of the IAS is a focus on health,” the AMA President said. “Health underpins many of these outcomes. We need to get the balance right and we, the AMA, need to ensure that health is seen as a foundation to these outcomes.”

He said that “spending on health is an investment. Investing in health must underpin our future policies to Close the Gap, and to address what is, for Australia, a prominent blight on our nation”.

Adrian Rollins

 

 

Choosing wisely: the message, messenger and method

Insights to guide Choosing Wisely activities in Australia, based on a South Australian Clinical Senate exercise

International movements are seeking to identify and reduce the use of health care services that provide little or no benefit, whether through overuse or misuse. England’s National Institute for Health and Clinical Excellence commenced a formal policy agenda in this area in 2005;1 however, the first truly physician-driven exercise commenced in 2009 in the United States.

The American Board of Internal Medicine Foundation invited professional societies to step forward as “stewards of finite health care resources”.2 Initially, groups of volunteers from three primary care specialties developed top-five lists. These lists described specialty-specific practice changes that would improve patient outcomes through better treatment choices, reduce risks and, where possible, reduce costs.

In 2012, the program was formally launched as the Choosing Wisely campaign, involving lists from nine specialty societies and including a patient-education component. In 2014, about 50 additional specialty societies joined, and clinicians put forward hundreds of health care practices as being interventions of limited value.2

The US Choosing Wisely campaign is unique in how it has framed its message, who has stepped forward as the messenger, and the proposed optimal methods for developing lists of inappropriate health care practices. In this article, we reflect on the relevance of this campaign for Australia.

The message and the messenger

The lists, entitled Five things physicians and patients should question, set an explicit premise to “spark discussion about the need — or lack thereof — for many frequently ordered tests and treatments”.2 These lists are freely available to the public via the internet, have been endorsed by consumer organisations and are supported by educational resources for consumers and health care professionals. The main objective of Choosing Wisely is one of improved safety and quality through a reduction in practices that are, at best, of little to no clinical utility and, in certain situations, harmful. The campaign recognises that the opportunity costs of expending scarce resources on low-value care means they are foregone and cannot be used in other areas where high-value care could have been delivered.

The engagement of about 60 US colleges and professional societies in the program is an acknowledgement by frontline clinicians that in some areas of care, less is more. Clinician leadership by specialty societies and engagement of consumer organisations greatly increase the likelihood of success. The US campaign has, however, been criticised for the variability of methods employed by the specialty groups, and the potential bias this has introduced to the process.3

The method

International programs such as Choosing Wisely have focused on creating momentum for clinicians to reflect on their work practices and take individual and collective responsibility for selecting health practices of limited value. They aim to change behaviour, rather than rely on policymakers or administrators to achieve similar outcomes.

Although the aims of the US Choosing Wisely campaign have been consistent, the methods employed for list development have not. Some services included on US lists have fallen under scrutiny for varying widely in terms of their potential impact on care and spending without a consistent approach in terms of cost, volume or potential for harm. Some societies’ lists have been criticised for including low-impact items while excluding high-impact items.4 Furthermore, some participating societies have named other specialties’ services as low value, avoiding their own.

A recent analysis4 showed the most common service types listed by the first 25 Choosing Wisely participants: 29% of listed items target radiology; 21%, cardiac testing; 21%, medications; 12%, laboratory tests or pathology; and 18%, other. It is clear from the numbers that some interventions have been double counted. It is also feasible that groups (eg, primary care, emergency medicine) are reflecting on the tests they order (eg, radiology, pathology) rather than carry out (and vice versa).

The broadest criticism is that most societies have not detailed the methods by which their lists were created. This has led to one particularly harsh comment,

In some cases, it is clear that the lists were developed without much input from frontline practitioners, using a process that was not transparent and without clear criteria for inclusion …3

At the other end of the spectrum, the method employed by the American College of Emergency Physicians (ACEP)5 has been held up as the gold standard3 because it:

  • used existing work of the ACEP Cost Effective Care Task Force;
  • surveyed the entire ACEP membership and grouped results into domains which were prioritised using serial voting;
  • reviewed the literature to establish a solid evidence base that specifically sought to include available cost data; and
  • made panellists’ disclosures and conflicts of interest publicly available.

The contribution of the ACEP list is as much about methodology (broad college discussion, practitioner surveys, transparency, clinician engagement, modified Delphi technique and solid scientific foundations) as it is about the final recommendations.3

A fundamental consideration is to ensure item development is evidence-based. As suggested by existing lists, services that are inappropriate for all patients and indications are rare. Typically, a service has safety and effectiveness profiles that depend on the characteristics of the patient to whom it is provided; a service that is of low value in certain clinical circumstances might be of high value in others. It is precisely for this reason that understanding of the local health care context is critical to identifying practices whose reduction is achievable and will have an impact in terms of quality improvement.6

An Australian experience in choosing wisely

In October 2013, the South Australian Clinical Senate met to consider health care quality improvement. The Senate is a diverse group of practising clinical experts who provide advice to the Minister and Chief Executive of the SA Department of Health and Ageing. The meeting was divided into a morning meeting of emerging clinical leaders and an afternoon session of the full (senior) Clinical Senate. Both groups had the opportunity to hear the case for quality improvement and economic reform of the health system.

As leaders of this clinical consultation group, including an invited content expert (A G E), we asked all senators (junior and senior) to provide, anonymously, their individual list of top-five items in line with the objectives of the Choosing Wisely campaign. Summary results (of the full report7) are presented in the Box. We provided all participants with a range of preparatory materials, which included an evidence-based list of low-value health care practices. The top-five identified were:

  • computed tomography pulmonary angiography for low-risk pulmonary embolism;
  • routine inpatient blood tests, electrocardiograms, medical imaging and preoperative screening investigations;
  • antibiotics, including prophylactic use;
  • arthroscopies in general; and
  • duplication of diagnostic testing with change of care teams or between health care contexts.

As might be expected, there was a high level of sensitivity (many selections) and poor specificity (focus). Further, while we often think of bias as reflecting perverse individual interests (and the protection of these), bias can also merely reflect an awareness of services based on one’s own exposure or proximity to their occurrence. Our results showed that relative temporal exposure can affect perceptions of services. This was particularly stark in our findings of differences in choice of top-five items between the emerging and established clinical leadership groups. Junior senators, while offering many purely clinical items, were far more likely to nominate work practices, protocols and processes of care as contributing to areas of low-value care; their senior colleagues focused on therapeutic and diagnostic practices. The role that experience plays is not explored in any Choosing Wisely literature that we have been able to identify, and points to a methodological nuance that any group devising similar initiatives might find valuable.

Conclusions

Existing lists of low-value services vary in level of cross-representation of items from Choosing Wisely.1,6,8 If Australian specialty colleges sought to replicate this initiative, how might they go about maximising list validity while minimising the limitations raised in the US?

We recommend the following steps.

  • Consider the methodological principles set out by the ACEP. What constitutes a gold-standard approach is debatable, but it should be transparent and inclusive.
  • Consider using existing lists to compile a mega-list1,2,6,8 of items, adding any others nominated by group members.
  • Seek explicitly to capture the views of emerging as well as experienced clinicians before working towards prioritisation with (for example) methods employed by the ACEP, and informed as necessary by complementary prioritisation tools.9
  • As a novel element, establish two top-five lists: one for clinical services and another reflecting administrative, policy and process waste.
  • Consider including other health care providers so that all clinical staff are surveyed for their unique, evidence-based perspectives of waste.

Finally, consumer representative organisations must also step forward, as they did in the US, to ensure any campaign complements the role of clinical autonomy while empowering and incorporating patients as partners in choosing wisely.

Summary results for the South Australian Clinical Senate Choosing Wisely items

Health care practice

Emerging leaders

Clinical senators

Evidence-based list8


Overuse or use not indicated under current guidelines or funding models

Routine inpatient blood tests, electrocardiography and diagnostic imaging for preoperative screening*

+

+

+

CT pulmonary angiography for low-risk pulmonary embolism*

+

+

CT of the brain without CNS signs

+

+

CT, MRI and x-ray for back pain

+

+

+

C-reactive protein

+

+

+

D-dimer testing

+

+

Antibiotics, including prophylactic use*

+

+

Proton-pump inhibitors

+

Statins

+

Stenting of non-critical coronary arteries

+

+

Physiotherapy

+

+

Sleep studies

+

+

Caesarean section

+

+

Bariatric surgery

+

Tonsillectomy

+

+

Prostate-specific antigen testing

+

+

Arthroscopy*

+

+

+

Steroid joint injections

+

+

Vitamin D testing

+

+

+

Grommets

+

+

+

Cardiac MRI

+

Surgery for chronic back pain

+

+

Robotic surgical techniques

+


CT = computed tomography. CNS = central nervous system. MRI = magnetic resonance imaging. + Identified by clinicians for inclusion in lists of low-value health care practices. − Not identified by clinicians for inclusion in lists of low-value health care practices. * One of five most commonly identified interventions of potentially limited value.

Summary results for the South Australian Clinical Senate Choosing Wisely items (continued)

Health care practice

Emerging leaders

Clinical senators

Evidence-based list8


Work practice protocols and processes of care

Duplication of diagnostic testing with change of care teams or between contexts*

+

+

na

Excessive outpatient referrals and follow-up

+

+

na

Excessive hospital delivery of care

+

na

Duplication of or excessive documentation; process duplication on electronic platforms

+

na

Delays in assessment for and discharge to placement

+

na

Clinical care delivery by inappropriate health care professional

+

na

Innovations in care such as acute medical units, clinical networks, hospital at home

+

+

na

Medical emergency teams

+

na

Use of locum and agency health care workers

+

na

Time and cost associated with excessive packaging (unpacking, disposing of)

+

na

Interventions in the context of limited life expectancy

Cataract surgery

+

na

Cardiac surgery

+

na

Surgery while on life support

+

na

Intensive care

+

+

na

Chemotherapy for advanced malignancy

+

na

Implantable cardiac devices

+

+

na

Hip replacements and surgery for fractures

+

+

na

Percutaneous enteric gastrostomy feeding

+

na

Faecal occult blood testing

+

na

Blood transfusions

+

na

Drugs such as statins and vitamin D replacement

+

na


na = not applicable. + Identified by clinicians for inclusion in lists of low-value health care practices. − Not identified by clinicians for inclusion in lists of low-value health care practices. * One of the five most commonly identified interventions of potentially limited value.

The serious challenge of medical research

Imagination is more important than knowledge. For knowledge is limited, whereas imagination embraces the entire world, stimulating progress, giving birth to evolution. It is, strictly speaking, a real factor in scientific research.

Albert Einstein

Two emails that landed on my computer screen recently gave clues to the amazing pace and reach of medical research. Both advertised conferences: one planned for Boston in July, and the other in San Diego in March this year.

The Boston meeting, entitled the Organ-on-a-Chip World Congress, is rather breathlessly described as concerning “assemblies of cell clusters using microfluidics that mimic in vivo organ structure”. Technology options to be reviewed at the congress resemble a fast-food menu — Lung-on-a-Chip, Brain-on-a-Chip and Gut-on-a-Chip.

The San Diego conference, Biomarker Summit 2015, will consider “all aspects of the biomarker and diagnostic development process from discovery to translation to commercialization”, with topics covering “big data analytics and management, regulatory and reimbursement trends, companion diagnostics development, and much more”.

In contemplating the future of medical research in Australia, the international context, typified by what lies behind these two meetings, is critical. Two features stand out.

Biology — make way for IT

First, wherever you look, the massive contributions to medical research by non-biological sciences are paramount. Craig Venter, a gene scientist who sequenced the human genome, states in his book Life at the speed of light that genetic research and information science are so interwoven as to be inseparable. His book takes its title from his suggestion that if a sophisticated probe found life in deep water below the surface of Mars, an on-board sequencer could decipher and digitise its genome and radio the code at the speed of light to a laboratory on earth (presumably his), to be reconstituted to build a Martian organism.

In neuroscience also, technology not thought of as medical is now thoroughly integrated with biology. Workers studying changes in brain function as they relate to behaviour depend heavily on such technology. Denis Le Bihan, a French neuroscientist and major inventor of imaging techniques, extols the contribution of magnetic resonance imaging to our understanding of brain function in his new book Looking inside the brain.

Neuroscience leapt forward in the 1970s when computerised neuroimaging became available to the research and clinical communities. Physics underpinned the development of the electroencephalograph. New levels of neurological and psychiatric understanding are leading to new therapies, such as deep brain stimulation. Depression, Bihan suggests, may soon be seen as a feature of many abnormalities, just as the once-solid disease called “fever” broke apart when its multiple causes were found. In all these discoveries, engineering, information science and mathematics are deeply embedded.

Medical research is good economics

Second, we need to see research much more clearly, as others are doing, as a major economic opportunity for government and the private sector alike. The two conferences I mentioned are almost entirely private sector-sponsored. Medical research is an intellectual industry. Smart, future-oriented economic thinking would be seeking ways to position Australia at the head of the pack. Pedalling happily in the Alpine sunshine at the back of the peloton is just plain dumb economics. The oft-repeated (appalling) mantra that we are “punching above our weight”, based on publications, seriously mistakes past achievement for future opportunity. Research is a fierce competition. Winners do well. They need expensive support teams.

How is it that our major project grants scheme — the National Health and Medical Research Council — supports fewer than one in five applicants? If one in five missed out, the arrangements would be credible.

It is among the project grants that bright, risky and imaginative ideas are often found. Imaginative questions are the essence of research: yes, it does require high-tech and massive investment to prosper, but if the intellectual electricity is missing, the wheels do not turn. Were the Medicare levy raised by 0.5%, the $3 billion raised each year could be applied to medical research — an amount much larger, and more equitably procured, than was to be raised through the proposed copayment for Medicare services. There would be no sitting and waiting for a future fund to bear fruit.

A big increase in our present fund also makes investment sense, so that we can more appropriately match the achievements of our economic peers and grow the world’s best research community, fit for future purpose, from our large talent pool. Channelling Henry Ford, we may say that what’s good for research is good for Australia.

While no one should promise that medical research will find a cure for cancer or Alzheimer’s disease, at least not in the next few years, it is certain that we will not find a cure any other way. Fortunately we live in a gilded age of science, and all of it — not just the disciplines classically seen as medical — has a contribution to make to medical achievement. It requires political and private enterprise and vision to enable it, through generous, imaginative funding.

Costs to Australian taxpayers of pharmaceutical monopolies and proposals to extend them in the Trans-Pacific Partnership Agreement

Intellectual property (IP) provisions being pursued by the United States in the 12-country Trans-Pacific Partnership Agreement (TPPA) negotiations have generated widespread alarm since the initial US proposals were leaked in 2011.15 Subsequent leaks of composite drafts of the IP chapter have shown ongoing resistance by most countries to many of the US proposals that would delay access to generic medicines.6,7 But while the most recently leaked draft suggests some modifications in the US position,7 major concerns related to medicines access remain unresolved.

This article focuses on three particular problems for Australia that remain in the 2014 draft. These are provisions that would further entrench secondary patenting and evergreening, lock in extensions to patent terms, and extend data protection for certain medicines. If agreed by negotiating countries, these provisions would future-proof existing low standards that are antithetical to promoting access to, and affordability of, medicines. These will not only extend monopolies over expensive new treatments, but will also make subsequent reform efforts increasingly difficult.

For each of the problems identified, we examined existing public domain data, drawn primarily from the 2013 Pharmaceutical Patents Review (PPR) and submissions to it, to identify the costs to Australian taxpayers of existing patent and data protection provisions, as well as those likely to accrue to taxpayers if the Australian Government accedes to US ambitions on these matters.

Secondary patents and evergreening

The pharmaceutical industry uses a practice known as evergreening to extend monopoly periods for medicines. Secondary patents are patents of very low inventiveness based on an original inventive patent for a new molecule. Evergreening patents are secondary patents held by the owner of the original patent. Evergreening presents a particular problem in countries with low patentability standards, such as Australia and the US.8,9

US researchers examined patents granted for two HIV drugs (ritonavir and lopinavir/ritonavir) and found that Abbott owned 82 secondary patents and had a further 26 pending applications in the US, all of which involved small variations on the original patents for these drugs.9 They found that these evergreening patents could delay generic competition for 19 years beyond the date from which generic entry would have been anticipated.9 This problem is largely due to low standards for patent grant, together with barriers to the challenge and revocation of questionable patents.

A study in Australia found an average of 49 secondary patents for each of the 15 highest-cost drugs over a 20-year period.10 One-quarter of these secondary patents were evergreening patents.

Evergreening delays generic market entry and imposes large unnecessary costs on the health care system — and on consumers. When a patent on a medicine expires and the first generic version is listed on the Pharmaceutical Benefits Scheme (PBS), a statutory reduction of 16% is applied to the PBS price and it is moved from the F1 to the F2 formulary. There, it becomes subject to the application of price disclosure,11 which further lowers prices over time.

Generic medicines manufacturer Alphapharm (a subsidiary of US-based Mylan) stated in its public submission to the PPR that:

In the case of Plavix (clopidogrel) the cost to the PBS of a near 3-year delay in the generic market entry caused by the grant of an interim injunction over an evergreening patent that was subsequently revoked has been estimated to be about $60 million. However, the total cost to the PBS attributable to the revoked patent has been estimated to be about $644 million (p. 6).12

The Australian Generic Medicines Industry Association analysed the costs to the health system for 39 PBS-listed medicines for which generic competition was delayed after the patent on the active pharmaceutical ingredient expired, as a result of secondary patenting.13 In the 12 months to November 2012, the cost of delayed generic launch was calculated at $37.8–$48.4 million. This estimate does not include subsequent price reductions due to price disclosure.

An illustration of how this affects consumers comes from the patents associated with an antidepressant, venlafaxine (Efexor). Two additional patents support the extended-release form, Efexor-XR. One of these was so broad that it delayed generic entry by two and a half years. By the time this patent was eventually declared invalid, the delay to generic market entry had cost Australian taxpayers $209 million.14

Pfizer also successfully patented desvenlafaxine (marketed as Pristiq), the active metabolite of venlafaxine. Not only was a patent granted for desvenlafaxine, it was also given a term extension until August 2023. There is no evidence that Pristiq offers any clinical benefit over venlafaxine.15,16 But the cost to taxpayers of doctors prescribing Pristiq in preference to off-patent Efexor-XR has been estimated at more than $21 million per year.14

The problem of evergreening in Australia is likely to be entrenched further by the provisions of the TPPA. A footnote to draft TPPA article QQE1 sets the current very low inventiveness approach in stone, making it difficult, if not impossible, to prevent further evergreening.17 Australia is supporting a provision that commits countries to make patents available for “any new uses, or alternatively, new methods of using a known product” (Art. QQE1.4(a)),7 as this is current Australian practice. But acceding to this provision in the treaty text will limit Australia’s options for much needed patent reform in future.

Patent term extension

Australia is obliged to provide 20-year patents under the World Trade Organization’s Agreement on TRIPS (Trade-Related Aspects of Intellectual Property Rights). In 1998, patent term extension provisions were introduced, allowing up to 5 years for delays in processing patent applications or in the regulatory approval process. These provisions were later locked in by the obligations of the Australia–US Free Trade Agreement (AUSFTA).3

The PPR found that about 58% of new molecules listed on the PBS from 2003 to 2010 received extensions of term. Of the term extensions granted since 1999, 47% received the full 5 years.18 The cost of these extensions to the PBS in 2012–13 was estimated at about $240 million in the medium term and about $480 million in the longer term.18

The PPR found that, contrary to claims by the pharmaceutical industry, there was no evidence that the public investment in extensions of term had led to a commensurate increase in investment in research and development.18 The PPR concluded that patent term extension was not in Australia’s interests, and recommended reducing the maximum length of extensions or the maximum effective patent life.

The most recent draft TPPA IP text includes provisions for term extensions for delays in the processing of patents and in the regulatory approval process.7 While the leaked text indicates opposition by Australia to the former, and the latter is consistent with the AUSFTA, patent term extension has been widely reported as an area where the US has little support from other countries. Moreover, the Therapeutic Goods Administration (TGA) regulatory approval process for medicines is subject to a statutory time limit of 255 working days, after which the TGA forfeits 25% of the evaluation fee (Therapeutic Goods Regulations 1990 [ss. 16C; 43AA]). Thus, the routine granting of extensions to compensate for rare delays in the marketing approval process makes little sense.

Earlier leaked TPPA negotiating documents show that the US was seeking to mandate patent term extensions not just for new molecules, but also for new uses and new methods of using existing products.6 This extension of scope for term extensions seems to have been dropped from the 2014 draft,7 a likely result of opposition by other countries. No evidence presented to the PPR indicated that extending the scope of patent term extensions would be in the national interest.18

Data protection

Data protection refers to preventing or delaying the reliance, by a generic manufacturer, on clinical trial data produced by the originator to support marketing approval of its product. Under the Commonwealth Therapeutic Goods Act 1989 (s. 25A), the TGA may not consider an application for a generic medicine where that application relies on undisclosed evidence of safety and efficacy submitted in support of the originator product for 5 years from the date of first registration. Data protection confers a monopoly that is distinct from that provided by the patent system, and is effective even where a patent has not been granted, or has expired. Unlike a patent, data protection cannot be subject to legal challenge.

We are not aware of any analyses of the financial impact of data protection on the Australian health system, but studies in other countries have shown that its introduction leads to increased costs. Oxfam International found that data protection introduced in Jordan in 2001, together with other TRIPS Plus measures, delayed generic entry for 79% of medicines launched between 2002 and 2006.19 A later, more comprehensive study found that between 1999 and 2004 there was a 17% increase in total medicines expenditure in Jordan, equating to additional costs of US$18 million in 2004.20 The study concluded that data protection had the most significant effect on this price increase.

In addition to its effects on medicines expenditure, data protection also presents a potential barrier to compulsory licensing — a TRIPS-compliant strategy that countries may use to bypass patents where this is necessary for public health purposes.21

Proposals for the TPPA include 5 years of data protection for new products, an additional 3 years for data produced to support new uses of existing products, and a longer period of data protection for biologics (possibly up to 12 years).7 Biologics are produced through biotechnology processes involving living organisms; these include many new cancer, anti-rheumatic and multiple sclerosis medicines.

In the 2014 TPPA draft, data protection is limited to undisclosed data and data required by regulatory agencies, representing a narrowing of the scope in comparison with earlier drafts.7 However, extending data protection to new uses of existing products and allowing longer periods of protection for biologics are likely to lead to significant delays in the market entry of cheaper generics and biosimilars in Australia. Additional periods of 3 years of data protection for new indications were previously rejected by Australia in the AUSFTA negotiations.3

The PPR found that “data protection appears to have little impact on the levels of pharmaceutical investment in a country” (p. 160).18 It concluded that there was no evidence to indicate that current data protection provided insufficient incentives to innovate and bring biologic products to market, and recommended against extending data protection for biologics. In the US, the Federal Trade Commission also concluded that lengthy data protection for biologics was not warranted.22

A useful example of the costs of delaying market entry of competitors for biologics is adalimumab (Humira), a drug for rheumatoid arthritis and other autoimmune conditions. This drug represented the third-highest cost to government in 2013–14, costing Australian taxpayers $272.7 million.23 When the first biosimilar version is listed on the PBS, it will trigger a 16% statutory price reduction on all versions of the product. This means savings to taxpayers of $43.6 million in the first year (based on 2013–14 expenditure data), and with flow-on effects resulting from price disclosure likely to lead to further savings in subsequent years.

Conclusions

Pharmaceutical monopoly protections already cost the Australian health system hundreds of millions of dollars each year. US ambitions for the TPPA IP chapter in the most recently leaked draft would expand and entrench costly monopolies in Australia, with no evidence of any countervailing benefit to the Australian public.

The PPR warned that the current Australian patent system was not well designed to serve Australia’s interests. The government’s stated concern about the need to ensure the sustainability of the PBS can hardly be credible if it ignores this warning in the final stages of the TPPA negotiations.

Optimising treatment for Australian melanoma patients can save taxpayers millions of dollars annually

To the Editor: Patients with BRAF-mutated metastatic melanoma benefit greatly from the novel BRAF inhibitor dabrafenib and the checkpoint inhibitor ipilimumab, recently listed under the Australian Pharmaceutical Benefits Scheme (PBS). Dabrafenib results in rapid responses; but the cancer later adapts, and patients relapse rapidly. Conversely, ipilimumab slowly reactivates anticancer immunity, meaningfully improving long-term survival (up to around 20% at 5 years).

The costs of these drugs are substantial. Dabrafenib costs A$8759 per month, and median duration of therapy is 9.4 months.1 The Australian price of ipilimumab is confidential, but potentially up to A$190 000 per patient, depending on weight. The 2014 year-to-September PBS cost of ipilimumab was $68 456 890 (data from https://www.medicareaustralia.gov.au/statistics/pbs_item.shtml).

Current PBS approval mandates that dabrafenib may only be used as first-line therapy. Commencing treatment with dabrafenib then switching to ipilimumab when the disease progresses may inadvertently deliver worse outcomes than using the slower but longer acting immunotherapy followed by the potent but impermanent BRAF inhibitor.2,3 After a BRAF inhibitor fails, there is often insufficient time to deliver the full course of ipilimumab, let alone for the immune system to reactivate. While some patients’ symptoms necessitate a BRAF inhibitor upfront, most are well enough to take ipilimumab first, with dabrafenib in reserve.4

Formal randomised trials of these sequences are underway (NCT01940809, NCT01673854, NCT02224781) but our clinical experience and two international case series reinforce that administering ipilimumab then a BRAF inhibitor is very likely to be superior. (Patients treated with BRAF inhibitor then ipilimumab: objective response rate, 0; stable disease, 6%; progressive disease, 94%.3 BRAF inhibitor then ipilimumab v ipilimumab then BRAF inhibitor: overall survival, 9.9 months v 14.5 months; P = 0.04.2)

In the absence of a formal economic analysis, we assume most of the approximately 1500 Australian patients who will die with metastatic melanoma every year accept treatment.5 Forty-six per cent of these patients have BRAF-mutated melanoma;6 and of these, 85% are well enough to defer treatment with a BRAF inhibitor.4 Thus, about 585 patients receive a potentially inferior treatment sequence, and around $36 million per annum of otherwise effective treatment is administered inefficiently.

Other countries with publicly funded health care (eg, the United Kingdom) do not restrict treatment sequences in metastatic melanoma. We argue that, until randomised trials identify inferior or superior sequences, Australian melanoma patients and taxpayers would benefit from flexibility in prescribing these breakthrough treatments.

[Series] Smart food policies for obesity prevention

Prevention of obesity requires policies that work. In this Series paper, we propose a new way to understand how food policies could be made to work more effectively for obesity prevention. Our approach draws on evidence from a range of disciplines (psychology, economics, and public health nutrition) to develop a theory of change to understand how food policies work. We focus on one of the key determinants of obesity: diet. The evidence we review suggests that the interaction between human food preferences and the environment in which those preferences are learned, expressed, and reassessed has a central role.

Economics and health — how does 2015 look?

The current discussion about copayments illustrates how hard it is to make sense of the interplay of the health and economic systems, especially when political wheels are engaged. When the copayment was proposed it was said to be necessary because the health service was unsustainable. Its purpose changed on the night of the presentation of the 2014 federal Budget, to funding medical research. Later it became a price signal, despite already obvious price signals in the form of private health insurance premiums and the Medicare levy.

Our complex and large contemporary health and economic systems interact frequently. Concerns about the cost of health care are commonplace; and likewise, fears about the way in which health is determined by the economic climate in a country are frequently expressed by public health professionals. Somewhere in the machinery connecting health and economics another set of cogs and wheels clicks in — politics.

At national and international levels the power of economics on health is also immense. At the beginning of 2015 it is wise to look at how the world economy is likely to perform, because this will determine the resources available to us for health care and influence the social environment here and abroad.

In an article titled Past and future tense in The Economist of 20 December 2014, the author explores three trends in the global economy. Looking like a replay of the late 1990s, when the world began to pull away from the burst dotcom bubble — a period similar to the current post-global financial crisis period — these trends could affect us all.

First, he or she identifies “the gap between America, where growth is accelerating, and almost everywhere else, where it is slowing”. Nevertheless, a stronger dollar, while beneficial to many Americans, does not help their exporters, so comfort in the United States will not be evenly distributed.

The second trend is a “dismal outlook for the rich world’s two other big economies” — Germany and Japan. Germany stands to lose, in the opinion of the author of Past and present tense, because of a slow growth rate (1%) and a “deeper malaise caused by years of underinvestment, a disastrous energy policy and a government that is too obsessed by its fiscal targets to spend money and too frightened of voters” to push through necessary structural reforms. Japan “has repeated the error it made in 1997” by prematurely raising its consumption tax, “thwarting its escape from stagnation”. Not much help is likely from either Germany or Japan.

The third current trend towards destabilisation of the world economy that resembles what was seen in the 1990s is what is happening in developing economies, in Africa especially. Then, fixed exchange rates and huge foreign debts were the problem. Now, it is falling commodity prices. Oil comprises 95% of Nigeria’s exports, the article states. How does health care fare when the oil price is halved? Would Nigeria now, this year, be able to handle Ebola as efficiently as it did in 2014?

A major change between now and the late 1990s has been the rise of China. China’s increased wealth may serve as a buffer to many nations.

But “add all this up”, the article states, “and 2015 seems likely to be bumpy”. The US Federal Reserve Bank has little room to move, and with interest rates hovering around zero, there is little that such banks can do to stimulate economies.

“All over the rich world voters are already grumpy with their governments … If they are squeezed [in 2015] discontent will turn to anger. The economics of 2015 may look similar to the late 1990s, but the politics will probably be rather worse.”

The discourse about Australian economics does not always take account of what is happening globally, and concentrates on the errors of politicians and decisionmakers who came before. It is important to be aware of the economic trends and determinants that set the level of our national wealth (and hence the amount available for health care) and be as prepared as we can be for the health consequences of economic forces on the health of the citizens we treat.