Pharmaceutical benefits scheme cost recovery

Since the beginning of 2010 the Australian Government has applied cost recovery to the listing process of the Pharmaceutical Benefits Scheme (PBS). Drug companies seeking to list their drugs on the PBS or vaccines on the National Immunisation Program pay a fee at two key points - upon lodgement of the application and at the pricing stage. The lodgement fee relates to the evaluation work of the Pharmaceutical Benefits Advisory Committee (PBAC) and all of its supporting administrative functions. The pricing fee relates to the pricing work of the Pharmaceutical Benefits Pricing Authority and its supporting functions. Companies that want an independent review of a PBAC recommendation to not list a drug on the PBS will also pay. The fees are not trivial - $119 500 for a major PBAC evaluation,$25 000 for a complex \u27pricing\u27 and $119 500 for an independent review. Hardly spare change, even for a pharmaceutical company. So what is the purpose of the cost recovery scheme and what are the likely consequences

Pharmaceutical Benefits Scheme cost recovery

Since the beginning of 2010 the Australian Government has applied cost recovery to the listing process of the Pharmaceutical Benefits Scheme (PBS). Drug companies seeking to list their drugs on the PBS or vaccines on the National Immunisation Program pay a fee at two key points - upon lodgement of the application and at the pricing stage. The lodgement fee relates to the evaluation work of the Pharmaceutical Benefits Advisory Committee (PBAC) and all of its supporting administrative functions. The pricing fee relates to the pricing work of the Pharmaceutical Benefits Pricing Authority and its supporting functions. Companies that want an independent review of a PBAC recommendation to not list a drug on the PBS will also pay. The fees are not trivial - $119 500 for a major PBAC evaluation,$25 000 for a complex \u27pricing\u27 and $119 500 for an independent review. Hardly spare change, even for a pharmaceutical company. So what is the purpose of the cost recovery scheme and what are the likely consequences

Bringing Feedback in From the Outback via a Generic and Preference-Sensitive Instrument for Course Quality Assessment

Background: Much effort and many resources have been put into developing ways of eliciting valid and informative student feedback on courses in medical, nursing, and other health professional schools. Whatever their motivation, items, and setting, the response rates have usually been disappointingly low, and there seems to be an acceptance that the results are potentially biased. Objective: The objective of the study was to look at an innovative approach to course assessment by students in the health professions. This approach was designed to make it an integral part of their educational experience, rather than a marginal, terminal, and optional add-on as feedback . It becomes a weighted, but ungraded, part of the course assignment requirements. Methods: A ten-item, two-part Internet instrument, MyCourseQuality (MCQ-10D), was developed following a purposive review of previous instruments. Shorthand labels for the criteria are: Content, Organization, Perspective, Presentations, Materials, Relevance, Workload, Support, Interactivity, and Assessment. The assessment is unique in being dually personalized. In part 1, at the beginning of the course, the student enters their importance weights for the ten criteria. In part 2, at its completion, they rate the course on the same criteria. Their ratings and weightings are combined in a simple expected-value calculation to produce their dually personalized and decomposable MCQ score. Satisfactory (technical) completion of both parts contributes 10% of the marks available in the course. Providers are required to make the relevant characteristics of the course fully transparent at enrollment, and the course is to be rated as offered. A separate item appended to the survey allows students to suggest changes to what is offered. Students also complete (anonymously) the standard feedback form in the setting concerned. Results: Piloting in a medical school and health professional school will establish the organizational feasibility and acceptability of the approach (a version of which has been employed in one medical school previously), as well as its impact on provider behavior and intentions, and on student engagement and responsiveness. The priorities for future improvements in terms of the specified criteria are identified at both individual and group level. The group results from MCQ will be compared with those from the standard feedback questionnaire, which will also be completed anonymously by the same students (or some percentage of them). Conclusions: We present a protocol for the piloting of a student-centered, dually personalized course quality instrument that forms part of the assignment requirements and is therefore an integral part of the course. If, and how, such an essentially formative Student-Reported Outcome or Experience Measure can be used summatively, at unit or program level, remains to be determined, and is not our concern here

The rising cost of anticancer drugs in Australia

Background: Anticancer drugs are often expensive and are contributing to the growing cost of cancer care. Concerns have been raised about the effect rising costs may have on availability of new anticancer drugs. Aim: This study aims to determine the recent changes in the costs of anticancer drugs in Australia. Methods: Publicly available expenditure and prices paid by the Australian Pharmaceutical Benefits Scheme (PBS) for anticancer drugs from 2000 to 2012 were reviewed. The measures used to determine changes in cost were total PBS expenditure and average price paid by the PBS per prescription for anticancer drugs and for all PBS listed drugs. An estimated monthly price paid for newly listed anticancer drugs was also calculated. Results: Annual PBS expenditure on anticancer drugs rose from A$65 million in 1999–2000 to A$466 million in 2011–2012; an average increase of 19% per annum. The average price paid by the PBS per anticancer drug prescription, adjusted for inflation, increased 133% from A$337 to A$786. The real average annual increase in the price per anticancer drug prescription was more than double that for all other PBS drugs combined (7.6% vs 2.8%, difference 4.8%, 95% confidence interval −0.4% to 10.1%, P = 0.07). The median price for a month’s treatment of the new anticancer drugs listed was A$4919 (range A$1003 to A$12 578, 2012 prices). Conclusions: PBS expenditure and the price of anticancer drugs in Australia rose substantially from 2000 to 2012. Dealing with these burgeoning costs will be a major challenge for our health system and for those affected by cancer

Patient and physician preferences for surgical and adjuvant treatment options for rectal cancer

Hypothesis Patients and their clinicians hold varying preferences for surgical and adjuvant treatment therapies for rectal cancer. Design Preferences were determined using the Prospective Measure of Preference. Setting Royal Prince Alfred and St Vincent\u27s hospitals in Sydney, Australia. Participants Patients with colorectal cancer were interviewed during their postoperative hospital stay, and physicians were asked to complete a mailed survey. Main Outcome Measures The Prospective Measure of Preference method produces 2 outcome measures of preference: willingness to trade and prospective measure of preference time trade-off. Results Patients\u27 strongest preference was to avoid a stoma: more than 60% would give up a mean of 34% of their life expectancy to avoid this surgical option. This was followed by treatment options involving chemoradiotherapy, where more than 50% would give up a mean of almost 25% of their life to avoid treatment. Surgeons held stronger preferences against all adjuvant options compared with oncologists (P ≤ .01). Conclusions Patients had strong preferences against all treatment options, and these preferences frequently differed from those of physicians. These results highlight the importance of determining patients\u27 own preferences in the clinical encounter. Furthermore, the diversity of preferences of clinical subspecialists emphasizes the need for multidisciplinary treatment planning to ensure a balanced approach to treatment decision making for patients with rectal cancer

Economic evaluation and EBM

In the world of textbook economics, the sovereign consumer weighs up the (freely available) evidence on the costs, risks, harms and benefits before purchasing health care. The value that consumers then attach to the evidence and the expected outcomes is revealed through their purchasing decisions in the market. Ultimately, the consumer\u27s decision represents the best or benefit maximising choice given the available information. The notion of this evidence-based market is however a long way from the reality of health care in Australia. Consumers (that is, patients) generally do not have current best evidence to hand. The same could be said of their agent (doctor) prior to worldwide interest in evidence-based medicine (especially through the Cochrane Collaboration). If the market is not capable of integrating external clinical evidence from systematic research and clinical expertise such that consumers (or their agents for that matter) can assess the quality of information easily then a mechanism is needed to perform that function. One such mechanism is economic evaluation. This approach describes a set of techniques, such as cost-effectiveness analysis and cost-benefit analysis, that require the systematic comparison of the costs and benefits of the full range of health care activities. Economic evaluation performs what individual consumers would otherwise do in a competitive market; it weighs up the costs and benefits of the available choices. That still leaves many questions about whose values count in the aggregation of costs and benefits and whether the value of the total is greater than the sum of individual values. Nonetheless, if one of the aims of a health care system is to be efficient, then choosing those programs that provide the greatest benefits for the resources available will delivery an efficient allocation of health care resources. Allocating health care resources is seldom simply a matter of choosing efficient programs; the \u27fairness\u27 or equity of resource allocation is also a desirable economic goal. The aim of this paper is to provide a brief account of what economic evaluation has achieved and could achieve in cancer control within an EBM environment. The first part looks at funding lor health services based on evidence of economic evaluation. The following section of the paper highlights some innovative research into the use of EBM to elicit consumer preferences for colorectal cancer screening

Increasing User Involvement in Health Care and Health Research Simultaneously: A Proto-Protocol for Person-as-Researcher and Online Decision Support Tools

Background: User involvement is appearing increasingly on policy agendas in many countries, with a variety of proposals for facilitating it. The belief is that it will produce better health for individuals and community, as well as demonstrate greater respect for the basic principles of autonomy and democracy. Objective: Our Web-based project aims to increase involvement in health care and health research and is presented in the form of an umbrella protocol for a set of project-specific protocols. We conceptualize the person as a researcher engaged in a continual, living, informal n-of-1 -type study of the effects of different actions and interventions on their health, including those implying contact with health care services. We see their research as primarily carried out in order to make better decisions for themselves, but they can offer to contribute the results to the wider population. We see the efforts of the person-as-researcher as contributing to the total amount of research undertaken in the community, with research not being confined to that undertaken by professional researchers and institutions. This view is fundamentally compatible with both the emancipatory and conventional approaches to increased user involvement, though somewhat more aligned with the former. Methods: Our online decision support tools, delivered directly to the person in the community and openly accessible, are to be seen as research resources. They will take the form of interactive decision aids for a variety of specific health conditions, as well as a generic one that supports all health and health care decisions through its focus on key aspects of decision quality. We present a high-level protocol for the condition-specific studies that will implement our approach, organized within the Populations, Interventions, Comparators, Outcomes, Timings, and Settings (PICOTS) framework. Results: Our underlying hypothesis concerns the person-as-researcher who is equipped with a prescriptive, transparent, expected value-based opinion-an opinion that combines their criterion importance weights with the Best Estimates Available Now for how well each of the available options performs on each of those outcomes. The hypothesis is that this person-as-researcher is more likely to be able to position themselves as an active participant in a clinical encounter, if they wish, than someone who has engaged with a descriptive decision aid that attempts to work with their existing cognitive processes and stresses the importance of information. The precise way this hypothesis is tested will be setting-specific and condition-specific and will be spelled out in the individual project protocols. Conclusions: Decision resources that provide fast access to the results of slower thinking can provide the stimulus that many individuals need to take a more involved role in their own health. Our project, advanced simply as one approach to increased user involvement, is designed to make progress in the short term with minimal resources and to do so at the point of decision need, when motivation is highest. Some basic distinctions, such as those between science and non-science, research and practice, community and individual, and lay and professional become somewhat blurred and may need to be rethought in light of this approach

Public preferences for engagement in Health Technology Assessment decision-making: protocol of a mixed methods study

Background Much attention in recent years has been given to the topic of public engagement in health technology assessment (HTA) decision-making. HTA organizations spend substantial resources and time on undertaking public engagement, and numerous studies have examined challenges and barriers to engagement in the decision-making process however uncertainty remains as to optimal methods to incorporate the views of the public in HTA decision-making. Little research has been done to ascertain whether current engagement processes align with public preferences and to what extent their desire for engagement is dependent on the question being asked by decision-makers or the characteristics of the decision. This study will examine public preferences for engagement in Australian HTA decision-making using an exploratory mixed methods design. Methods/Design The aims of this study are to: 1) identify characteristics about HTA decisions that are important to the public in determining whether public engagement should be undertaken on a particular topic, 2) determine which decision characteristics influence public preferences for the extent, or type of public engagement, and 3) describe reasons underpinning these preferences. Focus group participants from the general community, aged 18-70 years, will be purposively sampled from the Australian population to ensure a wide range of demographic groups. Each focus group will include a general discussion on public engagement as well as a ranking exercise using a modified nominal group technique (NGT). The NGT will inform the design of a discrete choice study to quantitatively assess public preferences for engagement in HTA decision-making. Discussion The proposed research seeks to investigate under what circumstances and how the public would like their views and preferences to be considered in health technology assessments. HTA organizations regularly make decisions about when and how public engagement should occur but without consideration of the public\u27s preferences on the method and extent of engagement. This information has the potential to assist decision-makers in tailoring engagement approaches, and may be particularly useful in decisions with potential for conflict where clarification of public values and preferences could strengthen the decision-making process

Health informatics can avoid committing symbolic violence by recognizing and supporting generic decision-making competencies

‘Symbolic violence’ is committed, however well-intentionally, by the imposition of particular conceptualizations of what information, in what form and quality, is needed in order to make an ‘informed choice’ and hence – by questionable segue - a high quality decision. The social and cultural forms of relevant cognitive capital possessed by those who fail, because of their low general literacy, professionally-set knowledge tests of functional health literacy, are being ignored. Failing to recognise and exploit a particular form of functional decision literacy, in fact leads to symbolic violence being experienced by individuals at any and all levels of general literacy. It leads many to adopt the same range of avoidant and other undesirable strategies within healthcare situations observed in those of low basic literacy. The alternative response we propose exploits the alternative generic decision literacy which comes in the form of the ability to access and use the decision-relevant resources provided for many consumer services and products on comparison websites and magazines. The methodology is the simple form of multi-criteria analysis in which the products\u27 ratings on multiple criteria are combined with criterion weights (supplied by the site) to produce scores and ‘best buys’ and ‘good value for money’ verdicts. Our alternative approach extends this approach to healthcare options and permits the incorporation of personal criterion weights in furtherance of person-centred care. Health informaticians, especially those in the decision support field, should build on this widespread generic competence. The fact that it is generic, far from implying context insensitivity, can be seen as a necessary basis for achieving context-sensitivity and sensitivisation at the level of the individual person as they experience a lifelong sequence of healthcare decisions

A matter of trust - Patient\u27s views on decision-making in colorectal cancer

Objectives: To determine which aspects of the treatment decision process, therapy and outcomes are most important to patients with colorectal cancer (CRC). Design: Cross-sectional survey. Participants: A total of 102 men and 73 women who had completed primary treatment for CRC in two teaching hospitals in Central Sydney, Australia. Main outcomes measures: Patient\u27s rating of the importance of the decision-making aspects and outcomes of treatment for CRC. Results: Trust in their surgeon and confidence of specialty training are of paramount importance to CRC patients. Patients also have a strong desire to get on with treatment quickly and rate the risk of disease recurrence and quality of life as being very important in their treatment decisions. Gender, age and whether the patient had undergone adjuvant radiotherapy were all significant predictors of preferred mode of treatment decision-making. Fifty-eight per cent of women preferred a shared decision-making role compared with 36% of men, whilst older patients and those who had undergone adjuvant radiotherapy were significantly more likely to prefer that their surgeon decide upon treatment when compared with younger patients and respondents who have not had radiotherapy. Conclusions: Regardless of whether a patient prefers an active or more passive role in decision-making, having a surgeon explain treatment options in a clear, unhurried and open manner is vital to how patients feel about their treatment. Whilst acknowledging that individual patients will have different needs for information and preferences for treatment, there are several factors amongst many in the process of decision-making which are considered very important by patients with CRC. A surgeon who adopts a consultation style that is open and informative, that offers patients the chance to participate in the process of decision-making and clearly explain treatment options and outcomes will engender trust with their patient