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

Who should decide how much and what information is important in person-centred health care?

Most guidelines for clinical practice, and especially those for the construction of decision support tools, assume that the individual person (the patient) needs to be in possession of information of particular sorts and amount in order to qualify as having made an 'informed decision'. This often implicitly segues into the patient having made a 'good decision'. In person-centred health care, whether, in what form, and with what weight, 'information' is included as a criterion of decision quality is a matter for the person involved, to decide in the light of their own values, preferences, and time and resource constraints

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 is hypothesis 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

Societal perspective on access to publicly subsidised medicines:A cross sectional survey of 3080 adults in Australia

Background Around the world government agencies responsible for the selection and reimbursement of prescribed medicines and other health technologies are considering how best to bring community preferences into their decision making. In particular, community views about the distribution or equity of funding across the population. These official committees and agencies often have access to the best available and latest evidence on clinical effectiveness, safety and cost from large clinical trials and population-based studies. All too often they do not have access to high quality evidence about community views. We therefore, conducted a large and representative population-based survey in Australia to determine what community members think about the factors that do and should influence government spending on prescribed medicines. Methods A choice-based survey was designed to elicit the importance of individual criteria when considering the equity of government spending on prescribed medicines. A representative sample of 3080 adult Australians completed the survey by allocating a hypothetical budget to different combinations of money spent on two patient populations. Societal preferences were inferred from absolute majority responses i.e. populations with more than 50% of respondents\u27 allocation for a particular allocation criterion. Results This study shows that, all else being equal, severity of disease, diseases for which there is no alternative treatment available on the government formulary, diseases that affect patients who are not financially well off, and life-style unrelated diseases are supported by the public as resource allocation criteria. Where \u27all else is not equal\u27, participants allocated more resources to the patient population that gained considerable improvement in health and fewer resources to those that gained little improvement in health. This result held under all scenarios except for \u27end-of-life treatments\u27. Responses to cost (and corresponding number of patients treated) trade-off scenarios indicated a significant reduction in the proportion of respondents choosing to divide resources equally and a shift in preference towards devoting resources to the population that were more costly to treat for all criteria with the exception of severity of disease. Conclusions The general public have clear views on what\u27s fair in terms of government spending on prescribed medicines. In addition to supporting the application of the \u27rule of rescue\u27, important considerations for government spending included the severity of disease being treated, diseases for which there is no alternative treatment available on the government formulary, diseases that affect patients who are not financially well off and life-style unrelated diseases. This study shows that the general public are willing to share their views on what constitutes an equitable allocation of the government\u27s drug budget. The challenge remains to how best to consider those views alongside clinical and economic considerations

Community views on factors affecting medicines resource allocation:Cross-sectional survey of 3080 adults in Australia

Objective: The aim of the present study was to determine Australian community views on factors that influence the distribution of health spending in relation to medicines. Methods: A cross-sectional web-based survey was performed of 3080 adults aged ≥18 years. Participants were asked to rank, in order of importance, 12 criteria according to which medicines funding decisions may be made. Results: Of all respondents, 1213 (39.4%) considered disease severity to be the most important prioritisation criterion for funding a new medicine. This was followed by medicines treating a disease affecting children (13.2%) and medicines for cancer patients (9.1%). Medicines targeting a disease for which there is no alternative treatment available received highest priority from 8.6% of respondents. The remaining eight prioritisation criteria were each assigned a top ranking from 6.6% to 1.7% of respondents. Medicines targeting a disease for which there is no alternative treatment available were ranked least important by 7.7% of respondents, compared with 2.4%, 1.9% and 1.0% for medicines treating severe diseases, diseases affecting children and cancer respectively. \u27End-of-life treatments\u27 and \u27rare disease therapies\u27 received the least number of highest priority rankings (2.0% and 1.7% respectively). Conclusions: These results provide useful information about public preferences for government spending on prescribed medicines. Understanding of public preferences on the funding of new medicines will help the Pharmaceutical Benefits Advisory Committee and government determine circumstances where greater emphasis on equity is required and help inform medicines funding policy that best meets the needs of the Australian population. What is known about this topic?: There is increased recognition of the importance of taking into account public preferences in the heath technology assessment (HTA) decision-making process. What does this paper add?: The Australian public view the severity of disease to be the most important funding prioritisation criterion for medicines, followed by medicines used to treat children or to treat cancer. What are the implications for practitioners?: The general public are capable of giving opinions on distributional preferences. This information can help inform medicines funding policy and ensure that it is consistent with the values of the Australian population

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