The financial burden of accessing care for people with scleroderma in Canada: a patient-oriented, cross-sectional survey.

BACKGROUND: Patients with scleroderma require a lifetime of treatment and frequent contacts with rheumatologists and other health care professionals. Although publicly funded health care systems in Canada cover many costs, patients may still face a substantial financial burden in accessing care. The purpose of this study was to quantify out-of-pocket costs borne by people with scleroderma in Canada and compare this burden for those living in large communities and smaller communities. METHODS: We analyzed responses to a Web-based survey of people living in Canada with scleroderma. Respondents reported annual out-of-pocket medical, travel and accommodation and other nonmedical costs (2019 Canadian dollars). We used descriptive statistics to describe travel distance and out-of-pocket costs. We used a 2-part model to estimate the impact on out-of-pocket costs of living in a large urban centre (≥ 100 000 population), compared with smaller urban centres or rural areas (< 100 000 population). We generated combined mean estimates from the 2-part models using predictive margins. RESULTS: The survey included 120 people in Canada with scleroderma. The mean, annual, total out-of-pocket costs were $3357 (standard deviation $5580). Respondents living in smaller urban centres and rural areas reported higher mean total costs ($4148, 95% confidence interval [CI] $3618-$4680) and travel or accommodation costs ($1084, 95% CI $804-$1364) than those in larger urban centres (total costs $2678, 95% CI $2252-$3104; travel or accommodation costs $332, 95% CI $207-$458). INTERPRETATION: Many patients with scleroderma incur considerable out-of-pocket costs, and this burden is exacerbated for those living in smaller urban centres and rural areas. Health care systems and providers should consider ways to alleviate this burden and support equitable access to care.

Improving rural and regional access to long-acting reversible contraception and medical abortion through nurse-led models of care, task-sharing and telehealth (ORIENT): a protocol for a stepped-wedge pragmatic cluster-randomised controlled trial in Australian general practice.

INTRODUCTION: Women living in rural and regional Australia often experience difficulties in accessing long-acting reversible contraception (LARC) and medical abortion services. Nurse-led models of care can improve access to these services but have not been evaluated in Australian general practice. The primary aim of the ORIENT trial (ImprOving Rural and regIonal accEss to long acting reversible contraceptioN and medical abortion through nurse-led models of care, Tasksharing and telehealth) is to assess the effectiveness of a nurse-led model of care in general practice at increasing uptake of LARC and improving access to medical abortion in rural and regional areas. METHODS AND ANALYSIS: ORIENT is a stepped-wedge pragmatic cluster-randomised controlled trial. We will enrol 32 general practices (clusters) in rural or regional Australia, that have at least two general practitioners, one practice nurse and one practice manager. The nurse-led model of care (the intervention) will be codesigned with key women's health stakeholders. Clusters will be randomised to implement the model sequentially, with the comparator being usual care. Clusters will receive implementation support through clinical upskilling, educational outreach and engagement in an online community of practice. The primary outcome is the change in the rate of LARC prescribing comparing control and intervention phases; secondary outcomes include change in the rate of medical abortion prescribing and provision of related telehealth services. A within-trial economic analysis will determine the relative costs and benefits of the model on the prescribing rates of LARC and medical abortion compared with usual care. A realist evaluation will provide contextual information regarding model implementation informing considerations for scale-up. Supporting nurses to work to their full scope of practice has the potential to increase LARC and medical abortion access in rural and regional Australia. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Monash University Human Research Ethics Committee (Project ID: 29476). Findings will be disseminated via multiple avenues including a knowledge exchange workshop, policy briefs, conference presentations and peer-reviewed publications. TRIAL REGISTRATION NUMBER: This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12622000086763).

Age-Related Variation in the Provision of Primary Care Services and Medication Prescriptions for Patients with Cardiovascular Disease.

As population aging progresses, demands of patients with cardiovascular diseases (CVD) on the primary care services is inevitably increased. However, the utilisation of primary care services across varying age groups is unknown. The study aims to explore age-related variations in provision of chronic disease management plans, mental health care, guideline-indicated cardiovascular medications and influenza vaccination among patients with CVD over differing ages presenting to primary care. Data for patients with CVD were extracted from 50 Australian general practices. Logistic regression, accounting for covariates and clustering effects by practices, was used for statistical analysis. Of the 14,602 patients with CVD (mean age, 72.5 years), patients aged 65-74, 75-84 and ≥85 years were significantly more likely to have a GP management plan prepared (adjusted odds ratio (aOR): 1.6, 1.88 and 1.55, respectively, p < 0.05), have a formal team care arrangement (aOR: 1.49, 1.8, 1.65, respectively, p < 0.05) and have a review of either (aOR: 1.63, 2.09, 1.93, respectively, p < 0.05) than those < 65 years. Patients aged ≥ 65 years were more likely to be prescribed blood-pressure-lowering medications and to be vaccinated for influenza. However, the adjusted odds of being prescribed lipid-lowering and antiplatelet medications and receiving mental health care were significantly lowest among patients ≥ 85 years. There are age-related variations in provision of primary care services and pharmacological therapy. GPs are targeting care plans to older people who are more likely to have long-term conditions and complex needs.

Assessing the impact of a combined nutrition counselling and cash transfer intervention on women's empowerment in rural Bangladesh: a randomised control trial protocol.

INTRODUCTION: There is growing interest in assessing the impact of health interventions, particularly when women are the focus of the intervention, on women's empowerment. Globally, research has shown that interventions targeting nutrition, health and economic development can affect women's empowerment. Evidence suggests that women's empowerment is also an underlying determinant of nutrition outcomes. Depending on the focus of the intervention, different domains of women's empowerment will be influenced, for example, an increase in nutritional knowledge, or greater control over income and access to resources. OBJECTIVE: This study evaluates the impact of the Shonjibon Cash and Counselling (SCC) Trial that combines nutrition counselling and an unconditional cash transfer, delivered on a mobile platform, on women's empowerment in rural Bangladesh. METHODS AND ANALYSIS: We will use a mixed-methods approach, combining statistical analysis of quantitative data from 2840 women in a cluster randomised controlled trial examining the impact of nutrition behaviour change communications (BCCs) and cash transfers on child undernutrition. Pregnant participants will be given a smartphone with a customised app, delivering nutrition BCC messages, and will receive nutrition counselling via a call centre and an unconditional cash transfer. This study is a component of the SCC Trial and will measure women's empowerment using a composite indicator based on the Project-Level Women's Empowerment in Agriculture Index, with quantitative data collection at baseline and endline. Thematic analysis of qualitative data, collected through longitudinal interviews with women, husbands and mothers-in-law, will elicit a local understanding of women's empowerment and the linkages between the intervention and women's empowerment outcomes. This paper describes the study protocol to evaluate women's empowerment in a nutrition-specific and sensitive intervention using internationally validated, innovative tools and will help fill the evidence gap on pathways of impact, highlighting areas to target for future programming. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the International Centre for Diarrhoeal Disease Research (Ref. PR 17106) and The University of Sydney (Ref: 2019/840). Findings from this study will be shared in Bangladesh with dissemination sessions in-country and internationally at conferences, and will be published in peer-reviewed journals.

Gender Comparison of Receipt of Government-Funded Health Services and Medication Prescriptions for the Management of Patients With Cardiovascular Disease in Primary Care.

BACKGROUND: Cardiovascular disease (CVD) and risk factors remains a major burden in terms of disease, disability, and death in the Australian population and mental health is considered as an important risk factor affecting cardiovascular disease. A multidisciplinary collaborative approach in primary care is required to ensure an optimal outcome for managing cardiovascular patients with mental health issues. Medicare introduced numerous primary care health services and medications that are subsidised by the Australian government in order to provide a more structured approach to reduce and manage CVD. However, the utilisation of these services nor gender comparison for CVD management in primary care has been explored. Therefore, the aim is to compare the provision of subsidised chronic disease management plans (CDMPs), mental health care and prescription of guideline-indicated medications to men and women with CVD in primary care practices for secondary prevention. METHODS: De-identified data for all active patients with CVD were extracted from 50 Australian primary care practices. Outcomes included the frequency of receipt of CDMPs, mental health care and prescription of evidence-based medications. Analyses adjusted for demography and clinical characteristics, stratified by gender, were performed using logistic regression and accounted for clustering effects by practices. RESULTS: Data for 14,601 patients with CVD (39.4% women) were collected. The odds of receiving the CDMPs was significantly greater amongst women than men (preparation of general practice management plan [GPMP]: (46% vs 43%; adjusted OR [95% CI]: 1.22 [1.12, 1.34]). Women were more likely to have diagnosed with mental health issues (32% vs 20%, p<0.0001), however, the adjusted odds of men and women receiving any government-subsidised mental health care were similar. Women were less often prescribed blood pressure, lipid-lowering and antiplatelet medications. After adjustment, only an antiplatelet medication or agent was less likely to be prescribed to women than men (44% vs 51%; adjusted OR [95% CI]: 0.84 [0.76, 0.94]). CONCLUSION: Women were more likely to receive CDMPs but less likely to receive antiplatelet medications than men, no gender difference was observed in the receipt of mental health care. However, the receipt of the CDMPs and the mental health treatment consultations were suboptimal and better use of these existing services could improve ongoing CVD management.

Potential approaches for the pricing of cancer medicines across Europe to enhance the sustainability of healthcare systems and the implications.

Introduction: There are growing concerns among European health authorities regarding increasing prices for new cancer medicines, prices not necessarily linked to health gain and the implications for the sustainability of their healthcare systems.Areas covered: Narrative discussion principally among payers and their advisers regarding potential approaches to the pricing of new cancer medicines.Expert opinion: A number of potential pricing approaches are discussed including minimum effectiveness levels for new cancer medicines, managed entry agreements, multicriteria decision analyses (MCDAs), differential/tiered pricing, fair pricing models, amortization models as well as de-linkage models. We are likely to see a growth in alternative pricing deliberations in view of ongoing challenges. These include the considerable number of new oncology medicines in development including new gene therapies, new oncology medicines being launched with uncertainty regarding their value, and continued high prices coupled with the extent of confidential discounts for reimbursement. However, balanced against the need for new cancer medicines. This will lead to greater scrutiny over the prices of patent oncology medicines as more standard medicines lose their patent, calls for greater transparency as well as new models including amortization models. We will be monitoring these developments.

The Medicines Intelligence Centre of Research Excellence: Co-creating real-world evidence to support the evidentiary needs of Australian medicines regulators and payers.

Regulators and payers play a pivotal role in facilitating timely and affordable access to safe and efficacious medicines. They use evidence generated from randomised clinical trials (RCTs) to support decisions to register and subsidise medicines. However, at the time of registration and subsidy approval, regulators and payers face uncertainty about how RCT outcomes will translate to real-world clinical practice. In response to this situation, medicines policy agencies worldwide have endorsed the use of real-world data (RWD) to derive novel insights on the use and outcomes of prescribed medicines. Recent reforms around data availability and use in Australia are creating unparalleled data access and opportunities for Australian researchers to undertake large-scale research to generate evidence on the safety and effectiveness of medicines in the real world. Highlighting the critical importance of research in this area, Quality Use of Medicines and Medicine Safety was announced as Australia's 10th National Health Priority in 2019. The National Health and Medical Research Council, Medicines Intelligence Centre of Research Excellence (MI-CRE) has been formed to take advantage of the renewed focus on quality use of medicines and the changing data landscape in Australia. It will generate timely research supporting the evidentiary needs of Australian medicines regulators and payers by accelerating the development and translation of real-world evidence on medicines use and outcomes. MI-CRE is developing a coordinated approach to identify, triage and respond to priority questions where there are significant uncertainties about medicines use, (cost)-effectiveness, and/or safety and creating a data ecosystem that will streamline access to Australian data to enable researchers to generate robust evidence in a timely manner. This paper outlines how MI-CRE will partner with policy makers, clinicians, and consumer advocates to leverage real-world data to co-create real-world evidence, to improve quality use of medicines and reduce medicine-related harm.

Out-of-pocket spending among a cohort of Australians living with gout.

OBJECTIVE: To measure the direct and indirect out-of-pocket (OOP) costs borne by Australians with gout. METHODS: A cross-sectional, Australia-wide, web-based survey was conducted over 12 months between May 2017 and April 2018. Participants were recruited via advertisements in doctors' clinics and healthcare organizations' websites, and social media platforms such as Facebook and Twitter. Survey questions collected information about participants' OOP spending on direct medical and non-medical gout-related healthcare costs. Participant demographics, gout status, healthcare sought, workdays lost to due gout and health-related quality of life were also collected. RESULTS: Seventy-nine patients with gout completed the survey; 70 (89%) were male, and on average were 56 (SD 16) years of age and had gout for 14 (SD 12) years. For this cohort, the median total OOP direct medical cost was AU$200 per year (interquartile range [IQR]: AU$60-AU$570). Sixty (76%) people with gout reported being affected by gout during work; however, only 0.25 (IQR: 0-3) days of work (approximately $60) were lost due to gout in a year. Nine percent (n = 7) of participants experienced cost-related treatment attrition and 33% reported economic hardship (n = 26). Participants who experienced economic hardship or cost-related treatment attrition had higher median total gout-related direct costs than those who did not. CONCLUSION: In Australia, gout has an OOP financial cost and reduces work productivity. The presence of cost-related treatment attrition among people with gout indicates that financial costs may be a significant barrier to seeking treatment for a subset of patients with gout.

Shonjibon cash and counselling: a community-based cluster randomised controlled trial to measure the effectiveness of unconditional cash transfers and mobile behaviour change communications to reduce child undernutrition in rural Bangladesh.

BACKGROUND: Undernutrition is strongly associated with poverty - levels of undernutrition are higher in poor countries than in better-off countries. Social protection especially cash transfer is increasingly recognized as an important strategy to accelerate progress in improving maternal and child nutrition. A critical method to improve nutrition knowledge and influence feeding practices is through behaviour change communication intervention. The Shonjibon Cash and Counselling study aims to assess the effectiveness of unconditional cash transfers combined with a mobile application on nutrition counselling and direct counselling through mobile phone in reducing the prevalence of stunting in children at 18 months. METHOD: The study is a longitudinal cluster randomised controlled trial, with two parallel groups, and cluster assignment by groups of villages. The cohort of mother-child dyads will be followed-up over the intervention period of approximately 24 months, starting from recruitment to 18 months of the child's age. The study will take place in north-central Bangladesh. The primary trial outcome will be the percentage of stunted children at 18 m as measured in follow up assessments starting from birth. The secondary trial outcomes will include differences between treatment arms in (1) Mean birthweight, percentage with low birthweight and small for gestational age (2) Mean child length-for age, weight for age and weight-for-length Z scores (3) Prevalence of child wasting (4) Percentage of women exclusively breastfeeding and mean duration of exclusive breastfeeding (5) Percentage of children consuming > 4 food groups (6) Mean child intake of energy, protein, carbohydrate, fat and micronutrients (7) Percentage of women at risk of inadequate nutrient intakes in all three trimesters (8) Maternal weight gain (9) Household food security (10) Number of events for child suffering from diarrhoea, acute respiratory illness and fever (11) Average costs of mobile phone BCC and cash transfer, and benefit-cost ratio for primary and secondary outcomes. DISCUSSION: The proposed trial will provide high-level evidence of the efficacy and cost-effectiveness of mobile phone nutrition behavior change communication, combined with unconditional cash transfers in reducing child undernutrition in rural Bangladesh. TRIAL REGISTRATION: The study has been registered in the Australian New Zealand Clinical Trials Registry ( ACTRN12618001975280 ).

Integrative Review of Managed Entry Agreements: Chances and Limitations.

BACKGROUND AND OBJECTIVE: Managed entry agreements (MEAs) consist of a set of instruments to reduce the uncertainty and the budget impact of new high-priced medicines; however, there are concerns. There is a need to critically appraise MEAs with their planned introduction in Brazil. Accordingly, the objective of this article is to identify and appraise key attributes and concerns with MEAs among payers and their advisers, with the findings providing critical considerations for Brazil and other high- and middle-income countries. METHODS: An integrative review approach was adopted. This involved a review of MEAs across countries. The review question was 'What are the health technology MEAs that have been applied around the world?' This review was supplemented with studies not retrieved in the search known to the senior-level co-authors including key South American markets. It also involved senior-level decision makers and advisers providing guidance on the potential advantages and disadvantages of MEAs and ways forward. RESULTS: Twenty-five studies were included in the review. Most MEAs included medicines (96.8%), focused on financial arrangements (43%) and included mostly antineoplastic medicines. Most countries kept key information confidential including discounts or had not published such data. Few details were found in the literature regarding South America. Our findings and inputs resulted in both advantages including reimbursement and disadvantages including concerns with data collection for outcome-based schemes. CONCLUSIONS: We are likely to see a growth in MEAs with the continual launch of new high-priced and often complex treatments, coupled with increasing demands on resources. Whilst outcome-based MEAs could be an important tool to improve access to new innovative medicines, there are critical issues to address. Comparing knowledge, experiences, and practices across countries is crucial to guide high- and middle-income countries when designing their future MEAs.

Can multi-criteria decision analysis (MCDA) be implemented into real-world drug decision-making processes? A Canadian provincial experience.

OBJECTIVE: To describe the implementation of multi-criteria decision analysis (MCDA) into a Canadian public drug reimbursement decision-making process, identifying the aspects of the MCDA approach, and the context that promoted uptake. METHODS: Narrative summary of case study describing the how, when, and why of implementing MCDA. RESULTS: Faced with a fixed budget, a pipeline of expensive but potentially valuable drugs, and potential delays to drug decision making, the Ministry of Health (i.e., decision makers) and its independent expert advisory committee (IAB) sought alternative values-based decision processes. MCDA was considered highly compatible with current processes, but the ability as a stand-alone intervention to address issues of opportunity cost was unclear. The IAB nevertheless collaboratively voted to implement an externally developed MCDA with support from decision makers. After several months of engagement and piloting, implementation was rapid and leveraged strong pre-existing formal and informal communication networks. The IAB as a whole rates new submissions which serves as an input into the deliberative process. CONCLUSIONS: MCDA can be a highly adaptable approach that can be implemented into a functioning drug reimbursement setting when facilitated by (i) a truly limited budget; (ii) a shared vision for change by end-users and decision makers; (iii) using pre-existing deliberative processes; and (iv) viewing the approach as a decision framework rather than the decision (when appropriate). Given the current limitations of MCDA, implementing an academically imperfect tool first and evaluating later reflects a practical solution to real-time fiscal constraints and impending delays to drug approvals that may be faced by decision makers.

What happens to drug use and expenditure when cost sharing is completely removed? Evidence from a Canadian provincial public drug plan.

OBJECTIVES: The role of cost-sharing for medicines is under active policy discussion, including in proposals for value-based insurance design. To inform this debate, we estimated the impact of completely removing cost-sharing on medication use and expenditure using a quasi-experimental approach. METHODS: Fair PharmaCare, British Columbia's income-based public drug plan, includes a household out-of-pocket limit. Therefore, when one household member starts a long-term high-cost drug surpassing this maximum, cost-sharing is completely removed for other family members. We used an interrupted time series design to estimate monthly prescriptions and expenditures of other household members, 24 months before and after cost-sharing removal. RESULTS: We studied 2191 household members newly free of cost-sharing requirements, most of whom had lower incomes. R emoving cost-sharing increased the level of drug expenditure and prescription numbers by 16 and 19%, respectively (i.e. $2659.43 (95%$1507.27-$3811.59, p < 0.001); 50.0 (95%CI 25.1-74.9, p < 0.001)) relative to prior expenditures and utilization without changing pre-existing trends. Much of this change was driven by 533 individuals initiating medication for the first time after cost-sharing removal. This initiation substantially increased average expenditure, especially for antiviral agents. CONCLUSIONS: Completely removing cost-sharing, independent of health status, significantly increased medication use and expenditure particularly due to medicine initiation by new users. While costs may be preventing use, the appropriateness of additional use, especially among new users, is unclear.

Formulating an Ethics of Pharmaceutical Disinvestment.

There is growing interest among pharmaceutical policymakers in how to "disinvest" from subsidized medicines. This is due to both the rapidly rising costs of healthcare and the increasing use of accelerated and conditional reimbursement pathways which mean that medicines are being subsidized on the basis of less robust evidence of safety and efficacy. It is crucial that disinvestment decisions are morally sound and socially legitimate, but there is currently no framework to facilitate this. We therefore reviewed the bioethics literature in order to identify ethical principles and concepts that might be relevant to pharmaceutical disinvestment decisions. This revealed a number of key ethical considerations-both procedural and substantive-that need to be considered when making pharmaceutical disinvestment decisions. These principles do not, however, provide practical guidance so we present a framework outlining how they might be applied to different types of disinvestment decisions. We also argue that, in this context, even the most rigorous ethical reasoning is likely to be overridden by moral intuitions and psychological biases and that disinvestment decisions will need to strike the right balance between respecting justifiable moral intuitions and overriding unjustifiable psychological impulses.

Who benefits most from extending financial protection for cataract surgery in Vietnam? An extended cost-effectiveness analysis of small incision surgery.

Treatment costs remain a barrier for having timely cataract surgery in Vietnam, particularly for females and the poor, despite significant progress in achieving universal health coverage (UHC). This study evaluated the potential impact, on health and financial protection, of eliminating medical and non-medical out-of-pocket costs associated with cataract surgery. An extended cost-effectiveness analysis (ECEA) was conducted with a societal perspective. The ECEA modelled how many more disability-adjusted life years (DALYs) and cases of catastrophic health expenditure (CHE) and medical impoverishment could be averted across income quintiles and between males and females. Two programmes were evaluated: (1) eliminating medical out-of-pocket costs for small incision cataract surgery and (2) Programme A plus a voucher programme covering non-medical out-of-pocket costs. Compared with current, the incremental cost per year of Programme A was estimated to be $833 396 and $1 641 835 for Programme B, each representing <0.01% of total health care spending in 2016. Males and females in the richest income quintiles would avert more DALYs than those in the poorest quintiles. For both programmes, most cases of CHE would be averted by individuals in the poorest income quintile. Programme B would avert the most CHE cases overall and females would have a greater share of benefits. All cases of impoverishing medical expenditure would be averted by individuals in the poorest quintile (A: 115 cases and B: 493 cases) for both programmes. The cost to avert each case of CHE with Programme A ranged from $67 to $292 and $100 to $232 for Programme B. We found a pro-rich health distribution and a pro-poor CHE distribution associated with eliminating out-of-pocket costs of cataract surgery in Vietnam. A programme that addressed both medical and non-medical out-of-pocket costs could have the greatest impact on improving financial protection in this population, particularly among the poorest income quintiles and for females. This study supports the concordance between the objectives of UHC and gender equity.

Cost-related nonadherence to medicines in people with multiple chronic conditions.

BACKGROUND: Multimorbidity is common and frequently associated with medicine nonadherence. Although cost is a common reason for nonadherence, very little research has quantified cost-related nonadherence (CRNA) to medicines specifically in people with multimorbidity, the prevalence of CRNA for different conditions nor the impact of cost when prioritising treatment between conditions. OBJECTIVE: To determine the extent of CRNA in people with multimorbidity and the patient characteristics associated with these behaviours. DESIGN AND SETTING: People reporting two or more chronic conditions responding to a rapid response module regarding prescription drug affordability fielded between January 1 and June 30 2016 in the Canadian Community Health Survey, a cross-sectional household survey. METHODS: Ordinal logistic regression, adjusted for key sociodemographic, clinical and treatment related variables, of weighted population estimates of self-reported CRNA within one group of conditions, across multiple groups of conditions, or no CRNA. RESULTS: 10.2% of 8420 Canadians with multimorbidity reported CRNA. The majority (61%) reported CRNA within one group of conditions, especially respiratory (16%) and mental health disorders (17%). CRNA was more common in younger adults, people without employer or association drug insurance plans, poorer health status, more chronic conditions, and increased out-of-pocket prescription costs. Having no prescription insurance was associated with a higher probability of CRNA across multiple groups of conditions. CONCLUSIONS: People with multimorbidity primarily forego medicines because of cost within one group of conditions. However, those without drug insurance extended these behaviours to multiple condition groups. Further work is needed to determine how people prioritise the conditions and treatments that are foregone because of cost, and how to best incorporate this information into treatment plans.

Cost-Related Underuse of Medicines for Asthma-Opportunities for Improving Adherence.

BACKGROUND: In asthma, underuse of cost-effective preventive treatments increases morbidity and mortality. The cost of medicines contributes to underuse ("nonadherence"), but the extent to which people with asthma skip or reduce doses or let prescriptions go unfilled when faced with cost pressures is unknown. OBJECTIVE: To estimate the extent of cost-related underuse behaviors and associated factors. METHODS: Using previously validated summary indicators, we conducted an online cross-sectional survey of adults and parents of children 5 to 17 years with asthma in Australia (a high-income country) and developed logistic regression models for adults and children with asthma, controlling for key clinical and demographic factors. RESULTS: The survey was completed by n = 792 adults (mean age, 47 [standard deviation, 17] years, male 47%, concession 60%) and n = 609 parents of children (5-10 years 51%, male 60%, concession 59%) with asthma. Cost-related underuse was reported by 52.9% adults and 34.3% parents, predominantly decreasing or skipping doses to make medicines last longer. Higher odds of cost-related underuse were observed with younger adults (adults: odds ratio [OR]: 1.19; 95% confidence interval [CI]: 1.12, 1.27), males (adults: OR: 1.49; 95% CI: 1.06, 2.08), having concerns about medicines (adults: OR: 3.12; 95% CI: 2.17, 4.35; parents: OR: 2.63; 95% CI: 1.56, 4.55), less comfortable talking to prescribers about cost (parents: OR: 1.22; 95% CI: 1.12, 1.33) or changing medicines (adults: OR: 1.12; 95% CI: 1.03, 1.22), feeling less engaged with prescribers about medicine decisions (parents: OR: 1.11; 95% CI: 1.01, 1.23), and with poorer asthma control (adults, poor control: OR: 1.87; 95% CI: 1.13, 3.09; parents, poor control: OR: 3.87; 95% CI: 1.99, 7.54), and requiring specialist (parents: OR: 1.83; 95% CI: 1.16, 2.87) or urgent health care visits (adults: OR: 1.54; 95% CI: 1.06, 2.23). Income and concession card status were not associated with cost-related underuse. CONCLUSIONS: Adults and parents of children with asthma indicate high rates of cost-related underuse of asthma medicines, even in the context of national medicines subsidies. Urgent targeting of interventions to promote discussion of medicines and costs between doctor and patients, particularly young adult males, is needed.

General practitioners' views on the influence of cost on the prescribing of asthma preventer medicines: a qualitative study.

Objective Out-of-pocket costs strongly affect patient adherence with medicines. For asthma, guidelines recommend that most patients should be prescribed regular low-dose inhaled corticosteroids (ICS) alone, but in Australia most are prescribed combination ICS-long-acting ß2-agonists (LABA), which cost more to patients and government. The present qualitative study among general practitioners (GPs) explored the acceptability, and likely effect on prescribing, of lower patient copayments for ICS alone. Methods Semistructured telephone interviews were conducted with 15 GPs from the greater Sydney area; the interviews were transcribed and thematically analysed. Results GPs reported that their main criteria for selecting medicines were appropriateness and effectiveness. They did not usually discuss costs with patients, had low awareness of out-of-pocket costs and considered that these were seldom prohibitive for asthma patients. GPs strongly believed that patient care should not be compromised to reduce cost to government. They favoured ICS-LABA combinations over ICS alone because they perceived that ICS-LABA combinations enhanced adherence and reduced costs for patients. GPs did not consider that lower patient copayments for ICS alone would affect their prescribing. Conclusion The results suggest that financial incentives, such as lower patient copayments, would be unlikely to encourage GPs to preferentially prescribe ICS alone, unless accompanied by other strategies, including evidence for clinical effectiveness. GPs should be encouraged to discuss cost barriers to treatment with patients when considering treatment choices. What is known about the topic? Australian guidelines recommend that most patients with asthma should be treated with low-dose ICS alone to minimise symptom burden and risk of flare ups. However, most patients in Australian general practice are instead prescribed combination ICS-LABA preventers, which are indicated if asthma remains uncontrolled despite treatment with ICS alone. It is not known whether GPs are aware that the combination preventers have a higher patient copayment and a higher cost to government. What does this paper add? This qualitative study found that GPs favoured combination ICS-LABA inhalers over ICS alone because they perceived ICS-LABA combinations to have greater effectiveness and promote patient adherence. This aligned with GPs' views that their primary responsibility was patient care rather than generating cost savings for government. However, it emerged that GPs rarely discussed medicine costs with patients, had low knowledge of medicine costs to patients and the health system and reported that patients rarely volunteered cost concerns. GPs believed that lower patient copayments for asthma preventer medicines would have little effect on their prescribing practices. What are the implications for practitioners? This study suggests that, when considering asthma treatment choices, GPs should empathically explore with the patient whether cost-related medication underuse is an issue, and should be aware of the option of lower out-of-pocket costs with guideline-recommended ICS alone treatment. Policy makers must be aware that differential patient copayments for ICS preventer medicines are unlikely to act as an incentive for GPs to preferentially prescribe ICS alone preventers, unless the position of these preventers in guidelines and evidence for their clinical effectiveness are also reiterated.

Does a Patient-Directed Financial Incentive Affect Patient Choices About Controller Medicines for Asthma? A Discrete Choice Experiment and Financial Impact Analysis.

BACKGROUND: In Australia, many patients who are initiated on asthma controller inhalers receive combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) despite having asthma of sufficiently low severity that ICS-alone would be equally effective and less costly for the government. METHODS: We conducted a discrete choice experiment (DCE) in a nationally representative sample of adults (n = 792) and parents of children (n = 609) with asthma. Mixed multinomial models were estimated and calibrated to reflect the estimated market shares of ICS-alone, ICS/LABA and no controller. We then simulated the impact of varying patient co-payment on demand and the financial impact on government pharmaceutical expenditure. RESULTS: Preference for inhaler decreased with increasing costs to the patient or government, increasing chance of a repeat visit to the doctor, and if fewer symptoms were present. Adults preferred high-strength controllers, but parents preferred low-strength inhalers for children (general beneficiaries only). The DCE predicted a higher proportion choosing controller treatment (89%) compared to current levels (57%) at the current co-payment level, with proportionately higher uptake of ICS-alone and a lower average cost per patient [32.73 Australian dollars (AU$) c.f. AU$38.54]. Reducing the co-payment on ICS-alone by 50% would increase its market share to 50%, whilst completely removing the co-payment would only have a small marginal impact on market share, but increased average cost of treatment to the government to AU$41.04 per person. CONCLUSIONS: Patient-directed financial incentives are unlikely to encourage much switching of medicines, and current levels of under-treatment are not explained by patient preferences. Interventions directed at prescribers are more likely to promote better use of asthma medicines.

Rapid and substantial increases in anticoagulant use and expenditure in Australia following the introduction of new types of oral anticoagulants.

OBJECTIVES: To quantify changes in anticoagulant use in Australia since the introduction of Non-vitamin K antagonist anticoagulants (NOACs) and to estimate government expenditure. DESIGN: Interrupted-time-series analysis quantifying anticoagulant dispensing, before and after first Pharmaceutical Benefits Scheme (PBS) NOAC listing in August 2009 for venous thromboembolism prevention; and expanded listing for stroke prevention in non-valvular atrial fibrillation (AF) in August 2013, up to June 2016. Estimated government expenditure on PBS-listed anticoagulants. SETTING AND PARTICIPANTS: PBS dispensing in 10% random sample of Australians, restricted to continuous concessional beneficiaries dispensed oral anticoagulants from July 2005 to June 2016. Total PBS anticoagulant expenditure was calculated using Medicare Australia statistics. MAIN OUTCOME MEASURES: Monthly dispensing and initiation of oral anticoagulants (warfarin, rivaroxaban, dabigatran or apixaban). Annual PBS anticoagulant expenditure. RESULTS: An estimated 149,180 concessional beneficiaries were dispensed anticoagulants (100% warfarin) during July 2005. This increased to 292,550 during June 2016, of whom 47.0%, 27.1%, 18.7% and 7.2% were dispensed warfarin, rivaroxaban, apixaban and dabigatran, respectively. Of 16,500 initiated on anticoagulants in June 2016, 24.3%, 38.2%, 30.0% and 7.5% were initiated on warfarin, rivaroxaban, apixaban, and dabigatran, respectively. Compared to July 2005-July 2013, from August 2013-June 2016, dispensings for all anticoagulants increased by 2,303 dispensings/month (p<0.001, 95%CI = [1,229 3,376]); warfarin dispensing decreased by 1,803 dispensings/month (p<0.001, 95%CI = [-2,606, -1,000]). Total PBS anticoagulant expenditure was $19.5 million (97.0% concessional) in 2008/09, of which 100% was warfarin and $203.3 million (86.2% concessional) in 2015/16, of which 11.2% was warfarin. CONCLUSIONS: The introduction of the NOACs led to substantial increases in anticoagulant use and expenditure in Australia.