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Prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) has emerged as a promising imaging tool in prostate cancer diagnosis. PSMA PET/CT radiotracers are produced in-house (gallium-68, eg,Hospitals and diagnostic facilities currently conducting PSMA PET/CT in Australia in metropolitan and regional areas completed a survey of PSMA PET/CT throughput, radiotracers involved, and the cost of assets, departmental staffing, consumables, and occupancy. Total costs were estimated using a top-down microcosting approach, involving identifying all relevant cost components and valuing each component for the average patient, and a gross costing approach, involving apportioning cost components at an aggregated level.Data were collected from 8 facilities. The most common radiotracer used wasThis study provides a detailed and accurate estimation of the cost of PSMA PET/CT in Australia. These costs can be used as a benchmark to identify potential efficiencies and help policy makers set the appropriate reimbursement rate for this procedure. The use of data from facilities using different radiotracers in metropolitan and regional areas and with different throughput increases the generalizability of the results, especially in countries with similar health systems.

BACKGROUND AND OBJECTIVES: Prostate-specific membrane antigen (PSMA) positron emission tomography (PET) combined with computed tomography (CT) is a new imaging modality to detect the extra-prostatic spread of prostate cancer. PSMA PET/CT has a higher sensitivity and specificity than conventional imaging (CT ± whole body bone scan [WBBS]). This study conducted a cost-utility analysis of PSMA PET/CT compared with conventional imaging for patients with newly diagnosed, intermediate-risk or high-risk primary prostate cancer. PERSPECTIVE: Australian healthcare perspective. SETTING: Tertiary. METHODS: A decision-analytic Markov model combined data from a variety of sources. The time horizon was 35 years. The sensitivity and specificity of PSMA PET/CT and CT alone were based on meta-analyses and the test accuracy of CT+WBBS was based on a single randomised controlled trial. Health outcomes included cases detected, life-years, and quality-adjusted life-years. Costs related to other diagnostic tests, initial treatment, adverse events, and post-disease progression were included. All costs were reported in 2021 Australian Dollars (A$). RESULTS: The deterministic incremental cost-effectiveness ratio of PSMA PET/CT was estimated to be A $21,147/quality-adjusted life-year gained versus CT+WBBS, and A$36,231/quality-adjusted life-year gained versus CT alone. The results were most sensitive to the time horizon, and the initial treatments received by patients diagnosed with metastatic cancer. The probability of PSMA PET/CT being cost effective was estimated to be 91% versus CT+WBBS and 89% versus CT alone, using a threshold of AU$50,000/quality-adjusted life-year gained. CONCLUSIONS: PSMA PET/CT is likely to be more costly than CT+WBBS or CT alone in Australia; however, it is still likely to be considered cost effective compared with conventional imaging.

Objective The National Institute for Health and Care Excellence (NICE) updated its eligibility criteria for unilateral cochlear implants (UCIs) in 2019. NICE claimed this would not impact the cost-effectiveness results used within its 2009 technology appraisal guidance. This claim is uncertain given changed clinical practice and increased healthcare unit costs. Our objective was to estimate the cost-effectiveness estimates of UCIs in UK adults with severe to profound hearing loss within the contemporary NHS environment. Methods A cost–utility analysis employing a Markov model was undertaken to compare UCIs with hearing aids or no hearing aids for people with severe to profound hearing loss. A clinical pathway was developed to estimate resource use. Health-related quality of life, potential adverse events, device upgrades and device failure were captured. Unit costs were derived mostly from the NHS data. Probabilistic sensitivity analysis further assessed the effect of uncertain model inputs. Results A UCI is likely to be deemed cost-effective when compared to a hearing aid (£11,946/QALY) or no hearing aid (£10,499/QALY). A UCI has an 93.0% and 98.7% likelihood of being cost-effective within the UK adult population when compared to a hearing aid or no hearing aid, respectively. ICERs were mostly sensitive to the proportion of people eligible for cochlear implant, discount rate, surgery and device costs and processor upgrade cost. Conclusion UCIs remain cost-effective despite changes to clinical practice and increased healthcare unit costs. Updating the NICE criteria to provide better access UCIs is projected to increase annual implants in adults and children by 70% and expenditure by £28.6 million within three years. This increased access to UCIs will further improve quality of life of recipients and overall social welfare.

Background Patients with Lynch syndrome (an inherited cancer predisposition syndrome) remain largely underdiagnosed despite clinically and cost-effective testing strategies to detect patients. This is largely due to poor referral rates for high-risk patients for consideration of genetic testing. Targeted approaches to improve the implementation of guidelines and thus uptake rates of genetic testing require the use of limited and valuable healthcare resources. Decision makers must carefully balance the potential health impacts of implementation approaches against the associated costs, similar to when assessing the direct impact of health interventions. This protocol outlines the methods used to conduct an economic evaluation of different implementation approaches aimed at improving referral rates of high-risk patients, including estimating implementation approach costs. Methods A cluster randomised controlled trial (the Hide and Seek Project, HaSP) is underway to compare two different implementation approaches aimed at improving referral rates, and thus detection, of Lynch syndrome among colorectal cancer patients across eight Australian hospital networks. An in-depth process evaluation is being conducted alongside the trial and includes measures to collect comprehensive data on both implementation and intervention costs. These costs, in addition to HaSP outcome data, will be incorporated as inputs into an existing microsimulation model—Policy1-Lynch—to project the downstream economic and health impacts and determine the more cost-effective implementation approach from the Australian healthcare perspective. Discussion The ability to model the impact of different implementation approaches will enable the most efficient way of improving Lynch syndrome detection. The approach used in this study could also be applied to assess other implementation approaches aimed at increasing the uptake of cost-effective health interventions. Trial registration ANZCTR, ACTRN12618001072202. Registered on 27 June 2018.

The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is gaining popularity as healthcare system funders increasingly seek value-based care. However, it is limited in its ability to estimate utilities and thus inform economic evaluations. This study develops the first mapping algorithm for estimating EuroQol 5-Dimension 5-Level (EQ-5D-5L) utilities from PROMIS-29 responses using a large dataset and through extensive comparisons between econometric models.An online survey was conducted to collect responses to PROMIS-29 and EQ-5D-5L from the general Australian population (N = 3013). Direct and indirect mapping methods were explored, including linear regression, Tobit, generalised linear model, censored regression model, beta regression (Betamix), the adjusted limited dependent variable mixture model (ALDVMM) and generalised ordered logit. The most robust model was selected by assessing the performance based on average ten-fold cross-validation geometric mean absolute error and geometric mean squared error, the predicted mean, maximum and minimum utilities, as well as the fitting across the entire distribution.The direct approach using ALDVMM was considered the preferred model based on lowest geometric mean absolute error and geometric mean squared error in cross-validation (0.0882, 0.0299) and its superiority in predicting the actual observed mean, full health states and lower utility extremes. The robustness and precision in prediction across the entire distribution of utilities with ALDVMM suggest it is an accurate and valid mapping algorithm. Moreover, the suggested mapping algorithm outperformed previously published algorithms using Australian data, indicating the validity of this model for economic evaluations.This study developed a robust algorithm to estimate EQ-5D-5L utilities from PROMIS-29. Consistent with the recent literature, the ALDVMM outperformed all other econometric models considered in this study, suggesting that the mixture models have relatively better performance and are an ideal candidate model for mapping.

Non-preference-based patient-reported outcome measures (PROMs) are popular in health outcomes research. These measures, however, cannot be used to estimate health state utilities, limiting their usefulness for economic evaluations. Mapping PROMs to a multi-attribute utility instrument is one solution. While mapping is commonly conducted using econometric techniques, failing to specify the complex interactions between variables may lead to inaccurate prediction of utilities, resulting in inaccurate estimates of cost-effectiveness and suboptimal funding decisions. These issues can be addressed using machine learning. This paper evaluates the use of machine learning as a mapping tool. We adopt a comprehensive approach to compare six machine learning techniques with eight econometric techniques to map the Patient-Reported Outcomes Measurement Information System Global Health 10 (PROMIS-GH10) to the EuroQol five dimensions (EQ-5D-5L). Using data collected from 2015 Australians, we find the least absolute shrinkage and selection operator (LASSO) model out-performed all machine learning techniques and the adjusted limited dependent variable mixture model (ALDVMM) out-performed all econometric techniques, with the LASSO performing better than ALDVMM. The variable selection feature of LASSO was then used to enhance the performance of the ALDVMM in a hybrid model. Our analysis identifies the potential benefits and challenges of using machine learning techniques for mapping and offers important insights for future research.

© 2019 ISPOR–The Professional Society for Health Economics and Outcomes Research Background: Migraine is a common, chronic, disabling headache disorder. Triptans, used as an acute treatment for migraine, are available via prescription in Australia. An Australian Therapeutic Goods Administration (TGA) committee rejected reclassifying sumatriptan and zolmitriptan from prescription medicine to pharmacist-only between 2005 and 2009, largely on the basis of concerns about patient risk. Nevertheless, pharmacist-only triptans may reduce migraine duration and free up healthcare resources. Objectives: To estimate the cost-effectiveness of reclassifying triptans from prescription-only to pharmacist-only in Australia. Methods: The study design included decision-analytic modeling combining data from various sources. Behavior before and after reclassification was estimated using medical practitioner and patient surveys and also administrative data. Health outcomes included migraine frequency and duration as well as adverse events (AEs) discussed by the TGA committee. Efficacy and AEs were estimated using randomized controlled trials and observational studies. Results: Reclassifying triptans will reduce migraine duration but increase AEs. This will result in 337 quality-adjusted life-years gained at an increased cost of A$5.9 million over 10 years for all Australian adults older than 15 years (19.6 million). The incremental cost-effectiveness ratio was estimated to be A$17 412/quality-adjusted life-year gained. Conclusions: The incremental cost-effectiveness ratio is likely to be considered cost-effective by Australian decision makers. Serotonin syndrome, a key concern of the TGA committee, had little impact on the results. Further research is needed regarding pharmacist-only triptan use by migraineurs currently using over-the-counter medicines and by nonmigraineurs, the efficacy of triptans, and the risk of cardiovascular and cerebrovascular AEs and chronic headaches with triptans.

Background Research has shown unilateral cochlear implants (CIs) significantly improve clinical outcomes and quality of life in adults. However, only 13% of eligible Swedish adults currently use a unilateral CI. The objective was to estimate the cost-effectiveness of unilateral CIs compared to a hearing aid for Swedish adults with severe to profound hearing loss. Methods A Markov model with a lifetime horizon and six-month cycle length was developed to estimate the benefits and costs of unilateral CIs from the Swedish health system perspective. A treatment pathway was developed through consultation with clinical experts to estimate resource use and costs. Unit costs were derived from the Swedish National Board of Health and Welfare and the Swedish Association of Local Authorities and Regions. Health outcomes were reported in terms of Quality Adjusted Life Years (QALYs). Results Unilateral CIs for Swedish adults with severe to profound hearing loss are likely to be deemed cost-effective when compared to a hearing aid (SEK 140,474 per QALY gained). The results were most sensitive to the age when patients are implanted with a CI and the proportion of patients eligible for CIs after triage. Conclusions An increase in the prevalence of Swedish adults with severe to profound hearing loss is expected as the population ages. Earlier implantation of unilateral CIs improves the cost-effectiveness among people eligible for CIs. Unilateral CIs are an efficacious and cost-effective option to improve hearing and quality of life in Swedish adults with severe to profound hearing loss.

Initially patients require a prescription to access most new medicines. Some medicines may later be reclassified, allowing patients to access them without a prescription. Currently, Australian Therapeutic Goods Administration guidelines regarding reclassification decisions focus on patient risk rather than on potential benefits to patient health and the healthcare system. We conducted two extensive case studies demonstrating an economic evaluation approach to medicine reclassification in Australia, which were presented at various conferences and to key stakeholders. This article discusses the advantages and challenges of using an economic evaluation approach to inform medicine reclassification decisions. Advantages identified include systematically and transparently synthesising evidence from multiple sources; predicting the overall expected impact of reclassification on health outcomes and costs before it occurs; considering a broader range of risks and benefits; aggregation of health impacts into a single measure (quality-adjusted life years); identification of drivers of uncertainty; insight into the effects of different regulatory decisions; and improved consistency of evidence. Challenges include data availability and quality, estimating behavioural changes, model complexity, the lack of an incremental cost-effectiveness ratio threshold, and funding of economic analyses. We recommend that regulatory decision makers use an economic evaluation approach to help inform reclassification decisions, although economic evaluation results should be considered as part of the broader body of evidence. Ultimately, the use of an economic evaluation approach will contribute to helping decision makers maximise population health outcomes in an efficient way. What is known about the topic? In the past, decisions regarding medicine reclassification have generally been made using a deliberative approach focusing on patient risk. However, there are also potential benefits to patient health and effects on the healthcare system. Increasing awareness of these benefits have led to the development of alternative approaches to decision making, including an economic evaluation approach. What does this paper add? This article discusses the advantages and challenges of using an economic evaluation approach to inform medicine reclassification decisions compared with alternative approaches. What are the implications for practitioners? Economic evaluation results should be considered as part of the broader body of evidence regarding the types of health impacts, the extent of the available evidence, who will be affected, and the role of medical practitioners and pharmacists in mitigating any risks. However, awareness of the advantages and challenges of this approach in advance will help mitigate some of the challenges and increase acceptance of the economic evaluation results by decision makers and stakeholders.

There are limited economic evaluations comparing coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) for multi-vessel coronary artery disease (MVCAD) in contemporary, routine clinical practice. The aim was to perform a cost-effectiveness analysis comparing CABG and PCI in patients with MVCAD, from the perspective of the Australian public hospital payer, using observational data sources. Clinical data from the Melbourne Interventional Group (MIG) and the Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) registries were analysed for 1022 CABG (treatment) and 978 PCI (comparator) procedures performed between June 2009 and December 2013. Clinical records were linked to same-hospital admissions and national death index (NDI) data. The incremental cost-effectiveness ratios (ICERs) per major adverse cardiac and cerebrovascular event (MACCE) avoided were evaluated. The propensity score bin bootstrap (PSBB) approach was used to validate base-case results. At mean follow-up of 2.7 years, CABG compared with PCI was associated with increased costs and greater all-cause mortality, but a significantly lower rate of MACCE. An ICER of $55,255 (Australian dollars)/MACCE avoided was observed for the overall cohort. The ICER varied across comparisons against bare metal stents (ICER $25,815/MACCE avoided), all drug-eluting stents (DES) ($56,861), second-generation DES ($42,925), and third-generation of DES ($88,535). Moderate-to-low ICERs were apparent for high-risk subgroups, including those with chronic kidney disease ($62,299), diabetes ($42,819), history of myocardial infarction ($30,431), left main coronary artery disease ($38,864), and heart failure ($36,966). At early follow-up, high-risk subgroups had lower ICERs than the overall cohort when CABG was compared with PCI. A personalised, multidisciplinary approach to treatment of patients may enhance cost containment, as well as improving clinical outcomes following revascularisation strategies.

Unplanned pregnancies can lead to poorer maternal and child health outcomes. The Australian Therapeutic Goods Administration committee rejected reclassifying a range of oral contraceptive pills (OCPs) from prescription to pharmacist-only medicines in 2015, mainly based on safety concerns. Improving access to OCPs may encourage some women to use contraceptives or switch from other contraceptive methods. However, some adverse events may increase and some women may stop using condoms, increasing their risk of sexually transmitted infections. This study aimed to estimate the cost effectiveness of reclassifying OCPs from prescription to pharmacist-only. Healthcare system. Australian primary care. A Markov model was used to synthesise data from a variety of sources. The model included all Australian women aged 15–49 years (N = 5,644,701). The time horizon was 35 years. Contraceptive use before reclassification was estimated using data from the Household, Income and Labour Dynamics in Australia (HILDA) survey, while survey data informed use after reclassification. Health outcomes included pregnancies, pregnancy outcomes (live birth, miscarriage, stillbirth, ectopic pregnancy and abortion), sexually transmitted infections, adverse events (venous thromboembolism, depression, myocardial infarction and stroke), ovarian cancer cases and quality-adjusted life-years. Costs included those related to general practitioner and specialist consultations, contraceptives and other medicines, pharmacist time, hospitalisations and adverse events. All costs were reported in 2016 Australian Dollars. A 5% discount rate was applied to health outcomes and costs. Reclassifying OCPs resulted in 85.70 million quality-adjusted life-years experienced and costs of $46,910.14 million over 35 years, vs. 85.68 million quality-adjusted life-years experienced and costs of $50,274.95 million with OCPs remaining prescription-only. Thus, reclassifying OCPs was more effective and cost saving. However, a sensitivity analysis found that more research on the probability of pregnancy in women not using contraception and not trying to conceive is needed. Reclassifying OCPs is likely to be considered cost effective by Australian decision makers.

© 2016, Springer International Publishing Switzerland. Introduction: Estimating the real-world cost-effectiveness of a new drug relies on understanding the differences between clinical trial data (pre-reimbursement) and clinical practice (post-reimbursement). This is important for decision makers when reviewing reimbursement decisions, prices, and considering other drugs for the same condition. Differences can arise from differences in patient characteristics, but also from the availability of new evidence and evolving treatment practices. This paper examines these issues using a case study. Methods: In 2001, the Australian Government funded trastuzumab for the treatment of HER2+ metastatic breast cancer through the Herceptin Program. The administrative arrangements of the Program resulted in rich observational data that captured information about patients treated with trastuzumab between 2001 and 2010 (n = 3830). The dataset included patient characteristics, dispensed medicines, medical service use and date of death. Results: Compared to participants in the clinical trials, patients were older, received more prior chemotherapies and a broader range of co-administered chemotherapies. Treatment practices differed from the clinical trials, but also changed over time. For example, in situ hybridization testing, rather than immunohistochemistry testing, and a three weekly administration schedule, rather than one weekly, were increasingly used. Compared to the clinical trials, patients administered trastuzumab with a concomitant chemotherapy generally experienced longer overall survival (151.3 weeks, 95 % CI: 142.6, 163.4), while those who received trastuzumab as a monotherapy experienced shorter overall survival (94.4 weeks, 95%CI: 86.4, 102.9). These findings may be due to a differing relative treatment effect in clinical practice, but may also be due to a range of other factors. Conclusion: This analysis demonstrates the challenges for decision makers that arise because new evidence and evolving treatment practices create a gap between clinical trial data and real-world clinical practice and outcomes.

BACKGROUND: Permanent childhood hearing loss is one of the most common birth conditions associated with speech and language delay. A hearing screening can result in early detection and intervention for hearing loss. OBJECTIVES: To update and expand previous systematic reviews of economic evaluations of childhood hearing screening strategies, and explore the methodological differences. DATA SOURCES: MEDLINE, Embase, the Cochrane database, National Health Services Economic Evaluation Database (NHS EED), the Health Technology Assessment (HTA) database, and Canadian Agency for Drugs and Technologies in Health’s (CADTH) Grey matters. STUDY ELIGIBILITY CRITERIA, PARTICIPANTS AND INTERVENTIONS: Economic evaluations reporting costs and outcomes for both the intervention and comparator arms related to childhood hearing screening strategies. RESULTS: Thirty evaluations (from 29 articles) were included for review. Several methodological issues were identified, including: few evaluations reported outcomes in terms of quality-adjusted life years (QALYs); none estimated utilities directly from surveying children; none included disutilities and costs associated with adverse events; few included costs and outcomes that differed by severity; few included long-term estimates; none considered acquired hearing loss; some did not present incremental results; and few conducted comprehensive univariate or probabilistic sensitivity analysis. Evaluations published post-2011 were more likely to report QALYs and disability-adjusted life years (DALYs) as outcome measures, include long-term treatment and productivity costs, and present incremental results. LIMITATIONS: We were unable to access the economic models and, although we employed an extensive search strategy, potentially not all relevant economic evaluations were identified. CONCLUSIONS AND IMPLICATIONS: Most economic evaluations concluded that childhood hearing screening is value for money. However, there were significant methodological limitations with the evaluations.

Background: Economic evaluation of mandatory health programmes generally do not consider the utility impact of a loss of consumer choice upon implementation, despite evidence suggesting that consumers do value having the ability to choose. Objectives: The primary aim of this study was to explore whether the utility impact of a loss of consumer choice from implementing mandatory health programmes can be measured using discrete choice experiments (DCEs). Methods: Three case studies were used to test the methodology: fortification of bread-making flour with folate, mandatory influenza vaccination of children, and the banning of trans-fats. Attributes and levels were developed from a review of the literature. An orthogonal, fractional factorial design was used to select the profiles presented to respondents to allow estimation of main effects. Overall, each DCE consisted of 64 profiles which were allocated to four versions of 16 profiles. Each choice task compared two profiles, one being voluntary and the other being mandatory, plus a 'no policy' option, thus each respondent was presented with eight choice tasks. For each choice task, respondents were asked which health policy they most preferred and least preferred. Data was analysed using a mixed logit model with correlated coefficients (200 Halton draws). The compensating variation required for introducing a programme on a mandatory basis (versus achieving the same health impacts with a voluntary programme) that holds utility constant was estimated. Results: Responses were provided by 535 participants (a response rate of 83 %). For the influenza vaccination and folate fortification programmes, the results suggested that some level of compensation may be required for introducing the programme on a mandatory basis. Introducing a mandatory influenza vaccination programme required the highest compensation (Australian dollars [A$] 112.75, 95 % CI -60.89 to 286.39) compared with folate fortification (A$18.05, 95 % CI -3.71 to 39.80). No compensation was required for introducing the trans-fats programme (-A$0.22, 95 % CI -6.24 to 5.80) [year 2010 values]. In addition to the type of mandatory health programme, the compensation required was also found to be dependent on a number of other factors. In particular, the study found an association between the compensation required and stronger libertarian preferences. Conclusions: DCEs can be used to measure the utility impact of a loss of consumer choice. Excluding the utility impact of a loss of consumer choice from an economic evaluation taking a societal perspective may result in a sub-optimal, or incorrect, funding decision. © 2013 Springer International Publishing Switzerland.

Objectives To evaluate the cost effectiveness of a community-delivered consultation aimed at improving infant sleep and maternal well-being. Methods A decision-analytic model was developed that compared the costs and benefits of an infant sleep consultation with usual care. The effectiveness of the consultation was based on clinical evidence, and improvements in maternal quality of life were estimated by mapping the Edinburgh Postnatal Depression Scale scores to published utility scores. Cost effectiveness was calculated as the incremental cost per quality-adjusted life-year gained (QALY). Results The statistically significant improvements in mean Edinburgh Postnatal Depression Scale scores at 4- and 16-month follow-ups were used to estimate the benefit in terms of QALYs. The modeled results demonstrated that the infant sleep consultation is low-cost (A$ 436), more effective in terms of QALYs gained (0.017), and cost-effective. The estimated incremental cost-effectiveness ratio was A$ 4031/QALY gained. The main drivers of the model were the use of early parenting centers and nurse training costs. Conclusions Community-based nurse-delivered infant sleep consultations aid infant sleep, improve maternal quality of life, and are cost-effective compared with usual care and lead to improvements in quality of life through a reduction in postnatal depression.

Published economic evaluations of trastuzumab for the treatment of HER2-positive metastatic breast cancer have arrived at different conclusions regarding the cost-effectiveness of trastuzumab, despite comparative efficacy being demonstrated by a small set of randomised controlled trials (RCTs). This article aims to provide insight into the quality of the evaluations and explore the possible drivers of the conflicting conclusions. A systematic literature review was conducted to identify all published economic evaluations that compared the incremental costs and outcomes of trastuzumab versus a comparator. Fifteen economic evaluations were identified. In the evaluations that estimated efficacy using an RCT, the key drivers of the conclusions regarding cost-effectiveness were: the approach used to estimate overall survival in the control group given crossover to trastuzumab following progression in the trials; the inclusion of treatment beyond progression; inclusion of wastage due to unused vial portions, adverse events, and the cost of HER2 testing. Four evaluations used non-randomised approaches to estimate efficacy, thus introducing the potential for confounding. As a result these evaluations reported relatively optimistic estimates of comparative effectiveness. Finally the evaluations used different thresholds to determine whether treatment with trastuzumab was cost-effective. There were numerous drivers of the different conclusions regarding the cost-effectiveness of trastuzumab, many of which are due to judgements made by the authors when translating data from RCTs. Many of the potential drivers were not identified by the published systematic reviews of economic evaluations and perhaps more remain unidentified because of inconsistent and limited reporting.

Background. The probability of reimbursement is a key factor in determining whether to proceed with or abandon a product during its development. The purpose of this article is to illustrate how the methods of iterative Bayesian economic evaluation proposed in the literature can be incorporated into the development process of new medical devices, adapting them to face the relative scarcity of data and time that characterizes the process. Methods. A 3-stage economic evaluation was applied: an early phase in which simple methods allow for a quick prioritization of competing products; a mid-stage in which developers synthesize the data into a decision model, identify the parameters for which more information is most valuable, and explore uncertainty; and a late stage, in which all relevant information is synthesized. A retrospective analysis was conducted of the case study of absorbable pins, compared with metallic fixation, in osteotomy to treat hallux valgus. Results. The results from the early analysis suggest absorbable pins to be cost-effective under the beliefs and assumptions applied. The outputs from the models at the mid-stage analyses show the device to be cost-effective with a high probability. Late-stage analysis synthesizes evidence from a randomized controlled trial and informative priors, which are based on previous evidence. It also suggests that absorbable pins are the most cost-effective strategy, although the uncertainty in the model output increased considerably. Conclusions. This example illustrates how the method proposed allows decisions in the product development cycle to be based on the best knowledge that is available at each stage.

Pharmaceutical expenditure has increased rapidly across many Organisation for Economic Cooperation and Development (OECD) countries over the past three decades. This growth is an increasing concern for governments and other third-party payers seeking to provide equitable and comprehensive healthcare within sustainable budgets. In order to create headroom for increasing utilisation, and to fund new high-cost therapies, there is an active push to ‘disinvest’ from low-value drugs. The aim of this article is to review how reimbursement policy decision makers have sought to partially or completely disinvest from drugs in a range of OECD countries (UK, France, Canada, Australia and New Zealand) where they are publicly funded or subsidised. We employed a systematic literature search strategy and the incorporation of grey literature known to the authorship team. We canvass key policy instruments from each country to outline key approaches to the identification of candidate drugs for disinvestment assessment (passive approaches vs. more active approaches); methods of disinvestment and value-based purchasing (de-listing, restricting treatment, price or reimbursement rate reductions, encouraging generic prescribing); lessons learnt from the various approaches; the potential role of coverage with evidence development; and the need for careful stakeholder management. Dedicated sections are provided with detailed coverage of policy approaches (with drug examples) from each country. Historically, countries have relied on ‘passive disinvestment’; however, due to (1) the availability of new cost-effectiveness evidence, or (2) ‘leakage’ in drug utilisation, or (3) market failure in terms of price competition, there is an increasing focus towards ‘active disinvestment’. Isolating low-value drugs that would create headroom for innovative new products to enter the market is also motivating disinvestment efforts by multiple parties, including industry. Historically, disinvestment has mainly taken the form of price reductions, especially when market failures are perceived to exist, and restricting treatment to subpopulations, particularly when a drug is no longer considered value for money. There is considerable experimentation internationally in mechanisms for disinvestment and the opportunity for countries to learn from each other. Ongoing evaluation of disinvestment strategies is essential, and ought to be reported in the peer-reviewed literature.

Background The last year of life is one of the most resource-intensive periods for people with cancer. Very little population-based research has been conducted on end-of-life cancer care in the Australian health care setting. The objective of this program is to undertake a series of observational studies examining resource use, costs and quality of end-of-life care in a cohort of elderly cancer decedents using linked, routinely collected data. Methods/Design This study forms part of an ongoing cancer health services research program. The cohorts for the end-of-life research program comprise Australian Government Department of Veterans’ Affairs decedents with full health care entitlements, residing in NSW for the last 18 months of life and dying between 2005 and 2009. We used cancer and death registry data to identify our decedent cohorts and their causes of death. The study population includes 9,862 decedents with a cancer history and 15,483 decedents without a cancer history. The median age at death is 86 and 87 years in the cancer and non-cancer cohorts, respectively. We will examine resource use and associated costs in the last 6 months of life using linked claims data to report on health service use, hospitalizations, emergency department visits and medicines use. We will use best practice methods to examine the nature and extent of resource use, costs and quality of care based on previously published indicators. We will also examine factors associated with these outcomes. Discussion This will be the first Australian research program and among the first internationally to combine routinely collected data from primary care and hospital-based care to examine comprehensively end-of-life care in the elderly. The research program has high translational value, as there is limited evidence about the nature and quality of care in the Australian end-of-life setting. Electronic supplementary material The online version of this article (doi:10.1186/s13012-014-0148-2) contains supplementary material, which is available to authorized users.

Objective: Governments are increasing their focus on mandatory public health programmes following positive economic evaluations of their impact. This review aims to examine whether loss of consumer choice should be included in economic evaluations of mandatory health programmes (MHP). Method: A systematic literature review was conducted to identify economic evaluations of MHP, whether they discuss the impact on consumer choice and any methodological limitations. Results: Overall 39 economic evaluations were identified, of which 10 discussed the loss of consumer choice and 6 attempted to place a value on the loss of consumer choice. Methodological limitations included: measuring the marginal cost of compliance, unavailability of price elasticity estimates, the impact of income effects, double counting health impacts, biased willingness-to-pay responses, and "protest" responses. Overall it was found that the inclusion of the loss of consumer choice rarely impacted on the final outcome of the study. Conclusion: The impact of MHP on the loss of consumer choice has largely been ignored in economic evaluations. Its importance remains uncertain due to its infrequent inclusion and significant methodological limitations. Further research regarding which methodology is best for valuing the loss of consumer choice and whether it is important to the final implementation decision is warranted. © 2010 Elsevier Ireland Ltd.