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Health technology assessment (HTA) can be used to make healthcare systems more equitable and efficient. Advances in precision oncology are challenging conventional thinking about HTA. Precision oncology advances are rapid, involve small patient groups, and are frequently evaluated without a randomized comparison group. In light of these challenges, mechanisms to manage precision oncology uncertainties are critical. We propose a life-cycle HTA framework and outline supporting criteria to manage uncertainties based on real world data collected from learning healthcare systems. If appropriately designed, we argue that life-cycle HTA is the driver of real world evidence generation and furthers our understanding of comparative effectiveness and value. We conclude that life-cycle HTA deliberation processes must be embedded into healthcare systems for an agile response to the constantly changing landscape of precision oncology innovation. We encourage further research outlining the core requirements, infrastructure, and checklists needed to achieve the goal of learning healthcare supporting life-cycle HTA. [ABSTRACT FROM AUTHOR]

Individuals with proven hereditary cancer syndrome (HCS) such as BRCA1 and BRCA2 have elevated rates of ovarian, breast, and other cancers. If these high-risk people can be identified before a cancer is diagnosed, risk-reducing interventions are highly effective and can be lifesaving. Despite this evidence, the vast majority of Canadians with HCS are unaware of their risk. In response to this unmet opportunity for prevention, the British Columbia Gynecologic Cancer Initiative convened a research summit "Gynecologic Cancer Prevention: Thinking Big, Thinking Differently" in Vancouver, Canada on 26 November 2021. The aim of the conference was to explore how hereditary cancer prevention via population-based genetic testing could decrease morbidity and mortality from gynecologic cancer. The summit invited local, national, and international experts to (1) discuss how genetic testing could be more broadly implemented in a Canadian system, (2) identify key research priorities in this topic and (3) outline the core essential elements required for such a program to be successful. This report summarizes the findings from this research summit, describes the current state of hereditary genetic programs in Canada, and outlines incremental steps that can be taken to improve prevention for high-risk Canadians now while developing an organized population-based hereditary cancer strategy. [ABSTRACT FROM AUTHOR]

Introduction: Utility instruments are used to assess patients' health-related quality of life for cost-utility analysis (CUA). However, for cancer patients, the dimensions of generic utility instruments may not capture all the information relevant to the impact of cancer. Cancer-specific utilities provide a useful alternative. Under the auspices of the Multi-Attribute Utility in Cancer Consortium, a cancer-specific utility algorithm was derived from the FACT-G. The new FACT-8D contains eight dimensions: pain, fatigue, nausea, sleep, work, support from family/friends, sadness, and worry health will get worse. The aim of the study was to obtain a Canadian value set for the FACT-8D.Methods: A discrete choice experiment was administered to a Canadian general population online panel, quota sampled by age, sex, and province/territory of residence. Respondents provided responses to 16 choice sets. Each choice set consisted of two health states described by the FACT-8D dimensions plus an attribute representing survival duration. Sample weights were applied and the responses were analyzed using conditional logistic regression, parameterized to fit the quality-adjusted life year framework. The results were converted into utility weights by evaluating the marginal rate of substitution between each level of each FACT-8D dimension with respect to duration.Results: 2228 individuals were recruited. The analysis dataset included n = 1582 individuals, who completed at least one choice set; of which, n = 1501 completed all choice sets. After constraining to ensure monotonicity in the utility function, the largest decrements were for the highest levels of pain (- 0.38), nausea (- 0.30), and problems doing work (- 0.23). The decrements of the remaining dimensions ranged from - 0.08 to - 0.18 for their highest levels. The utility of the worst possible health state was defined as - 0.65, considerably worse than dead.Conclusions: The largest impacts on utility included three generic dimensions (i.e., pain, support, and work) and nausea, a symptom caused by cancer (e.g., brain tumours, gastrointestinal tumours, malignant bowel obstruction) and by common treatments (e.g., chemotherapy, radiotherapy, opioid analgesics). This may make the FACT-8D more informative for CUA evaluating in many cancer contexts, an assertion that must now be tested empirically in head-to-head comparisons with generic utility measures. [ABSTRACT FROM AUTHOR]

Background: The trial assigning individualized options for treatment (Rx) (TAILORx) confirmed the predictive value of the 21-gene recurrence score (RS) assay in hormone receptor (HR)-positive, HER2-negative, node-negative breast cancer and established thresholds for chemotherapy benefit in younger and older patients. Real-world chemotherapy use and RS-guided treatment costs in British Columbia post-TAILORx were examined.Methods: The authors assembled 3 cohorts of HR-positive, HER2-negative, node-negative patients with breast cancer defined by diagnosis: before RS funding (cohort 1 [C1]: January 2013-December 2013), after introduction of public RS funding (cohort 2 [C2]: July 2015-June 2016), and after TAILORx results (cohort 3 [C3]: July 2018-June 2019). Chemotherapy use was compared between cohorts by age and RS. Budgetary impacts of RS testing on chemotherapy costs were evaluated pre- and post-TAILORx.Results: Among the 2066 patients included, chemotherapy use declined by 19% after RS funding was introduced and by an additional 23% after TAILORx publication (P = .001). Reduction in chemotherapy use was significant for RS 11-20 tumors (C3 vs C2, P = .004). There was no significant change in chemotherapy use in patients >50 years old (C2:12% vs C3:10%, P = .22). RS testing was associated with higher cost savings post-TAILORx, except in patients 70 to 80 years old, where testing led to excess costs when adjusting for the low rate of RS-concordant chemotherapy prescribed.Conclusions: TAILORx has had population-based impacts on chemotherapy prescribing in intermediate RS tumors and patients ≤50 years old. The lower clinical use of RS and increased spending in patients 70-80 years old highlights the importance of careful selection of older candidates for high-cost genomic testing.Lay Summary: The 21-gene recurrence score (RS) test helps predict whether patients with hormone-positive, HER2-negative, lymph node-negative breast cancer are likely to benefit from chemotherapy. The recent trial assigning individualized options for treatment (Rx) (TAILORx) found that patients with intermediate RS tumors did not benefit from chemotherapy. The authors assessed whether TAILORx results translated to real-world changes in chemotherapy prescribing patterns. In this study, chemotherapy use decreased by 23% after TAILORx, with the greatest reductions seen among intermediate RS tumors and younger patients. In contrast, RS testing had lower clinical value and increased treatment costs in elderly patients, which requires further study to ensure optimal care for this age group. [ABSTRACT FROM AUTHOR]

Covid-19 presents a unique opportunity to transform democratic engagement in the governance of global public goods. In this paper, I describe a global public goods framework and how it relates to Covid-19 vaccines, and summarize some of the global responses to Covid-19. I discuss some of the global threats to health and prosperity posed by the inequitable distribution of vaccines, and propose transformative thinking to democratically engage citizens in the governance of global public goods. In recent years, public-private partnerships and philanthropic organizations have successfully stepped in to help international organizations like the UN and WHO provide global public goods, but they are not democratically elected or publicly accountable. Global public goods are critical to addressing Covid-19, future pandemic preparedness, global health policy, health equity, and the unfolding climate crisis. To make us more resistant and resilient to future global health crises we need transformative thinking to democratically engage global citizens. We need to lay the foundations for a 'global social contract' on global public goods. [ABSTRACT FROM AUTHOR]

PURPOSE: This study aimed to investigate the impact of early versus not-early palliative care among cancer decedents on end-of-life health care costs. METHODS: Using linked administrative databases, we created a retrospective cohort of cancer decedents between 2004 and 2014 in Ontario, Canada. We identified those who received early palliative care (palliative care service used in the hospital or community 12 to 6 months before death [exposure]). We used propensity score matching to identify a control group of not-early palliative care, hard matched on age, sex, cancer type, and stage at diagnosis. We examined differences in average health system costs (including hospital, emergency department, physician, and home care costs) between groups in the last month of life. RESULTS: We identified 144,306 cancer decedents, of which 37% received early palliative care. After matching, we created 36,238 pairs of decedents who received early and not-early (control) palliative care; there were balanced distributions of age, sex, cancer type (24% lung cancer), and stage (25% stage III and IV). Overall, 56.3% of early group versus 66.7% of control group used inpatient care in the last month (P < .001). Considering inpatient hospital costs in the last month of life, the early group used an average (±standard deviation) of $7,105 (±$10,710) versus the control group of $9,370 (±$13,685; P < .001). Overall average costs (±standard deviation) in the last month of life for patients in the early versus control group was $12,753 (±$10,868) versus $14,147 (±$14,288; P < .001). CONCLUSION: Receiving early palliative care reduced average health system costs in the last month of life, especially via avoided hospitalizations [ABSTRACT FROM AUTHOR]

Purpose: To describe the trajectory of physical symptoms among cancer decedents who were receiving home care in the six months before death. Patients and Methods: An observational cohort study of cancer decedents in Ontario, Canada, who received home care services between 2007 and 2014. To be included, decedents had to use at least one home care service in the last six months of life. Outcomes were the presence of pain and several other physical symptoms at each week before death. Results: Our cohort included 27,295 cancer decedents (30,368 assessments). Forty-seven percent were female and 56% were age 75 years or older. The prevalence of all physical symptoms increased as one approached death, particularly in the last month of life. In the last weeks of life, 69% of patients reported having moderate–severe pain; however, only 20% reported that the pain was not controlled. Loss of appetite (63%), shortness of breath (59%), high health instability (50%), and self-reported poor health (44%) were also highly prevalent in the last week of life. Multivariate regression showed that caregiver distress, high health instability, social decline, uncontrolled pain, and signs of depression all worsened the odds of having a physical symptom in the last 3 months of life. Conclusion: In this large home care cancer cohort, trajectories of physical symptoms worsened close to death. While presence of moderate–severe pain was common, it was also reported as mostly controlled. Covariates, such as caregiver distress and social decline, were associated with having more physical symptoms at end of life. [ABSTRACT FROM AUTHOR]

Patients and physicians want rapid access to novel cancer therapies, particularly for advanced cancers with poor prognoses. The US FDA, the European Medicines Agency (EMA), and Health Canada (HC) all have pathways to accelerate and facilitate patient access to novel therapies. In Canada, after receiving HC approval, cancer drugs are evaluated by the Canadian Agency for Drugs and Technologies in Health (CADTH), specifically the pan-Canadian Oncology Drug Review (pCODR). The concern is that recommending drugs based on limited evidence can lead to prescribing treatment that may harm patients or that may not provide any meaningful benefit. [Extracted from the article]

Purpose: Understanding the end-of-life psychosocial needs of cancer patients at home is a knowledge gap. This study describes the trajectory of psychosocial symptoms in the last 6 months of life among cancer decedents who were receiving home care.Methods: Observational population-based cohort study of cancer decedents who were receiving home care services between 2007 and 2014. Decedents had to have at least one home care assessment in the last 6 months of life for inclusion. Outcomes were the presence of psychosocial symptoms (i.e., anxiety, loneliness, depression, social decline, caregiver distress, and cognitive decline) at each week before death.Results: Our cohort included 27,295 unique cancer decedents (30,368 assessments), of which 58% died in hospital. Fifty-six percent were older than 74, and 47% were female. The prevalence of all symptoms increased approaching death, except loneliness. Social decline (48%-78%) was the most prevalent psychosocial symptom, though loneliness was reported in less than 10% of the cohort. Caregiver distress rose over time from 15%-27%. A third of the cohort reported issues with cognitive impairment. Multivariate regression showed that physical symptoms such as uncontrolled pain, impairment in independent activities of daily living, and a high level of health instability all significantly worsened the odds of having a psychosocial symptom in the last 3 months of life.Conclusion: In this large home care cancer cohort, trajectories of psychosocial symptoms worsened close to death. Physical symptoms, such as uncontrolled pain, were associated with having worse psychosocial symptoms at end of life. [ABSTRACT FROM AUTHOR]

Background: In Canada, the Canadian Agency for Drugs and Technologies in Health (CADTH) evaluates and makes recommendations for the reimbursement of cancer drugs. One component of its recommendation is based on an economic evaluation, which typically takes the form of a cost-utility analysis. A cost-utility analysis measures the effects of competing therapies with quality-adjusted life-years (QALYs). The data for this calculation typically come from generic, preference-based measures of health-related quality of life (HRQOL). The objective of this review is to determine the frequency at which HRQOL data are collected alongside cancer drug trials and used in the cost-utility analysis submitted to the CADTH pan-Canadian Oncology Drug Review (pCODR).Methods: Submissions between 2015 and 2018 to pCODR, the group charged with evaluating cancer drug submissions at CADTH, were reviewed. All pCODR submissions, either in progress or completed, were publicly available online. The search was restricted to completed evaluations.Results: Forty-three submissions met the inclusion criteria. The incremental gain in QALYs in most submissions from the new technology was small (median incremental gain, 0.86; interquartile range, 0.6-1.39). More than half of the submissions (56%) did not include original data on HRQOL, with most relying on previous studies of variable relevance and quality. Re-analyses by pCODR based on concerns over HRQOL data used in the submitted model were common (52%).Conclusions: Drug manufacturers do not consistently collect data on HRQOL alongside clinical trials and instead rely on evidence generated in previous studies to inform cost-utility analyses. These findings should induce manufacturers to collect original HRQOL data that are simultaneously relevant to patients and decision makers. [ABSTRACT FROM AUTHOR]

Objectives: The Priorities and Evaluation Committee (PEC) funding recommendations for new cancer drugs in British Columbia, Canada have been based on both clinical and economic evidence. The British Columbia Ministry of Health makes funding decisions. We assessed the association between cost-effectiveness of cancer drugs considered from 1998 to 2008 and the subsequent funding decisions. Methods: All proposals submitted to the PEC between 1998 and 2008 were reviewed, and the association between cost-effectiveness and funding decisions was examined by (i) using logistic regression to test the hypothesis that interventions with higher incremental cost-effectiveness ratios (ICERs) have a lower probability of receiving a positive funding decision and (ii) using parametric and nonparametric tests to determine if a statistically significant difference exists between the mean cost-effectiveness of funded versus not funded proposals. A sub-analysis was conducted to determine if the findings varied across different outcome measures. Results: Of the 149 proposals reviewed, 78 reported cost-effectiveness using various outcome measures. In the proposals that used life-years gained as the outcome (n = 22), a statistically significant difference of nearly $115,000 was observed between the mean ICERs for funded proposals ($42,006) and for unfunded proposals ($156,967). An odds ratio indicating higher ICERs have a lower probability of being funded was also found to be statistically significant (p < .05). Conclusions: Economic evidence appears to play a role in British Columbia cancer funding decisions from 1998 to 2008; other decision-making criteria may also have an important role in recommendations and subsequent funding decisions. [ABSTRACT FROM AUTHOR]

Objectives: The Priorities and Evaluation Committee (PEC) funding recommendations for new cancer drugs in British Columbia, Canada have been based on both clinical and economic evidence. The British Columbia Ministry of Health makes funding decisions. We assessed the association between cost-effectiveness of cancer drugs considered from 1998 to 2008 and the subsequent funding decisions.Methods: All proposals submitted to the PEC between 1998 and 2008 were reviewed, and the association between cost-effectiveness and funding decisions was examined by (i) using logistic regression to test the hypothesis that interventions with higher incremental cost-effectiveness ratios (ICERs) have a lower probability of receiving a positive funding decision and (ii) using parametric and nonparametric tests to determine if a statistically significant difference exists between the mean cost-effectiveness of funded versus not funded proposals. A sub-analysis was conducted to determine if the findings varied across different outcome measures.Results: Of the 149 proposals reviewed, 78 reported cost-effectiveness using various outcome measures. In the proposals that used life-years gained as the outcome (n = 22), a statistically significant difference of nearly $115,000 was observed between the mean ICERs for funded proposals ($42,006) and for unfunded proposals ($156,967). An odds ratio indicating higher ICERs have a lower probability of being funded was also found to be statistically significant (p < .05).Conclusions: Economic evidence appears to play a role in British Columbia cancer funding decisions from 1998 to 2008; other decision-making criteria may also have an important role in recommendations and subsequent funding decisions. [ABSTRACT FROM AUTHOR]

Background. Management of low-grade oral dysplasias (LGDs) is complicated, as only a small percentage of lesions will progress to invasive disease. The current standard of care requires patients to undergo regular monitoring of their lesions, with intervention occurring as a response to meaningful clinical changes. Recent improvements in molecular technologies and understanding of the biology of LGDs may allow clinicians to manage lesions based on their genome-guided risk. Methods. We used a decision-analytic Markov model to estimate the cost-effectiveness of risk-stratified care using a genomic assay. In the experimental arm, patients with LGDs were managed according to their risk profile using the assay, with low- and intermediate-risk patients given longer screening intervals and high-risk patients immediately treated with surgery. Patients in the comparator arm had standard care (biannual follow-up appointments at an oral cancer clinic). Incremental costs and outcomes in life-years gained (LYG) and quality-adjusted life-years (QALY) were calculated based on the results in each arm. Results. The mean cost of assay-guided management was $8,123 (95% confidence interval [CI] $2,973 to $23,062 in 2013 Canadian dollars) less than the cost of standard care. This difference was driven largely by reductions in resource use among people who did not develop cancer. Mean incremental effectiveness was 0.18 LYG (95% CI 0.08 to 0.39) or 0.64 QALY (95% CI 0.46 to 0.89). Sensitivity analysis suggests that these findings are robust to both expected and extreme variation in all parameter values. Conclusion. Use of the assay-guided management strategy costs less and is more effective than standard management of LGDs. [ABSTRACT FROM AUTHOR]

Acute Myeloid Leukaemia ( AML) is a rare but serious group of diseases that require critical decision-making for curative treatment. Over the past decade, scientific discovery has revealed dozens of prognostic gene mutations for AML while sequencing costs have plummeted. In this study, we compared the cost-effectiveness of multigene integrative analysis (genomic analysis) with the standard molecular testing currently used for diagnosis of intermediate-risk AML. We used a decision analytic model with data for costs and outcomes from British Columbia, Canada, to assess the long-term (10-year) economic impacts. Our results suggest that genomic analysis would result in a 26% increase in the use of first-remission allogeneic stem cell transplantation. The resulting treatment decisions and downstream effects would come at an additional cost of $12 556 [2013 Canadian dollars ( CAD)] per person and the incremental cost-effectiveness ratio would be $49 493 per quality-adjusted life-year gained. Cost-effectiveness was dependent on quality of life during the long-term (5-10) years of survival, relapse rates following first-remission chemotherapy and the upfront cost of transplantation. Non-relapse mortality rates, short-term quality of life and the cost of genomic sequencing had only minor impacts. Further research on post-remission outcomes can lead to improvements in the cost-effectiveness of curative treatments for AML. [ABSTRACT FROM AUTHOR]

Background. Scientific advances have led to the discovery of novel treatments with high prices. The cost to publicly fund high-cost drugs may threaten the sustainability of drug budgets in different health care systems. In oncology, there are concerns that health-benefit gains are diminishing over time and that the economic evidence to support funding decisions is too limited. Methods. To assess the additional costs and benefits gained from oncology drugs over time, we used treatment protocols and efficacy results from U.S. Food and Drug Administration records to calculate cost-effectiveness ratios for drugs approved to treat first- and second-line metastatic or advanced breast, colorectal, and non-small cell lung cancer during the years 1994-2013. We assessed reimbursement recommendations reached by health technology assessment agencies in the U.K., Australia, and Canada. Results. Cost-effectiveness ratios were calculated for 50 drugs approved by the U.S. regulator. The more recent approvals were often based on surrogate efficacy outcomes and had extremely high costs, often triple the costs of drugs approved in previous years. Over time, the effectiveness gains have increased for some cancer indications; however, for other indications (non-small cell lung and second-line colorectal cancer), the magnitude of gains in effectiveness decreased. Reimbursement recommendations for drugs with the highest cost-effectiveness ratios were the most inconsistent. Conclusion. Evaluation of the clinical benefits that oncology drugs offer as a function of their cost has become highly complex, and for some clinical indications, health benefits are diminishing over time. There is an urgent need for better economic evidence from oncology drug trials and systematic processes to inform funding decisions. [ABSTRACT FROM AUTHOR]

Background: Health care decision making requires making resource allocation decisions among programs, services, and technologies that all compete for a finite resource pool. Methods of priority setting that use explicitly defined criteria can aid health care decision makers in arriving at funding decisions in a transparent and systematic way. The purpose of this paper is to review the published literature and examine the use of criteria-based methods in 'real-world' health care allocation decisions. Methods: A systematic review of the published literature was conducted to find examples of 'real-world' priority setting exercises that used explicit criteria to guide decision-making. Results: We found thirty-three examples in the peer-reviewed and grey literature, using a variety of methods and criteria. Program effectiveness, equity, affordability, cost-effectiveness, and the number of beneficiaries emerged as the most frequently-used decision criteria. The relative importance of criteria in the 'real-world' trials differed from the frequency in preference elicitation exercises. Neither the decision-making method used, nor the relative economic strength of the country in which the exercise took place, appeared to have a strong effect on the type of criteria chosen. Conclusions: Health care decisions are made based on criteria related both to the health need of the population and the organizational context of the decision. Following issues related to effectiveness and affordability, ethical issues such as equity and accessibility are commonly identified as important criteria in health care resource allocation decisions. [ABSTRACT FROM AUTHOR]

Background: An important challenge with the application of next-generation sequencing technology is the possibility of uncovering incidental genomic findings. A paucity of evidence on personal utility for incidental findings has hindered clinical guidelines. Our objective was to estimate personal utility for complex information derived from incidental genomic findings. Methods: We used a discrete-choice experiment to evaluate participants' personal utility for the following attributes: disease penetrance, disease treatability, disease severity, carrier status and cost. Study participants were drawn from the Canadian public. We analyzed the data with a mixed logit model. Results: In total, 1200 participants completed our questionnaire (available in English and French). Participants valued receiving information about high-penetrance disorders but expressed disutility for receiving information on low-penetrance disorders. The average willingness to pay was $445 (95% confidence interval [CI] $322-$567) to receive incidental findings in a scenario where clinicians returned information about high-penetrance, medically treatable disorders, but only 66% of participants (95% CI 63%-71%) indicated that they would choose to receive information in that scenario. On average, participants placed an important value ($725, 95% CI $600-$850) on having a choice about what type of findings they would receive, including receipt of information about high-penetrance, treatable disorders or receipt of information about high- penetrance disorders with or without available treatment. The predicted uptake of that scenario was 76% (95% CI 72%-79%). Interpretation: Most participants valued receiving incidental findings, but personal utility depended on the type of finding, and not all participants wanted to receive incidental results, regardless of the potential health implications. These results indicate that to maximize benefit, participant-level preferences should inform the decision about whether to return incidental findings. [ABSTRACT FROM AUTHOR]

Background The extent to which a genomic test will be used in practice is affected by factors such as ability of the test to correctly predict response to treatment (i.e. sensitivity and specificity of the test), invasiveness of the testing procedure, test cost, and the probability and severity of side effects associated with treatment. Methods Using discrete choice experimentation (DCE), we elicited preferences of the public (Sample 1, N = 533 and Sample 2, N = 525) and cancer patients (Sample 3, N = 38) for different attributes of a hypothetical genomic test for guiding cancer treatment. Samples 1 and 3 considered the test/treatment in the context of an aggressive curable cancer (scenario A) while the scenario for sample 2 was based on a non-aggressive incurable cancer (scenario B). Results In aggressive curable cancer (scenario A), everything else being equal, the odds ratio (OR) of choosing a test with 95% sensitivity was 1.41 (versus a test with 50% sensitivity) and willingness to pay (WTP) was $1331, on average, for this amount of improvement in test sensitivity. In this scenario, the OR of choosing a test with 95% specificity was 1.24 times that of a test with 50% specificity (WTP = $827). In non-aggressive incurable cancer (scenario B), the OR of choosing a test with 95% sensitivity was 1.65 (WTP = $1344), and the OR of choosing a test with 95% specificity was 1.50 (WTP = $1080). Reducing severity of treatment side effects from severe to mild was associated with large ORs in both scenarios (OR = 2.10 and 2.24 in scenario A and B, respectively). In contrast, patients had a very large preference for 95% sensitivity of the test (OR = 5.23). Conclusion The type and prognosis of cancer affected preferences for genomically-guided treatment. In aggressive curable cancer, individuals emphasized more on the sensitivity rather than the specificity of the test. In contrast, for a non-aggressive incurable cancer, individuals put similar emphasis on sensitivity and specificity of the test. While the public expressed strong preference toward lowering severity of side effects, improving sensitivity of the test had by far the largest influence on patients' decision to use genomic testing. [ABSTRACT FROM AUTHOR]

This paper has two objectives, first to review the relevant literature concerning the social importance of severity of pre-treatment condition, and second to present the results of a new analysis of the relationship between social value, individual assessment of health improvement and the severity of illness. The present study differs methodologically from others reported in the literature. The underlying hypothesis is that members of the public have an aversion to patients being in a severe health state irrespective of the reason for their being there, and that this aversion will affect the social valuation of a health program after taking account of the magnitude of the health improvement. This effect will be observable in a program which (compared to another) takes a person out of a severe health state-the usual case discussed in the literature-or in a program which (compared to another) leaves a person in a severe health state. The present study tests this second implication of the hypothesis. We present data consistent with the view that after taking account of health improvement, health programs are preferred which do not leave people in severe health states. Alternative explanations are considered and particularly the possibility that data reflect a social preference for individuals achieving their health potential. Both explanations imply the need to reconsider the rules for prioritising programs. In this analysis, Person Trade-Off (PTO) scores are used to measure social preferences ('value' or 'social utility') and Time Trade-Off (TTO) scores are used to measure individual assessments of health improvement and initial severity. Econometric results suggest that severity is highly significant and may more than double the index of social value of a health service. [ABSTRACT FROM AUTHOR]

Background: In the HPV FOCAL trial, we will establish the efficacy of hr-HPV DNA testing as a stand-alone screening test followed by liquid based cytology (LBC) triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ⩾ CIN3 as the outcome. Methods/Design: HPV-FOCAL is a randomized, controlled, three-armed study over a four year period conducted in British Columbia. It will recruit 33,000 women aged 25-65 through the province's population based cervical cancer screening program. Control arm: LBC at entry and two years, and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases; Two Year Safety Check arm: hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives; Four Year Intervention Arm: hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive cases Discussion: To date, 6150 participants have a completed sample and epidemiologic questionnaire. Of the 2019 women enrolled in the control arm, 1908 (94.5%) were cytology negative. Women aged 25-29 had the highest rates of HSIL (1.4%). In the safety arm 92.2% of women were hr-HPV negative, with the highest rate of hr-HPV positivity found in 25-29 year old women (23.5%). Similar results were obtained in the intervention arm HPV FOCAL is the first randomized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population-based cervical cancer screening program. Trial Registration: International Standard Randomised Controlled Trial Number Register, ISRCTN79347302. [ABSTRACT FROM AUTHOR]

This paper re-examines criticisms of cross-sectional methods used to test for supplier-induced demand (SID) and re-evaluates the empirical evidence using data from Australian medical services. Cross-sectional studies of SID have been criticised on two grounds. First, and most important, the inclusion of the doctor supply in the demand equation leads to an identification problem. This criticism is shown to be invalid, as the doctor supply variable is stochastic and depends upon a variety of other variables including the desirability of the location. Second, cross-sectional studies of SID fail diagnostic tests and produce artefactual findings due to model misspecification. Contrary to this, the re-evaluation of cross-sectional Australian data indicate that demand equations that do not include the doctor supply are misspecified. Empirical evidence from the re-evaluation of Australian medical services data supports the notion of SID. Demand and supply equations are well specified and have very good explanatory power. The demand equation is identified and the desirability of a location is an important predictor of the doctor supply. Results show an average price elasticity of demand of 0.22 and an average elasticity of demand with respect to the doctor supply of 0.46, with the impact of SID becoming stronger as the doctor supply rises. The conclusion we draw from this paper is that two of the main criticisms of the empirical evidence supporting the SID hypothesis have been inappropriately levelled at the methods used. More importantly, SID provides a satisfactory, and robust, explanation of the empirical data on the demand for medical services in Australia. [ABSTRACT FROM AUTHOR]

One of the clearest predictions of economic theory is that an autonomous increase in supply will depress the price which equilibriates supply and demand. However, US evidence with respect to medical fees has been perverse: higher fees have been observed in areas with more doctors even after standardizing for other relevant variables. This has resulted in two broad responses. Some have invoked the (once) controversial theory of supplier-induced demand to account for the anomaly. Others have suggested ingenious ways of explaining the results within the orthodox framework in which supply and demand are independent. There has been almost no analysis of price formulation in the Australian medical market. It has been generally assumed that the usual supply–demand relationships apply in the Australian context, and that perversity in the US is attributable to US-specific market characteristics. The present article examines the setting of GP fees in the Australian market using 1995 cross-section data from statistical sub-divisions. The implications of the results for workforce planning and for the analysis of consumer benefits are discussed. [ABSTRACT FROM AUTHOR]

Background: Decisions relating to the funding of new drugs are becoming increasingly challenging due to a combination of aging populations, rapidly increasing list prices, and greater numbers of drug-indication pairs being brought to market. This is especially true in cancer, where rapid list price inflation is coupled with steeply rising numbers of incident cancer cases. Within a publicly funded health care system, there is increasing recognition that resource allocation decisions should consider the reassessment of, and potential disinvestment from, currently funded interventions alongside new investments. Public input into the decision-making process can help legitimize the outcomes and ensure priority-setting processes are aligned with public priorities.Methods: In September 2014, a public deliberation event was held in Vancouver, Canada, to obtain public input on the topic of cancer drug funding. Twenty-four members of the general public were tasked with making collective recommendations for policy-makers about the principles that should guide funding decisions for cancer drugs in the province of British Columbia. Deliberative questions and decision aids were used to elicit individuals' willingness to make trade-offs between expenditures and health outcomes.Results: Participants discussed the implications of disinvestment decisions from cancer drugs in terms of its impact on patient choice, fairness and quality of life. Their discussions indicate that in order for a decision to disinvest from currently-funded cancer drugs to be acceptable, it must align with three main principles: the decision must be accompanied by significant gains, described both in terms of cost savings and opportunities to re-invest elsewhere in the health care system; those who are currently prescribed a cancer drug should be allowed to continue their course of treatment (referred to as a continuance clause, or "grandfathering" approach); and it must consider how access to care for specialized populations is impacted.Conclusions: The results from this deliberation event provide insight into what is acceptable to British Columbians with respect to disinvestment decisions for cancer drugs. These recommendations can be considered within wider health system decision-making frameworks for funding decisions relating to all drugs, as well as for cancer drugs. [ABSTRACT FROM AUTHOR]

Background: Spending on cancer drugs has risen dramatically in recent years compared to other areas of health care, due in part to higher prices associated with newly approved drugs and increased demand for these drugs. Addressing this situation requires making difficult trade-offs between cost, harms, and ability to benefit when using public resources, making it important for policy makers to have input from many people affected by the issue, including citizens.Methods: In September 2014, a deliberative public engagement event was conducted in Vancouver, British Columbia (BC), on the topic of priority setting and costly cancer drugs. The aim of the study was to gain citizens' input on the topic and have them generate recommendations that could inform cancer drug funding decisions in BC. A market research company was engaged to recruit members of the BC general public to deliberate over two weekends (four days) on how best to allocate resources for expensive cancer treatments. Participants were stratified based on the 2006 census data for BC. Participants were asked to discuss disinvestment, intravenous versus oral chemotherapy delivery, and decision governance. All sessions were audio recorded and transcribed. Transcripts were analyzed using NVivo 11 software.Results: Twenty-four individuals participated in the event and generated 30 recommendations. Participants accepted the principle of resource scarcity and the need of governments to make difficult trade-offs when allocating health-care resources. They supported the view that cost-benefit thresholds must be set for high-cost drugs. They also expected reasonable health benefits in return for large expenditures, and supported the view that some drugs do not merit funding. Participants also wanted drug funding decisions to be made in a non-partisan and transparent way.Conclusion: The recommendations from the Vancouver deliberation can provide guidance to policy makers in BC and may be useful in challenging pricing by pharmaceutical companies. [ABSTRACT FROM AUTHOR]

Background: Health care decision making requires making resource allocation decisions among programs, services, and technologies that all compete for a finite resource pool. Methods of priority setting that use explicitly defined criteria can aid health care decision makers in arriving at funding decisions in a transparent and systematic way. The purpose of this paper is to review the published literature and examine the use of criteria-based methods in 'real-world' health care allocation decisions.Methods: A systematic review of the published literature was conducted to find examples of 'real-world' priority setting exercises that used explicit criteria to guide decision-making.Results: We found thirty-three examples in the peer-reviewed and grey literature, using a variety of methods and criteria. Program effectiveness, equity, affordability, cost-effectiveness, and the number of beneficiaries emerged as the most frequently-used decision criteria. The relative importance of criteria in the 'real-world' trials differed from the frequency in preference elicitation exercises. Neither the decision-making method used, nor the relative economic strength of the country in which the exercise took place, appeared to have a strong effect on the type of criteria chosen.Conclusions: Health care decisions are made based on criteria related both to the health need of the population and the organizational context of the decision. Following issues related to effectiveness and affordability, ethical issues such as equity and accessibility are commonly identified as important criteria in health care resource allocation decisions. [ABSTRACT FROM AUTHOR]

Background: The extent to which a genomic test will be used in practice is affected by factors such as ability of the test to correctly predict response to treatment (i.e. sensitivity and specificity of the test), invasiveness of the testing procedure, test cost, and the probability and severity of side effects associated with treatment.Methods: Using discrete choice experimentation (DCE), we elicited preferences of the public (Sample 1, N = 533 and Sample 2, N = 525) and cancer patients (Sample 3, N = 38) for different attributes of a hypothetical genomic test for guiding cancer treatment. Samples 1 and 3 considered the test/treatment in the context of an aggressive curable cancer (scenario A) while the scenario for sample 2 was based on a non-aggressive incurable cancer (scenario B).Results: In aggressive curable cancer (scenario A), everything else being equal, the odds ratio (OR) of choosing a test with 95% sensitivity was 1.41 (versus a test with 50% sensitivity) and willingness to pay (WTP) was $1331, on average, for this amount of improvement in test sensitivity. In this scenario, the OR of choosing a test with 95% specificity was 1.24 times that of a test with 50% specificity (WTP = $827). In non-aggressive incurable cancer (scenario B), the OR of choosing a test with 95% sensitivity was 1.65 (WTP = $1344), and the OR of choosing a test with 95% specificity was 1.50 (WTP = $1080). Reducing severity of treatment side effects from severe to mild was associated with large ORs in both scenarios (OR = 2.10 and 2.24 in scenario A and B, respectively). In contrast, patients had a very large preference for 95% sensitivity of the test (OR = 5.23).Conclusion: The type and prognosis of cancer affected preferences for genomically-guided treatment. In aggressive curable cancer, individuals emphasized more on the sensitivity rather than the specificity of the test. In contrast, for a non-aggressive incurable cancer, individuals put similar emphasis on sensitivity and specificity of the test. While the public expressed strong preference toward lowering severity of side effects, improving sensitivity of the test had by far the largest influence on patients' decision to use genomic testing. [ABSTRACT FROM AUTHOR]