O’Mahony, James F.
O’Mahony, James F.
Now showing 1 - 10 of 23
- PublicationCost-effectiveness evidence on approved cancer drugs in Ireland: the limits of data availability and implications for public accountabilityBackground: We surveyed evidence published by Ireland’s National Centre for Pharmacoeconomics (NCPE) on the cost-effectiveness of cancer drugs approved for funding within the Irish public healthcare system. The purpose is threefold: to assess the completeness and clarity of publicly available cost-effectiveness data of such therapies; to provide summary estimates of that data; to consider the implications of constraints on data availability for accountability regarding healthcare resource allocation. Methods: The National Cancer Control Programme lists 91 drug-indication pairs approved between June 2012 and July 2020. Records were retrieved from the NCPE website for each drug-indication pair, including, where available, health technology assessment (HTA) summary reports. We assessed what cost-effectiveness data regarding approved interventions is available, aggregated it and considered the consequences of reporting constraints. Results: Among the 91 drug-indication pairs 61 were reimbursed following full HTA, 22 after a rapid review process and 8 have no corresponding NCPE record. Of the 61 where an HTA report was available, 41 presented costs and quality-adjusted life-year (QALY) estimates of the interventions compared. Cost estimates and corresponding incremental cost-effectiveness ratios (ICERs) are based on prices on application for reimbursement. Reimbursed prices are not published. Aggregating over the drug-indication pairs for which data is available, we find a mean incremental health gain of 0.85 QALY and an aggregate ICER of €100,295/QALY, which exceeds Ireland’s cost-effectiveness threshold of €45,000/QALY. Conclusion: Reimbursement applications by pharmaceutical manufacturers for cancer drugs typically exceed Ireland’s cost-effectiveness threshold, often by a considerable margin. On aggregate, the additional total net cost of new drugs relative to current treatments needs to be more than halved for the prices sought on application to be justified for reimbursement. Commercial confidentiality regarding prices and cost-effectiveness upon reimbursement compromises accountability regarding the fair and efficient allocation of scarce healthcare resources.
Scopus© Citations 1 6
- PublicationCervical screening during the COVID-19 pandemic: optimising recovery strategiesDisruptions to cancer screening services have been experienced in most settings as a consequence of the COVID-19 pandemic. Ideally, programmes would resolve backlogs by temporarily expanding capacity; however, in practice, this is often not possible. We aim to inform the deliberations of decision makers in high-income settings regarding their cervical cancer screening policy response. We caution against performance measures that rely solely on restoring testing volumes to pre-pandemic levels because they will be less effective at mitigating excess cancer diagnoses than will targeted measures. These measures might exacerbate pre-existing inequalities in accessing cervical screening by disregarding the risk profile of the individuals attending. Modelling of cervical screening outcomes before and during the pandemic supports risk-based strategies as the most effective way for screening services to recover. The degree to which screening is organised will determine the feasibility of deploying some risk-based strategies, but implementation of age-based risk stratification should be universally feasible.
Scopus© Citations 28 5
- PublicationInterpreting cost-effectiveness ratios in a cost-effectiveness analysis of risk-tailored prostate screening: A critique of Callender et al.(Taylor and Francis, 2020-10-20)Callender et al. recently published a model-based cost-effectiveness analysis of a risk-tailored approach to prostate cancer screening. It considers the costs and effects of prostate cancer screening offered to all men aged 55-69 without any risk selection and, alternatively, over a range of risk-tailored strategies in which screen eligibility is determined by a varying threshold of disease risk. The analysis finds that the strategy of screening men once they reach a 10-year absolute risk of disease of 5% or more is cost-effective in a UK context. I believe there are several problems with the study, mostly stemming from an incorrect interpretation of the cost-effectiveness estimates. I show that one reinterpretation of their results indicates that screening is much less cost-effective than the original analysis suggests, indicating that screening should be restricted to a much smaller group of higher risk men. More broadly, I explain the challenges of attempting to meaningfully reinterpret the originally published results due to the simulation of non-mutually exclusive intervention strategies. Finally, I consider the relevance of considering sufficient alternative screening intensities. This critique highlights the need for appropriate interpretation of cost-effectiveness results for policymakers, especially as risk stratification within screening becomes increasingly feasible.
- PublicationColorectal Cancer Screening within Colonoscopy Capacity Constraints: Can FIT-Based Programs Save More Lives by Trading off More Sensitive Test Cutoffs against Longer Screening Intervals?Introduction. Colorectal cancer (CRC) prevention programs using fecal immunochemical testing (FIT) in screening rely on colonoscopy for secondary and surveillance testing. Colonoscopy capacity is an important constraint. Some European programs lack sufficient capacity to provide optimal screening intensity regarding age ranges, intervals, and FIT cutoffs. It is currently unclear how to optimize programs within colonoscopy capacity constraints. Design. Microsimulation modeling, using the MISCAN-Colon model, was used to determine if more effective CRC screening programs can be identified within constrained colonoscopy capacity. A total of 525 strategies were modeled and compared, varying 3 key screening parameters: screening intervals, age ranges, and FIT cutoffs, including previously unevaluated 4- and 5-year screening intervals (using a lifetime horizon and 100% adherence). Results were compared with the policy decisions taken in Ireland to provide CRC screening within available colonoscopy capacity. Outcomes estimated net costs, quality-adjusted life-years (QALYs), and required colonoscopies. The optimal strategies within finite colonoscopy capacity constraints were identified. Results. Combining a reduced FIT cutoff of 10 µg Hb/g, an extended screening interval of 4 y and an age range of 60–72 y requires 6% fewer colonoscopies, reduces net costs by 23% while preventing 15% more CRC deaths and saving 16% more QALYs relative to a strategy (FIT 40 µg Hb/g, 2-yearly, 60–70 year) approximating current policy. Conclusion. Previously overlooked longer screening intervals may optimize cancer prevention with finite colonoscopy capacity constraints. Changes could save lives, reduce costs, and relieve colonoscopy capacity pressures. These findings are relevant to CRC screening programs across Europe that employ FIT-based testing, which face colonoscopy capacity constraints.
Scopus© Citations 4 6
- PublicationThe Irish Cost-Effectiveness Threshold: Does it Support Rational Rationing or Might it Lead to Unintended Harm to Ireland's Health System?Ireland is one of the few countries worldwide to have an explicit cost-effectiveness threshold. In 2012, an agreement between government and the pharmaceutical industry that provided substantial savings on existing medications set the threshold at €45,000/quality-adjusted life-year (QALY). This replaced a previously unofficial threshold of €20,000/QALY. According to the agreement, drugs within the threshold will be granted reimbursement, whereas those exceeding it may still be approved following further negotiation. A number of drugs far exceeding the threshold have been approved recently. The agreement only applies to pharmaceuticals. There are four reasons for concern regarding Ireland's threshold. The absence of an explicit threshold for non-drug interventions leaves it unclear if there is parity in willingness to pay across all interventions. As the threshold resembles a price floor rather than a ceiling, in principle it only offers a weak barrier to cost-ineffective interventions. It has no empirical basis. Finally, it is probably too high given recent estimates of a threshold for the UK based on the cost effectiveness of services forgone of approximately £13,000/QALY. An excessive threshold risks causing the Irish health system unintended harm. The lack of an empirically informed threshold means the policy recommendations of cost-effectiveness analysis cannot be considered as fully evidence- based rational rationing. Policy makers should consider these issues and recent Irish legislation that defined cost effectiveness in terms of the opportunity cost of services forgone when choosing what threshold to apply once the current industry agreement expires at the end of 2015.
Scopus© Citations 30 5
- PublicationExpanding health technology assessment towards broader value: Ireland as a case studyHealthcare innovations often represent important improvements in population welfare, but at what cost, and to whom? Health technology assessment (HTA) is a multidisciplinary process to inform resource allocation. HTA is conventionally anchored on health maximization as the only relevant output of health services. If we accept the proposition that health technologies can generate value outside the healthcare system, resource allocation decisions could be suboptimal from a societal perspective. Incorporating broader value in HTA as derived from social values and patient experience could provide a richer evaluative space for informing resource allocation decisions. This article considers how HTA is practiced and what its current context implies for adopting broader value to evaluating health technologies. Methodological challenges are highlighted, as is a future research agenda. Ireland serves as an example of a healthcare system that both has an explicit role for HTA and is evolving under a current program of reform to offer universal, single-tier access to public services. There are various ways in which HTA processes could move beyond health, including considering the processes of care delivery and/or expanding the evaluative space to some broader concept of well-being. Methods to facilitate the latter exist, but their adaptation to HTA is still emerging. We recommend a multi-stakeholder working group to develop and advance an international agenda for HTA that captures welfare/benefit beyond health.
- PublicationDealing with Time in Health Economic Evaluation: Methodological Issues and Recommendations for PracticeTime is an important aspect of health economic evaluation, as the timing and duration of clinical events, healthcare interventions and their consequences all affect estimated costs and effects. These issues should be reflected in the design of health economic models. This article considers three important aspects of time in modelling: (1) which cohorts to simulate and how far into the future to extend the analysis; (2) the simulation of time, including the difference between discrete-time and continuous-time models, cycle lengths, and converting rates and probabilities; and (3) discounting future costs and effects to their present values. We provide a methodological overview of these issues and make recommendations to help inform both the conduct of cost-effectiveness analyses and the interpretation of their results. For choosing which cohorts to simulate and how many, we suggest analysts carefully assess potential reasons for variation in cost effectiveness between cohorts and the feasibility of subgroup-specific recommendations. For the simulation of time, we recommend using short cycles or continuous-time models to avoid biases and the need for half-cycle corrections, and provide advice on the correct conversion of transition probabilities in state transition models. Finally, for discounting, analysts should not only follow current guidance and report how discounting was conducted, especially in the case of differential discounting, but also seek to develop an understanding of its rationale. Our overall recommendations are that analysts explicitly state and justify their modelling choices regarding time and consider how alternative choices may impact on results.
9Scopus© Citations 55
- PublicationWe need to talk about values: a proposed framework for the articulation of normative reasoning in health technology assessmentIt is acknowledged that health technology assessment (HTA) is an inherently value-based activity that makes use of normative reasoning alongside empirical evidence. But the language used to conceptualise and articulate HTA's normative aspects is demonstrably unnuanced, imprecise, and inconsistently employed, undermining transparency and preventing proper scrutiny of the rationales on which decisions are based. This paper – developed through a cross-disciplinary collaboration of 24 researchers with expertise in healthcare priority-setting – seeks to address this problem by offering a clear definition of key terms and distinguishing between the types of normative commitment invoked during HTA, thus providing a novel conceptual framework for the articulation of reasoning. Through application to a hypothetical case, it is illustrated how this framework can operate as a practical tool through which HTA practitioners and policymakers can enhance the transparency and coherence of their decision-making, while enabling others to hold them more easily to account. The framework is offered as a starting point for further discussion amongst those with a desire to enhance the legitimacy and fairness of HTA by facilitating practical public reasoning, in which decisions are made on behalf of the public, in public view, through a chain of reasoning that withstands ethical scrutiny.
- PublicationMagnetic Tweezers-Based Force Clamp Reveals Mechanically Distinct apCAM Domain InteractionsCell adhesion molecules of the immunoglobulin superfamily (IgCAMs) play a crucial role in cell-cell interactions during nervous system development and function. The Aplysia CAM (apCAM), an invertebrate IgCAM, shares structural and functional similarities with vertebrate NCAM and therefore has been considered as the Aplysia homolog of NCAM. Despite these similarities, the binding properties of apCAM have not been investigated thus far. Using magnetic tweezers, we applied physiologically relevant, constant forces to apCAM-coated magnetic particles interacting with apCAM-coated model surfaces and characterized the kinetics of bond rupture. The average bond lifetime decreased with increasing external force, as predicted by theoretical considerations. Mathematical simulations suggest that the apCAM homophilic interaction is mediated by two distinct bonds, one involving all five immunoglobulin (Ig)-like domains in an antiparallel alignment and the other involving only two Ig domains. In summary, this study provides biophysical evidence that apCAM undergoes homophilic interactions, and that magnetic tweezers-based, force-clamp measurements provide a rapid and reliable method for characterizing relatively weak CAM interactions.
462Scopus© Citations 17
- PublicationA Simple Cost-Effectiveness Model of Screening: An Open-Source Teaching and Research Tool Coded in RApplied cost-effectiveness analysis models are an important tool for assessing health and economic effects of healthcare interventions but are not best suited for illustrating methods. Our objective is to provide a simple, open-source model for the simulation of disease-screening cost-effectiveness for teaching and research purposes. We introduce our model and provide an initial application to examine changes to the efficiency frontier as input parameters vary and to demonstrate face validity. We described a vectorised, discrete-event simulation of screening in R with an Excel interface to define parameters and inspect principal results. An R Shiny app permits dynamic interpretation of simulation outputs. An example with 8161 screening strategies illustrates the cost and effectiveness of varying the disease sojourn time, treatment effectiveness, and test performance characteristics and costs on screening policies. Many of our findings are intuitive and straightforward, such as a reduction in screening costs leading to decreased overall costs and improved cost-effectiveness. Others are less obvious and depend on whether we consider gross outcomes or those net to no screening. For instance, enhanced treatment of symptomatic disease increases gross effectiveness, but reduces the net effectiveness and cost-effectiveness of screening. A lengthening of the preclinical sojourn time has ambiguous effects relative to no screening, as cost-effectiveness improves for some strategies but deteriorates for others. Our simple model offers an accessible platform for methods research and teaching. We hope it will serve as a public good and promote an intuitive understanding of the cost-effectiveness of screening.