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BACKGROUND: High prices of pharmaceutical products are an increasing challenge in high- and low-income countries. Governments in many countries have implemented pricing policies to ensure affordability of medicines to patients and healthcare systems. The World Health Organization published in 2015 the Guideline on Country Pharmaceutical Pricing Policies, which was based on a series of evidence reviews in the preceding years.
As part of the ongoing update of this guideline, we present a protocol for 10 systematic literature reviews on pharmaceutical pricing policies to be covered by the updated guideline.
METHODS: The systematic literature reviews will be undertaken according to the principles embodied in the Cochrane Handbook and Centre for Reviews and Dissemination. The interventions studied are pharmaceutical pricing policies implemented by public institutions or a group of purchasing organizations/individuals (e.g. health services). Studies reporting price, volume, availability and/or affordability as the primary outcomes will be eligible for inclusion. Studies in any country or jurisdiction, in any language and in any setting published in 2004 or later are eligible. Eligible study designs are randomized and non-randomized trials, and observational studies including cohort studies, panel data analyses, comparative time series design (including interrupted time-series and repeated measures studies), and controlled before-after studies. A list of 21 databases of peer-reviewed and grey literature will be searched, along with supplementary searches of relevant national and international organizational and governmental websites. Risk of bias will be assessed according to the Cochrane Effective Practice and Organisation of Care (EPOC) guidelines. A summary table according to the EPOC Worksheets for preparing a Summary of Findings table (SoF) using GRADE will be provided.
DISCUSSION: The results of the review will be used as part of the update of the WHO Guideline on Country Pharmaceutical Pricing Policies. The current protocol may serve as an example for performing systematic literature reviews to inform policy makers.
The health economic evidence of nutrition tends to be limited. An important reason is that nutritionals do not always fall under the coverage requirements for reimbursement, like pharmaceuticals, which often require health economic data. The objective of this paper is to assess the relevance of proactively generating cost-effectiveness data from a nutrition company perspective. After a general introduction into health economics, we will address the key question of this paper: Are cost-effectiveness data in nutrition a double edged sword for nutrition companies?
The conclusion is that, as things currently stand, nutrition companies should be cautious in proactively generating cost-effectiveness data in terms of cost per QALY. Disaggregated economic and outcomes data may be more relevant and less risky for nutrition companies.
BACKGROUND: Local oestrogens, the current treatment for vulvar and vaginal atrophy (VVA), are not suitable for all women. Standard of care (SoC) consists of over-the-counter lubricants and moisturisers. Senshio® (ospemifene) provides a treatment option for postmenopausal women who are not candidates for local vaginal oestrogen therapy who would otherwise have an unmet clinical need.
OBJECTIVES: The aim of this study was to estimate the cost-effectiveness of ospemifene, a selective oestrogen receptor modulator, for the treatment of moderate to severe symptomatic VVA in postmenopausal women who are not candidates for local vaginal oestrogen therapy.
METHODS: The Scottish Medicines Consortium (SMC) recently evaluated the clinical and cost-effectiveness evidence of ospemifene plus SoC compared with SoC alone. A cost-effectiveness study, from a National Health Service (NHS) Scotland perspective over a lifetime time horizon, was submitted to the SMC. The cohort-based Markov model used robust clinical evidence from two large pivotal phase III randomised controlled studies and included four health states classified by dyspareunia symptom severity: none, mild, moderate and severe. The movement of women between health states was dependent on the effectiveness of treatment in reducing dyspareunia. Extensive sensitivity analyses were undertaken to assess the level of confidence associated with the base-case results.
RESULTS: Treatment with ospemifene was associated with an additional cost of £847 per patient and an increase in quality-adjusted life-years (QALY) of 0.06 per patient. Ospemifene had an incremental cost-effectiveness ratio of £14,138 per QALY. In the probabilistic sensitivity analysis, there was a probability of 89% that ospemifene was cost-effective at a threshold of £20,000 per QALY gained. Ospemifene remained cost-effective under all scenario analyses. The SMC reviewed the clinical and economic evidence and judged that the evidence demonstrated a robust case to support prescribing ospemifene in NHS Scotland.
CONCLUSION: Ospemifene is a cost-effective intervention that has recently been accepted by the SMC for the treatment of postmenopausal women with moderate to severe VVA who are not candidates for local oestrogen.
BACKGROUND: Lower gastrointestinal symptoms are common in the general population and it can be difficult to discriminate between inflammatory bowel disease (IBS) and irritable bowel syndrome (IBD) due to overlap of symptoms. The York Fecal Calprotectin Care Pathway (YFCCP) was introduced in 2016 as an alternative to the NICE fecal calprotectin pathway (DG11). This analysis uses the prospective data from the first 1005 patients in the YFCCP. Previous analysis demonstrated the YFCCP may be cost-saving when compared with the DG11 pathway. This analysis examined the short-term health-related quality of life (HRQoL) impact for patients in the YFCCP for IBD and IBS.
METHODS: A decision tree model was used to estimate the proportion of people presenting with lower gastrointestinal symptoms that were correctly or falsely diagnosed with IBS and IBD. Time to diagnosis data was estimated and HRQoL data was estimated from published sources. Costs and QALYs were calculated for the YFCCP and each comparator.
RESULTS: The YFCCP was cost-effective at a £20,000 threshold when compared with the current NICE recommended pathways and was cost-saving with a QALY gain (dominant)in four of the five comparators. Conclusions: The YFCCP demonstrated a QALY benefit when compared with all alternative pathways.
BACKGROUND: Genomic surveillance of methicillin-resistant Staphylococcus aureus (MRSA) identifies unsuspected transmission events and outbreaks. Used proactively, this could direct early and highly targeted infection control interventions to prevent ongoing spread. Here, we evaluated the cost-effectiveness of this intervention in a model that compared whole-genome sequencing plus current practice versus current practice alone.
METHODS: A UK cost-effectiveness study was conducted using an early model built from the perspective of the National Health Service and personal social services. The effectiveness of sequencing was based on the relative reduction in total MRSA acquisitions in a cohort of hospitalized patients in the year following their index admissions. A sensitivity analysis was used to illustrate and assess the level of confidence associated with the conclusions of our economic evaluation.
RESULTS: A cohort of 65 000 patients were run through the model. Assuming that sequencing would result in a 90% reduction in MRSA acquisition, 290 new MRSA cases were avoided. This gave an absolute reduction of 28.8% and avoidance of 2 MRSA-related deaths. Base case results indicated that the use of routine, proactive MRSA sequencing would be associated with estimated cost savings of over £728 290 per annual hospitalized cohort. The impact in total quality-adjusted life years (QALYs) was relatively modest, with sequencing leading to an additional 14.28 QALYs gained. Results were most sensitive to changes in the probability of a MRSA-negative patient acquiring MRSA during their hospital admission.
CONCLUSIONS: We showed that proactive genomic surveillance of MRSA is likely to be cost-effective. Further evaluation is required in the context of a prospective study.
OBJECTIVE: This economic evaluation aims to provide a preliminary assessment of the cost-effectiveness of radiofrequency ablation (RFA) compared with argon plasma coagulation (APC) when used to treat APC-refractory gastric antral vascular ectasia (GAVE) in symptomatic patients.
METHODS: A Markov model was constructed to undertake a cost-utility analysis for adults with persistent symptoms secondary to GAVE refractory to first line endoscopic therapy. The economic evaluation was conducted from a UK NHS and personal social services (PSS) perspective, with a 20-year time horizon, comparing RFA with APC. Patients transfer between health states defined by haemoglobin level. The clinical effectiveness data were sourced from expert opinion, resource use and costs were reflective of the UK NHS and benefits were quantified using Quality Adjusted Life Years (QALYs) with utility weights taken from the literature. The primary output was the Incremental Cost-Effectiveness Ratio (ICER), expressed as cost per QALY gained.
RESULTS: Over a lifetime time horizon, the base case ICER was £4840 per QALY gained with an 82.2% chance that RFA was cost-effective at a threshold of £20,000 per QALY gained. The model estimated that implementing RFA would result in reductions in the need for intravenous iron, endoscopic intervention and requirement for blood transfusions by 27.1%, 32.3% and 36.5% respectively. Compared to APC, RFA was associated with an estimated 36.7% fewer procedures.
CONCLUSIONS: RFA treatment is likely to be cost-effective for patients with ongoing symptoms following failure of first line therapy with APC and could lead to substantive reductions in health care resource.
OBJECTIVES: Life story work involves gathering information about a person, their history and interests, and producing a tangible output, usually a book. It is used increasingly in dementia care. However, theory about if, how, and why it affects outcomes is poorly developed, making the choice of evaluation methods and appropriate outcomes difficult. This article uses a systematic review to uncover theories of change and outcomes for life story work in dementia care. We describe the methods and their use in identifying appropriate outcomes for evaluative research, and their potential for improving evaluation of 'theory poor' interventions.
METHODS: A systematic review, carried out using Centre for Reviews and Dissemination guidelines, searched for evidence on underlying theory, good practice, and effectiveness of life story work to inform a feasibility study for the formal evaluation of life story work in dementia care. For the theory element, a 'landscaping review' analysed the extracted text, using qualitative techniques and mind maps to uncover both explicit and implicit causal links between life story work and outcomes. We triangulated the review findings with qualitative research, which used focus groups with people with dementia, caregivers, and professionals that explored the outcomes that they would like to see from life story work.
RESULTS: Of the 56 publications reviewed, only 16 were useful for the theory analysis. Six overarching outcomes were identified: the self-worth and empowerment of people with dementia, individual psychological outcomes, improved relationships between care staff and the individual with dementia, better care, more effective engagement of family members/carers within the care setting, and helping carers to cope. Twelve final theories linking these outcomes to life story work via a causal pathway were elicited. There was substantial overlap in the outcomes identified by the review and by carers, people with dementia, and professionals. Together, the results informed our choice of outcome measures for the pilot evaluation.
CONCLUSIONS: This approach may enable researchers to identify and develop the theory necessary before evaluation of a complex intervention in other under- or un-theorized areas. It has the potential both to shorten development stages (and thereby costs) in intervention research and improve the intervention itself.
