To estimate the cost-effectiveness of using a removable boot versus a cast following ankle fracture from the National Health Service and Personal Social Services (NHS+PSS) payer and societal perspectives and explore the impact of both treatments on participants’ activities of daily living.
Cost-effectiveness analyses and qualitative interviews performed alongside a pragmatic multicentre randomised controlled trial.
Eight UK NHS secondary care trusts.
243 participants (60.5% female, on average 48.2 years of age (SD 16.4)) with ankle fracture. Qualitative interviews with 16 participants. Interventions removable air boot versus plaster cast 2 weeks after surgery weight bearing as able with group-specific exercises.
Quality-adjusted life years (QALYs) estimated from the EQ-5D-5L questionnaire, costs and incremental net monetary benefit statistics measured 12 weeks after surgery, for a society willing-to-pay £20 000 per QALY.
Care in the boot group cost, on average, £88 (95% CI £22 to £155) per patient more than in the plaster group from the NHS+PSS perspective. When including all societal costs, the boot saved, on average, £676 per patient (95% CI –£337 to £1689). Although there was no evidence of a QALY difference between the groups (–0.0020 (95% CI –0.0067 to 0.0026)), the qualitative findings suggest participants felt the boot enhanced their quality of life. Patients in the boot felt more independent and empowered to take on family responsibilities and social activities.
While the removable boot is slightly more expensive than plaster cast for the NHS+PSS payer at 12 weeks after surgery, it reduces productivity losses and the need for informal care while empowering patients. Given that differences in QALYs and costs to the NHS are small, the decision to use a boot or plaster following ankle surgery could be left to patients’ and clinicians’ preferences.
ISRCTN15497399, South Central—Hampshire A Research Ethics Committee (reference 14/SC/1409).
This study aimed to evaluate the prospective cost-effectiveness of the Identification and Referral to Improve Safety plus (IRIS+) intervention compared with usual care using feasibility data derived from seven UK general practice sites.
A cost–utility analysis was conducted to assess the potential cost-effectiveness of IRIS+, an enhanced model of the UK’s usual care. IRIS+ assisted primary care staff in identifying, documenting and referring not only women, but also men and children who may have experienced domestic violence/abuse as victims, perpetrators or both. A perpetrator group programme was not part of the intervention per se but was linked to the IRIS+ intervention via a referral pathway and signposting. A Markov model was constructed from a societal perspective to estimate mean incremental costs and quality-adjusted life years (QALYs) of IRIS+ compared with to usual care over a 10-year time horizon.
The IRIS+ intervention saved £92 per patient and produced QALY gains of 0.003. The incremental net monetary benefit was positive (£145) and the IRIS+ intervention was cost-effective in 55% of simulations at a cost-effectiveness threshold of £20 000 per QALY.
The IRIS+ intervention could be cost-effective or even cost saving from a societal perspective in the UK, though there are large uncertainties, reflected in the confidence intervals and simulation results.
Increasing the price of tobacco is one of the most effective measures to reduce the prevalence of smoking. In the Netherlands, the excise tax on tobacco increased by 1.14 in 2020, raising the price of a standard package of cigarettes to 8.00. This study investigates how young adults intend to change their smoking behaviour in the case of hypothetical price increases of a pack of cigarettes, and which background characteristics are associated with intended behaviour change.
A cross-sectional online survey was carried out between September and November 2020. Smokers indicated how they would react to several hypothetical increases in price. Four behavioural options were investigated: smoking less, quitting smoking, switching to another/cheaper product and buying cheaper cigarettes cross-border.
Data were obtained from 776 Dutch smokers between 15 and 25 years.
At a hypothetical price of 10 per package, most respondents reported an intention to smoke less (67%), followed by switching to another/cheaper product (61%), quitting smoking (49%) and shopping for cigarettes cross-border (47%). Prior quit attempts, agreeing with the increase in excise tax and the intention to quit smoking in the future increased the odds of changing behaviour. Higher self-efficacy decreased the odds of behavioural change.
Many young adults intend to change their smoking behaviour in the event of increased prices. Although intended behaviour can deviate significantly from actual behaviour, an increase in excise tax may result in a significant amount of quit attempts and reduced smoking among young adults.
This study examined whether the US President’s Emergency Plan for AIDS Relief (PEPFAR) funding had effects beyond HIV, specifically on several measures of maternal and child health in low-income and middle-income countries (LMICs). The results of previous research on the question of PEPFAR health spillovers have been inconsistent. This study, using a large, multicountry panel data set of 157 LMICs including 90 recipient countries, adds to the literature.
Seven indicators including child and maternal mortality, several child vaccination rates and anaemia among childbearing-age women are important population health indicators. Panel data and difference-in-differences estimators (DID) were used to estimate the impact of the PEPFAR programme from inception in 2004 to 2018 using a comparison group of 67 LMICs. Several different models of baseline (2004) covariates were used to help balance the comparison and treatment groups. Staggered DID was used to estimate impacts since all countries did not start receiving aid at PEPFAR’s inception.
All 157 LMICs from 1990 to 2018.
90 LMICs receiving PEPFAR aid and cohorts of those countries, including those required to submit annual country operational plans (COP), other recipient countries (non-COP), and three groupings of countries based on cumulative amount of per capita aid received (high, medium, low).
PEPFAR aid to combat the HIV epidemic.
Maternal mortality and child mortality rates, vaccination rates to protect children for diphtheria, whooping cough and tetanus, measles, HepB3, and tetanus, and prevalence of anaemia in women of childbearing age.
Across PEPFAR recipient countries, large, favourable PEPFAR health effects were found for rates of childhood immunisation, child mortality and maternal mortality. These beneficial health effects were large and significant in all segments of PEPFAR recipient countries studied. We also found significant and favourable programme effects on the prevalence of anaemia in women of childbearing age in PEPFAR recipient countries receiving the most intensive financial support from the PEPFAR programme. Other recipient countries did not demonstrate significant effects on anaemia.
This study demonstrated that important health indicators, beyond HIV, have been consistently and favourably influenced by PEPFAR presence. Child and maternal mortality have been substantially reduced, and childhood immunisation rates increased. We also found no evidence of ‘crowding out’ or negative spillovers in these resource-poor countries. These findings add to the body of evidence that PEPFAR has had favourable health effects beyond HIV. The implications of these findings are that foreign aid for health in one area may have favourable health effects in other areas in recipient countries. More research is needed on the influence of the mechanisms at work that create these spillover health effects of PEPFAR.
This study aimed to investigate the cost-effectiveness of adding Chinese-developed anti-PD-1 antibody camrelizumab to first-line platinum-doublet chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma (L/M NPC) from the perspective of Chinese healthcare system.
A Markov model consisting of four health states, progression-free survival, first progression survival, second progression survival and death, was built to simulate 3-week patient transitions over a 20-year horizon. A direct comparison between first-line camrelizumab in combination with gemcitabine plus cisplatin and gemcitabine plus cisplatin was performed by calculating transition probabilities from the CAPTAIN-1st trial. Costs and utilities were collected from the local public database and literature. One-way and probabilistic sensitivity analyses were employed to evaluate the robustness of the model.
The Chinese healthcare system perspective.
A hypothetical cohort of Chinese patients with pathologically diagnosed L/M NPC who had an Eastern Cooperative Oncology Group performance status of 0 or 1.
First-line camrelizumab in combination with camrelizumab and gemcitabine plus cisplatin (CGP) versus gemcitabine plus cisplatin (GP).
Cost, quality-adjusted life-years (QALYs), incremental cost-effectiveness ratio (ICER).
The baseline analysis demonstrated that, compared with first-line GP, first-line CGP yields an effectiveness increase of 0.26 QALY, accompanied by an increment of US$6137.59 in healthcare cost. This results in an ICER of US$23 482.32/QALY. With the willingness-to-pay (WTP) threshold for a QALY set at US$37 654.50, first-line CGP proves to be cost-effective in 97.20% of the iterations. Deterministic sensitivity analyses indicated that the uncertainty in model parameters had no substantial effect on our results. Probability sensitivity analysis indicated that CGP was cost-effective at the assumed WTP threshold.
For Chinese patients with L/M NPC, adding Chinese-developed anti-PD-1 antibody camrelizumab to the first-line GP chemotherapy may be cost-effective.
The objective of this study was to evaluate the cost-effectiveness of durvalumab in combination with chemotherapy compared with chemotherapy alone as first-line therapy for metastatic non-small-cell lung cancer (NSCLC) from the perspective of the US payer.
Based on the POSEIDON clinical trial, a partition survival model was developed to compare the cost-effectiveness of durvalumab in combination with chemotherapy versus chemotherapy alone for the first-line treatment of metastatic NSCLC. The model’s primary outcomes were costs, life years (LYs), quality-adjusted LYs (QALYs) and the incremental cost-effectiveness ratio (ICER). The analysis only considered direct medical costs, and health utility value was determined using published literature. The robustness of the model was tested by probabilistic sensitivity analyses.
The combination therapy of durvalumab and chemotherapy improved survival by 0.713 QALYs at an incremental cost of $64 104.638 compared with chemotherapy alone, resulting in an ICER of $89 908.328 per QALY gained from the US payer perspective. The combination therapy had a 92.3% probability of being cost-effective at a willingness-to-pay threshold of $150 000 per QALY based on incremental net health benefits. Sensitivity analyses confirmed the model’s consistency, and none of the parameters significantly influenced the findings.
Durvalumab in combination with chemotherapy represents a more cost-effective strategy for first-line therapy in patients with metastatic NSCLC in the USA compared with chemotherapy alone.
The Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART) trial is a randomised controlled trial of using mobile health (mHealth) technologies to improve adherence to medications and management of adverse events (AEs) in people with multidrug-resistant tuberculosis (MDR-TB) undergoing treatment in Vietnam. This economic evaluation seeks to quantify the cost-effectiveness of this mHealth intervention from a healthcare provider and societal perspective.
The V-SMART trial will recruit 902 patients treated for MDR-TB across seven participating provinces in Vietnam. Participants in both intervention and control groups will receive standard community-based therapy for MDR-TB. Participants in the intervention group will also have a purpose-designed App installed on their smartphones to report AEs to health workers and to facilitate timely management of AEs. This economic evaluation will compare the costs and health outcomes between the intervention group (mHealth) and the control group (standard of care). Costs associated with delivering the intervention and health service utilisation will be recorded, as well as patient out-of-pocket costs. The health-related quality of life (HRQoL) of study participants will be captured using the 36-Item Short Form Survey (SF-36) questionnaire and used to calculate quality-adjusted life-years (QALYs). Incremental cost-effectiveness ratios (ICERs) will be based on the primary outcome (proportion of patients with treatment success after 24 months) and QALYs gained. Sensitivity analysis will be conducted to test the robustness of the ICERs. A budget impact analysis will be conducted from a payer perspective to provide an estimate of the total budget required to scale-up delivery of the intervention.
Ethical approval for the study was granted by the University of Sydney Human Research Ethics Committee (2019/676), the Scientific Committee of the Ministry of Science and Technology, Vietnam (08/QD-HDQL-NAFOSTED) and the Institutional Review Board of the National Lung Hospital, Vietnam (13/19/CT-HDDD). Study findings will be published in peer-reviewed journals and conference proceedings.
ACTRN12620000681954.
This study aims to estimate the cost-effectiveness of oral spironolactone plus routine topical treatment compared with routine topical treatment alone for persistent acne in adult women from a British NHS perspective over 24 weeks.
Economic evaluation undertaken alongside a pragmatic, parallel, double-blind, randomised trial.
Primary and secondary healthcare, community and social media advertising.
Women ≥18 years with persistent facial acne judged to warrant oral antibiotic treatment.
Participants were randomised 1:1 to 50 mg/day spironolactone (increasing to 100 mg/day after 6 weeks) or matched placebo until week 24. Participants in both groups could continue topical treatment.
Cost-utility analysis assessed incremental cost per quality-adjusted life year (QALY) using the EQ-5D-5L. Cost-effectiveness analysis estimated incremental cost per unit change on the Acne-QoL symptom subscale. Adjusted analysis included randomisation stratification variables (centre, baseline severity (investigator’s global assessment, IGA
Spironolactone did not appear cost-effective in the complete case analysis (n=126 spironolactone, n=109 control), compared with no active systemic treatment (adjusted incremental cost per QALY £67 191; unadjusted £34 770). Incremental cost per QALY was £27 879 (adjusted), just below the upper National Institute for Health and Care Excellence’s threshold value of £30 000, where multiple imputation took account of missing data. Incremental cost per QALY for other sensitivity analyses varied around the base-case, highlighting the degree of uncertainty. The adjusted incremental cost per point change on the Acne-QoL symptom subscale for spironolactone compared with no active systemic treatment was £38.21 (complete case analysis).
The results demonstrate a high level of uncertainty, particularly with respect to estimates of incremental QALYs. Compared with no active systemic treatment, spironolactone was estimated to be marginally cost-effective where multiple imputation was performed but was not cost-effective in complete case analysis.
ISRCTN registry (ISRCTN12892056).
The Core Outcome Measures for Improving Care (COM-IC) project aims to deliver practical recommendations on the selection and implementation of a suite of core outcomes to measure the effectiveness of interventions for dementia care.
COM-IC embeds a participatory action approach to using the Alignment–Harmonisation–Results framework for measuring dementia care in Australia. Using this framework, suitable core outcome measures will be identified, analysed, implemented and audited. The methods for analysing each stage will be codesigned with stakeholders, through the conduit of a Stakeholder Reference Group including people living with dementia, formal and informal carers, aged care industry representatives, researchers, clinicians and policy actors. The codesigned evaluation methods consider two key factors: feasibility and acceptability. These considerations will be tested during a 6-month feasibility study embedded in aged care industry partner organisations.
COM-IC has received ethical approval from The University of Queensland (HREC 2021/HE001932). Results will be disseminated through networks established over the project, and in accordance with both the publication schedule and requests from the Stakeholder Reference Group. Full access to publications and reports will be made available through UQ eSpace (https://espace.library.uq.edu.au/), an open access repository hosted by The University of Queensland.
To compared the cost-effectiveness of coadministration of a probiotic adjuvant with peanut oral immunotherapy (PPOIT) with placebo (no treatment) in children with peanut allergy.
Prospectively planned cost-effectiveness analysis alongside a randomised control trial.
The Royal Children’s Hospital, Melbourne, Australia.
56 children with peanut allergy aged 1–10 years at recruitment.
A daily dose of probiotic Lactobacillus rhamnosus CGMCC 1.3724 (NCC4007) and peanut oral immunotherapy administered for 1.5 years.
Costs were considered from a healthcare system perspective and included costs of treatment delivery and adverse events. Effectiveness outcomes included rate of sustained unresponsiveness (SU) and quality-adjusted life years (QALYs). The cost-effectiveness of PPOIT versus placebo was analysed using patient-level data. Time horizon was 10 years from commencement of PPOIT treatment, comprising 1.5 years of treatment (actual data), 4 years of post-treatment follow-up (actual data), and 4.5 years of extrapolation thereafter (modelling).
Healthcare cost per patient over 10 years was higher for PPOIT compared with placebo ($A9355 vs $A1031, p
Cost per QALY gained using PPOIT compared with no treatment is approximately $A20 000 (£10 000) and is well below the conventional value judgement threshold of $A50 000 (£25 000) per QALY gained, thus deemed good value for money ($A1= £0.5 approximately).
Australian New Zealand Clinical Trials Registry ACTRN12608000594325; Post-results.
The ASTRUM-007 study confirmed the significant efficacy and safety of serplulimab plus chemotherapy for patients with locally advanced/metastatic, programmed cell death-ligand 1 positive oesophageal squamous cell carcinoma (OSCC). The economics of this regimen, however, is unclear. Therefore, this study aimed to evaluate the cost-effectiveness of adding serplulimab to chemotherapy for the treatment of advanced OSCC from the perspective of the Chinese healthcare system.
A partitioned survival model was established to simulate the costs and outcomes of chemotherapy versus serplulimab plus chemotherapy. The survival data came from the ASTRUM-007 study. Only direct medical costs were considered, and utility values were referred to the literature. Sensitivity analysis was performed to assess the effect of parameter uncertainty on the model.
Total costs, incremental costs, life years, quality-adjusted life years (QALYs), incremental QALYs and incremental cost-effectiveness ratio (ICER).
The base case analysis showed that the cost of serplulimab plus chemotherapy (US$69 356) was US$41 607 higher than that of chemotherapy (US$27 749), but it also gained 0.38 QALYs more (1.38 vs 1 QALYs), with an ICER of US$110 744.36/QALY, which was higher than the willingness to pay. The factors that most influenced the ICER were the price of serplulimab, weight and utility value of the progression-free survival stage. The subgroup analysis and scenario analysis also demonstrated that serplulimab plus chemotherapy was not economical.
Compared with chemotherapy, serplulimab coupled with chemotherapy was not cost-effective for the treatment of advanced OSCC in China.
Increasing numbers of young people attending university has raised concerns about the capacity of student mental health services to support them. We conducted a randomised controlled trial (RCT) to explore whether provision of an 8 week mindfulness course adapted for university students (Mindfulness Skills for Students—MSS), compared with university mental health support as usual (SAU), reduced psychological distress during the examination period. Here, we conduct an economic evaluation of MSS+SAU compared with SAU.
Economic evaluation conducted alongside a pragmatic, parallel, single-blinded RCT comparing provision of MSS+SAU to SAU.
616 university students randomised.
The primary economic evaluation assessed the cost per quality-adjusted life year (QALY) gained from the perspective of the university counselling service. Costs relate to staff time required to deliver counselling service offerings. QALYs were derived from the Clinical Outcomes in Routine Evaluation Dimension 6 Dimension (CORE-6D) preference based tool, which uses responses to six items of the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM; primary clinical outcome measure). Primary follow-up duration was 5 and 7 months for the two recruitment cohorts.
It was estimated to cost £1584 (2022 prices) to deliver an MSS course to 30 students, £52.82 per student. Both costs (adjusted mean difference: £48, 95% CI £40–£56) and QALYs (adjusted mean difference: 0.014, 95% CI 0.008 to 0.021) were significantly higher in the MSS arm compared with SAU. The incremental cost-effectiveness ratio (ICER) was £3355, with a very high (99.99%) probability of being cost-effective at a willingness-to-pay threshold of £20 000 per QALY.
MSS leads to significantly improved outcomes at a moderate additional cost. The ICER of £3355 per QALY suggests that MSS is cost-effective when compared with the UK’s National Institute for Health and Care Excellence thresholds of £20 000 per QALY.
Australian and New Zealand Clinical Trials Registry, ACTRN12615001160527.
Aortic stenosis (AS) is one of the most common acquired cardiac valvular diseases. The success of transcatheter aortic valve implantation (TAVI) for severe AS has led to increasing interest in its use to earlier disease—moderate AS (MAS).
Model-based study using a Markov microsimulation technique to evaluate the long-term costs and benefits associated with ‘early’ TAVI. Key data inputs were sourced from the international literature and costs were obtained from Australian sources.
Australian health care system perspective.
10 000 hypothetical MAS patients with or without left ventricular diastolic dysfunction or impaired left ventricular ejection fraction.
Comparing early TAVI to medical management over a life time horizon for MAS patients aged >65 years. We evaluated the cost-effectiveness of offering early TAVI in five scenarios (10%, 25%, 50%, 75% and 90% take-up rates).
The primary outcome measure is quality-adjusted life years (QALY) gained and the incremental cost–utility ratio (ICUR). Secondary outcomes are life-years gained and the number of heart failure case avoided.
Offering early TAVI for MAS patients resulted in both higher healthcare costs and greater benefits (an increase of 3.02 QALYs or 3.99 life-years) per person treated. The ICUR was around $A10 867 and $A11 926 per QALY gained for all five scenarios, with the total cost of early TAVI to the healthcare system being anticipated to be up to $A3.66 billion. Sensitivity analyses indicated a 100% probability of being cost-effective with a willingness to pay threshold of $A50 000/QALY. The benefits remained, even with assumptions of high levels of repeat valve replacement after TAVI.
While ongoing randomised controlled trials will define the benefit of TAVI to MAS patients, these results suggest that this intervention is likely to be cost-effective.