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BACKGROUND: It has been suggested that probiotics may improve gastrointestinal discomfort. Not all probiotics exhibit the same effects and consequently meta-analyses on probiotics should be confined to well-defined strains or strain combinations. The aim of this study was to evaluate the effectiveness of a probiotic fermented milk (PFM) that includes Bifidobacterium lactis (B. lactis) CNCM I-2494 and lactic acid bacteria on gastrointestinal discomfort in the general adult population.
METHODS: Double-blind randomized controlled trials in the general adult population comparing PFM with a control dairy product for at least 4 weeks were searched from multiple literature databases (up to February 2015). Meta-analyses using random-effects models, with individual participant data were undertaken to calculate an odds ratio (OR) or standard mean difference (SMD), with a 95% confidence interval (CI).
RESULTS: The search strategy identified 12,439 documents. Overall, three trials with a total of 598 adults (female = 96.5%) met the inclusion criteria. Consumption of the PFM product was associated with a significant improvement in overall gastrointestinal discomfort compared with the control product (OR = 1.48; 95% CI 1.07-2.05), with a number needed to treat (NNT) of 10.24 (95% CI 5.64-55.93). PFM was also superior to the control in reducing digestive symptoms, as measured using a composite score (SMD = -0.21; 95% CI -0.37 to -0.05). Sensitivity analyses produced similar results, and the heterogeneity between studies was minimal.
CONCLUSIONS: This meta-analysis shows that the consumption of PFM with B. lactis CNCM I-2494 and lactic acid bacteria is associated with a modest but consistent and significant improvement of outcomes related to gastrointestinal discomfort in healthy adults.
In England, general practitioners are incentivized through a national pay-for-performance scheme to adopt evidence-based quality improvement initiatives using a portfolio of Quality and Outcomes Framework (QOF) indicators. We describe the development of the methods used to assess the cost-effectiveness of these pay-for-performance indicators and how they have contributed to the development of new indicators. Prior to analysis of new potential indicators, an economic subgroup of the National Institute for Health and Care Excellence (NICE) Indicator Advisory Committee is formed to assess evidence on the cost-effectiveness of potential indicators in terms of the health benefits gained, compared to the cost of the intervention and the cost of the incentive. The expert subgroup is convened to reach consensus on the amounts that could potentially be paid to general practices for achieving new indicators. Indicators are also piloted in selected general practices and evidence gathered about their practical implementation. The methods used to assess economic viability of new pilot indicators represent a pragmatic and effective way of providing information to inform recommendations. Current policy to reduce QOF funding could shift the focus from national (QOF) to local schemes, with economic appraisal remaining central.
BACKGROUND: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Tofacitinib is approved in the United States for use in adults with moderately to severely active RA and an inadequate response or intolerance to methotrexate.
OBJECTIVES: To (a) evaluate, using an economic model, the treatment costs of an RA strategy including tofacitinib, compared with adalimumab, etanercept, certolizumab and tocilizumab biologic RA treatment strategies, which are commonly prescribed in the United States, and (b) assess the economic impact of monotherapy and combination therapy in patients who had an inadequate response to methotrexate therapy (MTX-IR analysis) and to combination therapy in patients who had an inadequate response to a tumor necrosis factor inhibitor (TNF-IR analysis).
METHODS: A transparent, Excel-based economic model with a decision-tree approach was developed to evaluate costs over a 1- and 2-year time horizon. The model compared tofacitinib 5 mg twice a day (BID) either as monotherapy or in combination with MTX with similarly labeled biologic therapies. Response to treatment was modeled as American College of Rheumatology (ACR) 20/50/70 response. ACR20 represented clinical response and determined whether patients continued therapy. ACR response rates at 6-month intervals were sourced from prescribing information and safety event rates from a published meta-analysis. Following an adverse event or a lack of response to treatment, it was assumed that 75% of patients switched to the next line of treatment (first to abatacept and then to rituximab). The perspective was that of a U.S. payer. Costs were reported in 2015 U.S. dollars and included drug wholesale acquisition costs, monitoring, drug administration, and treatment for minor and serious adverse events. The patient population eligible for treatment was based on the total number of members (i.e., RA and non-RA) in a payer organization; members with RA treated with biologic therapies were estimated using epidemiological data. Sensitivity analyses were conducted to explore the impact of varying key parameters, including treatment-switching probability, product rebate, major rates of adverse drug reaction, and ACR20 rates, on the model outcomes.
RESULTS: Tofacitinib combination therapy after MTX failure was associated with the lowest cost per member per month (PMPM) over a 2-year time frame at $5.53, compared with $6.49 for adalimumab, $6.43 for etanercept, $5.95 for certolizumab, and $5.89 for tocilizumab. Similar savings were observed when all biologics were administered as monotherapy. Tofacitinib combination therapy was also associated with the lower PMPM cost compared with adalimumab combination therapy in the TNF-IR analysis. Tofacitinib was also among the lowest cost per ACR20 responder in each analysis. Sensitivity analyses demonstrated that tofacitinib would potentially be cost saving even in the least optimistic scenarios.
CONCLUSIONS: This analysis suggests that tofacitinib 5 mg BID following MTX failure is a lower cost per patient treatment option when used either as monotherapy or combination therapy, compared with adalimumab, etanercept, certolizumab and tocilizumab biologic regimens. Tofacitinib + MTX in TNF-IR patients was also predicted to be a lower-cost treatment option compared with adalimumab+MTX and was associated with the lowest cost per ACR 20/50/70 responder.
BACKGROUND: The numbers of incarcerated people suffering from drug dependence has steadily risen since the 1980s and only a small proportion of these receive appropriate treatment. A systematic review to evaluate the effectiveness and economic evidence of non-pharmacological interventions for drug using offenders was conducted.
METHODS: Cochrane Collaboration criteria were used to identify trials across 14 databases between 2004 and 2014. A series of meta-analyses and an economic appraisal were conducted.
RESULTS: 43 trials were identified showing to have limited effect in reducing re-arrests RR 0.97 (95% CI 0.89-1.07) and drug use RR 0.90 (95% CI 0.80-1.00) but were found to significantly reduce re-incarceration RR 0.70 (95% CI 0.57-0.85). Therapeutic community programs were found to significantly reduce the number of re-arrests RR 0.70 (95% CI 0.56-0.87). 10 papers contained economic information. One paper presented a cost-benefit analysis and two reported on the cost and cost effectiveness of the intervention.
CONCLUSIONS: We suggest that therapeutic community interventions have some benefit in reducing subsequent re-arrest. We recommend that economic evaluations should form part of standard trial protocol
BACKGROUND: Asthma affects an estimated 300 million people worldwide with the condition associated with significant healthcare utilisation costs and a large impact on patient quality of life. The SQ® HDM SLIT-tablet (ACARIZAX®, Hørsholm, Denmark) is a sublingually administered allergy immunotherapy tablet for house dust mite allergic asthma and allergic rhinitis and has recently been licensed in Europe.
OBJECTIVE: To assess the cost-effectiveness of ACARIZAX plus pharmacotherapy versus placebo plus pharmacotherapy in patients with house dust mite allergic asthma that is uncontrolled by inhaled corticosteroids, in a German setting. Eligible patients should also have symptoms of mild to severe allergic rhinitis.
METHODS: A cost utility analysis was undertaken, based on the results of a European phase III randomised controlled trial, in which ACARIZAX was compared with placebo with both treatment groups also receiving pharmacotherapy in the form of inhaled corticosteroids and short-acting ß2-agonists. Cost and quality-adjusted life years from the trial were extrapolated over a nine year time horizon and the incremental cost-effectiveness ratio calculated to compare treatment options.
RESULTS: ACARIZAX plus pharmacotherapy was estimated to generate 6.16 quality-adjusted life years per patient at a cost of €5658, compared with 5.50 quality-adjusted life years (QALYs) at a cost of €2985 for placebo plus pharmacotherapy. This equated to an incremental cost of €2673, incremental QALYs of 0.66 and an incremental cost-effectiveness ratio (ICER) of €4041. The ICER was, therefore, substantially lower than the €40,000 willingness-to-pay threshold per QALY adopted for the analysis. Deterministic sensitivity analyses indicate the results are most sensitive to the utility score of ACARIZAX patients during years 2 and 3 of treatment.
CONCLUSION: This analysis indicates that ACARIZAX plus pharmacotherapy is cost-effective compared with placebo plus pharmacotherapy for house dust mite allergic asthma patients in Germany. If a disease-modifying effect can be proven the results of this analysis may underestimate the true benefits of ACARIZAX.
INTRODUCTION: The objective of this study was to assess the cost-effectiveness of the d-Nav Insulin Guidance Service (Hygieia Inc.), a system designed to improve glycemic control via the use of insulin titration, in people with diabetes at risk of developing neuropathic foot ulcers.
METHODS: A Markov model containing four health states (no ulcer, uninfected ulcer, infected ulcer, and amputation) was developed to compare d-Nav with current National Health Service standard care. Patient movement between the health states was governed by event rates taken from the wider literature. Both the healing rate for uninfected ulcers and the rate of recurrence for uninfected ulcers were directly influenced by the patient's glycated hemoglobin (HbA1c). Separate mean HbA1c values were assigned to treatment and control patients and taken from a single-arm study that examined the effect of d-Nav on the outcomes of 122 patients, with HbA1c for control patients based on values recorded in the 12-month period prior to the study and HbA1c for d-Nav based on values recorded during the trial. Weekly cycles were applied, and patient resource use and quality-adjusted life years (QALYs) were estimated over a 3-year time horizon. Univariate sensitivity analysis was undertaken.
RESULTS: In the base case, d-Nav was cost-saving and produced more QALYs than standard care, with a total net monetary benefit value of £1459 per patient. Univariate analysis indicated that the model results are relatively robust to variations in underlying parameters, with patient HbA1c having the most significant impact on outcomes.
CONCLUSION: Interventions that aim to improve glycemic control, such as d-Nav, appear to be a cost-effective use of healthcare resources when targeted at those with poor glycemic control at high risk of developing foot ulcers.
OBJECTIVE: To evaluate the cost-effectiveness of neurothrombectomy with a stent retriever (Solitaire * Revascularization Device) in treating acute ischemic stroke patients from the UK healthcare provider perspective.
METHODS: A Markov model was developed to simulate health outcomes and costs of two therapies over a lifetime time horizon: stent-retriever thrombectomy in combination with intravenous tissue-type plasminogen activator (IV t-PA), and IV t-PA alone. The model incorporated an acute phase (0-90 days) and a rest of life phase (90+ days). Health states were defined by the modified Rankin Scale score. During the rest of life phase, patients remained in the same health state until a recurrent stroke or death. Clinical effectiveness and safety data were taken from the SWIFT PRIME study. Resource use and health state utilities were informed by published data.
RESULTS: Combined stent-retriever thrombectomy and IV t-PA led to improved quality-of-life and increased life expectancy compared to IV t-PA alone. The higher treatment costs associated with the use of stent-retriever thrombectomy were offset by long-term cost savings due to improved patient health status, leading to overall cost savings of £33 190 per patient and a net benefit of £79 402. Deterministic and probabilistic sensitivity analyses demonstrated that the results were robust to a wide range of parameter inputs.
LIMITATIONS: The acute and long-term costs resource use data were taken from a study based on a patient population that was older and may have had additional comorbidities than the SWIFT PRIME population, resulting in costs that may not be representative of the cohort within this model. In addition, the estimates may not reflect stroke care today as no current evidence is available; however, the cost estimates were deemed reasonable by clinical opinion.
CONCLUSIONS: Combined stent-retriever neurothrombectomy and IV t-PA is a cost-effective treatment for acute ischemic stroke compared with IV t-PA alone.
