Economic Burden of Itch-Related Sleep Loss in Moderate-to-Severe Atopic Dermatitis in the United Kingdom.

INTRODUCTION: Atopic dermatitis is associated with intense itch, which has been shown to cause sleep disruption that significantly impacts the lives of patients with atopic dermatitis. Despite this, little is known about its burden to the healthcare system and society. This study aimed to quantify the economic burden of itch-related sleep loss in moderate-to-severe atopic dermatitis in the UK. METHODS: A literature-based decision-analytic model was developed from a healthcare payer and societal perspective. The model quantifies the economic burden by linking the severity of itch to the number of days of sleep disruption. The model captures the direct costs of healthcare resource utilization and treatment alongside the indirect costs of productivity loss from absenteeism and presenteeism at work over a 5-year time horizon. The patient population considered was patients aged ≥ 15 years with moderate-to-severe atopic dermatitis and itch-related sleep disruption. RESULTS: The model estimated that itch-related sleep disruption as a result of moderate-to-severe atopic dermatitis would affect an average of 821,142 people over the time horizon (2022 to 2026). This translates into an average net economic burden of £3.8 billion (£4687 per patient), with an average of 172 million days being affected by sleep disruption per year in the UK. The greatest contributor to the annual average net economic burden was productivity loss from absenteeism and presenteeism, each accounting for 34%. The direct costs (treatment costs and healthcare resource use) accounted for 32% of the net economic burden. The results showed a high and gradually increasing economic burden over the 5-year time horizon. CONCLUSIONS: Sleep disruption has a high economic burden and reducing itch may provide substantial direct and indirect savings. Quantifying the economic burden of itch-related sleep loss may provide support for analyses to inform public health policies for treatment of atopic dermatitis, particularly within the moderate-to-severe level.

Disutility of injectable therapies in obesity and type 2 diabetes mellitus: general population preferences in the UK, Canada, and China.

INTRODUCTION: Once-daily and once-weekly injectable glucagon-like peptide-1 receptor agonist therapies (GLP-1 RAs) are established in obesity and type 2 diabetes mellitus (T2DM). In T2DM, both once-daily and once-weekly insulin are expected to be available. This study elicited utilities associated with these treatment regimens from members of the general public in the UK, Canada, and China, to quantify administration-related disutility of more-frequent injectable treatment, and allow economic modelling. METHODS: Two anchor states (no pharmacological treatment), and seven treatment states (daily oral tablet and generic injectable regimens of variable frequency), with identical outcomes were tested A broadly representative sample of the general public in each country participated (excluding individuals with diabetes or pharmacologically treated obesity). An adapted Measurement and Valuation of Health protocol was administered 1:1 in web-enabled interviews by trained moderators: visual analogue scale (VAS) as a "warm-up", and time trade-off (TTO) using a 20-year time horizon for utility elicitation. RESULTS: A total of 310 individuals participated. The average disutility of once-daily versus once-weekly GLP-1 RA was - 0.048 in obesity and - 0.033 in T2DM; the corresponding average disutility for insulin was - 0.064. Disutilities were substantially greater in China, relative to UK and Canada. DISCUSSION: Within obesity and T2DM, more-frequent treatment health states had lower utility. Scores by VAS also followed a logical order. The generated utility values are suitable for use in modelling injectable therapy regimens in obesity and T2DM, due to the use of generic descriptions and assumption of equal efficacy. Future research could examine the reasons for greater administration-related disutility in China.

Treatment Options for Dementia with Lewy Bodies: A Network Meta-Analysis of Randomised Control Trials.

INTRODUCTION: Dementia with Lewy bodies (DLB) is the third most common type of dementia after Alzheimer's disease (AD) and vascular dementia. Treatment is targeted at specific disease manifestations/symptoms. While donepezil is approved for the treatment of DLB in Japan, to date no other treatment has been approved for this indication anywhere in the world. Notwithstanding, many of the medications that are approved for AD are widely used in the treatment of DLB with varying degrees of success. Consequently, clinical evidence is limited, and there is a need to understand the comparative efficacy and safety of currently used therapies for DLB. The aim of this study was to conduct a network meta-analysis (NMA) to evaluate the outcomes of the available treatment options based on currently used trial endpoints. METHODS: Using data from a previously published systematic review, we conducted an NMA to investigate the efficacy and safety of treatments in patients with DLB. Networks were based on change from baseline of efficacy endpoints (Mini-Mental State Examination; Neuropsychiatric Inventory; Unified Parkinson's Disease Rating Scale) and rate of safety events (overall adverse events [AEs]; discontinuations; discontinuations due to AEs; psychiatric events). RESULTS: Focused around a common treatment option of placebo, the NMA comprised studies on donepezil, rivastigmine, memantine and quetiapine. Donepezil 3 mg, 5 mg and 10 mg doses were compared against each other and placebo. Overall, donepezil consistently performed better than the alternative treatments when compared to placebo for all efficacy and safety endpoints. However, the small sample size and/or heterogeneity of the studies led to uncertainty, resulting in no statistically significant differences favouring any treatment above another or placebo. CONCLUSION: Despite the lack of statistical significance, when assessing the efficacy and safety outcomes for each drug in the evidence network, donepezil appeared to have a more favourable overall benefit/risk profile for patients with DLB. Further comparative trials are required to improve understanding of the true difference between existing and potential future treatment options.

Use of opioid substitution therapies in the treatment of opioid use disorder: results of a UK cost-effectiveness modelling study.

AIMS: This study investigated the cost-effectiveness of buprenorphine maintenance treatment (BMT) and methadone maintenance treatment (MMT) vs no opioid substitution therapy (OST) for the treatment of opioid use disorder, from the UK National Health Service (NHS)/personal social services (PSS) and societal perspectives over 1 year. METHODS: Cost-effectiveness of OST vs no OST was evaluated by first replicating and then expanding an existing UK health technology assessment model. The expanded model included the impact of OST on infection rates of human immunodeficiency virus (HIV) and hepatitis C virus (HCV) infection. RESULTS: Versus no OST, incremental cost-effectiveness ratios (ICERs) for BMT and MMT were £13,923 and £14,206 per quality-adjusted life year (QALY), respectively, from a NHS/PSS perspective. When total costs (NHS/PSS and societal) are considered, there are substantial savings associated with adopting OST; these savings are in excess of £14,032 for BMT vs no OST and £17,174 for MMT vs no OST over 1 year. This is primarily driven by a reduction in victim costs. OST treatment also impacted other aspects of criminality and healthcare resource use. LIMITATIONS: The model's 1-year timeframe means long-term costs and benefits, and the influence of changes over time are not captured. CONCLUSIONS: OST can be considered cost-effective vs no OST from the UK NHS/PSS perspective, with a cost per QALY well below the UK's willingness-to-pay threshold. There were only small differences between BMT and MMT. The availability of two or more cost-effective options is beneficial to retaining patients in OST programs. From a societal perspective, OST is estimated to save over £14,032 and £17,174 per year for BMT and MMT vs no OST, respectively, due to savings in victim costs. Further work is required to fully quantify the clinical and health economic impacts of different OST formulations and their societal impact over the long-term.

Utility elicitation study in the UK general public for late-stage chronic lymphocytic leukaemia.

OBJECTIVES: In the United Kingdom (UK), chronic lymphocytic leukaemia (CLL) makes up 40 % of all leukaemias in patients over 65 years. The study objective was to obtain societal preferences in the UK for "progression-free" and "progressive" states of late-stage CLL, refractory to current first and second line regimens. Preferences were also obtained for selected treatment-related adverse events (AEs). METHODS: A utility elicitation study, using the time trade-off (TTO) method, was conducted by face-to-face interviews with 110 subjects for a baseline disease state (before treatment), three primary disease states [progression-free survival (PFS) and treatment responder, PFS and treatment non-responder and disease progression], and 4 AE sub-states (PFS responder with thrombocytopenia, neutropenia, and infection, and PFS non-responder with infection). TTO scores were converted into utility values, and disutilities were calculated for AEs. Visual analogue scale (VAS) scores were obtained. RESULTS: The primary disease state mean TTO utility scores were: baseline: 0.549; PFS response: 0.671; PFS non-response: 0.394; and progression: 0.214. The mean TTO utility (disutility) scores for the AEs were: PFS response with thrombocytopenia, 0.563 (-0.108), neutropenia, 0.508 (-0.163), and infection, 0.476 (-0.195); PFS non-response with infection, 0.333 (-0.061). The VAS results were in line with the TTO results. CONCLUSIONS: The utility was higher for the PFS state than baseline, but decreased below baseline in non-response and disease progression states. AEs had an impact on utility within the PFS response state. The severe infection AE had a greater impact on utilities for the responding to treatment state compared to the non-responder state.

Economic burden of neural tube defects and impact of prevention with folic acid: a literature review.

Neural tube defects (NTDs) are the second most common group of serious birth defects. Although folic acid has been shown to reduce effectively the risk of NTDs and measures have been taken to increase the awareness, knowledge, and consumption of folic acid, the full potential of folic acid to reduce the risk of NTDs has not been realized in most countries. To understand the economic burden of NTDs and the economic impact of preventing NTDs with folic acid, a systematic review was performed on relevant studies. A total of 14 cost of illness studies and 10 economic evaluations on prevention of NTDs with folic acid were identified. Consistent findings were reported across all of the cost of illness studies. The lifetime direct medical cost for patients with NTDs is significant, with the majority of cost being for inpatient care, for treatment at initial diagnosis in childhood, and for comorbidities in adult life. The lifetime indirect cost for patients with spina bifida is even greater due to increased morbidity and premature mortality. Caregiver time costs are also significant. The results from the economic evaluations demonstrate that folic acid fortification in food and preconception folic acid consumption are cost-effective ways to reduce the incidence and prevalence of NTDs. This review highlights the significant cost burden that NTDs pose to healthcare systems, various healthcare payers, and society and concludes that the benefits of prevention of NTDs with folic acid far outweigh the cost. Further intervention with folic acid is justified in countries where the full potential of folic acid to reduce the risk of NTDs has not been realized.

Cost-utility analysis of rufinamide versus topiramate and lamotrigine for the treatment of children with Lennox-Gastaut Syndrome in the United Kingdom.

PURPOSE: To estimate the cost-effectiveness of rufinamide relative to topiramate and lamotrigine as adjunctive treatment for children with Lennox-Gastaut Syndrome (LGS). METHODS: A Markov decision analytic model was developed to estimate the incremental cost-effectiveness ratio over a three-year time horizon in patients with LGS uncontrolled by up to three antiepileptic drugs. Utilities were assigned to health states, defined according to a patient's response to treatment (> or =75%, > or =50% and <75%, and <50% reduction in tonic-atonic [drop attack] seizure frequency and death). Efficacy and safety estimates were made using indirect/mixed-treatment comparisons of data obtained from published literature. Outcomes included costs and quality-adjusted life-years (QALYs), allowing the incremental cost-effectiveness ratio to be estimated as cost per QALY gained. RESULTS: Over three years, the total cumulative costs for rufinamide, topiramate, and lamotrigine were pound24,992, pound23,360, and pound21,783, respectively. Rufinamide resulted in an incremental QALY gain of 0.079 relative to topiramate and 0.021 relative to lamotrigine. The incremental costs of rufinamide were pound1632 and pound3209, relative to topiramate and lamotrigine, resulting in an incremental cost per QALY gained of pound20,538 and pound154,831, respectively. CONCLUSIONS: Considering the underlying assumptions, this current economic evaluation demonstrates that rufinamide is likely to be a cost-effective alternative to topiramate as adjunctive treatment for children with LGS in the UK. In addition, when compared to lamotrigine, which is an inexpensive treatment, rufinamide should be considered as a cost-effective alternative due to the importance of patient choice and equity of access in such a rare and devastating condition.