Cost-effectiveness of edoxaban compared to warfarin for the treatment and secondary prevention of venous thromboembolism in the UK

Background: Venous thromboembolism (VTE), which includes pulmonary embolism (PE) and deep vein thrombosis (DVT), is the third most common acute cardiovascular disease and represents an important burden for patients and payers. Objective: The aim was to estimate the cost-effectiveness of edoxaban, a non-VKA oral anticoagulant vs. warfarin, the currently most prescribed treatment for VTE in the UK. Study design: A Markov model was built using data from the Hokusai-VTE randomised controlled trial to estimate the lifetime costs and quality-adjusted life years (QALYs) in patients with VTE treated with edoxaban or warfarin over a lifetime horizon, from the UK National Health Services perspective. The model included VTE recurrences, VTE-related complications (post-thrombotic syndrome and chronic thromboembolic pulmonary hypertension), and several types of bleeds associated with anticoagulation treatment. Patients were treated during a period of 6 months after the first VTE event, followed by flexible treatment duration (from 6 months to lifetime) after recurrence, i.e., tertiary prevention. Results: Edoxaban was found dominant vs. warfarin with 0.033 additional QALY and £55 less costs. The reduction of patient management costs, specifically monitoring costs, outweighed the higher drug costs. Edoxaban was dominant in all subgroups (index DVT only, all PE cases (PE with or without DVT), PE without DVT and PE with DVT). Cost-savings ranged from £54 to £81 while additional QALYs ranged from 0.031 to 0.046. Edoxaban was found dominant in 88.6% of cases and cost-effective in additional 10.9% of cases considering a £20,000 threshold in the probabilistic sensitivity analysis. Conclusion: Edoxaban may improve patients' quality of life in a lifetime horizon without additional costs for the healthcare system due to lower bleeding risk and no monitoring cost compared to warfarin

Non-fatal disease burden for subtypes of depressive disorder: population-based epidemiological study

Background: Major depression is the leading cause of non-fatal disease burden. Because major depression is not a homogeneous condition, this study estimated the non-fatal disease burden for mild, moderate and severe depression in both single episode and recurrent depression. All estimates were assessed from an individual and a population perspective and presented as unadjusted, raw estimates and as estimates adjusted for comorbidity. Methods: We used data from the first wave of the second Netherlands-Mental-Health-Survey-and-Incidence-Study (NEMESIS-2, n = 6646; single episode Diagnostic and Statistical Manual (DSM)-IV depression, n = 115; recurrent depression, n = 246). Disease burden from an individual perspective was assessed as 'disability weight * time spent in depression' for each person in the dataset. From a population perspective it was assessed as 'disability weight * time spent in depression *number of people affected'. The presence of mental disorders was assessed with the Composite International Diagnostic Interview (CIDI) 3.0. Results: Single depressive episodes emerged as a key driver of disease burden from an individual perspective. From a population perspective, recurrent depressions emerged as a key driver. These findings remained unaltered after adjusting for comorbidity. Conclusions: The burden of disease differs between the subtype of depression and depends much on the choice of perspective. The distinction between an individual and a population perspective may help to avoid misunderstandings between policy makers and clinicians. © 2016 Biesheuvel-Leliefeld et al

Patients' preferences regarding the timing of highly active antiretroviral therapy initiation for chronic asymptomatic HIV-1 infection

Objective: In patients with a chronic asymptomatic HIV-1 infection and >200 CD4(+) T-cells/mu l, the optimal timing of highly active antiretroviral therapy (HAART) initiation is unclear. It involves a trade-off between a potentially reduced risk of mortality, when started earlier in the course of infection, and an earlier exposure to pill burden and potential toxicities. We investigated patients' preferences for immediate HAART initiation relative to delaying HAART for 1 year. Methods: Consecutive patients were asked for their preference during an interview. A hypothetical difference in 3-year mortality risk between both options was systematically varied between 0% and 10% to determine the threshold at which preference would switch to HAART initiation. Results: About 30% of patients preferred HAART initiation even if the mortality risk would be equal for both options. Almost 25% always preferred delaying HAART even if this would result in a 10% greater mortality risk. Most treatment guidelines recommend delaying HAART >350 CD4(+) T-cells/mu l. However, at a risk difference between starting and delaying HAART that corresponds with this CD4(+) T-cell count, about 50% would prefer to start HAART immediately. Most guidelines recommend starting HAART below 200 CD4(+) T-cells/mu l. However, at a risk difference between both options corresponding with this CD4(+) T-cell count, about 40% preferred delaying HAART. Conclusions: We found large variation in patients' preferences. Some patients were more inclined to initiate HAART earlier than the recommended guidelines, whereas others were more inclined to delay HAART. These findings emphasize the need for shared decision-making when deciding on the most optimal timing of HAART initiation in chronic asymptomatic HIV-1 infectio

Quality of life and the duration of treatment with vitamin K antagonists in patients with deep venous thrombosis

In clinical practice, decisions on the duration of treatment with vitamin K antagonists are usually based on the presence of persistent risk factors, the risk of bleeding and centre policy. Little is known about the influence of patients' experienced quality of life. The objectives of this study were: 1) to explore the course of quality of life in patients with venous thrombosis treated for 3 months versus patients treated for 6 months with vitamin K antagonists; 2) to investigate the factors that were associated with the duration of treatment with vitamin K antagonists. The study sample comprised patients participating in a multicentre clinical trial. Quality of life was assessed at study entry, after 10-14 days, 3 and 6 months in 360 patients. Overall, no differences in quality of life were found between the 2 patient groups. An interaction effect between group and time was found for physical functioning. Regression analyses indicated that the presence of one or more permanent risk factors, duration of hospitalisation, mobility prior to deep-vein thrombosis and study centre were associated with the duration of treatment with vitamin K antagonists. Interestingly, quality of life was not associated with treatment duration. Since study centre was the most important factor associated with treatment duration, local policy appears to have a great influence on decisions regarding the duration of treatment with vitamin K antagonist

Self-reported adherence is more predictive of virological treatment response among patients with a lower tendency towards socially desirable responding

Background: Self-report is the most commonly used measure of adherence to highly active antiretroviral therapy, but typically shows weaker associations with virological treatment outcome than more objective adherence assessment methods. Socially desirable responding might hamper the validity of self-reported adherence. We investigated whether stratifying patients according to their socially desirable response set might improve the prediction of virological treatment response by self-reported adherence. Methods: Patients enrolled in the focus group of the Dutch national cohort ATHENA completed a social desirability scale, four self-report adherence questions, and had their plasma HIV type-1 (HIV-1) RNA concentrations measured. We calculated odds ratios and 95% confidence intervals for self-reported non-adherence to predict HIV-1 RNA>50 copies/ml among patients with a lower or a higher tendency towards socially desirable responding. Results: A total of 331 patients were included. Self-reported non-adherence was significantly predictive of HIV-1 RNA>50 copies/ml on three out of four questions among patients with lower socially desirable responding (n=198). Self-reported non-adherence did not predict HIV-1 RNA>50 copies/ml among patients with higher socially desirable responding (n=132). Conclusions: Stratifying patients according to their socially desirable response set improved the prediction of virological treatment response by self-reported adherence. This finding emphasizes the importance of discussing medication adherence with patients in a non-threatening and non-judgemental way that normalizes non-adherence in order to reduce socially desirable respondin

A comparison of 3 valuation methods for temporary health states in patients treated with oral anticoagulants.

Contains fulltext : 57317.pdf (publisher's version ) (Closed access)BACKGROUND: The application of the time tradeoff (TTO) method in temporary health states may lead to less valid results because an unrealistic scenario is presented to patients. The chained TTO has been proposed to solve this problem. OBJECTIVES: To compare a chained TTO method with a conventional TTO method in the valuation of temporary health states, in terms of consistency and reliability. To compare both TTO methods with direct rating. PATIENTS AND METHODS: Eighty-four patients treated with oral anticoagulants were interviewed twice. During the 1st interview, values for 5 temporary health states were obtained with a rank ordering procedure, direct rating, and the chained TTO method. During the 2nd interview, either the 1st interview was repeated (n = 30) or health state values were obtained with the conventional TTO method (n = 54). Consistency was assessed by comparing the 3 valuation methods with the rank ordering procedure. Generalizability theory was used to assess reliability. RESULTS: The 3 methods produced significantly different valuations of health states. Chained TTO values were higher than values obtained with direct rating and the conventional TTO. Consistency and reliability did not differ across the 3 methods. CONCLUSION: The authors found no evidence for a difference in consistency and reliability between the chained TTO method and the conventional TTO method in the valuation of temporary health states. As direct rating is simpler to administer than both TTO methods, one could consider using direct ratings for the valuation of temporary health states. Biases associated with the conventional and the chained TTO method are discussed