The analysis shows that the estimated cost-effectiveness of ipilimumab is within what has been shown to be acceptable to payers for oncology products in the US.
IND/GLY is cost-minimising vs IND + GLY and dominates SFC in the maintenance treatment of COPD patients in Sweden. Encouraging dual bronchodilator therapy over an ICS-containing combination results in lower total costs and better outcomes compared to combination therapy including fluticasone in moderate-to-severe COPD patients with low exacerbation risk.
BackgroundWarfarin, an inexpensive drug that has been available for over half a century, has been the mainstay of anticoagulant therapy for stroke prevention in patients with atrial fibrillation (AF). Recently, rivaroxaban, a novel oral anticoagulant (NOAC) which offers some distinct advantages over warfarin, the standard of care in a world without NOACs, has been introduced and is now recommended by international guidelines.ObjectiveThe aim of this study was to evaluate, from a Belgian healthcare payer perspective, the cost-effectiveness of rivaroxaban versus use of warfarin for the treatment of patients with non-valvular AF at moderate to high risk.MethodsA Markov model was designed and populated with local cost estimates, safety-on-treatment clinical results from the pivotal phase III ROCKET AF trial and utility values obtained from the literature.ResultsRivaroxaban treatment was associated with fewer ischemic strokes and systemic embolisms (0.308 vs. 0.321 events), intracranial bleeds (0.048 vs. 0.063), and myocardial infarctions (0.082 vs. 0.095) per patient compared with warfarin. Over a lifetime time horizon, rivaroxaban led to a reduction of 0.042 life-threatening events per patient, and increases of 0.111 life-years and 0.094 quality-adjusted life-years (QALYs) versus warfarin treatment. This resulted in an incremental cost-effectiveness ratio of €8,809 per QALY or €7,493 per life-year gained. These results are based on valuated data from 2010. Sensitivity analysis indicated that these results were robust and that rivaroxaban is cost-effective compared with warfarin in 87 % of cases should a willingness-to-pay threshold of €35,000/QALY gained be considered.ConclusionsThe present analysis suggests that rivaroxaban is a cost-effective alternative to warfarin therapy for the prevention of stroke in patients with AF in the Belgian healthcare setting.Electronic supplementary materialThe online version of this article (doi:10.1007/s40273-013-0087-9) contains supplementary material, which is available to authorized users.
ObjectivesThe study (206347) compared organ damage progression in patients with systemic lupus erythematosus (SLE) who received belimumab in the BLISS long-term extension (LTE) study with propensity score (PS)-matched patients treated with standard of care (SoC) from the Toronto Lupus Cohort (TLC).MethodsA systematic literature review identified 17 known predictors of organ damage to calculate a PS for each patient. Patients from the BLISS LTE and the TLC were PS matched posthoc 1:1 based on their PS (±calliper). The primary endpoint was difference in change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) score from baseline to 5 years.ResultsFor the 5- year analysis, of 567 (BLISS LTE n=195; TLC n=372) patients, 99 from each cohort were 1:1 PS matched. Change in SDI score at Year 5 was significantly lower for patients treated with belimumab compared with SoC (−0.434; 95% CI –0.667 to –0.201; p<0.001). For the time to organ damage progression analysis (≥1 year follow-up), the sample included 965 (BLISS LTE n=259; TLC n=706) patients, of whom 179 from each cohort were PS-matched. Patients receiving belimumab were 61% less likely to progress to a higher SDI score over any given year compared with patients treated with SoC (HR 0.391; 95% CI 0.253 to 0.605; p<0.001). Among the SDI score increases, the proportion of increases ≥2 was greater in the SoC group compared with the belimumab group.ConclusionsPS-matched patients receiving belimumab had significantly less organ damage progression compared with patients receiving SoC.
Objective
To report long‐term health‐related quality of life (HRQoL) and fatigue outcomes in patients with systemic lupus erythematosus (SLE) receiving belimumab.
Methods
Patients with SLE who completed the Study of Belimumab in Subjects with SLE 76‐week trial (BLISS‐76) were enrolled in this continuation study (BEL112233 [ClinicalTrials.gov identifier: NCT00724867]). The belimumab groups continued to receive the same dose (1 mg/kg or 10 mg/kg) intravenously. After March 2011, all patients received belimumab 10 mg/kg every 28 days plus standard therapy. The placebo group switched to belimumab 10 mg/kg. HRQoL and fatigue assessments included the Short Form 36 (SF‐36) health survey and the Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue subscale. Post hoc subgroup analyses (BEL206350) assessed clinical characteristics associated with improved HRQoL and fatigue.
Results
Of the 268 patients enrolled, 140 completed the study. Patients receiving long‐term belimumab treatment reported continued improvements in HRQoL and fatigue. At study year 6, the mean ± SD SF‐36 physical component summary (PCS) score and the mental component summary (MCS) score increased from 37.0 ± 9.9 at baseline to 41.7 ± 10.0 (mean ± SD change 4.8 ± 9.4) and from 44.3 ± 11.3 to 47.0 ± 11.6 (mean ± SD change 2.7 ± 11.3) for the PCS and MCS, respectively, exceeding the minimum clinically important difference (MCID) for improvement (2.5 units). The mean ± SD FACIT–Fatigue score exceeded the MCID of 4 at study years 1–5; at study year 6, the mean ± SD change was 3.7 ± 11.8. Statistically significant associations were observed between parent trial treatment groups and change from baseline in PCS, MCS, and FACIT–Fatigue scores (P < 0.01).
Conclusion
Long‐term control of SLE disease activity with belimumab plus standard therapy translates into meaningful improvements in patient‐reported fatigue and HRQoL.
BackgroundChronic obstructive pulmonary disease (COPD) is a progressive and irreversible disease responsible for the deaths of 3 million people worldwide in 2005, and predicted to be the third leading cause of death worldwide by 2030. Many COPD models developed to date have followed a Markov structure, in which patients or populations can move between defined health states over successive time periods or cycles. In COPD, health states are typically based on disease severity defined solely by lung function, as described by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines. These current modelling methods may restrict the ability to reflect the disease progression/clinical pathway or clinical practice.ObjectivesGiven these limitations in previous COPD models, the authors aimed to develop a more flexible model that could improve on the description of the clinical disease pathway. The overall objective of this model was to inform the development of policies, guidelines or cost-effectiveness analyses. A second objective was to validate the model in relation to existing epidemiology studies of COPD.MethodsA patient simulation model was developed in Microsoft Excel™. The predictability of the model was tested by populating it with data from natural history of disease studies as well as with clinical trial data. Each patient moves through the model with demographic characteristics randomly generated from a set distribution. These characteristics determine the risk of clinical events occurring in the model.ResultsThe validation with these studies found the model to have generally good predictive ability, yielding in this way a good degree of external validity.ConclusionsThe micro-simulation model is a flexible approach for modelling COPD that allows consideration of complex COPD treatment pathways. The model was found to be generally robust in terms of predicting clinical outcomes of published studies when tested against other studies. It has significant potential as a tool for supporting future COPD treatment positioning decisions as well as to inform the development of policies, guidelines or cost-effectiveness analyses.
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