Economic Evaluations of Pharmacological Treatments in Heart Failure Patients: A Methodological Review with a Focus on Key Model Drivers.
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ABSTRACT:
SUBMITTER: Di Tanna GL
PROVIDER: S-EPMC7426354 | biostudies-literature | 2020 Sep
REPOSITORIES: biostudies-literature
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Economic Evaluations of Pharmacological Treatments in Heart Failure Patients: A Methodological Review with a Focus on Key Model Drivers.
Di Tanna Gian Luca GL Chen Shuxian S Bychenkova Anna A Wirtz Heidi S HS Burrows Karen L KL Globe Gary G
PharmacoEconomics - open 20200901 3
Various decision analytic models exist for evaluating the cost-effectiveness of pharmacological interventions for heart failure (HF). Despite this, studies that explore drivers influencing these modeling approaches remain scarce. Through a systematic review of the literature, the present study sought to identify model drivers that emerge from economic evaluations of HF pharmacological interventions. Among the 72 cost effectiveness papers evaluating HF drug interventions, the most frequently iden ...[more]
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Project description:Background and aimsChronic migraine is a common neurovascular brain disorder with substantial economic costs. We performed a systematic review to identify economic evaluations of pharmacological treatments for adults with chronic migraine.MethodsWe undertook systematic literature searches using terms for migraine/headache and prophylactic drug interventions, combined with economic/cost terms where appropriate. Using inclusion and exclusion criteria, two reviewers independently assessed the citations and abstracts, and full-text articles were retrieved. A review of study characteristics and methodological quality was assessed.ResultsSixteen citations met the inclusion criteria and were model-based cost-utility studies evaluating: Botox (n = 6); Erenumab (n = 8); Fremanezumab (n = 2); and Galcanezumab (n = 1) as the main treatment. They varied in their use of comparators, perspective, and model type. Botox was cost-effective compared to placebo with an incremental cost-effectiveness ratio (ICER) ranging between £15,028 (€17,720) and £16,598 (€19,572). Erenumab, Fremanezumab and Galcanezumab when compared to Botox, was associated with ICERs ranging between £59,712 ($81,080) and £182,128 (€218,870), with the ICERs above the most common willingness-to-pay thresholds (WTPs). But they were cost-effective within the commonly used WTPs among the population for whom the previous treatments including Botox were failed. Three studies compared the cost-effectiveness of Erenumab against the placebo and found that Erenumab was dominant. All studies performed sensitivity analyses to check the robustness of their results. None of the findings from the included articles were generalisable and none of the included studies fulfilled all the criteria mentioned in the CHEERS 2022 reporting checklist and Phillips's checklist for economic models.ConclusionsEvidence to support the cost-effectiveness of pharmacological treatments of chronic migraine in the adult population using Botox and Erenumab were identified. Our findings suggest that both Botox and Erenumab, are cost-effective compared to placebo; although Erenumab had more incremental economic benefits compared to Botox, the ICERs were above the most common willingness-to-pay thresholds. Hence, Erenumab might be an acceptable treatment for chronic migraine for patients whom other treatments such as Botox do not work. Further research is needed to help characterise the data to adequately structure and parameterise an economic model to support decision-making for chronic migraine therapies.
| S-EPMC9479409 | biostudies-literature
Project description:In a rapidly growing and aging population, heart failure (HF) has become recognised as a public health concern that imposes high economic and societal costs worldwide. HF management stems from the use of highly cost-effective angiotensin converting enzyme inhibitors (ACEi) and β-blockers to the use of newer drugs such as sodium-glucose cotransporter-2 inhibitors (SGLT2i), ivabradine, and vericiguat. Modelling studies of pharmacological treatments that report on cost effectiveness in HF is important in order to guide clinical decision making. Multiple cost-effectiveness analysis of dapagliflozin for heart failure with reduced ejection fraction (HFrEF) suggests that it is not only cost-effective and has the potential to improve long-term clinical outcomes, but is also likely to meet conventional cost-effectiveness thresholds in many countries. Similar promising results have also been shown for vericiguat while a cost effectiveness analysis (CEA) of empagliflozin has shown cost effectiveness in HF patients with Type 2 diabetes. Despite the recent FDA approval of dapagliflozin and empagliflozin in HF, it might take time for these SGLT2i to be widely used in real-world practice. A recent economic evaluation of vericiguat found it to be cost effective at a higher cost per QALY threshold than SGLT2i. However, there is a lack of clinical or real-world data regarding whether vericiguat would be prescribed on top of newer treatments or in lieu of them. Sacubitril/valsartan has been commonly compared to enalapril in cost effectiveness analysis and has been found to be similar to that of SGLT2i but was not considered a cost-effective treatment for heart failure with reduced ejection fraction in Thailand and Singapore with the current economic evaluation evidences. In order for more precise analysis on cost effectiveness analysis, it is necessary to take into account the income level of various countries as it is certainly easier to allocate more financial resources for the intervention, with greater effectiveness, in high- and middle-income countries than in low-income countries. This review aims to evaluate evidence and cost effectiveness studies in more recent HF drugs i.e., SGLT2i, ARNi, ivabradine, vericiguat and omecamtiv, and gaps in current literature on pharmacoeconomic studies in HF.
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Project description:BackgroundGuideline recommendations for the treatment of heart failure with mildly reduced ejection fraction (HFmrEF) derive from small subgroups in post-hoc analyses of randomized trials.ObjectivesWe investigated predictors of renin-angiotensin system inhibitors/angiotensin receptor neprilysin inhibitors (RASI/ARNI) and beta-blockers use, and the associations between these medications and mortality/morbidity in a large real-world cohort with HFmrEF.Methods and resultsPatients with HFmrEF (EF 40-49%) from the Swedish HF Registry were included. The associations between medications and cardiovascular (CV) mortality/HF hospitalization (HFH), and all-cause mortality were assessed through Cox regressions in a 1:1 propensity score-matched cohort. A positive control analysis was performed in patients with EF < 40%, while a negative control outcome analysis had cancer-related hospitalization as endpoint. Of 12 421 patients with HFmrEF, 84% received RASI/ARNI and 88% beta-blockers. Shared-independent predictors of RASI/ARNI and beta-blockers use were younger age, being an outpatient, follow-up in specialty care, and hypertension. In the matched cohorts, use of both RASI/ARNI and beta-blocker use was separately associated with lower risk of CV mortality/HFH [hazard ratio (HR) = 0.90, 95% confidence interval (CI): 0.83-0.98 and HR = 0.82, 95% CI: 0.74-0.90, respectively] and of all-cause mortality (HR = 0.75, 95% CI: 0.69-0.81 and HR = 0.79, 95% CI: 0.72-0.87, respectively). Results were consistent at the positive control analysis, and there were no associations between treatment use and the negative control outcome.ConclusionsRASI/ARNI and beta-blockers were extensively used in this large real-world cohort with HFmrEF. Their use was safe since associated with lower mortality and morbidity. Our findings confirm the real-world evidence from previous post-hoc analyses of trials, and represent a further call for implementing guideline recommendations.
| S-EPMC10509568 | biostudies-literature
Project description:BackgroundDiffering methodological requirements and decision-making criteria are recognised as barriers to transferability of cost-effectiveness analysis (CEA) across jurisdictions.ObjectiveWe assessed the generic and specific transferability of published CEAs of systemic treatments for advanced melanoma to the Irish setting.MethodsCEAs of treatments for melanoma were identified by systematic review. Transferability to the Irish setting was assessed using the EUnetHTA transferability tool for Economic Evaluation. We present a narrative discussion comparing the differences in key parameter inputs and the likely impact of these differences on the model outcomes and the reimbursement recommendation. Transferability is considered within the context of the Irish cost-effectiveness threshold, using the net monetary benefit (NMB) framework.ResultsNo published CEAs (n = 15) aligned with the Irish reference case for CEA. Changes to key parameters were unlikely to change the conclusions of the CEA when the cost-effectiveness threshold was considered. Ten studies (19 pairwise comparisons) were compared with findings by the National Centre for Pharmacoeconomics (NCPE) using NMB. Without accounting for differences in the cost-effectiveness threshold, there was alignment between the study conclusions and NCPE recommendations in 73.7% cases. When the Irish cost-effectiveness threshold was applied in the estimation of NMB, there was agreement in 89.5% of cases.ConclusionsAlignment in methodological requirements for CEA is important to facilitate joint health technology assessment (HTA) by regional collaborations in Europe. When parameter inputs are not exactly aligned, conclusions may still be comparable across jurisdictions. For international joint procurement initiatives, determining and implementing joint decision rules may be more important than trying to align rules regarding methodological and parameter inputs.
| S-EPMC7081651 | biostudies-literature
Project description:Background: The disease burden of active tuberculosis (TB) is considerable, but systematic reviews of economic evaluations of active TB treatments are scarce. Methods: PubMed, EMBASE, and the Cochrane Library databases were used to search for articles on cost-effectiveness analysis or cost-utility analysis that economically evaluated active TB treatments, which were then systematically reviewed by two independent reviewers. We extracted vital components of the included studies, such as country, population, intervention/comparator, primary outcome, values of outcomes, thresholds, model type, time horizon, and health states included in the model. Results: Seventeen studies were included in this systematic review. Thirteen dealt with interventions of medications, and the remaining four compared care strategies. The Markov model was the most commonly used tool to compare medications, whereas studies on care plans mainly used decision trees. The most commonly used primary outcome was disability-adjusted life years, followed by quality-adjusted life years. For treatment-naïve TB, the 4-month regimen was more cost-effective than the 6-month regimen mainly in low- and middle-income countries. For multidrug-resistant TB, a bedaquiline-based regimen was cost-effective. For multidrug-resistant TB, decentralized care that employed the use of home or mobile devices was more cost-effective than hospital-based centralized care in low- and middle-income countries. Conclusion: New treatment strategies to improve therapeutic outcomes by enhancing treatment adherence, such as regimens with shorter durations (2 or 4 months) and decentralized care, or new anti-TB agents (e.g., bedaquiline) have been suggested as cost-effective interventions for active TB. This review provides information on the economic evaluation of active TB from good-quality studies, thus aiding the future economic evaluation of active TB.
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| S-EPMC11451011 | biostudies-literature
Project description:IntroductionThe aim of this review is to systematically assess the methodological quality of economic evaluations in integrated care and to identify challenges with conducting such studies.Theory and methodsSearches of grey-literature and scientific papers were performed, from January 2000 to December 2018. A checklist was developed to assess the quality of economic evaluations. Authors' statements of challenges encountered during their evaluations were qualitatively coded.ResultsForty-four articles were eligible for inclusion. The review found that study design, measurement of cost and outcomes, statistical analysis and presentation of data were the areas with most quality variation. Authors identified challenges mostly related to time horizon of the evaluation, inadequate or lack of comparator group, contamination bias, and a post-hoc evaluation culture.DiscussionOur review found significant differences in quality, with some studies showing poor methodological rigor; challenging conclusions on the cost-effectiveness of integrated care.ConclusionIt is essential for evaluators to use best-practice standards when planning and conducting economic evaluations, in order to build a reliable evidence base for decision-making in integrated care.
| S-EPMC6743034 | biostudies-literature
Project description:ObjectiveFor assessing cost-effectiveness, Health Technology Assessment (HTA) organisations may use primary economic evaluations (P-HEs) or Systematic Reviews of Health Economic evaluations (SR-HEs). A prerequisite for meaningful results of SR-HEs is that the results from existing P-HEs are transferable to the decision context (e.g, HTA jurisdiction). A particularly pertinent issue is the high variability of costs and resource needs across jurisdictions. Our objective was to review the methods documents of HTA organisations and compare their recommendations on considering transferability in SR-HE.MethodsWe systematically hand searched the webpages of 158 HTA organisations for relevant methods documents from 8th January to 31st March 2019. Two independent reviewers performed searches and selected documents according to pre-defined criteria. One reviewer extracted data in standardised and piloted tables and a second reviewer checked them for accuracy. We synthesised data using tabulations and in a narrative way.ResultsWe identified 155 potentially relevant documents from 63 HTA organisations. Of these, 7 were included in the synthesis. The included organisations have different aims when preparing a SR-HE (e.g. to determine the need for conducting their own P-HE). The recommendations vary regarding the underlying terminology (e.g. transferability/generalisability), the assessment approaches (e.g. structure), the assessment criteria and the integration in the review process.ConclusionOnly few HTA organisations address the assessment of transferability in their methodological recommendations for SR-HEs. Transferability considerations are related to different purposes. The assessment concepts and criteria are heterogeneous. Developing standards to consider transferability in SR-HEs is desirable.
| S-EPMC8858549 | biostudies-literature
Project description:BACKGROUND:Public drug plans are faced with increasingly difficult funding decisions. In Canada, the pan-Canadian Oncology Drug Review (pCODR) makes funding recommendations to the provincial and territorial drug plans responsible for cancer drugs. Assessments of the economic models submitted by pharmaceutical manufacturers are publicly reported. OBJECTIVES:The main objective of this research was to identify recurring methodological issues in economic models submitted to pCODR for funding reviews. The secondary objective was to explore whether there exists any observed relationships between reported methodological issues and funding recommendations made by pCODR's expert review committee. METHODS:Publicly available Economic Guidance Reports from July 2011 (inception) until June 2014 for drug reviews with a final funding recommendation (N = 34) were independently examined by two authors. Major methodological issues from each review were abstracted and grouped into nine main categories. Each issue was also categorized based on perception of the reviewer's actions to manage it. RESULTS:The most commonly reported issues involved costing (59% of reviews), time horizon (56%), and model structure (36%). Several types of issues were identified that usually could not be resolved, such as quality of clinical data or uncertainty with indirect comparisons. Issues with costing or choice of utility estimates could usually be addressed or explored by reviewers. No statistically significant relationship was found between any methodological issue and funding recommendations from the expert review committee. CONCLUSIONS:The findings provide insights that can be used by parties who submit or review economic evidence for continuous improvement and consistency in economic modeling, reporting, and decision making.
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