Dataset Information

Evaluating Cost-Effectiveness Models for Pharmacologic Interventions in Adults with Heart Failure: A Systematic Literature Review.

ABSTRACT:

Background

Heart failure (HF) is a well-recognized public health concern and imposes high economic and societal costs. Decision analytic models exist for evaluating the economic ramifications associated with HF. Despite this, studies that appraise these modelling approaches for augmenting best-practice decisions remain scarce.

Objective

Our objective was to conduct a systematic literature review (SLR) of published economic models for the management of HF and describe their general and methodological features.

Methods

This SLR employed a combination of relevant search terms associated with HF, which were used in a number of databases, including MEDLINE, Embase, the National Health Service Economic Evaluation Database, Cost-Effectiveness Analysis Registry, ScHARR Health Utilities Database and Cochrane Library Database. A number of model features (i.e. model structure, specification, outcomes assessed, scenario and sensitivity analysis, key model drivers) were extracted and subsequently summarized.

Results

Of 64 publications retained, a selection of modelling approaches were identified, including Markov (n?=?28), trial-based analytic (n?=?22), discrete-event simulation (n?=?6), survival analytic (n?=?7) and decision-tree modelling (n?=?1) approaches. The bulk of publications employed either a cost-utility (n?=?27) or cost-effectiveness (n?=?36) analysis and evaluated more than one study outcome, which typically included overall costs (n?=?59), incremental cost-effectiveness ratios (n?=?55), life-years gained (n?=?48) and willingness-to-pay thresholds (n?=?37). Most publications focused on patients with chronic HF (n?=?40) and used New York Heart Association (NYHA) disease classifications to categorize patients and determine disease severity. Few (n?=?19) publications documented the use of hospitalization states for modelling patient outcomes and associated costs. A quality assessment of the included publications revealed most articles demonstrated reasonable methodological value.

Conclusions

We identified numerous decision analytic modelling approaches for evaluating the cost effectiveness of pharmacologic treatments in HF. A Markov cohort model approach was most commonly used, and most models relied on NYHA classes as a proxy of HF severity, disease progression and prognosis.

SUBMITTER: Di Tanna GL

PROVIDER: S-EPMC6386015 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Evaluating Cost-Effectiveness Models for Pharmacologic Interventions in Adults with Heart Failure: A Systematic Literature Review.

Di Tanna Gian Luca GL Bychenkova Anna A O'Neill Frank F Wirtz Heidi S HS Miller Paul P Ó Hartaigh Briain B Globe Gary G

PharmacoEconomics 20190301 3

<h4>Background</h4>Heart failure (HF) is a well-recognized public health concern and imposes high economic and societal costs. Decision analytic models exist for evaluating the economic ramifications associated with HF. Despite this, studies that appraise these modelling approaches for augmenting best-practice decisions remain scarce.<h4>Objective</h4>Our objective was to conduct a systematic literature review (SLR) of published economic models for the management of HF and describe their general ...[more]

PMID: 30596210

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Project description:BACKGROUND:The ability to predict risk allows healthcare providers to propose which patients might benefit most from certain therapies, and is relevant to payers' demands to justify clinical and economic value. To understand the robustness of risk prediction models for heart failure (HF), we conducted a systematic literature review to (1) identify HF risk-prediction models, (2) assess statistical approach and extent of validation, (3) identify common variables, and (4) assess risk of bias (ROB). METHODS:Literature databases were searched from March 2013 to May 2018 to identify risk prediction models conducted in an out-of-hospital setting in adults with HF. Distinct risk prediction variables were ranked according to outcomes assessed and incorporation into the studies. ROB was assessed using Prediction model Risk Of Bias ASsessment Tool (PROBAST). RESULTS:Of 4720 non-duplicated citations, 40 risk-prediction publications were deemed relevant. Within the 40 publications, 58 models assessed 55 (co)primary outcomes, including all-cause mortality (n = 17), cardiovascular death (n = 9), HF hospitalizations (n = 15), and composite endpoints (n = 14). Few publications reported detail on handling missing data (n = 11; 28%). The discriminatory ability for predicting all-cause mortality, cardiovascular death, and composite endpoints was generally better than for HF hospitalization. 105 distinct predictor variables were identified. Predictors included in >5 publications were: N-terminal prohormone brain-natriuretic peptide, creatinine, blood urea nitrogen, systolic blood pressure, sodium, NYHA class, left ventricular ejection fraction, heart rate, and characteristics including male sex, diabetes, age, and BMI. Only 11/58 (19%) models had overall low ROB, based on our application of PROBAST. In total, 26/58 (45%) models discussed internal validation, and 14/58 (24%) external validation. CONCLUSIONS:The majority of the 58 identified risk-prediction models for HF present particular concerns according to ROB assessment, mainly due to lack of validation and calibration. The potential utility of novel approaches such as machine learning tools is yet to be determined. REGISTRATION NUMBER:The SLR was registered in Prospero (ID: CRD42018100709).

Project description:OBJECTIVES:This study aimed to evaluate the cost-effectiveness of the CardioMEMS (CardioMEMS Heart Failure System, St Jude Medical Inc, Atlanta, Georgia) device in patients with chronic heart failure. BACKGROUND:The CardioMEMS device, an implantable pulmonary artery pressure monitor, was shown to reduce hospitalizations for heart failure and improve quality of life in the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients) trial. METHODS:We developed a Markov model to determine the hospitalization, survival, quality of life, cost, and incremental cost-effectiveness ratio of CardioMEMS implantation compared with usual care among a CHAMPION trial cohort of patients with heart failure. We obtained event rates and utilities from published trial data; we used costs from literature estimates and Medicare reimbursement data. We performed subgroup analyses of preserved and reduced ejection fraction and an exploratory analysis in a lower-risk cohort on the basis of the CHARM (Candesartan in Heart failure: Reduction in Mortality and Morbidity) trials. RESULTS:CardioMEMS reduced lifetime hospitalizations (2.18 vs. 3.12), increased quality-adjusted life-years (QALYs) (2.74 vs. 2.46), and increased costs ($176,648 vs. $156,569), thus yielding a cost of $71,462 per QALY gained and $48,054 per life-year gained. The cost per QALY gained was $82,301 in patients with reduced ejection fraction and $47,768 in those with preserved ejection fraction. In the lower-risk CHARM cohort, the device would need to reduce hospitalizations for heart failure by 41% to cost <$100,000 per QALY gained. The cost-effectiveness was most sensitive to the device's durability. CONCLUSIONS:In populations similar to that of the CHAMPION trial, the CardioMEMS device is cost-effective if the trial effectiveness is sustained over long periods. Post-marketing surveillance data on durability will further clarify its value.

Project description:OBJECTIVES:Assessing the cost-effectiveness credentials of this intervention in patients with concomitant atrial fibrillation (AF) and heart failure (HF) compared with usual medical therapy. DESIGN:A Markov model comprising two health states (ie, alive or dead) was constructed. The transition probabilities were directly derived from published Kaplan-Meier curves of the pivotal randomised controlled trial and extrapolated over the cohort's lifetime using recommended methods. Costs of catheter ablation, outpatient consultations, hospitalisation, medications and examinations were included. Resource use and unit costs were sourced from government websites or published literature. A lifetime horizon and a healthcare system perspective were taken. All costs and benefits were discounted at 3% annually. Deterministic (DSA) and probabilistic sensitivity analyses (PSA) were run around the key model parameters to test the robustness of the base case results. PARTICIPANTS:A hypothetical Australian cohort of patients with concomitant AF and HF who are resistant to antiarrhythmic treatment. INTERVENTIONS:Catheter ablation versus medical therapy. RESULTS:The catheter ablation was associated with a cost of $A44 377 per person, in comparison to $A28 506 for the medical therapy alone over a lifetime. Catheter ablation contributed to 4.58 quality-adjusted life years (QALYs) and 6.99 LY gains compared with 4.30 QALYs and 6.53 LY gains, respectively, in the medical therapy arm. The incremental cost-effectiveness ratio was $A55 942/QALY or $A35 020/LY. The DSA showed that results were highly sensitive to costs of ablation and time horizon. The PSA yielded very consistent results with the base case. CONCLUSIONS:Offering catheter ablation procedure to patients with systematic paroxysmal or persistent AF who failed to respond to antiarrhythmic drugs was associated with higher costs, greater benefits. When compared with medical therapy alone, this intervention is not cost-effective from an Australia healthcare system perspective.

Project description:BACKGROUND:Several heart failure studies have shown promising results for implementing telehealthcare. These studies have led to clinical and political interest in telehealthcare as a way to improve heart failure outcomes and lower costs. However, there is a need for large-scale clinical trials with cost-effectiveness assessments. METHODS/DESIGN:The present study is known as the TeleCare North Heart Failure Trial in Denmark. We are studying the health effectiveness and cost-effectiveness of a telehealth (Telekit) solution compared with usual care for patients with heart failure. The design is a multicenter, two-arm, parallel-group, nonblinded, superiority randomized controlled trial. Outpatient healthcare centers will be responsible for recruiting eligible participants (600 participants are expected) for the trial in the geographic area of the North Denmark Region. Participants are qualified for inclusion if they have been diagnosed according to national guidelines and are categorized in New York Heart Association class 2, 3, or 4. Patients must have a permanent residence and be motivated to use telehealth care. The primary outcomes are changes in health-related quality of life (assessed using the Kansas City Cardiomyopathy Questionnaire, the EuroQol EQ-5D-5L questionnaire, and the Short Form Health Survey [SF-36]) and in the incremental cost-effectiveness ratio measured from baseline to follow-up. The secondary outcomes are changes in mortality and in physiological indicators such as blood pressure, pulse, and weight. DISCUSSION:The TeleCare North Heart Failure Trial is intended to improve the international evidence base for the health effectiveness and cost-effectiveness of telehealthcare for patients with heart failure. The expectation is that the results of the trial can be generalized to all municipalities in Denmark and serve as an inspiration for further international research. TRIAL REGISTRATION:ClinicalTrials.gov ( NCT02860013 ). Registered on 28 July 2016.

Project description:Background and objectiveCertain patients with heart failure (HF) are unable to tolerate spironolactone therapy due to hyperkalemia. Patiromer is a novel agent used to treat hyperkalemia and has been shown to be efficacious, safe, and well-tolerated. The potential clinical outcomes and economic value of using patiromer and spironolactone in patients with HF unable to otherwise tolerate spironolactone due to hyperkalemia are unclear. The objective of this analysis was to model the potential pharmacoeconomic value of using patiromer and spironolactone in patients with a history of hyperkalemia that prevents them from utilizing spironolactone.MethodsWe performed a cost-effectiveness analysis of treatment with patiromer, spironolactone, and an angiotensin-converting enzyme inhibitor (ACEI) in patients with New York Heart Association (NYHA) class III-IV HF compared with ACEI alone. A Markov model was constructed to simulate a cohort of 65-year-old patients diagnosed with HF from the payer perspective across the lifetime horizon. Clinical inputs were derived from the RALES and OPAL-HK randomized trials of spironolactone and patiromer, respectively. Utility estimates and costs were derived from the literature and list prices. Outcomes assessed included hospitalization, life expectancy, and quality-adjusted life-years (QALYs), costs, and the incremental cost-effectiveness ratio (ICER). One-way and probability sensitivity analyses were performed to test the robustness of the model findings.ResultsTreatment with patiromer-spironolactone-ACEI was projected to increase longevity compared with ACEI alone (5.29 vs. 4.62 life-years gained, respectively), greater QALYs (2.79 vs. 2.60), and costs (US$28,200 vs. US$18,200), giving an ICER of US$52,700 per QALY gained. The ICERs ranged from US$40,000 to US$85,800 per QALY gained in 1-way sensitivity analyses.ConclusionOur results suggest that the use of spironolactone-patiromer-ACEI may provide clinical benefit and good economic value in patients with NYHA class III-IV HF unable to tolerate spironolactone due to hyperkalemia.

Dataset Information

Evaluating Cost-Effectiveness Models for Pharmacologic Interventions in Adults with Heart Failure: A Systematic Literature Review.

Background

Objective

Methods

Results

Conclusions

Publications

Evaluating Cost-Effectiveness Models for Pharmacologic Interventions in Adults with Heart Failure: A Systematic Literature Review.

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