scholarly journals Cost-Effectiveness and Formulary Evaluation: Imaginary Worlds and Entresto Claims in Heart Failure

2016 ◽  
Vol 7 (3) ◽  
Author(s):  
Paul C Langley
Keyword(s):  
Heart Failure ◽  
Cost Effectiveness ◽  
Ace Inhibitor ◽  
Lifetime Cost ◽  
Cost Effective ◽  
Standard Of Care ◽  
Evidence Base ◽  
Pharmaceutical Products ◽  
Product Placement ◽  
Neprilysin Inhibitor

The Program in Social and Administrative Pharmacy at the University of Minnesota recently released its proposed guidelines for formulary evaluation. The guidelines were focused on ensuring that comparative claims made for pharmaceutical products and devices rested on a credible evidence base. The argument was put forward that if value claims for clinical and cost-effectiveness outcomes were to be accepted then they had to be empirically evaluable. The purpose of this commentary is to explore alternative modeled claims for Entresto, an angiotensin receptor neprilysin inhibitor, versus the standard of care with an ACE inhibitor in patients with chronic heart failure. Two models are compared: a lifetime cost-per-QALY model and a 3-year cost and budget impact model. The primary reason for this comparison is the puzzling feature that for a product which is over 120 time as expensive compared to the standard of care (Entresto $380 per month vs. ACE inhibitor $3 per month) the modeled claim can be made that the product is, in willingness to pay terms, cost-effective. The analysis illustrates that, perhaps not surprisingly, different models can generate quite different perspectives on the presumption of ‘cost-effectiveness’. In the present case the simple decision model yields a breakeven monthly cost for Entresto of only $23.74. If modeled claims are to be useful for formulary decision making, then we need to eschew ‘black box’ models with non-evaluable claims in favor of those models that yield credible, evaluable and replicable claims that can support defensible product placement and pricing decisions. Conflict of Interest None   Type: Commentary

scholarly journals Evaluation of a Heart Failure Telemonitoring Program Through a Microsimnulation Model: Cost-Utility Analysis (Preprint)

2020 ◽  
Author(s):  
Chris Boodoo ◽  
Qi Zhang ◽  
Heather J Ross ◽  
Ana Carolina Alba ◽  
Audrey Laporte ◽  
...  
Keyword(s):  
Public Health ◽  
Heart Failure ◽  
Cost Effectiveness ◽  
Standard Care ◽  
Cost Effective ◽  
Standard Of Care ◽  
Cost Utility ◽  
Cost Utility Analysis ◽  
Model Parameters ◽  
Utility Analysis

BACKGROUND Heart failure (HF) is a major public health issue in Canada that is associated with high prevalence, morbidity, and mortality rates and high financial and social burdens. Telemonitoring (TM) has been shown to improve all-cause mortality and hospitalization rates in patients with HF. The <i>Medly</i> program is a TM intervention integrated as standard of care at a large Canadian academic hospital for ambulatory patients with HF that has been found to improve patient outcomes. However, the cost-effectiveness of the <i>Medly</i> program is yet to be determined. OBJECTIVE This study aims to conduct a cost-utility analysis of the <i>Medly</i> program compared with the standard of care for HF in Ontario, Canada, from the perspective of the public health care payer. METHODS Using a microsimulation model, individual patient data were simulated over a 25-year time horizon to compare the costs and quality-adjusted life years (QALYs) between the <i>Medly</i> program and standard care for patients with HF treated in the ambulatory care setting. Data were sourced from a <i>Medly</i> Program Evaluation study and literature to inform model parameters, such as <i>Medly</i>’s effectiveness in reducing mortality and hospitalizations, health care and intervention costs, and model transition probabilities. Scenario analyses were conducted in relation to HF severity and TM deployment models. One-way deterministic effectiveness analysis and probabilistic sensitivity analysis were performed to explore the impact on the results of uncertainty in model parameters. RESULTS The <i>Medly</i> program was associated with an average total cost of Can $102,508 (US $77,626) per patient and total QALYs of 5.51 per patient compared with the average cost of Can $97,497 (US $73,831) and QALYs of 4.95 per patient in the Standard Care Group. This led to an incremental cost of Can $5011 (US $3794) and incremental QALY of 0.566, resulting in an incremental cost-effectiveness ratio of Can $8850 (US $6701)/QALY. Cost-effectiveness improved in relation to patients with advanced HF and with deployment models in which patients used their own equipment. Baseline and alternative scenarios consistently showed probabilities of cost-effectiveness greater than 85% at a willingness-to-pay threshold of Can $50,000 (US $37,718). Although the results showed some sensitivity to assumptions about effectiveness parameters, the intervention was found to remain cost-effective. CONCLUSIONS The <i>Medly</i> program for patients with HF is cost-effective compared with standard care using commonly reported willingness-to-pay thresholds. This study provides evidence for decision makers on the use of TM for HF, supports the use of a nurse-led model of TM that embeds clinically validated algorithms, and informs the use of economic modeling for future evaluations of early-stage health informatics technology.

scholarly journals Supporting Formulary Decisions: The Discovery of New Facts or Constructed Evidence?

2016 ◽  
Vol 7 (2) ◽  
Author(s):  
Paul C Langley
Keyword(s):  
Cost Effectiveness ◽  
Lifetime Cost ◽  
Cost Effective ◽  
Evidence Base ◽  
Normal Science ◽  
Critical Question ◽  
Reference Case ◽  
Life Years ◽  
The One ◽  
The Uk

A critical question, given the growing importance of more targeted therapies to support personalized and precision medicine, is the credibility of the evidence base to support formulary decisions and pricing. On the one hand, for those who subscribe to the reference case model of the National Institute of Health and Care Excellence (NICE) in the UK, the decision rests upon the creation of modeled or simulated imaginary worlds and the application of threshold willingness-to-pay cost-per-QALY thresholds. On the other hand, for those who subscribe to the standards of normal science, the decision rests upon the ability to evaluate competing claims, both clinical and cost-effective, in a timeframe that is meaningful to a formulary committee. If we subscribe to the scientific method where the focus is on the discovery of new facts, untestable claims for clinical benefit and cost-effectiveness, such as created claims for lifetime cost per-quality-adjusted discounted life years (QALYs), are properly relegated to the category of pseudoscience. We have no idea, and will never know, whether the claims are right or even if they are wrong. If formulary decisions are to respect the standards of normal science then there has to be a commitment to claims evaluation. A willingness to accept new products provisionally, subject to an agreed protocol to support the evaluation of clinical and cost-effectiveness claims. This dichotomy between the standards of normal science and pseudoscience is explored in the context of published claims for cost-effectiveness and recommendations for product pricing in the US.   Type: Commentary

scholarly journals First-Line Atezolizumab Plus Bevacizumab versus Sorafenib in Hepatocellular Carcinoma: A Cost-Effectiveness Analysis

Cancers ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 931
Author(s):  
Chi-Leung Chiang ◽  
Sik-Kwan Chan ◽  
Shing-Fung Lee ◽  
Horace Cheuk-Wai Choi
Keyword(s):  
Hepatocellular Carcinoma ◽  
Cost Effectiveness ◽  
Lifetime Cost ◽  
Cost Effective ◽  
First Line ◽  
First Line Therapy ◽  
Payer Perspective ◽  
Life Years ◽  
Using Data

Background: The IMbrave 150 trial revealed that atezolizumab plus bevacizumab (atezo–bev) improves survival in patients with unresectable hepatocellular carcinoma (HCC) (1 year survival rate: 67.2% vs. 54.6%). We assessed the cost-effectiveness of atezo–bev vs. sorafenib as first-line therapy in patients with unresectable HCC from the US payer perspective. Methods: Using data from the IMbrave 150, we developed a Markov model to compare the lifetime cost and efficacy of atezo–bev as first-line systemic therapy in HCC with those of sorafenib. The main outcomes were life-years, quality-adjusted life-years (QALYs), lifetime costs, and incremental cost-effectiveness ratio (ICER). Results: Atezo–bev demonstrated a gain of 0.44 QALYs, with an additional cost of USD 79,074. The ICER of atezo–bev was USD 179,729 per QALY when compared with sorafenib. The model was most sensitive to the overall survival hazard ratio and body weight. If we assumed that all patients at the end of the IMbrave 150 trial were cured of HCC, atezo–bev was cost-effective (ICER USD 53,854 per QALY). However, if all patients followed the Surveillance, Epidemiology, and End Results data, the ICER of atezo–bev was USD 385,857 per QALY. Reducing the price of atezo–bev by 20% and 29% would satisfy the USD 150,000/QALY and 100,000/QALY willingness-to-pay threshold. Moreover, capping the duration of therapy to ≤12 months or reducing the dosage of bev to ≤10 mg/kg would render atezo–bev cost-effective. Conclusions: The long-term effectiveness of atezo–bev is a critical but uncertain determinant of its cost-effectiveness. Price reduction would favorably influence cost-effectiveness, even if long-term clinical outcomes were modest. Further studies to optimize the duration and dosage of therapy are warranted.

scholarly journals Cost Needed to Treat (CNT) and Number Needed to Treat (NNT) analysis of drugs for treatment of heart failure in India

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K Mullavelil ◽  
V George ◽  
A Thannikkal ◽  
R Aravindakshan ◽  
D John ◽  
...  
Keyword(s):  
Heart Failure ◽  
Cost Effectiveness ◽  
Treatment Strategies ◽  
Future Research ◽  
Number Needed To Treat ◽  
Neprilysin Inhibitor ◽  
Long Term Treatment ◽  
The Cost ◽  
Cost Effectiveness Threshold ◽  
Effectiveness Threshold

Abstract Background Only little attention has been paid to treatment strategies of chronic disease conditions that require long term treatment and repeated hospitalizations Purpose Our aim was to review cost-effectiveness of guideline directed medical therapy of heart failure in India and identify drugs that can be made available free of cost or at subsidized rates to the patient population. Methods Data extracted from ten landmark trials in heart failure was used to compute Number Needed to Treat (NNT) and Cost Needed to Treat (CNT) of drugs used in heart failure, to prevent cardiovascular mortality and heart failure re-hospitalization using HDS Plotter- Incremental Cost Effectiveness Calculator. Since various brands (i.e. trade names) with wide cost range are available in Indian market, the average retail price in Indian Rupees for year 2019 was considered and converted to US dollars and used for the analysis.NNT and CNT of each drug was computed and the cost-effectiveness was analyzed. WHO recommendation of three times per capita GDP was used as the cost effectiveness threshold. Results Medications that were labeled as class I for the treatment of heart failure, were included in our analysis. Ivabradine, Valsartan and Angiotensin Receptor Neprilysin inhibitor (ARNi) did not meet the cost effectiveness criteria for preventing cardio-vascular mortality. For prevention of heart failure re-hospitalization, all drugs except ARNi, met the cost effectiveness threshold. Conclusion Any future research would need to consider compliance factor along with Willingness to Pay (WTP) to understand the real acceptance of these drugs on the ground in India. Log prices (in US$) of various HF drugs Funding Acknowledgement Type of funding source: None

scholarly journals Cost-Effectiveness of Peer-Delivered HIV Self-Tests for MSM in Uganda

2021 ◽  
Vol 9 ◽  
Author(s):  
Stephen Okoboi ◽  
Barbara Castelnuovo ◽  
Jean-Pierre Van Geertruyden ◽  
Oucul Lazarus ◽  
Lung Vu ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Incremental Cost ◽  
Hiv Testing ◽  
Cost Effective ◽  
Hiv Infections ◽  
Standard Of Care ◽  
Sub Saharan Africa ◽  
High Risk Population ◽  
Self Testing ◽  
The Cost

Introduction: Distribution of HIV self-testing (HIVST) kits through MSM peer networks is a novel and effective strategy to increase HIV testing coverage in this high-risk population. No study has evaluated the cost or cost effectiveness of peer distribution of HIVST strategies among MSM in sub-Saharan Africa.Methods: From June to August 2018, we conducted a pilot study of secondary MSM peer HIVST kit distribution at The AIDS Support Organization at Entebbe and Masaka. We used an ingredients approach to estimate the cost of MSM peer HIVST kit distribution relative to standard-of-care (SOC) hotspot testing using programme expenditure data reported in US dollars. The provider perspective was used to estimate incremental cost-effective ratios per HIV infection averted using the difference in HIV annual transmission rates between MSM with HIV who knew their status and were not virologically suppressed and MSM with HIV who did not know their status.Results: We enrolled 297 participants of whom 150 received MSM peer HIVST kit distribution (intervention group) and 147 received TASO standard of care HIV testing (control group). Provider cost for the intervention was $2,276 compared with $1,827 for SOC during the 3-month study period. Overall, the intervention resulted in higher HIV positivity yield (4.9 vs. 1.4%) and averted more HIV infections per quarter (0.364 vs. 0.104) compared with SOC. The cost per person tested was higher for the intervention compared to SOC ($15.90 vs. $12.40). Importantly, the cost per new HIV diagnosis ($325 vs. $914) and cost per transmission averted ($6,253 vs. $ 17,567) were lower for the intervention approach relative to SOC. The incremental cost per HIV transmission averted by the self-testing program was $1,727. The incremental cost to providers per additional HIV-positive person identified by the intervention was $147.30.Conclusion: The intervention strategy was cost-effective, and identified more undiagnosed HIV infections than SOC hotspot testing at a cost-effectiveness threshold of US $2,129. Secondary distribution of HIVST kits through peers should further be evaluated with longer duration aimed at diagnosing 95% of all persons with HIV by 2030; the first UNAIDS 95-95-95 target.

Cost-effectiveness and budget impact of flucytosine as induction therapy in the treatment of cryptococcal meningitis in HIV-infected adults in South Africa

2020 ◽  
Author(s):  
Jacqui Miot ◽  
Trudy Leong ◽  
Simbarashe Takuva ◽  
Andrew Parrish ◽  
Halima Dawood
Keyword(s):  
South Africa ◽  
Cost Effectiveness ◽  
Amphotericin B ◽  
Induction Therapy ◽  
Cryptococcal Meningitis ◽  
Budget Impact ◽  
Cost Effective ◽  
Standard Of Care ◽  
Sub Saharan Africa ◽  
Oral Regimen

Abstract Background Cryptococcal meningitis in HIV-infected patients in sub-Saharan Africa accounts for three-quarters of the global cases and 135 000 deaths per annum. Current treatment includes the use of fluconazole and amphotericin B. Recent evidence has shown that the synergistic use of flucytosine improves efficacy and reduces toxicity, however affordability and availability has hampered access to flucytosine in many countries. This study investigated the evidence and cost implications of introducing flucytosine as induction therapy for cryptococcal meningitis in HIV-infected adults in South Africa. Methods A decision analytic cost-effectiveness and budget impact model was developed based on survival estimates from the ACTA trial and local costs for flucytosine as induction therapy in HIV-infected adults with cryptococcal meningitis in a public sector setting in South Africa. The model considered four treatment arms: (a) standard of care; 2-week course of amphotericin B/fluconazole (2wk AmBd/Flu), (b) 2-week course of amphotericin B/flucytosine (2wk AmBd/5FC), (c) short course; 1-week course amphotericin B/flucytosine (1wk AmBd/5FC) and (d) oral course; 2-week oral fluconazole/flucytosine (oral). A sensitivity analysis was conducted on key variables. Results The highest total treatment costs were in the 2-week AmBd/5FC arm followed by the 2-week oral regimen, then the 1-week AmBd/5FC with the lowest cost in the standard of care arm. Compared to standard of care the 1-week flucytosine course is most cost-effective at USD31/QALY, followed by the oral 2-week course at USD155/QALY and the 2-week flucytosine course at USD568/QALY. The budget impact analysis shows that the 1-week course has the lowest incremental cost, followed by the oral course and then the 2-week flucytosine course compared to what is currently spent on standard of care. Sensitivity analyses suggest that the model is most sensitive to the price of flucytosine and hospital costs, particularly length of stay. Conclusions The addition of flucytosine as induction therapy for the treatment of cryptococcal meningitis in patients infected with HIV is cost-effective regardless of whether it is used as a 1-week, 2-week or oral regimen. Savings could be achieved with early discharge of patients as well as a reduction in the price of flucytosine.

scholarly journals Challenges in synthesising cost-effectiveness estimates

2020 ◽  
Vol 9 (1) ◽  
Author(s):  
Gemma E. Shields ◽  
Jamie Elvidge
Keyword(s):  
Cost Effectiveness ◽  
Systematic Reviews ◽  
Meta Analysis ◽  
Cost Effective ◽  
Evidence Base ◽  
Decision Makers ◽  
Economic Evaluations ◽  
Quality Adjusted Life Years ◽  
Life Years ◽  
Study Designs

AbstractEconomic evaluations help decision-makers faced with tough decisions on how to allocate resources. Systematic reviews of economic evaluations are useful as they allow readers to assess whether interventions have been demonstrated to be cost effective, the uncertainty in the evidence base, and key limitations or gaps in the evidence base. The synthesis of systematic reviews of economic evaluations commonly takes a narrative approach whereas a meta-analysis is common step for reviews of clinical evidence (e.g. effectiveness or adverse event outcomes). As they are common objectives in other reviews, readers may query why a synthesis has not been attempted for economic outcomes. However, a meta-analysis of incremental cost-effectiveness ratios, costs, or health benefits (including quality-adjusted life years) is fraught with issues largely due to heterogeneity across study designs and methods and further practical challenges. Therefore, meta-analysis is rarely feasible or robust. This commentary outlines these issues, supported by examples from the literature, to support researchers and reviewers considering systematic review of economic evidence.

scholarly journals Cost-Effectiveness of the International Late Effects of Childhood Cancer Guideline Harmonization Group Screening Guidelines to Prevent Heart Failure in Survivors of Childhood Cancer

2020 ◽  
Vol 38 (33) ◽  
pp. 3851-3862 ◽  
Author(s):  
Matthew J. Ehrhardt ◽  
Zachary J. Ward ◽  
Qi Liu ◽  
Aeysha Chaudhry ◽  
Anju Nohria ◽  
...  
Keyword(s):  
Heart Failure ◽  
Cost Effectiveness ◽  
High Risk ◽  
Childhood Cancer ◽  
Late Effects ◽  
Cost Effective ◽  
Risk Groups ◽  
Low Risk ◽  
Moderate Risk ◽  
Survivors Of Childhood Cancer

PURPOSE Survivors of childhood cancer treated with anthracyclines and/or chest-directed radiation are at increased risk for heart failure (HF). The International Late Effects of Childhood Cancer Guideline Harmonization Group (IGHG) recommends risk-based screening echocardiograms, but evidence supporting its frequency and cost-effectiveness is limited. PATIENTS AND METHODS Using the Childhood Cancer Survivor Study and St Jude Lifetime Cohort, we developed a microsimulation model of the clinical course of HF. We estimated long-term health outcomes and economic impact of screening according to IGHG-defined risk groups (low [doxorubicin-equivalent anthracycline dose of 1-99 mg/m2 and/or radiotherapy < 15 Gy], moderate [100 to < 250 mg/m2 or 15 to < 35 Gy], or high [≥ 250 mg/m2 or ≥ 35 Gy or both ≥ 100 mg/m2 and ≥ 15 Gy]). We compared 1-, 2-, 5-, and 10-year interval-based screening with no screening. Screening performance and treatment effectiveness were estimated based on published studies. Costs and quality-of-life weights were based on national averages and published reports. Outcomes included lifetime HF risk, quality-adjusted life-years (QALYs), lifetime costs, and incremental cost-effectiveness ratios (ICERs). Strategies with ICERs < $100,000 per QALY gained were considered cost-effective. RESULTS Among the IGHG risk groups, cumulative lifetime risks of HF without screening were 36.7% (high risk), 24.7% (moderate risk), and 16.9% (low risk). Routine screening reduced this risk by 4% to 11%, depending on frequency. Screening every 2, 5, and 10 years was cost-effective for high-risk survivors, and every 5 and 10 years for moderate-risk survivors. In contrast, ICERs were > $175,000 per QALY gained for all strategies for low-risk survivors, representing approximately 40% of those for whom screening is currently recommended. CONCLUSION Our findings suggest that refinement of recommended screening strategies for IGHG high- and low-risk survivors is needed, including careful reconsideration of discontinuing asymptomatic left ventricular dysfunction and HF screening in low-risk survivors.

Evaluation of ACE Inhibitor Therapy for Congestive Heart Failure in an Outpatient Setting

1998 ◽  
Vol 14 (1) ◽  
pp. 7-11 ◽  
Author(s):  
Barry E Bleske ◽  
Laura A Cornish ◽  
Steven R Erickson ◽  
John M Nicklas
Keyword(s):  
Heart Failure ◽  
Congestive Heart Failure ◽  
Ace Inhibitor ◽  
Standard Of Care ◽  
Outpatient Setting ◽  
Inhibitor Therapy ◽  
University Teaching ◽  
Patient Specific ◽  
Heart Failure Clinic ◽  
History Of

Objective: Angiotensin-converting enzyme (ACE) inhibitor therapy is considered the standard of care for the treatment of congestive heart failure. Despite this, clinical experience suggests that not all patients may be receiving ACE inhibitor therapy or may be receiving low dosages. This study was performed to better understand the use of ACE inhibitor therapy in clinical practice. Design and Participants: We reviewed the medical therapy of 110 patients with a history of congestive heart failure referred to an outpatient heart failure clinic at a university teaching hospital. Outcome Measures: This observational study evaluated the use of ACE inhibitors, including dosage, as well as other drugs to treat congestive heart failure. Results: Approximately 85% (93/110) of patients were receiving an ACE inhibitor. Twenty percent (22/110) were receiving enalapril 20 mg/d or more, captopril 150 mg/d or more, lisinopril 20 mg/d or more, or quinapril 40 mg/d or more. The remaining patients (n = 71) were receiving these drugs at lower dosages. However, 21 of the remaining patients (19% of all patients) were receiving lower dosages based on patient-specific parameters; 47 of the remaining patients (43% of all patients) were eligible to have their dosage increased. Ten eligible patients were not receiving an ACE inhibitor. The majority of patients were also receiving digoxin (70%) and loop diuretic (80%) therapy. Conclusions: Approximately 85% of patients were receiving ACE inhibitor therapy, with 9% of eligible patients not receiving an ACE inhibitor. In the patients receiving ACE inhibitor therapy, approximately 50% (47/93) were receiving dosages below those suggested in the guidelines. Overall, the use of ACE inhibitor therapy is varied and intervention appears required to ensure that all patients receive appropriate therapy for the treatment of congestive heart failure.

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