Cost-effectiveness Ratio Threshold Research Articles

Cost-Effectiveness Analysis of Pharmaceutical-Grade Chondroitin Sulfate for Knee Osteoarthritis Based on Individual Patient Data from a Randomized Clinical Trial.

In a previously published randomised, placebo-controlled trial, 800mg/day of pharmaceutical-grade chondroitin sulfate (CS) was shown to be superior to placebo in reducing pain and improving function over 6months in patients with symptomatic knee osteoarthritis (OA). The aim of the current posthoc analyses was to evaluate the cost-effectiveness of CS compared with placebo in a European perspective using individual patient data from this clinical trial. Patients with knee OA randomised to CS or placebo were followed up at 1, 3 and 6months. The algo-functional Lequesne index was used to derive the EuroQol Five-Dimension Five-Level (EQ-5D-5L) score based on a validated formula. The EQ-5D-5L scores at each time point were used to calculate the changes in quality-adjusted life years (QALYs) with the area under the curve method. Costs were assessed using the average price of CS in the countries where the original study took place and where CS is currently marketed. The costs of CS in three countries were then used (i.e. the Czech Republic, Italy and Switzerland). The incremental cost-effectiveness ratio (ICER) threshold for CS to be considered cost-effective was set at 91,870EUR per QALY (equivalent to the usually recommended threshold of US$100,000). The study used an intention-to-treat population, i.e. patients who received one dose of the study drug, and imputed missing values using the basal observation carried forward method. No significant differences in baseline characteristics were observed between the CS group (N = 199) and the placebo group (N = 205). The mean cost of CS for 6months of treatment was 194.74EUR. After 6months of treatment, CS showed a mean ICER of 33,462 (95%CI 5130-61,794) EURper QALY gained, indicating cost-effectiveness compared with placebo. The acceptability curve for cost-effectiveness shows that the CS treatment is likely to be cost-effective compared with placebo, with a 93% probability when the ceiling ratio is set at 91,870EUR per QALY gained. These results highlight the role of CS as a cost-effective therapeutic option in the management of OA. However, further studies taking into account the use of other healthcare resources are warranted for a more complete understanding.

Information and Communications Technology-Based Monitoring Service for Tailored Chronic Disease Management in Primary Care: Cost-Effectiveness Analysis Based on ICT-CM Trial Results.

Information and communications technology-based tailored management (TM) intervention is a novel automatic system in which a smartphone app for the management of patients with hypertension and diabetes, the provider web, and Bluetooth devices are linked. However, little evidence exists regarding the cost-effectiveness of the interventions using mobile apps. This study aimed to assess the cost-effectiveness of TM intervention for adult patients with hypertension or diabetes in primary care compared with usual care (UC). Cost-effectiveness analysis using a Markov model was conducted from the Korean health care system perspective. Based on 6-month outcome data from an information and communications technology-based tailored chronic disease management (ICT-CM) trial, effectiveness over a lifetime beyond the trial periods was extrapolated using a cardiovascular disease risk prediction model. Costs were estimated using ICT-CM trial data and national health insurance claims data. Health utility weights were obtained from the Korea National Health and Nutrition Examination Survey. In the base-case analysis, compared with UC, TM was more costly (US $23,157 for TM vs US $22,391 for UC) and more effective (12.006 quality-adjusted life-years [QALYs] for TM vs 11.868 QALYs for UC). The incremental cost-effectiveness ratio was US $5556 per QALY gained. Probabilistic sensitivity analysis showed that the probability of TM being cost-effective compared with UC was approximately 97% at an incremental cost-effectiveness ratio threshold of US $26,515 (KRW 35 million) per QALY gained. Compared with UC, TM intervention is a cost-effective option for patients with hypertension or diabetes in primary care settings. The study results can assist policy makers in making evidence-based decisions when implementing accessible chronic disease management services.

Cost-Effectiveness of Fruquintinib for Refractory Metastatic Colorectal Cancer in the USA.

The FRESCO-2 trial established the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer. However, its cost-effectiveness in the US context is not well documented. This study evaluates the cost-effectiveness of fruquintinib versus placebo for this patient population from the perspective of US payers. We developed a partitioned survival model on the basis of patient-level data reconstructed from the survival curves of the FRESCO-2 trial. Parametric estimation was conducted to estimate long-term clinical outcomes and medical costs over a lifetime horizon. Cost inputs and utilities were sourced from public data and previous literature. We used a discount rate of 3.0% per year for both clinical outcomes and costs. We adopted an incremental cost-effectiveness ratio (ICER) threshold of US$100,000 per quality-adjusted life-year (QALY) gained. We performed sensitivity and scenario analyses to examine the robustness of cost-effectiveness results. Fruquintinib treatment resulted in incremental gains of 0.108 life years (LYs) and 0.073 QALYs compared with the placebo, at an additional cost of US$112,294, primarily driven by medication expenses. The ICER for fruquintinib versus placebo was calculated at US$1,037,855 per LY and US$1,546,619 per QALY gained, exceeding the predefined cost-effectiveness threshold. The cost-effectiveness results were robust across all sensitivity and scenario analyses. Despite the survival benefit, fruquintinib was not cost-effective compared with the placebo in patients with refractory metastatic colorectal cancer in the US setting, on the basis of the conventional willingness-to-pay threshold. Our findings may provide a basis for informing the pricing and reimbursement decisions regarding fruquintinib.

Lifetime Cost-Effectiveness of Structured Education and Exercise Therapy for Knee Osteoarthritis in Australia.

Structured education and exercise therapy programs have been proposed to reduce reliance on total knee replacement (TKR) surgery and improve health care sustainability. The long-term cost-effectiveness of these programs is unclear. To estimate the lifetime cost-effectiveness of implementing a national structured education and exercise therapy program for individuals with knee osteoarthritis with the option for future TKR compared with usual care (TKR for all). This economic evaluation used a life table model in combination with a Markov model to compare costs and health outcomes of a national education and exercise therapy program vs usual care in the Australian health care system. Subgroup, deterministic, and probabilistic sensitivity analyses were completed. A hypothetical cohort of adults aged 45 to 84 years who would undergo TKR was created. Structured education and exercise therapy intervention provided by physiotherapists. The comparator was usual care where all people undergo TKR without accessing the program in the first year. Incremental net monetary benefit (INMB), with an incremental cost-effectiveness ratio threshold of 28 033 Australian dollars (A$) per quality-adjusted life-year (QALY) gained, was calculated from a health care perspective. Transition probabilities, costs, and utilities were estimated from national registries and a randomized clinical trial. The hypothetical cohort included 61 394 individuals (53.9% female; 93.6% aged ≥55 years). Implementation of an education and exercise therapy program resulted in a lifetime cost savings of A$498 307 942 (US $339 922 227), or A$7970 (US $5537) per individual, and resulted in fewer QALYs (0.43 per individual) compared with usual care. At a population level, education and exercise therapy was not cost-effective at the lifetime horizon (INMB, -A$4090 [-US $2841]). Subgroup analysis revealed that the intervention was cost-effective only for the first 9 years and over a lifetime only in individuals with no or mild pain at baseline (INMB, A$11 [US $8]). Results were robust to uncertainty around model inputs. In this economic evaluation of structured education and exercise therapy compared with usual care, the intervention was not cost-effective over the lifetime for all patients but was for the first 9 years and for those with minimal pain. These findings point to opportunities to invest early cost savings in additional care or prevention, including targeted implementation to specific subgroups.

The Economic Impact of Community Paramedics Within Emergency Medical Services: A Systematic Review.

Globally, emergency medical services (EMSs) report that their demand is dominated by non-emergency (such as urgent and primary care) requests. Appropriately managing these is a major challenge for EMSs, with one mechanism employed being specialist community paramedics. This review guides policy by evaluating the economic impact of specialist community paramedic models from a healthcare system perspective. A multidisciplinary team (health economics, emergency care, paramedicine, nursing) was formed, and a protocol registered on PROSPERO (CRD42023397840) and published open access. Eligible studies included experimental and analytical observational study designs of economic evaluation outcomes of patients requesting EMSs via an emergency telephone line ('000', '111', '999', '911' or equivalent) responded to by specialist community paramedics, compared to patients attended by usual care (i.e. standard paramedics). A three-stage systematic search was performed, including Peer Review of Electronic Search Strategies (PRESS) and Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA). Two independent reviewers extracted and verified 51 unique characteristics from 11 studies, costs were inflated and converted, and outcomes were synthesised with comparisons by model, population, education and reliability of findings. Eleven studies (n = 7136 intervention group) met thecriteria. These included one cost-utility analysis (measuring both costs and consequences), four costing studies (measuring cost only) and six cohort studies (measuring consequences only). Quality was measured using Joanna Briggs Institute tools, and was moderate for ten studies, and low for one. Models included autonomous paramedics (six studies, n = 4132 intervention), physician oversight (three studies, n = 932 intervention) and/or special populations (five studies, n = 3004 intervention). Twenty-one outcomes were reported. Models unanimously reduced emergency department (ED) transportation by 14-78% (higher quality studies reduced emergency department transportation by 50-54%, n = 2639 intervention, p < 0.001), and costs were reduced by AU$338-1227 per attendance in four studies (n = 2962). One study performed an economic evaluation (n = 1549), finding both that the costs were reduced by AU$454 per attendance (although not statistically significant), and consequently that the intervention dominated with a > 95% chance of the model being cost effective at the UK incremental cost-effectiveness ratio threshold. Community paramedic roles within EMSs reduced ED transportation by approximately half. However, the rate was highly variable owing to structural (such as local policies) and stochastic (such as the patient's medical condition) factors. As models unanimously reduced ED transportation-a major contributor to costs-they in turn lead to net healthcare system savings, provided there is sufficient demand to outweigh model costs and generate net savings. However, all models shift costs from EDs to EMSs, and therefore appropriate redistribution of benefits may be necessary to incentivise EMS investment. Policymakers for EMSs could consider negotiating with their health department, local ED or insurers to introduce a rebate for successful community paramedic non-ED-transportations. Following this, geographical areas with suitable non-emergency demand could be identified, and community paramedic models introduced and tested with a prospective economic evaluation or, where this is not feasible, with sufficient data collection to enable a post hoc analysis.

Cost-effectiveness analysis of cell-based versus egg-based quadrivalent influenza vaccines in the pediatric population in Taiwan.

Cell-based influenza vaccines avoid egg-adaptive mutations, potentially improving vaccine effectiveness. We assessed the one-season cost-effectiveness of cell-based quadrivalent influenza vaccine (QIVc) against that of egg-derived quadrivalent influenza vaccines (QIVe) in children (6 months to 17 years of age) from payer and societal perspectives in Taiwan using an age-stratified static model. Base case and high egg adaptation scenarios were assessed. Deterministic and probabilistic sensitivity analyses were performed. The incremental cost-effectiveness ratio (ICER) threshold in Taiwan was assumed to be USD 99 177/quality-adjusted life year (QALY). Compared to QIVe, QIVc would prevent 15 665 influenza cases, 2244 complicated cases, and 259 hospitalizations per year. The base case ICER was USD 68 298/QALY and USD 40 085/QALY from the payer and societal perspective, respectively. In the high egg adaptation scenario, the ICER was USD 45 782/QALY from the payer's perspective and USD 17 489/QALY from the societal perspective. Deterministic sensitivity analyses indicated that infection incidence rate, vaccination coverage, and prevalence of the A/H3N2 strain were the main drivers of ICER. In conclusion, switching the immunization strategy from QIVe to QIVc is predicted to reduce the influenza-associated disease burden and be cost-effective for the pediatric population in Taiwan. The potential benefits of QIVc would be even higher during influenza seasons with high levels of egg adaptation.

SGLT2 inhibitors for patients with heart failure with preserved ejection fraction in China: a cost-effectiveness study.

Background: The potential benefits of intervention with empagliflozin or dapagliflozin for patients with heart failure with preserved ejection fraction (HFpEF) were first demonstrated in the EMPEROR-Preserved and DELIVER studies. However, the cost-effectiveness of this intervention (empagliflozin or dapagliflozin) is yet to be established. Methods: In the context of Chinese healthcare, a Markov model was proposed, which incorporates clinical outcomes from the EMPEROR-Preserved and DELIVER studies, to predict the utility and costs over a lifetime. The time horizon was 20years, and a 5% discount rate was applied to the costs and utilities. The incremental cost-effectiveness ratio (ICER) threshold against willingness to pay (WTP) was set as the primary outcome. The robustness of the decision was evaluated using sensitivity analyses. Results: After a simulated 20-year lifetime, a 72-year-old patient with HFpEF in the intervention group (empagliflozin) showed an increase of 0.44 quality-adjusted life years (QALYs) and $1,623.58 with an ICER of $3,691.56 per QALY, which was lower than the WTP threshold of $12,032.10 per QALY. A 72-year-old patient with HFpEF in the intervention group (dapagliflozin) showed an increase of 0.34 QALYs and $2,002.13 with an ICER of $5,907.79 per QALY, which was lower than the WTP threshold of $12,032.10 per QALY. One-way sensitivity analyses showed that cardiovascular (CV) mortality in the intervention and comparator groups was the most sensitive to the decision. Cost-effectiveness was demonstrated in the intervention group (empagliflozin or dapagliflozin) in 67.9% or 62.2% of 1000 Monte Carlo simulations, respectively. Conclusion: In Chinese healthcare, the interventions (empagliflozin or dapagliflozin) for HFpEF were more cost-effective than the comparators. Our study has provided a quantitative evaluation of the costs and benefits of such interventions for a lifetime using the model.

An Industry Survey on Unmet Needs in South Korea's New Drug Listing System.

Since introducing the positive listing system in 2007, the South Korean government has undergone multiple changes in its drug listing system. As there is a lack of studies that evaluate the system from an industry perspective, this paper examined South Korea's new drug listing system from the suppliers' perspective. We surveyed members of the three main pharmaceutical industry associations online. The survey (a 5-point Likert scale) covered their satisfactory levels, demands, and updates on the current new drug listing system, especially pharmacoeconomic evaluation, pharmacoeconomic evaluation exemption, and risk-sharing agreement. A total of 56 respondents participated in the survey. The self-reported satisfaction level for value recognition of new drugs was 1.6 (± 0.7) points (5 points = very satisfied). The most highly demanded reforms for PE, RSA, and PEE were incremental cost-effectiveness ratio threshold (92.9%), reimbursement scope expansion (91.1%), and eligible disease (83.9%). Lastly, they also claimed that the indication-based pricing system must be introduced (83.9%). Pricing and reimbursement policies need to improve in such a way that would enable better access to new drugs while still facilitating their development. Given the nature of the current system, some innovative rare disease treatments and anticancer drugs remain unreimbursed, resulting in low satisfaction levels across the pharmaceutical industry. Hence, pathways to speed up the reimbursement assessment process and expand the range of reimbursable diseases are required. Pharmaceutical companies are also important stakeholders, like in the case of clinicians and patients, and their opinions should also be considered in the process of pricing and reimbursement policy reforms.

What is the Value of a Balanced Total Knee Arthroplasty? Getting It Right the First Time

BackgroundInstability is a leading cause of early failure following total knee arthroplasty (TKA). Enabling technologies can improve accuracy, but their clinical value remains undetermined. The purpose of this study was to determine the value of achieving a balanced knee joint at the time of TKA. MethodsA Markov model was developed to determine the value from reduced revisions and improved outcomes associated with TKA joint balance. Patients were modeled for the first 5 years following TKA. The threshold to determine cost-effectiveness was set at an incremental cost effectiveness ratio of $50,000/quality-adjusted life year (QALY). A sensitivity analysis was performed to evaluate the influence of QALY improvement (ΔQALY) and Revision Rate Reduction on additional value generated compared to a conventional TKA cohort. The impact of each variable was evaluated by iterating over a range of ΔQALY (0 to 0.046) and Revision Rate Reduction (0% to 30%) and calculating the value generated while satisfying the incremental cost effectiveness ratio threshold. Finally, the impact of surgeon volume on these outcomes was analyzed. ResultsThe total value of a balanced knee for the first 5 years was $8,750, $6,575, and $4,417 per case, for low, medium, and high-volume surgeons, respectively. Change in QALY accounted for greater than 90% of the value gain with a reduction in revisions making up the rest in all scenarios. The economic contribution of revision reduction was relatively constant regardless of surgeon volume ($500/case). ConclusionAchieving a balanced knee had the greatest impact on ΔQALY over early revision rate. These results can help assign value to enabling technologies with joint balancing capabilities.

The cost-effectiveness of universal hepatitis B screening for reaching WHO diagnosis targets in Australia by 2030.

To assess the impact on diagnosis targets, cost, and cost-effectiveness of universal hepatitis B screening in Australia. Markov model simulation of disease and care cascade progression for people with chronic hepatitis B in Australia. Three scenarios were compared: 1. no change to current hepatitis B virus (HBV) testing practice; 2. universal screening strategy, with the aim of achieving the WHO diagnosis target by 2030 (90% of people with chronic hepatitis B diagnosed), based on opportunistic (general practitioner-initiated) screening for HBsAg; 3. universal screening strategy, and also ensuring that 50% of people with chronic hepatitis B are receiving appropriate clinical management by 2030. Projected care cascade for people with chronic hepatitis B, cumulative number of HBV-related deaths, intervention costs, and health utility (quality-adjusted life-years [QALYs] gained during 2020-2030). An incremental cost-effectiveness ratio (ICER) threshold (v scenario 1) of $50 000 per QALY gained was applied. Compared with scenario 1, 80 HBV-related deaths (interquartile range [IQR], 41-127 deaths) were averted during 2020-2030 in scenario 2, 315 HBV-related deaths (IQR, 211-454 deaths) in scenario 3. Scenario 2 cost $84 million (IQR, $41-106 million) more than scenario 1 during 2020-2030 (+8%), yielding an ICER of $104 921 (IQR, $49 587-107 952) per QALY gained. Scenario 3 cost $263 million (IQR, $214-316 million) more than scenario 1 during 2020-2030 (+24%), yielding an ICER of $47 341 (IQR, $32 643-58 200) per QALY gained. Scenario 3 remained cost-effective if the test positivity rate was higher than 0.35% or the additional costs per person tested did not exceed $4.02. Universal screening for hepatitis B will be cost-effective only if the cost of testing is kept low and people receive appropriate clinical management.

Cost-effectiveness of neuromuscular electrical stimulation for the treatment of mild obstructive sleep apnea: an exploratory analysis.

To assess the potential cost-effectiveness of neuromuscular electrical stimulation (NMES) for treatment of mild obstructive sleep apnea (OSA). A decision-analytic Markov model was developed to estimate health state progression, incremental cost, and quality-adjusted life year (QALY) gain of NMES compared to no treatment, continuous airway pressure (CPAP), or oral appliance (OA) treatment. The base case assumed no cardiovascular (CV) benefit for any of the interventions, while potential CV benefit was considered in scenario analyses. Therapy effectiveness was based on a recent multi-center trial for NMES, and on the TOMADO and MERGE studies for OA and CPAP. Costs, considered from a United States payer perspective, were projected over lifetime for a 48-year-old cohort, 68% of whom were male. An incremental cost-effectiveness ratio (ICER) threshold of USD150,000 per QALY gained was applied. From a baseline AHI of 10.2 events/hour, NMES, OA and CPAP reduced the AHI to 6.9, 7.0 and 1.4 events/hour respectively. Long-term therapy adherence was estimated at 65-75% for NMES and 55% for both OA and CPAP. Compared to no treatment, NMES added between 0.268 and 0.536 QALYs and between USD7,481 and USD17,445 in cost, resulting in ICERs between USD15,436 and USD57,844 per QALY gained. Depending on long-term adherence assumptions, either NMES or CPAP were found to be the preferred treatment option, with NMES becoming more attractive with younger age and assuming CPAP was not used for the full night in all patients. NMES might be a cost-effective treatment option for patients with mild OSA.

Cost-Effectiveness of Universal Screening for Blunt Cerebrovascular Injury: A Markov Analysis.

Blunt cerebrovascular injury (BCVI) is a significant cause of morbidity and mortality after blunt trauma. Numerous screening strategies exist, although which is used is institution- and physician-dependent. We sought to identify the most cost-effective screening strategy for BCVI, hypothesizing that universal screening would be optimal among the screening strategies studied. A Markov decision analysis model was used to compare the following screening strategies for identification of BCVI: (1) no screening; (2) Denver criteria; (3) extended Denver criteria; (4) Memphis criteria; and (5) universal screening. The base-case scenario modeled 50-year-old patients with blunt traumatic injury excluding isolated extremity injures. Patients with BCVI detected on imaging were assumed to be treated with antithrombotic therapy, subsequently decreasing risk of stroke and mortality. One-way sensitivity analyses were performed on key model inputs. A single-year horizon was used with an incremental cost-effectiveness ratio threshold of $100,000 per quality-adjusted life-year. The most cost-effective screening strategy for patients with blunt trauma among the strategies analyzed was universal screening. This method resulted in the lowest stroke rate, mortality, and cost, and highest quality-adjusted life-year. An estimated 3,506 strokes would be prevented annually as compared with extended Denver criteria (incremental cost-effectiveness ratio of $71,949 for universal screening vs incremental cost-effectiveness ratio of $12,736 for extended Denver criteria per quality-adjusted life-year gained) if universal screening were implemented in the US. In 1-way sensitivity analyses, universal screening was the optimal strategy when the incidence of BCVI was greater than 6%. This model suggests universal screening may be the cost-effective strategy for BCVI screening in blunt trauma for certain trauma centers. Trauma centers should develop institutional protocols that take into account individual BCVI rates.

Humeral shaft fractures: a cost-effectiveness analysis of operative versus nonoperative management.

Humeral shaft fractures can be managed operatively or nonoperatively with functional bracing in the absence of neurovascular injury, open fracture, or polytrauma. A consensus on optimal management has not been reached, nor has the cost-effectiveness perspective been investigated. A decision tree was constructed describing the management of humeral shaft fractures with open reduction-internal fixation (ORIF), intramedullary nailing (IMN), and functional bracing in a non-elderly population. Probabilities were defined using weighted averages determined from systematic review of the literature. Cost-effectiveness was evaluated with incremental cost-effectiveness ratios, measured in cost per quality-adjusted life-year (QALY). Willingness-to-pay thresholds of $50,000/QALY and $100,000/QALY were evaluated. Eighty-six studies were included. Using bracing as the referent in the health care model, we observed that bracing was the preferred strategy at both incremental cost-effectiveness ratio thresholds. ORIF and IMN had higher overall effectiveness (0.917 QALYs and 0.913 QALYs, respectively) compared with bracing (0.877 QALYs). The cost-effectiveness of bracing was driven by a substantially lower overall cost. In the societal model-accounting for both health care and societal costs-the cost difference narrowed between bracing, ORIF, and IMN. Bracing remained the preferred strategy at the $50,000/QALY threshold; ORIF was preferred at the $100,000/QALY threshold. ORIF and IMN were comparable strategies across a range of probability values in sensitivity analyses. Functional bracing, with its low cost and satisfactory clinical outcomes, is often the most cost-effective strategy for humeral shaft fracture management. ORIF becomes preferable at the higher willingness-to-pay threshold when societal burden is considered. QALY values for ORIF and IMN were comparable.

HTA4 Applicability of Willingness to Pay Thresholds for Oncology Drugs: A Review of Submissions Made to the Canadian Agency for Drugs and Technologies in Health

Canadian Agency for Drugs and Technologies in Health (CADTH) has no established incremental cost-effectiveness ratio (ICER) threshold for reimbursement purposes. However, a willingness to pay (WTP) threshold of $50,000 per Quality Adjusted Life Year (QALY) is viewed favourably for both oncology and non-oncology products. We aimed to review the submissions of cancer drugs made to CADTH from January 2016 to June 2021, to understand the applicability of willingness to pay thresholds acceptable for CADTH.

125-LB: Individualized Cost-Effectiveness Assessment of Sodium–Glucose Cotransporter 2 Inhibitors (SGLT2i) vs. Sulfonylureas as Add-On Therapy in People with Inadequately Controlled Type 2 Diabetes (T2D) Under Metformin Monotherapy

The cost-effectiveness of SGLT2i can be modulated by patients’ characteristics, such as cardiovascular risks. We performed an individualized cost-effectiveness assessment of SGLT2i when added to metformin in people with inadequately controlled T2D to quantify the modulating effect of patients’ characteristics on the cost-effectiveness of SGLT2i. We identified survey participants with T2D receiving metformin monotherapy who had an A1c level above 7.0% from the National Health and Nutrition Examination Survey (2013-2018) . We applied a simulation-based smoothing method to populate the survey sample to its represented national population. We used the BRAVO diabetes model to simulate the lifetime cost and QALYs associated with SGLT2i or sulfonylureas. Treatment escalations were governed by the A1c level at 7% and 8% consequentially. Both costs and QALYs were discounted at 3% annually, and the incremental cost-effectiveness ratio (ICER) threshold was set at $100,000/QALYs. The study sample included 2.89 million individuals. Compared with sulfonylureas, the use of SGLT2i was associated with an average of $9,400 higher medical cost and 0.10 additional QALY, leading to an ICER of $94,000/QALY in the overall population. SGLT2i was cost-effective in people with a history of heart failure (ICER: $67,000/QALY) and myocardial infarction (ICER: $94,000/QALY) , and marginally cost-effective in stroke patients (ICER: $100,000/QALY) . Among individuals without CVD, SGLT2i was cost-effective only in subgroups with HbA1c &amp;gt; 7.5%, age &amp;gt; 60, and diabetes duration &amp;gt; 10 years. Overall, SGLT2i was only cost-effective in individuals with a baseline 10-year CVD risk over 16%, constituting 51.6% of the overall population. Our results align closely with the ADA guideline on the recommended population for SGLT2i use. Out-of-pocket payment subsidy or cost-sharing reduction of SGLT2i should be prioritized in patient subgroups in which SGLT2i has high economic values. Disclosure D. Guan: None. S. Niu: None. V. Fonseca: Consultant; Abbott, Asahi Kasei Corporation, Bayer AG, Novo Nordisk, Sanofi, Research Support; Fractyl Health, Inc., Jaguar Gene Therapy, Stock/Shareholder; Abbott, Amgen Inc., BRAVO4Health, Mellitus Health. L. Shi: None. N. Laiteerapong: None. J. Guo: None. H. Shao: Board Member; BRAVO4HEALTH, LLC.

Cost-effectiveness of prophylactic retropubic sling at the time of vaginal prolapse surgery

Prophylactic midurethral sling placement at the time of prolapse repair significantly reduces the risk for de novo stress urinary incontinence, but it is associated with some small but significant morbidities. Because there has not been a standardized approach to midurethral sling utilization, decision analysis provides a method to evaluate the cost and effectiveness associated with varying midurethral sling placement strategies in addressing the risk for de novo stress urinary incontinence. We aimed to compare the cost effectiveness of the 3 midurethral sling utilization strategies in treating de novo stress urinary incontinence 1 year after vaginal prolapse repair. The 3 approaches are (1) staged strategy in which prolapse repair is done without prophylactic midurethral sling placement, (2) universal sling placement in which prolapse repair is accompanied by prophylactic midurethral sling placement, and (3) selective sling placement in which prolapse repair is accompanied by prophylactic midurethral sling placement only in patients with a positive prolapse-reduced cough stress test. We created a decision analysis model to compare staged strategy, universal sling placement, and selective sling placement. We modeled probabilities of de novo stress urinary incontinence, patients choosing subsequent midurethral sling surgery for de novo stress urinary incontinence, and outcomes related to midurethral sling placement. De novo stress urinary incontinence rates were determined for each strategy from published data. The likelihood of patients with de novo stress urinary incontinence choosing midurethral sling surgery as their first-line treatment was also determined from the literature, and this scenario was only applied to patients without prophylactic midurethral sling placement at their index prolapse repair. Finally, outcomes related to midurethral sling placement, including recurrent or persistent stress urinary incontinence, voiding dysfunction requiring sling lysis, mesh exposure requiring excision, and de novo overactive bladder requiring medications, were all derived from publicly available data. All midurethral sling placement procedures were assumed to be retropubic. The costs for each procedure were obtained from the 2020 Centers for Medicare & Medicaid Services Physician Fee Schedule or from previous literature with convertion to 2020 equivalent US dollar prices using the Consumer Price Index. The primary outcome was modeled as the incremental cost-effectiveness ratio. We performed multiple 1-way sensitivity analyses to assess model robustness. The lowest-cost strategy was the staged strategy, which cost $1051.70 per patient, followed by $1093.75 for selective sling placement and $1125.54 for universal sling placement. The selective sling approach, however, had the highest health utility value; therefore, universal sling placement was dominated by selective sling placement because it is both less costly and more effective. When compared with the staged strategy, selective sling placement was cost effective with an incremental cost-effectiveness ratio of $2664 per quality adjusted life-years, meeting the predetermined threshold. In multiple 1-way sensitivity analyses, the variable with the largest effect was the percentage of patients electing to undergo subsequent midurethral sling surgery for de novo stress urinary incontinence after the index surgery. Only when this proportion exceeded 62% did universal sling placement become the cost-effective option because selective sling placement surpassed the predetermined incremental cost-effectiveness ratio threshold and became dominated. Selective sling placement was the preferred and cost-effective strategy in treating de novo stress urinary incontinence 1 year after vaginal prolapse repair. Surgeons should counsel their patients preoperatively regarding the possibility of de novo stress urinary incontinence after prolapse repair, as well as on the benefits and risks of prophylactic midurethral sling placement surgery.

Cost-Effectiveness Analysis of Evolocumab in Adult Patients with Atherosclerotic Cardiovascular Disease in Canada.

IntroductionTo evaluate the cost-effectiveness of evolocumab when added to standard of care lipid-lowering treatment (LLT) for patients with atherosclerotic cardiovascular disease (ASCVD) who cannot adequately control their low-density lipoprotein cholesterol (LDL-C) despite optimized LLT in Canada.MethodsAn incremental cost-utility analysis was conducted using a Markov cohort state transition model adapted to the Canadian setting. Analyses were conducted from a public health and societal perspective using a lifetime time horizon for Canada. Scenario analyses were conducted on the basis of recommendations from the 2021 Canadian Cardiovascular Society (CCS) dyslipidemia guidelines.ResultsIn ASCVD patients with prior myocardial infarction (MI) and baseline LDL-C ≥ 1.8 mmol/L, adding evolocumab to optimized statin therapy with or without ezetimibe is associated with an incremental cost per quality-adjusted life year (QALY) gained of $66,453 CAD. Furthermore, for every 100 patients treated with evolocumab for lifetime, adding evolocumab to optimized LLT will prevent approximately 52 cardiovascular (CV) events, of which seven would be fatal. The results are generally robust using univariate and simultaneous variation in model input parameters. Scenario analyses for patient populations as per the CCS guidelines suggest that evolocumab added to optimized LLT may be considered cost-effective, given an incremental cost-effectiveness ratio (ICER) threshold of CAD$100,000 per QALY gained. Limitations associated with this analysis should be interpreted in the context of data and modeling assumptions used.ConclusionOverall, this analysis supports reimbursement of evolocumab by payers in patients with ASCVD who cannot reach LDL-C thresholds despite optimized LLT to reduce unnecessary fatal and non-fatal CV events.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-022-02130-4.

Adjuvant treatment of high-risk melanoma \u2013 cost-effectiveness analysis of treatment options for BRAF 600 mutated tumors

IntroductionUntil recently, adjuvant treatment options for higher stage resectable cutaneous melanoma were limited. Two studies with a similar set-up, published 2017, led to registration of targeted therapy for BRAF-mutated melanoma with dabrafenib and trametinib as well as of the immunotherapy with nivolumab irrespective of BRAF-mutation status. Both options have been positively assessed in Germany since 2019 for the adjuvant treatment of BRAF-V600 mutated melanoma. This study evaluates the cost-effectiveness of both treatment alternatives (dabrafenib/trametinib and nivolumab) against observation as a comparative therapy from the perspective of German statutory health funds.MethodsPartitioned survival analysis based on published survival curves for the investigated treatment options was used for a cohort model for the health states relapse free survival, progression, and death. The partitioned survival analysis approach was based on the survival curves published for the key studies Combi AD and Checkmate-238. The modelling was performed for the remaining lifetime for a cohort with starting age of 50 years. For extrapolation of the survival curves, convergence to general population mortality rates was assumed in the long term. Within the progression state, a Markov model uses three levels of progressions (locoregional, distant metastases with 1st and 2nd line treatment). Lifetime treatment costs were calculated using the German statutory health fund reimbursement scheme. Quality adjusted life years (QALYs) associated to the health states were adopted from previously published utilities based on the Combi AD study.ResultsThe treatment with dabrafenib/trametinib yielded an increase in quality adjusted life years of 2.28 QALY at an incremental lifetime cost of 86.1 T€. The incremental cost effectiveness ratio of dabrafenib/trametinib and nivolumab was comparable with 37.8 T€/QALY and 30.0 T€/QALY, respectively. Several sensitivity analyses proved the result to be insensitive. General model parameters like discount rate and length of the time horizon had stronger influence. For nivolumab, the model showed lower discounted lifetime costs (118.1 T€) compared to dabrafenib/trametinib [155.1 T€], associated with a lower gain in QALYs (1.64 years) compared to observation.ConclusionBoth dabrafenib/trametinib and nivolumab turned out to be cost effective within internationally accepted Incremental Cost Effectiveness Ratio (ICER) thresholds with comparable cost effectiveness ratios.

Methodological Approaches to Cost-Effectiveness Analysis in Saudi Arabia: What Can We Learn? A Systematic Review.

ObjectiveThe recent establishment of the health technology assessment (HTA) entity in the Kingdom of Saudi Arabia (KSA) has resulted in increased interest in economic evaluation. The aim of this study is to evaluate the technical approaches used in published economic evaluations and the limitations reported by the authors of the respective studies that could affect the ability to perform economic evaluations in the KSA.MethodsWe conducted a systematic literature review of published economic evaluations performed for the KSA over the past 10 years. An electronic literature search of the PubMed, EMBASE, and Cochrane databases was performed. A CHEERS checklist was used to assess the quality of reporting. Reported limitations were classified into domains including the definition of perspectives, identification of comparators, estimation of costs and resources, and use of the incremental cost-effectiveness ratio threshold.ResultsTwelve evaluations were identified; most involved cost-effectiveness analysis (92%). Missing and unclear data were found within the CHEERS criteria. Regardless of the perspective used, most described the perspective as an “institutional” perspective (70%) and almost half were reclassified by the current reviewer (42%). Most did not clearly state the comparator (83%), and published model comparators were commonly used (50%). Resource estimation was mostly performed by the authors of the respective studies (67%), and costs were mostly obtained from hospital institutional data (75%). The lack of an established threshold for the country-specific willingness to pay was observed in 50% of the analyses.ConclusionsEconomic evaluations from the KSA are limited. Capacity building and country-specific HTA guidelines could improve the quality of evaluations to better inform decision making.HighlightsEconomic analysis of health technology should follow standard guidelines. Unfortunately, these guides are often underutilized, and our findings identify considerable missing, not clearly stated, or incomplete data within the analyses, which can weaken the impact of the recommendations.The limitations reported by the authors of the respective studies emphasize the suboptimal quality of the reporting. A lack of data was frequently identified and resulted in using “institutional” practice as a major source of data input for the analyses.In light of the call for the establishment of an HTA entity in the KSA, framing a standard analytic approach when conducting economic evaluations will support HTA in informing resource allocation decisions. We hope that our findings highlight the need for country-specific guidance to improve practice and enhance future research.

Cost-Effectiveness of Weight-Bearing Computed Tomography in Diagnosing Syndesmotic Instability

Category:Ankle; Sports; OtherIntroduction/Purpose:To optimize clinical outcomes, accurate diagnosis and treatment of syndesmotic instability is critical, but subtle instability can be challenging to identify. Weightbearing computed tomography (WBCT) has proved to be a reliable tool for diagnosing syndesmotic instability under physiologic load. We aimed to examine the cost-effectiveness of WBCT with radiographs and/or conventional CT for the diagnosis of syndesmotic instability from a patient perspective.Methods:A decision tree model was constructed to examine the cost-effectiveness of WBCT versus conventional CT (NWB CT) versus weightbearing (WB) radiographs versus non-weightbearing (NWB) radiographs (base case) as initial imaging with additional possible imaging for1268 patients with suspected syndesmotic instability. Patient's clinical and radiological notes were evaluated until the diagnosis of syndesmotic instability was established. The decision tree's probabilities, durations, and image counts were based on patient data. The main outcomes were 1) total imaging costs needed before syndesmotic instability was diagnosed, 2) quality-adjusted life-years (QALYs), 3) incremental cost-effectiveness ratios (ICERs), and 4) overall radiation dose prior to diagnosis. Imaging costs and radiation dose were derived from National Medicare reimbursement rates and the American College of Radiology, respectively. An incremental cost-effectiveness ratio threshold of $50,000 per quality-adjusted life years was used to evaluate cost-effectiveness. In addition, one-way and two-way sensitivity analyses were performed to determine the robustness of our findings.Results:WBCT resulted in 0.057 additional QALY gained per week compared with NWB radiographs, indicating WBCT to be more effective than NWB radiographs. Costs for WBCT imaging were $38.71 higher than NWB radiographs for an ICER of $38,563.96/QALY. Applying a commonly used threshold of $50,000 per QALY, the patient's willingness-to-pay for the amount of quality-adjusted life-year gained from using WBCT as an initial imaging modality was $54.41, suggesting WBCT first imaging strategy was a cost-effective intervention. In our study, the cost of WBCT imaging was $157.35. Sensitivity analyses demonstrated that WBCT was more cost effective than NWB radiographs up to a cost of $173.05. Additionally, initial WBCT resulted in lower overall radiation dosage (6.4 uSv) compared to the use of the other three imaging modalities as initial imaging strategy (initial NWB radiographs - 12.41 uSv; initial WB radiographs - 8.30 uSv, NWB CT first - 25 uSv).Conclusion:WBCT leads to higher QALYs compared to other diagnostic imaging modalities, resulting in improved outcomes for patients by eliminating redundant imaging.