Comparative analysis of differences between preoperative endoscopic biopsy and postoperative pathological examination for diagnosis of gastric intraepithelial neoplasia

ObjectiveThis study was performed to compare the differences between preoperative endoscopic biopsy (PEB) and postoperative pathological examination (PPE) for diagnosis of gastric intraepithelial neoplasia (GIN).MethodsFrom September 2016 to July 2019, 188 consecutive patients with GIN at Yuyao People’s Hospital were retrospectively analyzed. The 188 patients had 218 GIN lesions. All patients underwent PEB and either endoscopic submucosal dissection or surgical treatment. PPE was performed on pathological tissues that had been surgically removed.ResultsAmong 138 cases of low-grade dysplasia (LGD) diagnosed by PEB, 46 were upgraded to high-grade dysplasia (HGD), 20 were upgraded to early gastric cancer (EGC), and 2 were downgraded to inflammation after PPE. Among 42 cases of HGD, 23 were upgraded to EGC, 2 were downgraded to LGD, and 2 were downgraded to inflammation after PPE. Among 38 cases of EGC, 1 was downgraded to HGD and 2 were downgraded to LGD after PPE. The original diagnosis was maintained after the operation in 120 cases of GIN.ConclusionBiopsy did not fully reflect the lesions of GIN. Biopsy review should be actively performed, and the lesions should be clarified by endoscopic submucosal dissection or surgery.     

Cost-Effectiveness and Net Monetary Benefit of Olaparib Maintenance Therapy Versus No Maintenance Therapy After First-line Platinum-based Chemotherapy in Newly Diagnosed Advanced BRCA1/2-mutated Ovarian Cancer in the Italian National Health Service

PurposeThe aim of this study was to evaluate the cost-effectiveness and net monetary benefit of olaparib maintenance therapy compared with no maintenance therapy after first-line platinum-based chemotherapy in newly diagnosed advanced BRCA1/2-mutated ovarian cancer from the Italian National Health Service (NHS) perspective.MethodsWe developed a lifetime Markov model in which a cohort of patients with newly diagnosed advanced BRCA1/2-mutated ovarian cancer was assigned to receive either olaparib maintenance therapy or active surveillance (Italian standard of care) after first-line platinum-based chemotherapy to compare cost-effectiveness and net monetary benefit of the 2 strategies. Data on clinical outcomes were obtained from related clinical trial literature and extrapolated using parametric survival analyses. Data on costs were derived from Italian official sources and relevant real-world studies. The incremental cost-effectiveness ratio (ICER), incremental cost-utility ratio (ICUR), and incremental net monetary benefit (INMB) were computed and compared against an incremental cost per quality-adjusted life-year (QALY) gained of €16,372 willingness-to-pay (WTP) threshold. We used deterministic sensitivity analysis (DSA) and probabilistic sensitivity analysis (PSA) to assess how uncertainty affects results; we also performed scenario analyses to compare results under different pricing settings.FindingsIn the base-case scenario, during a 50-year time horizon, the total costs for patients treated with olaparib therapy and active surveillance were €124,359 and €97,043, respectively, and QALYs gained were 7.29 and 4.88, respectively, with an ICER of €9,515 per life-year gained, an ICUR of €11,345 per QALY gained, and an INMB of €12,104. In scenario analyses, considering maximum selling prices for all other drugs, ICUR decreased to €11,311 per QALY and €7,498 per QALY when a 10% and 20% discount, respectively, was applied to the olaparib official price, and the INMB increased to €12,186 and €21,366, respectively. DSA found that the model results were most sensitive to the proportion of patients with relapsing disease in response to platinum-based chemotherapy, time receiving olaparib first-line maintenance treatment, and subsequent treatments price. According to PSAresults, olaparib was associated with a probability of being cost-effective at a €16,372 per QALY WTP threshold ranging from 70% to 100% in the scenarios examined.ImplicationsOur analysis indicates that olaparib maintenance therapy may deliver a significant health benefit with a contained upfront cost during a 50-year time horizon, from the Italian NHS perspective, providing value in a setting with curative intent.     

The role of radiofrequency ablation in the management of Barrett's esophagus

Studies in the last several years have consistently shown radiofrequency ablation (RFA) to be effective, safe, and well tolerated in the treatment of nondysplastic and dysplastic Barrett's esophagus (BE). The results found at academic medical centers have been reproduced in the community setting. RFA provides a safe and cost-effective alternative to surgery or surveillance in the management of high-grade dysplasia (HGD). RFA should be given serious consideration as first-line therapy for HGD. This article reviews the evidence behind RFA to differentiate it from other management strategies in terms of efficacy, durability, safety, tolerability, and cost-effectiveness. The role of RFA in the management of BE is described, including endoscopic resection. Future directions are identified for research that will help to better define the role of RFA in the management of BE.     

Cost-effectiveness Comparison of Ceftazidime/Avibactam Versus Meropenem in the Empirical Treatment of Hospital-acquired Pneumonia,Including Ventilator-associated Pneumonia,in Italy

PurposeCeftazidime/avibactam (CAZ-AVI) is a fixed-dose combination antibiotic approved in Europe and the United States for patients with hospital-acquired pneumonia, including ventilator-associated pneumonia (HAP/VAP). The economic benefits of a new drug such as CAZ-AVI are required to be assessed against those of available comparators, from the perspective of health care providers and payers, through cost-effectiveness and cost-utility analyses. The objective of this analysis was to compare the cost-effectiveness of CAZ-AVI versus meropenem in the empirical treatment of appropriate hospitalized patients with HAP/VAP caused by gram-negative pathogens, from the perspective of publicly funded health care in Italy (third-party perspective, based on the data from the REPROVE (Ceftazidime-Avibactam Versus Meropenem In Nosocomial Pneumonia, Including Ventilator-Associated Pneumonia) clinical study; ClinicalTrials.gov NCT01808092).MethodsA patient-level, sequential simulation model of the HAP/VAP clinical course was developed using spreadsheet software. The analysis focused on direct medical costs. The time horizon of the model selected was 5 years, with an annual discount rate of 3% on costs and quality-adjusted life-years (QALYs). Clinical inputs for treatment comparisons were mainly obtained from the REPROVE clinical study data. In addition to clinical outcomes observed in the trial, the model incorporated impact of resistance pathogens, based on data from published studies and expert opinion. Certain assumptions were made for some model parameters due to a lack of data.FindingsThe analysis demonstrated that the intervention sequence (CAZ-AVI followed by colistin + high-dose meropenem) versus the comparator sequence (meropenem followed by colistin + high-dose meropenem) provided a better clinical cure rate (+13.52%), which led to a shorter hospital stay (−0.40 days per patient), and gains in the number of life-years (+0.195) and QALYs (+0.350) per patient. The intervention sequence had an estimated net incremental total cost of €1254 ($1401) per patient, and the estimated incremental cost-effectiveness ratio was €3581 ($4000) per QALY gained, well below the willingness-to-pay threshold of €30,000 ($33,507) per QALY in Italy.ImplicationsThe model results showed that CAZ-AVI is expected to provide clinical benefits in hospitalized patients with HAP/VAP in Italy at an acceptable cost compared to meropenem.     

Cost-effectiveness of dronedarone in atrial fibrillation: results for Canada, Italy, sweden, and Switzerland

BackgroundDronedarone is a therapy for the treatment of patients with paroxysmal and persistent atrial fibrillation or atrial flutter. According to results in the ATHENA trial, dronedarone on top of standard of care (SOC) decreases the risk of cardiovascular hospitalizations or death by 24% compared with SOC alone.ObjectivesA patient-level health economic model was developed to evaluate the cost-effectiveness of dronedarone on top of SOC versus SOC alone.MethodsThe risk of experiencing stroke, congestive heart failure, acute coronary syndromes, treatment discontinuation, and death was modeled by separate health states, whereas adverse events were included as 1-time cost and utility decrements. State transition probabilities were primarily deduced from the patient-level data from ATHENA using survival analysis. Four sets of analyses were performed to reflect costs and treatment effects in Canada, Italy, Sweden, and Switzerland. Cost-effectiveness analysis was also conducted in a newly defined patient population identified by the European Medicines Agency (EMA) to avoid the use of dronedarone in permanent AF patients resembling those in the PALLAS study.ResultsThe predicted survival time was, for the Canadian cohort, extended from 10.11 to 10.24 years when dronedarone was added to SOC. Similar results were found for the other countries, resulting in incremental cost-effectiveness ratios (ICERs) of €5828, €5873, €14,970, and €8554 per QALYs for Canada, Italy, Sweden, and, Switzerland, respectively. These results are all well below current established cost-effectiveness thresholds. In the EMA-restricted population, all patients were predicted to live longer, and the ICER increased but remained within established thresholds, with an average cost per QALY gained of €15,900.ConclusionsDronedarone on top of SOC appears to be a cost-effective treatment for atrial fibrillation compared with SOC alone. Despite the differences in the local settings considered, the results were consistent among all the countries included in the study. ClinicalTrials.gov identifier: NCT00174785.     

Cost-utility of collaborative nurse-led self-management support for primary care patients with anxiety,depressive or somatic symptoms: A cluster-randomized controlled trial (the SMADS trial)

BackgroundAnxiety, depressive and somatoform disorders are highly prevalent and cause a huge economic burden. A nurse-led collaborative care intervention has been set up in order to improve self-management of patients with these mental disorders in primary care in Hamburg, Germany. The aim of this study was to determine the cost-utility of this nurse-led intervention from the health care payer perspective.MethodsThis analysis was part of a 12-month cluster-randomized controlled trial aiming to increase perceived self-efficacy of primary care patients with anxiety, depressive or somatic symptoms by collaborative nurse-led self-management support compared with routine care. A cost-effectiveness analysis using quality-adjusted life years was performed. Net-monetary benefit regressions adjusted for baseline differences for different willingness-to-pay thresholds were conducted and cost-effectiveness acceptability curves were constructed.ResultsIn total, n = 325 patients (intervention group: n = 134; control group: n = 191) with a mean age of 40 from 20 primary care practices were included in the analysis. The adjusted differences in quality-adjusted life years and mean total costs between intervention group and control group were +0.02 and +€1145, respectively. Neither of the two differences was statistically significant. The probability for cost-effectiveness of the complex nurse-led intervention was 49% for a willingness-to-pay of €50,000 per additional quality-adjusted life year. The probability for cost-effectiveness did not exceed 65%, independent of the willingness-to-pay.ConclusionThe complex nurse-led intervention promoting self-management for primary care patients with anxiety, depressive or somatic symptoms did not prove to be cost-effective relative to routine care from a health care payer perspective.     

Cost-effectiveness and Net Monetary Benefit of Durvalumab Consolidation Therapy Versus No Consolidation Therapy After Chemoradiotherapy in Stage III Non–small Cell Lung Cancer in the Italian National Health Service

PurposeThe aim of this study was to evaluate the cost-effectiveness and net monetary benefit of durvalumab consolidation therapy compared with no consolidation therapy after chemoradiotherapy in patients with stage III non–small cell lung cancer with programmed cell death 1 ligand 1 expression ≥1% from the Italian National Health Service perspective.MethodsWe developed a 12-month decision tree combined with a lifetime cohort Markov model in which patients were assigned to receive durvalumab consolidation therapy or active follow-up (Italian standard of care) after chemoradiotherapy to compare cost-effectiveness and net monetary benefit of the two strategies during a 40-year period. Clinical outcomes data were obtained from the respective clinical trials and extrapolated using survival analysis; cost data were derived from Italian official sources and relevant real-world studies. The incremental cost-effectiveness ratio, incremental cost-utility ratio, and incremental net monetary benefit were computed and compared against a 16,372 € per quality-adjusted life-year (QALY) willingness-to-pay threshold. We performed deterministic sensitivity analysis and probabilistic sensitivity analysis to assess how uncertainty affected results; we also performed scenario analyses to compare results under different pricing settings.FindingsIn the base-case scenario, during a 40-year period, the total costs for patients treated with durvalumab consolidation therapy and active follow-up were €59,860 and €49,840 respectively; life-years gained were 3.47 and 3.31, respectively; and QALYs gained were 2.73 and 2.50, respectively, with an incremental cost-effectiveness ratio of €62,131 per life-year, an incremental cost-utility ratio of €42,322 per QALY, and an incremental net monetary benefit of €−6,144. We found that durvalumab was cost-effective (incremental net monetary benefit = 0) when a discount of 13% and 30% on its official price was applied, considering all other drugs priced according to official or maximum selling prices, respectively. Results were most sensitive to the progression-free survival rate for durvalumab and active follow-up, health utility in progression-free state, and price of subsequent treatments.ImplicationsOur analysis indicates that durvalumab consolidation is cost-effective when a discount is applied on its official price. These results suggest that durvalumab may deliver an incremental health benefit with a contained upfront cost during a 40-year period, from the Italian National Health Service perspective, providing added value in a potentially curative care setting.     

Long-term follow-up study of gastric adenoma/dysplasia

BACKGROUND AND STUDY AIMS: The natural course of gastric adenoma/dysplasia, regarded as a precancerous lesion, is still uncertain. PATIENTS AND METHODS: From 1976 to 2000, 48 lesions in 43 patients (37 men, six women; mean age 59 years) were diagnosed as having gastric adenoma/dysplasia based on their first biopsies. These lesions were followed for a median of 4.7 years (mean 6 years, range 3-18 years) to evaluate the risk of progression to invasive carcinoma. Retrospectively, histological diagnoses of the biopsy and resected specimens were reclassified according to the Vienna classification of gastrointestinal epithelial neoplasia, and macroscopic changes were evaluated. RESULTS: The diagnosis at first biopsy of the 48 lesions was low-grade adenoma/dysplasia (LGD; category 3) in 38 cases and high-grade adenoma/dysplasia (HGD; category 4) in 10 cases. Ninety-seven percent of the LGD (category 3) lesions (37 of 38) showed no histological changes during the follow-up period; the remaining lesion progressed to noninvasive carcinoma (category 4). Macroscopically, 84 % (32 of 38) of the LGD lesions (category 3) showed no remarkable changes in size, while 11 % (four of 38) shrank and 5 % (two of 38) grew larger. Nine of the 10 HGD lesions (category 4) remained histologically unchanged, while the other progressed to intramucosal carcinoma (category 5). Macroscopically, four of the 10 HGD lesions (category 4) (40 %) showed no remarkable changes in size, while the remaining six (60 %) grew larger. CONCLUSIONS: LGD lesions (category 3) have a quite low risk of progressing to HGD or noninvasive carcinoma (category 4), and were never observed to progress to invasive carcinoma (category 5). HGD lesions (category 4) occasionally progressed to intramucosal carcinoma (category 5), with no instance of invasion into the submucosa or beyond.     

Cost-effectiveness of activated protein C in real-life clinical practice

Background

Recombinant human activated protein C (rhAPC) has been reported to be cost-effective in severely ill septic patients in studies using data from a pivotal randomized trial. We evaluated the cost-effectiveness of rhAPC in patients with severe sepsis and multiple organ failure in real-life intensive care practice.

Methods

We conducted a prospective observational study involving adult patients recruited before and after licensure of rhAPC in France. Inclusion criteria were applied according to the label approved in Europe. The expected recruitment bias was controlled by building a sample of patients matched for propensity score. Complete hospitalization costs were quantified using a regression equation involving intensive care units variables. rhAPC acquisition costs were added, assuming that all costs associated with rhAPC were already included in the equation. Cost comparisons were conducted using the nonparametric bootstrap method. Cost-effectiveness quadrants and acceptability curves were used to assess uncertainty of the cost-effectiveness ratio.

Results

In the initial cohort (n = 1096), post-license patients were younger, had less co-morbid conditions and had failure of more organs than did pre-license patients (for all: P < 0.0001). In the matched sample (n = 840) the mean age was 62.4 ± 14.9 years, Simplified Acute Physiology Score II was 56.7 ± 18.5, and the number of organ failures was 3.20 ± 0.83. When rhAPC was used, 28-day mortality tended to be reduced (34.1% post-license versus 37.4% pre-license, P = 0.34), bleeding events were more frequent (21.7% versus 13.6%, P = 0.002) and hospital costs were higher (€47,870 versus €36,717, P < 0.05). The incremental cost-effectiveness ratios gained were as follows: €20,278 per life-year gained and €33,797 per quality-adjusted life-year gained. There was a 74.5% probability that rhAPC would be cost-effective if there were willingness to pay €50,000 per life-year gained. The probability was 64.3% if there were willingness to pay €50,000 per quality-adjusted life-year gained.

Conclusion

This study, conducted in matched patient populations, demonstrated that in real-life clinical practice the probability that rhAPC will be cost-effective if one is willing to pay €50,000 per life-year gained is 74.5%.     

Cost-Effectiveness of a Cardiac Rehabilitation Program Specifically Designed for Patients With Obesity Within the OPTICARE XL Randomized Controlled Trial

ObjectiveTo assess the cost-effectiveness of a cardiac rehabilitation (CR) program specifically designed for cardiac patients with obesity vs standard CR.DesignCost-effectiveness analysis based on observations in a randomized controlled trial.SettingThree regional CR centers in the Netherlands.ParticipantsCardiac patients (N=201) with obesity (BMI≥30 kg/m²) referred to CR.InterventionsParticipants were randomized to a CR program specifically designed for patients with obesity (OPTICARE XL; N=102) or standard CR. OPTICARE XL included aerobic and strength exercise and behavioral coaching on diet and physical activity during 12 weeks, followed by a 9-month after-care program with “booster” educational sessions. Standard CR consisted of a 6- to 12-week aerobic exercise program, supplemented with cardiovascular lifestyle education.Main Outcome MeasuresAn economic evaluation, with an 18-month time horizon, in terms of quality-adjusted life years (QALYs) and costs from the societal perspective was performed. Costs were reported in 2020 Euros, discounted at a 4% annual rate, and health effects were discounted at a 1.5% annual rate.ResultsOPTICARE XL CR and standard CR resulted in comparable health gain per patient (0.958 vs 0.965 QALYs, respectively; P=.96). Overall, OPTICARE XL CR saved costs (-€4542) compared with the standard CR group. The direct costs for OPTICARE XL CR were higher than for standard CR (€10,712 vs €9951), whereas indirect costs were lower (€51,789 vs €57,092), but these differences were not significant.ConclusionsThis economic evaluation showed no differences between OPTICARE XL CR and standard CR in health effects and costs in cardiac patients with obesity.     

Cytology in Barrett's esophagus

Brush cytology is complementary to endoscopic biopsy and is recommended by some to be part of the routine endoscopic surveillance of patients with BE. Advantages of cytology include the ability to sample a greater area of involved epithelium, preferential exfoliation of the less cohesive dysplastic cells, simplicity, and lower cost. There are clear cytologic criteria for dysplasia, and biomarker studies can be performed on cytologic specimens. Despite these advantages, cytology is used by only 17% of gastroenterologists in the United States today. Limited data are available on the usefulness of cytology in the diagnosis and surveillance of BE. Cytology has good sensitivity for the detection of adenocarcinoma and HGD and good specificity for the detection of IM without dysplasia. Furthermore, cytology may detect abnormalities missed by biopsy. Cytology has problems in the detection of LGD, however. For cytology to become a useful surveillance option, its sensitivity for low-grade lesions must be improved. One potential way to accomplish this is to add biomarkers to routine cytologic specimens to define patients at increased risk of progression to cancer. If simple prognostic biomarkers could be developed and validated in histology and cytologic specimens, this would provide additional support for the utility of cytologic brushings in the surveillance of BE. Cytology could then conceivably accomplish the goals of improved efficiency, risk stratification, and decreased costs in BE surveillance programs.     

Cost–benefit Analysis in Health Care: The Case of Bariatric Surgery Compared With Diet

PurposeThe aim of the present study was to assess, by using a cost–benefit analysis, the net monetary benefit (NMB) of bariatric surgery compared with diet (including physical exercise) for obese patients, from both an Italian payer perspective and the broader societal perspective.MethodsThe study considered the following groups of patients: (1) patients with a body mass index (BMI) ≥40 kg/m² without complications + patients with BMI ≥35 kg/m² with complications; (2) patients with BMI ≥35 kg/m² and diabetes; and (3) patients with BMI ranging from 30 to 35 kg/m² and diabetes. A Markov model was developed to project the lifetime health outcomes (life years and quality-adjusted life years [QALYs]) and costs associated with bariatric surgery and diet for the considered groups of patients. The clinical effectiveness of each strategy was based on the likelihood of experiencing cardiovascular events or events related to the presence of diabetes. Data on clinical effectiveness, quality of life, productivity losses, and out-of-pocket costs were mainly derived from the literature; direct costs were obtained from official tariffs or the literature. Different scenarios were considered for the analyses in addition to the base case. According to both perspectives considered, the NMB was calculated by first assuming a willingness-to-pay threshold (30,000€ per QALY), then converting health benefits (QALYs) into the common monetary metric (ie, the euro). NMB was calculated as follows: (incremental benefit × willingness-to-pay – incremental cost).FindingsFor all the scenarios and groups of patients considered, the NMB of bariatric surgery versus diet, on a lifetime horizon, from the payer perspective was positive and ranged from 54,647€ to 122,960€; it varied between 141,192€ and 380,286€ from the societal perspective. In the former case, the NMB turns positive after 3–4 years, indicating that bariatric surgery may be a worthy investment also in the short run for the National Health Service; in the latter case, for a time horizon longer than 2–3 years, the surgical option begins to show advantages for the whole society.ImplicationsDespite its defined cost-effectiveness, bariatric surgery is under-diffused because the initial investment for the technology is often considered a barrier. The cost–benefit analysis showed that bariatric surgery, compared with diet, may be a worthwhile technology for obese patients in Italy from both a payer perspective and the broader societal perspective.     

Cost-effectiveness analysis of fidaxomicin for the treatment of Clostridioides (Clostridium) difficile infection in Japan

BackgroundThe cost of treating Clostridioides difficile infection (CDI), particularly recurrent disease, is high. In clinical trials, fidaxomicin has been associated with significantly lower recurrence rates and higher sustained cure rates versus vancomycin. The high acquisition cost of fidaxomicin has limited its acceptance into clinical practice.ObjectiveTo evaluate the cost-effectiveness of fidaxomicin versus vancomycin in patients with CDI after failure of metronidazole in the Japanese healthcare setting.MethodsClinical results from three phase III trials and inputs based on assumptions validated by clinical experts in Japan were used in a semi-Markov model with 1-year time horizon. Incremental cost-effectiveness ratios (ICERs) for fidaxomicin versus vancomycin were expressed as cost per quality-adjusted life year (QALY) and interpreted using willingness-to-pay thresholds of JPY 5,000,000 (primary) and JPY 7,500,000 (secondary) per QALY gained in Japan. Probabilistic sensitivity analyses and scenario analyses were performed.ResultsHigher drug acquisition costs for fidaxomicin were partially offset by lower hospitalization costs driven by fewer recurrences, lower costs of complications, and fewer general practitioner visits versus vancomycin. The ICER for fidaxomicin versus vancomycin was estimated at JPY 5,715,183 per QALY gained. Sensitivity analyses showed a 46% probability of fidaxomicin being cost-effective versus vancomycin at a willingness-to-pay threshold of JPY 5,000,000 per QALY gained. At a threshold of JPY 7,500,000, there was a 54% probability of fidaxomicin being cost-effective.ConclusionsFidaxomicin treatment in patients with CDI following failure of metronidazole improves health outcomes with partial offset of higher drug acquisition costs versus vancomycin.     

A Trial-Based Economic Evaluation Comparing Spinal Cord Stimulation With Best Medical Treatment in Painful Diabetic Peripheral Neuropathy

The objective was to perform an economic evaluation comparing spinal cord stimulation (SCS) in combination with best medical treatment (BMT) with BMT in painful diabetic peripheral neuropathy patients. Alongside a prospective 2-center randomized controlled trial, involving 36 painful diabetic peripheral neuropathy patients with severe lower limb pain not responding to conventional therapy, an economic evaluation was performed. Incremental cost-effectiveness ratios were based on: 1) societal costs and quality-adjusted life years (QALYs), and 2) direct health care costs and the number of successfully treated patients, respectively, both with a time horizon of 12 months. Bootstrap and secondary analyses were performed to address uncertainty. Total societal cost amounted to €26,539.18 versus €5,313.45 per patient in the SCS and BMT group, respectively. QALYs were .58 versus .36 and the number of successfully treated patients was 55% versus 7% for the SCS and BMT group, respectively. This resulted in incremental cost-effectiveness ratios of €94,159.56 per QALY and €34,518.85 per successfully treated patient, respectively. Bootstrap analyses showed that the probability of SCS being cost-effective ranges from 0 to 46% with willingness to pay threshold values ranging between €20,000 and €80,000 for a QALY. Secondary analyses showed that cost-effectiveness of SCS became more favorable after correcting for baseline cost imbalance between the 2 groups, extending the depreciation period of SCS material to 4 years, and extrapolation of the data up to 4 years. Although SCS was considerably more effective compared with BMT, the substantial initial investment that is required resulted in SCS not being cost-effective in the short term. Cost-effectiveness results were sensitive to baseline cost imbalances between the groups and the depreciation period of the SCS material.

Cost-Utility Analysis of Transarterial Radioembolization With Yttrium-90 Resin Microspheres Compared With Sorafenib in Locally Advanced and Inoperable Hepatocellular Carcinoma

PurposeThe SARAH (Sorafenib Versus Radioembolization in Advanced Hepatocellular Carcinoma) trial (ClinicalTrials.gov Identifier NCT01482442) did not show a significant survival benefit for patients treated with transarterial radioembolization (TARE) compared with continuous oral sorafenib. The improved toxicity profile of patients treated with TARE in the trial, however, could result in a quality of life benefit in economic evaluations. Our objective was to perform a cost-utility analysis of TARE versus sorafenib for locally advanced and inoperable hepatocellular carcinoma.MethodsThis study used patient-level data of the SARAH trial regarding resource use, progression-free and overall survival, and quality of life for the within-trial period for the patients who received at least 1 dose of sorafenib or 1 treatment with TARE according to their randomization arm. Data were extrapolated by using a partitioned survival model that incorporated costs and health outcomes, measured in life-years and quality-adjusted life-years (QALYs).FindingsThe use of TARE resulted in an average loss of 0.036 life-year and a gain of 0.006 QALY compared with sorafenib. The aerage cost for the TARE arm was €17,179 (95% CI, 9,926–24,280) higher than the sorafenib arm, for an incremental cost-effectiveness ratio of €3,153,086/QALY. The probabilistic sensitivity analysis revealed a 50% risk that the TARE strategy was dominated. TARE was consistently dominated by sorafenib or had an incremental cost-effectiveness ratio more than €450,000/QALY in all sensitivity analyses.ImplicationsThis economic evaluation of SARAH found that using radioembolization with yttrium-90 microspheres for the treatment of hepatocellular carcinoma was not a cost-effective option at the usually accepted willingness-to-pay thresholds.     

Cost-effectiveness of 7-day-Holter monitoring alone or in combination with transthoracic echocardiography in patients with cerebral ischemia

Background and purpose

Prolonged Holter monitoring of patients with cerebral ischemia increases the detection rate of paroxysmal atrial fibrillation (PAF); this leads to improved antithrombotic regimens aimed at preventing recurrent ischemic strokes. The aim of this study was to compare a 7-day-Holter monitoring (7-d-Holter) alone or in combination with prior selection via transthoracic echocardiography (TTE) to a standard 24-h-Holter using a cost-utility analysis.

Methods

Lifetime cost, quality-adjusted life years (QALY), and incremental cost-effectiveness ratios (ICER) were estimated for a cohort of patients with acute cerebral ischemia and no contraindication to oral anticoagulation. A Markov model was developed to simulate the long-term course and progression of cerebral ischemia considering the different diagnostic algorithms (24-h-Holter, 7-d-Holter, 7-d-Holter after preselection by TTE). Clinical data for these algorithms were derived from the prospective observational Find-AF study (ISRCTN 46104198).

Results

Predicted lifelong discounted costs were 33,837 € for patients diagnosed by the 7-d-Holter and 33,852 € by the standard 24-h-Holter. Cumulated QALYs were 3.868 for the 7-d-Holter compared to 3.844 for the 24-h-Holter. The 7-d-Holter dominated the 24-h-Holter in the base-case scenario and remained cost-effective in extensive sensitivity analysis of key input parameter with a maximum of 8,354 €/QALY gained. Preselecting patients for the 7-d-Holter had no positive effect on the cost-effectiveness.

Conclusions

A 7-d-Holter to detect PAF in patients with cerebral ischemia is cost-effective. It increases the detection which leads to improved antithrombotic regimens; therefore, it avoids recurrent strokes, saves future costs, and decreases quality of life impairment. Preselecting patients by TTE does not improve cost-effectiveness.     

No evidence for stratified exercise therapy being cost-effective compared to usual exercise therapy in patients with knee osteoarthritis: Economic evaluation alongside cluster randomized controlled trial

BackgroundA stratified approach to exercise therapy may yield superior clinical and economic outcomes, given the large heterogeneity of individuals with knee osteoarthritis (OA).ObjectiveTo evaluate the cost-effectiveness during a 12-month follow-up of a model of stratified exercise therapy compared to usual exercise therapy in patients with knee OA, from a societal and healthcare perspective.MethodsAn economic evaluation was conducted alongside a cluster-randomized controlled trial in patients with knee OA (n = 335), comparing subgroup-specific exercise therapy for a ‘high muscle strength subgroup’, ‘low muscle strength subgroup’, and ‘obesity subgroup’ supplemented by a dietary intervention for the ‘obesity subgroup’ (experimental group), with usual (‘non-stratified’) exercise therapy (control group). Clinical outcomes included quality-adjusted life years – QALYs (EuroQol-5D-5 L), knee pain (Numerical Rating Scale) and physical functioning (Knee Injury and Osteoarthritis Outcome Score in daily living). Costs were measured by self-reported questionnaires at 3, 6, 9 and 12-month follow-up. Missing data were imputed using multiple imputation. Data were analyzed through linear regression. Bootstrapping techniques were applied to estimate statistical uncertainty.ResultsDuring 12-month follow-up, there were no significant between-group differences in clinical outcomes. The total societal costs of the experimental group were on average lower compared to the control group (mean [95% confidence interval]: € 405 [-1728, 918]), albeit with a high level of uncertainty. We found a negligible difference in QALYs between groups (mean [95% confidence interval]: 0.006 [-0.011, 0.023]). The probability of stratified exercise therapy being cost-effective compared to usual exercise therapy from the societal perspective was around 73%, regardless of the willingness-to-pay threshold. However, this probability decreased substantially to 50% (willingness-to-pay threshold of €20.000/QALY) when using the healthcare perspective. Similar results were found for knee pain and physical functioning.ConclusionsWe found no clear evidence that stratified exercise therapy is likely to be cost-effective compared to usual exercise therapy in patients with knee OA. However, results should be interpreted with caution as the study power was lower than intended, due to the Coronavirus disease (COVID-19) pandemic.     

Ruling out IBD: estimation of the possible economic effects of pre-endoscopic screening with F-calprotectin

ObjectivesTo estimate the possible economic effects of a sequential testing strategy with F-calprotectin to minimize colonoscopies.Design and methodsRetrospective study in a third party payer perspective. The costs were calculated from initial F-calprotectin test results of 3639 patients. Two cut-off levels were used: 50 μg/g feces and 100 μg/g feces, respectively. The cost-effectiveness of the testing strategy was estimated through the short-term cost avoidance and reduction in demand for colonoscopies.ResultsThe estimated demand for colonoscopies was reduced by 50% with the 50 μg/g cut-off and 67% with the 100 μg/g cut-off. This corresponded to a cost avoidance of approximately €1.57 million and €2.13 million, respectively.ConclusionsThe use of F-calprotectin as a screening test substantially could reduce the number of invasive measurements necessary in the diagnostic work-up of patients with suspected IBD, as well as the associated costs.     

Follow-up for high-grade dysplasia in Barrett's esophagus

This article will focus on the value of endoscopic follow-up for patients with high-grade dysplasia (HGD). Because the diagnosis of HGD in Barrett's esophagus is not a simple straightforward task, the article first will discuss the controversies regarding the histological diagnosis, followed by a discussion of the importance of endoscopic imaging for making the clinical diagnosis of HGD, and a systematic review of the literature relating to the presence of synchronous cancers in patients with HGD and the occurrence of cancer during endoscopic follow-up in these patients (metachronous cancers). Furthermore, the article will also discuss endoscopic techniques currently available for surveillance of these patients and make recommendations regarding surveillance intervals and the optimal biopsy protocol.     

结直肠息肉样病变内镜活检和内镜切除术后病理差异分析*

目的探讨结直肠息肉样病变的内镜活检病理与内镜切除术后病理的差异,分析其相关危险因素以及内镜活检的局限性。方法回顾性分析结直肠息肉样病变52例,内镜活检病理包括增生性息肉、炎性息肉以及腺瘤伴低级别上皮内瘤变(LGIN)或高级别上皮内瘤变(HGIN)。所有患者根据内镜下分型及大小选择不同的内镜下切除方式:圈套器高频电切除术、内镜下黏膜切除术(EMR)以及内镜黏膜下剥离术(ESD)。统计患者的临床资料、镜下特点、活检病理及内镜切除术后的病理差异,分析病理结果发生显著差异的危险因素。结果52例患者中,24例的活检病理与内镜切除病理存在差异,总体差异率为46.2%。其中增生性息肉、炎性息肉、LGIN以及HGIN活检与内镜切除病理的差异率分别为20.0%、42.9%、44.4%及54.5%。直径大于2.0 cm和病变表面充血是影响病理学差异的关键因素(P<0.05)。结论内镜活检对于结直肠息肉样病变性质的判断有一定的局限性,应警惕其对结直肠癌前病变及癌变的延迟诊治以及漏诊。