MRI and 18F-FET PET for Multimodal Treatment Monitoring in Patients with Brain Metastases: A Cost-Effectiveness Analysis.

PET using the radiolabeled amino acid O-(2-[18F]fluoroethyl)-l-tyrosine (18F-FET) has been shown to be of value for treatment monitoring in patients with brain metastases after multimodal therapy, especially in clinical situations with equivocal MRI findings. As medical procedures must be justified socioeconomically, we determined the effectiveness and cost-effectiveness of 18F-FET PET for treatment monitoring of multimodal therapy, including checkpoint inhibitors, targeted therapies, radiotherapy, and combinations thereof in patients with brain metastases secondary to melanoma or non-small cell lung cancer. Methods: We analyzed already-published clinical data and calculated the associated costs from the German statutory health insurance system perspective. Two clinical scenarios were considered: decision tree model 1 determined the effectiveness of 18F-FET PET alone for identifying treatment-related changes, that is, the probability of correctly identifying patients with treatment-related changes confirmed by neuropathology or clinicoradiographically using the Response Assessment in Neuro-Oncology criteria for immunotherapy. The resulting cost-effectiveness ratio showed the cost for each correctly identified patient with treatment-related changes in whom MRI findings remained inconclusive. Decision tree model 2 calculated the effectiveness of both 18F-FET PET and MRI, that is, the probability of correctly identifying nonresponders to treatment. The incremental cost-effectiveness ratio was calculated to determine cost-effectiveness, that is, the cost for each additionally identified nonresponder by 18F-FET PET who would have remained undetected by MRI. One-way deterministic and probabilistic sensitivity analyses tested the robustness of the results. Results: 18F-FET PET identified 94% of patients with treatment-related changes, resulting in €1,664.23 (€1.00 = $1.08 at time of writing) for each correctly identified patient. Nonresponders were correctly identified in 60% by MRI and in 80% by 18F-FET PET, resulting in €3,292.67 and €3,915.83 for each correctly identified nonresponder by MRI and 18F-FET PET, respectively. The cost to correctly identify 1 additional nonresponder by 18F-FET PET, who would have remained unidentified by MRI, was €5,785.30. Conclusion: Given the considerable annual cost of multimodal therapy, the integration of 18F-FET PET can potentially improve patient care while reducing costs.

The optimal timing of FDG-PET/CT in non-small cell lung cancer diagnosis and staging in an Australian centre.

BACKGROUND: Clinical practice guidelines and re-imbursement schedules vary in the recommended timing of FDG-PET/CT in the diagnostic evaluation of suspected or confirmed lung cancer. The aim was to estimate the probability of requiring more than one invasive test to complete diagnosis and staging in non-small cell lung cancer if FDG-PET/CT was used prior to initial biopsy (FDG-PET/CT First) compared to current Australian funding criteria (CT First). METHODS: Single-centre retrospective study of individuals with pathologically confirmed NSCLC without evidence of metastatic disease on baseline computed tomography (CT) of the chest. Decision tree analysis based on diagnosis and staging approaches estimated the probability of requiring more than one invasive biopsy. A Monte Carlo analysis with 1000 simulations was used to estimate decision tree precision. RESULTS: After exclusions, 115 patients were included with median (IQR) age of 71 (63-79) and 55.6% were male. The majority of cases were early stage (Stage I 43.5%, Stage II 19.1%) and adenocarcinoma (65.2%) histological subtype. The estimated probability of requiring more than one invasive biopsy with FDG-PET/CT prior was 0.12 compared to 0.19 when using the base case CT First scenario. Using the Monte Carlo analysis, the mean (95% CI) probability using the FDG-PET First approach was 0.15 (95%CI 0.12-0.20) versus 0.20 (95% CI 0.15-0.27) for the CT First approach. Only 7.8% had CT Chest-occult metastatic disease on FDG-PET that was accessible by percutaneous biopsy. CONCLUSION: FDG-PET/CT performed prior to initial biopsy may reduce the proportion of people with NSCLC who require more than one biopsy attempt, but the clinical significance and overall cost-utility requires evaluation.

Cost-effectiveness of surveillance with CT colonography after resection of colorectal cancer.

OBJECTIVE: Surveillance following colorectal cancer (CRC) resection uses optical colonoscopy (OC) to detect intraluminal disease and CT to detect extracolonic recurrence. CT colonography (CTC) might be an efficient use of resources in this situation because it allows for intraluminal and extraluminal evaluations with one test. DESIGN: We developed a simulation model to compare lifetime costs and benefits for a cohort of patients with resected CRC. Standard of care involved annual CT for 3 years and OC for years 1, 4 and every 5 years thereafter. For the CTC-based strategy, we replace CT+OC at year 1 with CTC. Patients with lesions greater than 6 mm detected by CTC underwent OC. Detection of an adenoma 10 mm or larger was followed by OC at 1 year, then every 3 years thereafter. Test characteristics and costs for CTC were derived from a clinical study. Medicare costs were used for cancer care costs as well as alternative test costs. We discounted costs and effects at 3% per year. RESULTS: For persons with resected stage III CRC, the standard-of-care strategy was more costly (US$293) and effective (2.6 averted CRC cases and 1.1 averted cancer deaths per 1000) than the CTC-based strategy, with an incremental cost-effectiveness ratio of US$55 500 per quality-adjusted life-year gained. Our analysis was most sensitive to the sensitivity of CTC for detecting polyps 10 mm or larger and assumptions about disease progression. CONCLUSION: In a simulation model, we found that replacing the standard-of-care approach to postdiagnostic surveillance with a CTC-based strategy is not an efficient use of resources in most situations.

Exploratory cost-effectiveness analysis of 68Gallium-PSMA PET/MRI-based imaging in patients with biochemical recurrence of prostate cancer.

Men treated for prostate cancer with curative intent face a recurrence rate of up to 53% at 10 years. 68Ga-PSMA imaging is a new technique that can more accurately stage cancer recurrences and facilitate personalised treatment. We evaluated the cost-effectiveness of 68Ga-PSMA PET/MRI for staging men with prostate cancer biochemical recurrence. A cost-effectiveness analysis using a decision-analytic model with Markov chains was constructed. 68Ga-PSMA PET/MRI was compared with usual care in staging of men with suspected prostate cancer recurrence. Men with biochemical recurrence from a study in Brisbane, Australia (n = 30) provided key estimates for the model. The primary outcomes were health system costs and years of life (survival) over 10 years. Deterministic and probabilistic sensitivity analyses were undertaken to address uncertainty in model estimates. On average, a strategy of 68Ga-PSMA was expected to cost AU$56 961(US$39 426) and produce 7.48 life years compared with AU$64 499 (US$44 667) and 7.41 life years in usual care. Therefore, 68Ga-PSMA was potentially cost saving (- AU$7 592 95% UI - $24 846, $7 825) (- US$5 258) and slightly more effective 0.07 life years (95% UI - 0.01, 0.16). The likelihood that 68Ga-PSMA strategy was cost-effective at acceptable thresholds was 87%. The findings were sensitive to the lesion detection rate of the 68Ga-PSMA strategy (52-75%) and the cost of follow up in usual care (AU$1 947 to $2 635). In this exploratory economic evaluation, using 68Ga-PSMA PET/MRI to detect prostate cancer recurrence appears to be cost-effective relative to usual care.

Prostate Cancer Detection Rate of Freehand versus 3-Dimensional Template Mapping Biopsy Using a Magnetic Resonance Imaging-Ultrasound Fusion Device in Biopsy Naïve Men.

PURPOSE: Targeted prostate biopsy devices include a 3-dimensional digital template grid to guide systematic biopsy locations. Following a template could better ensure uniform and well distributed sampling of the prostate compared to the traditional freehand biopsy approach, possibly decreasing the chance of false-negative biopsy. Thus, we determined cancer detection rates obtained by conventional freehand systematic sampling vs template mapping sampling using a magnetic resonance imaging-ultrasound fusion device. MATERIALS AND METHODS: Men who underwent first line conventional or image guided prostate biopsy were identified retrospectively in an institutional review board approved protocol. Excluded from study were men with prior biopsy or treatment or fewer than 10 cores taken. Targeted cores obtained by image guided biopsy were censored from analysis to simulate systematic template biopsy. The resulting cancer detection rate was compared to that of conventional biopsy. RESULTS: We identified 1,582 patients between 2006 and 2014 who met the criteria for analysis, including 1,052 who underwent conventional biopsy and 530 who underwent template biopsy with a magnetic resonance imaging-ultrasound fusion device. Patient age, prostate specific antigen and the number of systematic cores were the same in the 2 groups. Template biopsy detected any prostate cancer in 257 of 530 men (48.5%) and clinically significant cancer in 196 (37.0%) while conventional biopsy detected any cancer in 432 of 1,052 (41.0%) (p=0.005) and clinically significant cancer in 308 (29.2%) (p=0.002). CONCLUSIONS: Template mapping systematic biopsy detected more prostate cancer than conventional sampling in biopsy naïve men. It is a promising cost-effective alternative to magnetic resonance imaging-ultrasound fusion biopsy as an upfront screening tool.

18F-Choline PET/mpMRI for Detection of Clinically Significant Prostate Cancer: Part 2. Cost-Effectiveness Analysis.

The objective of this study was to evaluate the cost-effectiveness of 18F-choline PET/multiparametric MRI (mpMRI) versus mpMRI alone for the detection of primary prostate cancer with a Gleason score of greater than or equal to 3 + 4 in men with elevated prostate-specific antigen levels. Methods: A Markov model of prostate cancer onset and progression was used to estimate the health and economic consequences of 18F-choline PET/mpMRI for the detection of primary prostate cancer with a Gleason score of greater than or equal to 3 + 4 in men with elevated prostate-specific antigen levels. Multiple simultaneous hybrid 18F-choline PET/mpMRI strategies were evaluated using Likert or Prostate Imaging Reporting and Data System version 2 (PI-RADSv2) scoring; the first was biopsy for Likert 5 mpMRI lesions or Likert 3-4 lesions with 18F-choline target-to-background ratios of greater than or equal to 1.58, and the second was biopsy for PI-RADSv2 5 mpMRI lesions or PI-RADSv2 3-4 mpMRI lesions with 18F-choline target-to-background ratios of greater than or equal to 1.58. These strategies were compared with universal standard biopsy, mpMRI alone with biopsy only for PI-RADSv2 3-5 lesions, and mpMRI alone with biopsy only for Likert 4-5 lesions. For each mpMRI strategy, either no biopsy or standard biopsy could be performed after negative mpMRI results were obtained. Deaths averted, quality-adjusted life years (QALYs), cost, and incremental cost-effectiveness ratios were estimated for each strategy. Results: When the results of 18F-choline PET/mpMRI were negative, performing a standard biopsy was more expensive and had lower QALYs than performing no biopsy. The best screening strategy among those considered in this study performed hybrid 18F-choline PET/mpMRI with Likert scoring on men with elevated PSA, performed combined biopsy (targeted biopsy and standard 12-core biopsy) for men with positive imaging results, and no biopsy for men with negative imaging results ($22,706/QALY gained relative to mpMRI alone); this strategy reduced the number of biopsies by 35% in comparison to mpMRI alone. When the same policies were compared using PI-RADSv2 instead of Likert scoring, hybrid 18F-choline PET/mpMRI cost $46,867/QALY gained relative to mpMRI alone. In a threshold analysis, the best strategy among those considered remained cost-effective when the sensitivity and specificity of PET/mpMRI and combined biopsy (targeted biopsy and standard 12-core biopsy) were simultaneously reduced by 20 percentage points. Conclusion:18F-choline PET/mpMRI for the detection of primary prostate cancer with a Gleason score of greater than or equal to 3 + 4 is cost-effective and can reduce the number of unneeded biopsies in comparison to mpMRI alone.

Effectiveness of Multimodal imaging for the Evaluation of Retinal oedema And new vesseLs in Diabetic retinopathy (EMERALD).

INTRODUCTION: Diabetic macular oedema (DMO) and proliferative diabetic retinopathy (PDR) are the major causes of sight loss in people with diabetes. Due to the increased prevalence of diabetes, the workload related to these complications is increasing making it difficult for Hospital Eye Services (HSE) to meet demands. METHODS AND ANALYSIS: Effectiveness of Multimodal imaging for the Evaluation of Retinal oedema And new vesseLs in Diabetic retinopathy (EMERALD) is a prospective, case-referent, cross-sectional diagnostic study. It aims at determining the diagnostic performance, cost-effectiveness and acceptability of a new form of surveillance for people with stable DMO and/or PDR, which entails multimodal imaging and image review by an ophthalmic grader, using the current standard of care (evaluation of patients in clinic by an ophthalmologist) as the reference standard. If safe, cost-effective and acceptable, this pathway could help HES by freeing ophthalmologist time. The primary outcome of EMERALD is sensitivity of the new surveillance pathway in detecting active DMO/PDR. Secondary outcomes include specificity, agreement between new and the standard care pathway, positive and negative likelihood ratios, cost-effectiveness, acceptability, proportion of patients requiring subsequent full clinical assessment, unable to undergo imaging, with inadequate quality images or indeterminate findings. ETHICS AND DISSEMINATION: Ethical approval was obtained for this study from the Office for Research Ethics Committees Northern Ireland (reference 17/NI/0124). Study results will be published as a Health Technology Assessment monograph, in peer-reviewed national and international journals and presented at national/international conferences and to patient groups. TRIAL REGISTRATION NUMBER: NCT03490318 and ISRCTN:10856638.

PET-Based Imaging of Ischemic Heart Disease.

PET-based cardiac nuclear imaging plays a large role in the management of ischemic heart disease. Compared with conventional single-photon emission CT myocardial perfusion imaging, PET provides superior accuracy in diagnosis of coronary artery disease and, with the incorporation of myocardial blood flow and coronary flow reserve, adds value in assessing prognosis for established coronary and microvascular disease. This review describes these and other uses of PET in ischemic heart disease, including assessing myocardial viability in ischemic cardiomyopathy. Developments in novel PET flow tracers and molecular imaging tools to assess atherosclerotic plaque vulnerability, vascular calcification, and vascular remodeling also are described.

State-of-the-art imaging techniques in the management of preoperative staging and re-staging of prostate cancer.

We aimed to review the current state-of-the-art imaging methods used for primary and secondary staging of prostate cancer, mainly focusing on multiparametric magnetic resonance imaging and positron-emission tomography/computed tomography with new radiotracers. An expert panel of urologists, radiologists and nuclear medicine physicians with wide experience in prostate cancer led a PubMed/MEDLINE search for prospective, retrospective original research, systematic review, meta-analyses and clinical guidelines for local and systemic staging of the primary tumor and recurrence disease after treatment. Despite magnetic resonance imaging having low sensitivity for microscopic extracapsular extension, it is now a mainstay of prostate cancer diagnosis and local staging, and is becoming a crucial tool in treatment planning. Cross-sectional imaging for nodal staging, such as computed tomography and magnetic resonance imaging, is clinically useless even in high-risk patients, but is still suggested by current clinical guidelines. Positron-emission tomography/computed tomography with newer tracers has some advantage over conventional images, but is not cost-effective. Bone scan and computed tomography are often useless in early biochemical relapse, when salvage treatments are potentially curative. New imaging modalities, such as prostate-specific membrane antigen positron-emission tomography/computed tomography and whole-body magnetic resonance imaging, are showing promising results for early local and systemic detection. Newer imaging techniques, such as multiparametric magnetic resonance imaging, whole-body magnetic resonance imaging and positron-emission tomography/computed tomography with prostate-specific membrane antigen, have the potential to fill the historical limitations of conventional imaging methods in some clinical situations of primary and secondary staging of prostate cancer.

Enhancing Value of MRI: A Call for Action.

As national healthcare spending has spiraled out of control, payment reform that moves from volume to value-based payment has been introduced as a practical solution. Under alternative value-based payment models, physicians and clinical teams must deliver the best care possible at a lower cost. Medical imaging has changed the way we diagnose disease, evaluate severity, assess treatment effects, and provide biological insights for the pathophysiology of many diseases. Over the past 50 years, imaging techniques have become increasingly advanced-from X-ray to computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and multi-modal imaging. Advanced imaging such as MRI has given clinicians remarkable insights into medical conditions and saved innumerable lives. Under the value proposition, however, we must ask if each imaging study changes treatment decisions, improves patient outcomes, and is cost-effective. Imaging research has been focused on developing new technologies and clinical applications to assess diagnostic accuracy. What is needed is the higher-level technology assessment. In this article we review why we need to demonstrate the value of MRI, how we define value, what strategies can enhance MR value through partnership with various stakeholders, and how imaging scientists can contribute to healthcare delivery in the future. Level of Evidence: 5 Technical Efficacy: Stage 3 J. Magn. Reson. Imaging 2019;49:e40-e48.

A low-cost multimodal head-mounted display system for neuroendoscopic surgery.

Background: With rapid advances in technology, wearable devices as head-mounted display (HMD) have been adopted for various uses in medical science, ranging from simply aiding in fitness to assisting surgery. We aimed to investigate the feasibility and practicability of a low-cost multimodal HMD system in neuroendoscopic surgery. Methods: A multimodal HMD system, mainly consisted of a HMD with two built-in displays, an action camera, and a laptop computer displaying reconstructed medical images, was developed to assist neuroendoscopic surgery. With this intensively integrated system, the neurosurgeon could freely switch between endoscopic image, three-dimensional (3D) reconstructed virtual endoscopy images, and surrounding environment images. Using a leap motion controller, the neurosurgeon could adjust or rotate the 3D virtual endoscopic images at a distance to better understand the positional relation between lesions and normal tissues at will. Results: A total of 21 consecutive patients with ventricular system diseases underwent neuroendoscopic surgery with the aid of this system. All operations were accomplished successfully, and no system-related complications occurred. The HMD was comfortable to wear and easy to operate. Screen resolution of the HMD was high enough for the neurosurgeon to operate carefully. With the system, the neurosurgeon might get a better comprehension on lesions by freely switching among images of different modalities. The system had a steep learning curve, which meant a quick increment of skill with it. Compared with commercially available surgical assistant instruments, this system was relatively low-cost. Conclusions: The multimodal HMD system is feasible, practical, helpful, and relatively cost efficient in neuroendoscopic surgery.

Additional Clinical Value for PET/MRI in Oncology: Moving Beyond Simple Diagnosis.

Initial clinical research comparing the diagnostic performance of PET/MRI and PET/CT has largely shown equivalent diagnostic capabilities for these modalities in oncology. These uncertainties about the magnitude of diagnostic benefit are compounded by the considerable health economic challenges associated with clinical implementation. Therefore, there is a need to identify ways to extend the use of this technology beyond simple diagnosis so that PET/MRI can add sufficient clinical value beyond PET/CT or MRI alone and become a cost-effective imaging modality in clinical practice. A major advantage of PET/MRI over other imaging modalities is the ability to generate multiple quantitative images from a single examination. This article describes how a multiparametric PET/MRI approach not only can add clinical value through contributing to precision medicine but also can establish PET/MRI as a potentially cost-effective imaging modality in oncology.

Targeted biopsy: benefits and limitations.

PURPOSE OF REVIEW: To review the current literature regarding the role of multiparametric MRI and fusion-guided biopsies in urologic practice. RECENT FINDINGS: Fusion biopsies consistently show an increase in the detection of clinically significant cancers and decrease in low-risk disease that may be more suitable for active surveillance. Although, when to incorporate multiparametric MRI into workup is not clearly agreed upon, studies have shown a clear benefit in both biopsy naïve and those with prior negative biopsies in determining the appropriate treatment strategy. More recently, cost-analysis models have been published that show that upfront MRIs are more cost-effective when considering missed cancers and treatment courses. SUMMARY: With improved accuracy over systematic biopsies, fusion biopsies are a superior method for detection of the true grade of cancer for both biopsy naïve and patients with prior negative biopsies, choosing appropriate candidates for active surveillance, and monitoring progression on active surveillance.

Estimating Cost-effectiveness of a Multimodal Ovarian Cancer Screening Program in the United States: Secondary Analysis of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS).

IMPORTANCE: The United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) is the largest randomized clinical trial to evaluate screening's impact on ovarian cancer mortality, assigning women to multimodal screening (MMS) with serum cancer antigen 125 (CA-125) interpreted using a risk algorithm. If the MMS screening method is eventually shown to reduce mortality and be cost-effective, then it may be accepted by the medical community as a feasible screening tool. OBJECTIVE: To estimate the cost-effectiveness of an MMS screening program in the United States. DESIGN, SETTING, AND PARTICIPANTS: A Markov simulation model was constructed using data from UKCTOCS to compare MMS with no screening in the United States. Screening would begin at the age of 50 years for women in the general population. Published estimates of the long-term effect of MMS screening on ovarian cancer mortality and the trial's published hazard ratios were used to simulate mortality estimates up to 40 years from start of screening. Base-case costs included CA-125, ultrasound, and false-positive work-up results, in addition to a risk algorithm cost estimate of $100. The utility and costs of ovarian cancer treatment were incorporated into the model. INTERVENTIONS: Screening strategies varied by costs of the algorithm and treatment for advanced ovarian cancer, rates of screening compliance, ovarian cancer incidence, and extrapolation of ovarian cancer mortality. MAIN OUTCOMES AND MEASURES: Costs, quality-adjusted life-years (QALYs), and mortality reduction of ovarian cancer screening. RESULTS: Multimodal screening is both more expensive and more effective in reducing ovarian cancer mortality over a lifetime than no screening. After accounting for uncertainty in the underlying parameters, screening women starting at age 50 years with MMS is cost-effective 70% of the time, when decision makers are willing to pay $150 000 per QALY. Screening reduced mortality by 15%, with an incremental cost-effectiveness ratio (ICER) ranging from $106 187 (95% CI, $97 496-$127 793) to $155 256 (95% CI, $150 369-$198 567). CONCLUSIONS AND RELEVANCE: Ovarian cancer screening is potentially cost-effective in the United States depending on final significance of mortality reduction and cost of the CA-125 risk algorithm. These results are limited by uncertainty around the effect of screening on ovarian cancer mortality beyond the 11 years of UKCTOCS.

PET/MRI-knocking on the doors of the rich and famous.

Since 2010 the portfolio of positron emission tomography (PET)-based imaging has been expanded by industry with the introduction of combined whole-body PET/MRI systems with the intent of merging PET-based molecular imaging with the strengths of MRI. PET/MRI has created a lot of hype in the scientific community but comparatively little traction in the clinic. The first years of whole-body PET/MRI were used to address inherent technical challenges; however, it is now time to make use of the full potential of this integrated imaging modality. This opinion piece highlights the continuing challenges for the clinical adoption of PET/MRI and cautions against putting too much emphasis on comparisons with clinical PET/CT. In order for PET/MRI to enter clinical practice, cross-specialty co-operation must be pursued with rigour and use-case scenarios must be propagated, following long-awaited expansion of reimbursement strategies and protocol standardization.

Cost-effectiveness of response evaluation after chemoradiation in patients with advanced oropharyngeal cancer using 18F-FDG-PET-CT and/or diffusion-weighted MRI.

BACKGROUND: Considerable variation exists in diagnostic tests used for local response evaluation after chemoradiation in patients with advanced oropharyngeal cancer. The yield of invasive examination under general anesthesia (EUA) with biopsies in all patients is low and it may induce substantial morbidity. We explored four response evaluation strategies to detect local residual disease in terms of diagnostic accuracy and cost-effectiveness. METHODS: We built a decision-analytic model using trial data of forty-six patients and scientific literature. We estimated for four strategies the proportion of correct diagnoses, costs concerning diagnostic instruments and the proportion of unnecessary EUA indications. Besides a reference strategy, i.e. EUA for all patients, we considered three imaging strategies consisting of 18FDG-PET-CT, diffusion-weighted MRI (DW-MRI), or both 18FDG-PET-CT and DW-MRI followed by EUA after a positive test. The impact of uncertainty was assessed in sensitivity analyses. RESULTS: The EUA strategy led to 96% correct diagnoses. Expected costs were €468 per patient whereas 89% of EUA indications were unnecessary. The DW-MRI strategy was the least costly strategy, but also led to the lowest proportion of correct diagnoses, i.e. 93%. The PET-CT strategy and combined imaging strategy were dominated by the EUA strategy due to respectively a smaller or equal proportion of correct diagnoses, at higher costs. However, the combination of PET-CT and DW-MRI had the highest sensitivity. All imaging strategies considerably reduced (unnecessary) EUA indications and its associated burden compared to the EUA strategy. CONCLUSIONS: Because the combined PET-CT and DW-MRI strategy costs only an additional €927 per patient, it is preferred over immediate EUA since it reaches the same diagnostic accuracy in detecting local residual disease while leading to substantially less unnecessary EUA indications. However, if healthcare resources are limited, DW-MRI is the strategy of choice because of lower costs while still providing a large reduction in unnecessary EUA indications.

Imaging tests in staging and surveillance of non-metastatic breast cancer: changes in routine clinical practice and cost implications.

BACKGROUND: Although guidelines do not recommend computerised tomography (CT), positron emission tomography (PET) or magnetic resonance imaging (MRI) for the staging or follow-up of asymptomatic patients with non-metastatic breast cancer, they are often requested in routine clinical practice. The aim of this study was to determine the staging and follow-up patterns, and relative costs in a large population of breast cancer patients living and treated in a Southern Italian region. METHODS: We analysed the clinical computerised information recorded by 567 primary-care physicians assisting about 650 000 inhabitants in the Campania region. Patients with non-metastatic breast cancer were identified and divided into calendar years from 2001 to 2010. The number of diagnostic tests prescribed per 100 patients (N/Pts) and the mean cost per patient was determined 3 months before diagnosis and up to 1 year after diagnosis. Costs are expressed in constant 2011 euros. RESULTS: We identified 4680 newly diagnosed cases of asymptomatic non-metastatic breast cancer. N/Pts increased significantly (P<0.0001) from 2001 to 2010. The mean number of prescribed mammograms, bone scans, abdominal ultrasound and chest X-rays ('routine tests'), and costs was unchanged. However, the number of CT, PET scans and MRI ('new tests')prescriptions almost quadrupled and the mean cost per patient related to these procedures significantly increased from [euro ]357 in 2001 to [euro ]830 in 2010 (P<0.0001). CONCLUSIONS: New test prescriptions and relative costs significantly and steadily increased throughout the study period. At present there is no evidence that the delivery of new tests to asymptomatic patients improves breast cancer outcome. Well-designed clinical trials are urgently needed to shed light on the impact of these tests on clinical outcome and overall survival.

Cost-Effectiveness of Reduced Waiting Time for Head and Neck Cancer Patients due to a Lean Process Redesign.

BACKGROUND: Compared with new technologies, the redesign of care processes is generally considered less attractive to improve patient outcomes. Nevertheless, it might result in better patient outcomes, without further increasing costs. Because early initiation of treatment is of vital importance for patients with head and neck cancer (HNC), these care processes were redesigned. OBJECTIVES: This study aimed to assess patient outcomes and cost-effectiveness of this redesign. METHODS: An economic (Markov) model was constructed to evaluate the biopsy process of suspicious lesion under local instead of general anesthesia, and combining computed tomography and positron emission tomography for diagnostics and radiotherapy planning. Patients treated for HNC were included in the model stratified by disease location (larynx, oropharynx, hypopharynx, and oral cavity) and stage (I-II and III-IV). Probabilistic sensitivity analyses were performed. RESULTS: Waiting time before treatment start reduced from 5 to 22 days for the included patient groups, resulting in 0.13 to 0.66 additional quality-adjusted life-years. The new workflow was cost-effective for all the included patient groups, using a ceiling ratio of €80,000 or €20,000. For patients treated for tumors located at the larynx and oral cavity, the new workflow resulted in additional quality-adjusted life-years, and costs decreased compared with the regular workflow. The health care payer benefited €14.1 million and €91.5 million, respectively, when individual net monetary benefits were extrapolated to an organizational level and a national level. CONCLUSIONS: The redesigned care process reduced the waiting time for the treatment of patients with HNC and proved cost-effective. Because care improved, implementation on a wider scale should be considered.

Cost-effectiveness of para-aortic lymphadenectomy before chemoradiotherapy in locally advanced cervical cancer.

OBJECTIVE: To evaluate the cost-effectiveness of nodal staging surgery before chemoradiotherapy (CRT) for locally advanced cervical cancer in the era of positron emission tomography/computed tomography (PET/CT). METHODS: A modified Markov model was constructed to evaluate the cost-effectiveness of para-aortic staging surgery before definite CRT when no uptake is recorded in the para-aortic lymph nodes (PALN) on PET/CT. Survival and complication rates were estimated based on the published literature. Cost data were obtained from the Korean Health Insurance Review and Assessment Service. Strategies were compared using an incremental cost-effectiveness ratio (ICER). Sensitivity analyses were performed, including estimates for the performance of PET/CT, postoperative complication rate, and varying survival rates according to the radiation field. RESULTS: We compared two strategies: strategy 1, pelvic CRT for all patients; and strategy 2, nodal staging surgery followed by extended-field CRT when PALN metastasis was found and pelvic CRT otherwise. The ICER for strategy 2 compared to strategy 1 was $19,505 per quality-adjusted life year (QALY). Under deterministic sensitivity analyses, the model was relatively sensitive to survival reduction in patients who undergo pelvic CRT alone despite having occult PALN metastasis. A probabilistic sensitivity analysis demonstrated the robustness of the case results, with a 91% probability of cost-effectiveness at the willingness-to-pay thresholds of $60,000/QALY. CONCLUSION: Nodal staging surgery before definite CRT may be cost-effective when PET/CT imaging shows no evidence of PALN metastasis. Prospective trials are warranted to transfer these results to guidelines.