Impact of 18FFDG-PET/CT and Laparoscopy in Staging of Locally Advanced Gastric Cancer: A Cost Analysis in the Prospective Multicenter PLASTIC-Study.

BACKGROUND: Unnecessary D2-gastrectomy and associated costs can be prevented after detecting non-curable gastric cancer, but impact of staging on treatment costs is unclear. This study determined the cost impact of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18FFDG-PET/CT) and staging laparoscopy (SL) in gastric cancer staging. MATERIALS AND METHODS: In this cost analysis, four staging strategies were modeled in a decision tree: (1) 18FFDG-PET/CT first, then SL, (2) SL only, (3) 18FFDG-PET/CT only, and (4) neither SL nor 18FFDG-PET/CT. Costs were assessed on the basis of the prospective PLASTIC-study, which evaluated adding 18FFDG-PET/CT and SL to staging advanced gastric cancer (cT3-4 and/or cN+) in 18 Dutch hospitals. The Dutch Healthcare Authority provided 18FFDG-PET/CT unit costs. SL unit costs were calculated bottom-up. Gastrectomy-associated costs were collected with hospital claim data until 30 days postoperatively. Uncertainty was assessed in a probabilistic sensitivity analysis (1000 iterations). RESULTS: 18FFDG-PET/CT costs were €1104 including biopsy/cytology. Bottom-up calculations totaled €1537 per SL. D2-gastrectomy costs were €19,308. Total costs per patient were €18,137 for strategy 1, €17,079 for strategy 2, and €19,805 for strategy 3. If all patients undergo gastrectomy, total costs were €18,959 per patient (strategy 4). Performing SL only reduced costs by €1880 per patient. Adding 18FFDG-PET/CT to SL increased costs by €1058 per patient; IQR €870-1253 in the sensitivity analysis. CONCLUSIONS: For advanced gastric cancer, performing SL resulted in substantial cost savings by reducing unnecessary gastrectomies. In contrast, routine 18FFDG-PET/CT increased costs without substantially reducing unnecessary gastrectomies, and is not recommended due to limited impact with major costs. TRIAL REGISTRATION: NCT03208621. This trial was registered prospectively on 30-06-2017.

Costs and clinical outcomes of patients with diffuse large B-cell lymphoma in first remission: role of PET/CT surveillance.

BACKGROUND/AIMS: The role of [18F]-f luorodeoxyglucose positron emission tomography-computed tomography (PET/CT) in patients with diffuse large B-cell lymphoma (DLBCL) in first remission is unclear. METHODS: Medical costs within the first 3 years of treatment completion and clinical outcomes of 118 patients with DLBCL in first remission with and without surveillance PET/CT (PET/CT [+] group [n = 76] and PET/CT [-] group [n = 42], respectively) were retrospectively analyzed. RESULTS: In a propensity matched cohort with adjustment for International Prognostic Index risk and relapse, the PET/CT (+) group was shown to have similar medical costs as the PET/CT (-) group. Relapse-free survival (RFS) and overall survival (OS) were comparable between the two groups (median RFS not reached [NR] for both groups, p = 0.133; median OS NR, p = 0.542). Among 76 patients with surveillance PET/CT, 31 (40.8%) had findings suggestive of recurrence and 16 of these (51.6%) were later confirmed to have recurrent disease. Fifteen patients (48.4%) were confirmed to not have recurrence after follow-up CT or PET/CT evaluation (n = 10) and biopsy (n = 4). None of the patients with negative PET/CT findings had disease recurrence. Sensitivity, specificity, positive predictive value, and negative predictive value of PET/CT for detection of recurrence were 1, 0.75, 0.52, and 1, respectively. CONCLUSION: Surveillance PET/CT resulted in similar clinical outcomes and medical costs compared to no surveillance PET/CT. Approximately half of patients with PET/CT findings of recurrence had no recurrence after follow-up imaging and biopsy, which would not have been carried out if PET/CT had not been performed in the first place.

Access, knowledge and experience with fluorodeoxyglucose positron emission tomography/computed tomography in infection management: a survey of Australia and New Zealand infectious diseases physicians and microbiologists.

BACKGROUND: Despite fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) being funded only for staging and restaging of some malignancies in Australia, there is evidence of benefit of FDG-PET/CT for infection indications such as pyrexia of unknown origin (PUO), prolonged neutropenic fever (NF) and prosthetic device infection. AIM: To evaluate the current knowledge, utilisation of and gaps in access to FDG-PET/CT for infectious indications by Australasian infectious diseases (ID) physicians and microbiologists. METHODS: An online survey was administered to ID and microbiology doctors practising in adult medicine in Australia and New Zealand through two established email networks. Using targeted questions and case-based examples, multiple themes were explored, including access to FDG-PET/CT, use and perceived benefit of FDG-PET/CT in diagnosis and monitoring of non-malignant conditions such as NF and PUO, and barriers to clinical use of FDG-PET/CT. RESULTS: A response was received from 120 participants across all states and territories. Onsite and offsite FDG-PET/CT access was 63% and 31% respectively. Eighty-six percent reported using FDG-PET/CT for one or more infection indications and all had found it clinically useful, with common indications being PUO, prosthetic device infections and use in the immunocompromised host for prolonged NF and invasive fungal infection. Thirty-eight percent reported barriers in accessing FDG-PET/CT for infection indications and 76% would utilise FDG-PET/CT more frequently if funding existed for infection indications. CONCLUSION: Access to FDG-PET/CT in Australia and New Zealand is modest and is limited by lack of reimbursement for infection indications. There is discrepancy between recognised ID indications for FDG-PET/CT and funded indications.

In patients with unprovoked VTE, does the addition of FDG PET/CT to a limited occult cancer screening strategy offer good value for money? A cost-effectiveness analysis from the publicly funded health care systems.

INTRODUCTION: Unprovoked venous thromboembolism (VTE) may be the first manifestation of an undiagnosed cancer. We assessed the cost-effectiveness of 18F-Fluorodesoxyglucose Positron Emission/Computed Tomography (FDG PET/CT) plus limited screening and limited screening strategies in patients with unprovoked VTE from the perspectives of the Ontario (Canada) and French health care systems. METHODS: We conducted a cost-effectiveness analysis based on a published randomized controlled trial of 394 patients aged 18 years or older who were diagnosed with unprovoked VTE. We obtained data with respect to efficacy and health care utilization from the published trial. The primary measure of effectiveness was the number of avoided cases of delayed cancer diagnosis and the secondary measure of effectiveness was the quality adjusted life year (QALY) at the end of the study in each group. We used generalized linear models to estimate incremental cost-effectiveness ratios (ICER) while controlling for patient demographic and clinical characteristics. Results were presented as the incremental cost to avoid one case of delayed cancer diagnosis and the incremental cost per QALY gained. The 95% confidence intervals (CIs) were estimated using bootstrap re-sampling procedures with 5000 iterations. RESULTS: Compared to a limited screening strategy, the ICER of limited strategy plus FDG PET/CT scan was C$ 26,840.19 (95% CI: C$ 24,046.51; C$ 34,581.53) per one avoided case of delayed cancer diagnosis from the Ontario health system perspective and €16,370.45 (95% CI: € 9904.48; € 39,578.91) per one avoided case of delayed cancer diagnosis from the French health system perspective. The probabilities that addition of FDG PET/CT to limited screening is cost-effective rose with increasing willingness to pay values. Compared with the limited screening, the extensive screening was associated with C$ 3412.85 per QALY gained (95% CI: 1463.89; -13,935.88) from the Ontario health system perspective and €2162.83 per QALY gained (95% CI 958.78; -10,544.42) from the French health system perspective. CONCLUSION: Addition of a FDG PET/CT for occult cancer diagnosis was associated with better health outcomes (fewer cases of delayed cancer diagnosis and greater QALYs) and a higher cost from the perspective of publicly funded health care systems; the cost-effectiveness results are however highly uncertain.

PET Radiopharmaceuticals in Brazil and Belarus: Economic Comparison Using the Case of 18FDG.

BACKGROUND: The production of radiopharmaceuticals, especially the PET ones, is a complex combination of economic and social factors. Despite the social aspects, that are essential, the economic issue must be considered and play an important parameter for the implementation and maintenance of producer centers around the world, with especial regards for countries which face economic crisis and/or belongs to aegis of under development countries. OBJECTIVES: In order to evaluate this scenario with carried out this study, comparing a well-established producer center in Brazil and a new on in Belarus. RESULTS: The results showed that the producer center in Brazil face serious economic problems and all the production logistic must be re-done. On the other hand the new producer center in Belarus started following a new model of production and although it has not been profitable, the perspectives seem to be better than the Brazilian producer center. CONCLUSION: The Brazilian model for PET radiopharmaceutical productions should be revised in order to avoid waste and create a new perspective for the research area.

Cost-effectiveness analysis of routine surveillance imaging of patients with diffuse large B-cell lymphoma in first remission.

PURPOSE: Surveillance imaging of asymptomatic patients with diffuse large B-cell lymphoma (DLBCL) in first remission remains controversial. A decision-analytic Markov model was developed to evaluate the cost-effectiveness of follow-up strategies following first-line immunochemotherapy. PATIENTS AND METHODS: Three strategies were compared in 55-year-old patient cohorts: routine clinical follow-up without serial imaging, routine follow-up with biannual computed tomography (CT) scans for 2 years, or routine follow-up with biannual [(18)F]-fluorodeoxyglucose positron emission tomography-computed tomography (PET/CT) for 2 years. The baseline model favored imaging-based strategies by associating asymptomatic imaging-detected relapses with improved clinical outcomes. Lifetime costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated for each surveillance strategy. RESULTS: Surveillance strategies utilizing 2 years of routine CT or PET/CT scans were associated with minimal survival benefit when compared with clinical follow-up without routine imaging (life-years gained: CT, 0.03 years; PET/CT, 0.04 years). The benefit of imaging-based follow-up remained small after quality-of-life adjustments (CT, 0.020 QALYs; PET/CT, 0.025 QALYs). Costs associated with imaging-based surveillance strategies are considerable; ICERs for imaging strategies compared with clinical follow-up were $164,960/QALY (95% CI, $116,510 to $766,930/QALY) and $168,750/QALY (95% CI, $117,440 to 853,550/QALY) for CT and PET/CT, respectively. Model conclusions were robust and remained stable on one-way and probabilistic sensitivity analyses. CONCLUSION: Our cost-effectiveness analysis suggests surveillance imaging of asymptomatic DLBCL patients in remission offers little clinical benefit at substantial economic costs.

Cost-effectiveness of PET and PET/computed tomography: a systematic review.

The development of clinical diagnostic procedures comprises early-phase and late-phase studies to elucidate diagnostic accuracy and patient outcome. Economic assessments of new diagnostic procedures compared with established work-ups indicate additional cost for 1 additional unit of effectiveness measure by means of incremental cost-effectiveness ratios when considering the replacement of the standard regimen by a new diagnostic procedure. This article discusses economic assessments of PET and PET/computed tomography reported until mid-July 2014. Forty-seven studies on cancer and noncancer indications were identified but, because of the widely varying scope of the analyses, a substantial amount of work remains to be done.

[18FDG-PET/CT cost-effectiveness compared to CT at the end of treatment in pediatric Hodgkin's lymphoma patients]. / Costo-efectividad de 18FDG-PET/CT vs CT al final del tratamiento en pacientes pediátricos con Linfoma Hodgkin.

OBJECTIVE: Estimating the cost-effectiveness of 18FDG-PET/CT (positron emission tomography) compared to computer tomography (CT) followed by 18FDG-PET/CT as a confirmatory test for a positive case at the end of treatment in Hodgkin's lymphoma (HL) patients under 18 years-old. METHODS: A decision tree was built for comparing 18FDG-PET/CT to CT followed by 18FDG-PET/CT as a confirmatory test for a positive case in detecting residual lesions; outcome was measured in life years gained (LYG). The cost-effectiveness ratio was calculated; the threshold was 3 times the per capita GDP per LYG. Values were expressed in Colombian pesos for 2010 (1 US dollar=$ 1,897.89) and submitted to deterministic and probabilistic sensitivity analysis. RESULTS: Assuming a difference of 13 months in true positives' life expectancy compared to that for false negatives, the cost of an additional LYG with 18FDG-PET/CT compared to CT followed by 18FDG-PET/CT as a confirmatory test for a positive case when evaluating the end of pediatric HL patients' treatment was $ 34,508,590 (COP). CONCLUSION: If differential life-expectancy between true positives and false negatives is at least 1.03 years, then using 18FDG-PET/CT for evaluating the end of HL pediatric patients' therapy is a cost-effective strategy for Colombia.

PET-CT in oncological patients: analysis of informal care costs in cost-benefit assessment.

PURPOSE: The authors analysed the impact of nonmedical costs (travel, loss of productivity) in an economic analysis of PET-CT (positron-emission tomography-computed tomography) performed with standard contrast-enhanced CT protocols (CECT). MATERIALS AND METHODS: From October to November 2009, a total of 100 patients referred to our institute were administered a questionnaire to evaluate the nonmedical costs of PET-CT. In addition, the medical costs (equipment maintenance and depreciation, consumables and staff) related to PET-CT performed with CECT and PET-CT with low-dose nonenhanced CT and separate CECT were also estimated. RESULTS: The medical costs were 919.3 euro for PET-CT with separate CECT, and 801.3 euro for PET-CT with CECT. Therefore, savings of approximately 13% are possible. Moreover, savings in nonmedical costs can be achieved by reducing the number of hospital visits required by patients undergoing diagnostic imaging. CONCLUSIONS: Nonmedical costs heavily affect patients' finances as well as having an indirect impact on national health expenditure. Our results show that PET-CT performed with standard dose CECT in a single session provides benefits in terms of both medical and nonmedical costs.

Cost-effectiveness analysis of 18F-FDG PET/CT in detecting suspected recurrence or metastasis in well-differentiated thyroid carcinoma patients with negative diagnostic total body scan in Thailand: a decision analysis.

OBJECTIVE: To evaluate cost-effectiveness analysis of 18F-FDG PET/CT to detect tumor recurrence or metastasis in well-differentiated thyroid cancer patients with high Tg but negative TBS in Thailand. MATERIAL AND METHOD: A retrospective literature review of 55 studies published between 1978 and 2010 was done. Decision analysis by TreeAge program showed an evaluation of the most cost-effective treatment and 18F-FDG PET/CT scan in thyroid cancer patients with high Tg but negative TBS. The incremental cost and life years gained associated with seven strategies approached were analyzed by the decision tree model. The first strategy was treatment with empirical high dose 131I therapy. The second to the seventh strategies were using imaging investigations by CT scan of neck and chest, 99mTc MIBI scan, and 18F-FDG PET/CT scan to identify recurrent, persistent, and metastatic lesions before the specific treatment via curative surgery, external radiotherapy, and high dose 131I therapy. All strategies were adopted using hospital perspective and direct medical cost was estimated based on the reference price of Siriraj Hospital. Deterministic sensitivity analysis was conducted to investigate the effect of the cost of PET/CT scan. RESULTS: The strategy using 18F-FDG PET/CT scan to detect recurrence or metastasis and possible curative surgery in operable cases and high dose 131I therapy in inoperable cases gave the highest life years gained of 27.08 with cost of 90,227.61 Baht (2,926.24 US dollars) and acceptable incremental cost effectiveness ratio (ICER) of 6,936.88 Baht (224.98 US dollars) per life year gained when compared to the least costly strategy using 99mTc MIBI scan and additional 18F-FDG PET/CT scan in negative MIBI result. Other strategies were dominated by this PET/CT strategy. Deterministic sensitivity analysis (based on the willingness to pay (WTP) 360,000 Baht (11,675.42 US dollars) showed that the cost of PET/CT scan has no impact on the net health benefit. CONCLUSION: Based on the hospital perspective, the cost-effectiveness of 18F-FDG PET/CT scan in detecting suspected recurrence or metastasis in thyroid carcinoma patients with negative diagnostic TBS but high Tg was first done using 18F-FDG PET/CT scan to identify disease, followed by curative surgery or high dose 131I therapy. Moreover cost of PET/CT scan did not influence the net health benefit. This PET/CT benefit is helpfulfor considering the proper PET/CT use for thyroid cancer in Thailand.

[Analysis of cost-effectiveness in the diagnosis of fever of unknown origin and the role of (18)F-FDG PET-CT: a proposal of diagnostic algorithm]. / Análisis de costo-efectividad en el diagnóstico de fiebre de origen desconocido y el papel de la (18)F-FDG PET-TC: propuesta de algoritmo diagnóstico.

AIM: To analyze the costs of Fever of Unknown Origin (FUO) prior to the PET-CT study. To determine the effectiveness of PET-CT in the diagnosis of FUO. A proposal of diagnostic algorithm. MATERIAL AND METHODS: A retrospective study was performed that included 20 patients who had been studied between January 2007 and January 2011, with a mean age of 57.75 years and FUO diagnosis. All underwent a PET-CT study with (18)F-FDG. Individual and mean costs of FUO in these patients were assessed, including hospitalization days and complementary tests prior to the PET-CT study. The effectiveness of the PET-CT study in the diagnosis of FUO was analyzed. Costs of the FUO process were determined, including those of the PET-CT study, and if it had been done earlier in the diagnostic process. RESULTS: Mean hospital stay per patient until the PET-CT study was 28 days. The cost per hospitalization day was 342 €. Average cost per patient in complementary tests was 1395 €. Total cost of the FUO process until the PET-CT study was around 11167 € per patient. The PET-CT study showed a 78% sensitivity, 83% specificity, 92% PPV and 62% NPV. If PET-CT had been performed earlier in the FUO process, assuming the same effectiveness, 5471 € per patient would have been saved. CONCLUSION: The PET-CT study could be cost-effective in the FUO process if used at an early stage, helping to establish an early diagnosis, reducing hospitalization days due to diagnostic purposes and the repetition of unnecessary tests.

The impact of baseline and interim PET/CT parameters on clinical outcome in patients with diffuse large B cell lymphoma.

Taking a step forward from the IPI, attention is focused on the role of 18F-FDG PET/CT as a tool for guidance in risk stratification in patients with aggressive non-Hodgkin's lymphoma (NHL). Here, we analyzed the predictive value of various PET/CT parameters in patients with DLBCL. Particularly, we were interested in patients with an IPI score of 1, 2, or 3, whose prognosis are confusing. Between Jul 2008 and Feb 2010, a total of 100 patients (including 57 patients with an IPI score of 1-3) who were treated with R-CHOP for DLBCL, and had assessable PET/CT parameters were analyzed in this study. Absolute value of SUVmax, SUVsum(sum of SUVmax) and TLGsum(SUVmean x Volumemeta) from baseline and interim PET/CT, and ΔSUVsum, ΔSUVmax, and ΔTLGsum between baseline and interim PET/CT were selected as PET/CT parameters. The median number of R-CHOP cycles was 6, and interim PET/CT was performed after 2 or 3 cycles. None of the parameters which showed percentile change between initial and interim PET/CT were associated with prognosis. Instead, absolute value of SUVsum from baseline PET/CT, and SUVmax and SUVsum from interim PET/CT were significantly relevant to PFS in all patients, and in patients with an IPI score of 1­3.

Is FDG PET/CT cost-effective for pre-operation staging of potentially operative non-small cell lung cancer? - From Chinese healthcare system perspective.

OBJECTIVES: The remarkable morbidity and mortality of lung cancer in the large population address major economic challenges to Chinese healthcare system. This study aims to assess the cost-effectiveness of fluorodeoxyglucose positron emission tomography (FDG PET)/CT for staging patients with non-small cell lung cancer (NSCLC) in China. METHODS: Management of potentially operative NSCLC was modeled on decision analysis employing data in China. The strategies compared were conventional CT staging (strategy A), additional PET/CT in all patients (strategy B) or only in patients with normal-sized lymph nodes on CT (strategy C). Published medical data for Chinese patients was extracted. The costs corresponded to reimbursement by Chinese public health provider in 2010. Uncertainly of employed parameters was calculated in sensitivity analysis. RESULTS: Taking strategy A as baseline, the incremental cost-effectiveness ratio (ICER) of strategy B was 23,800RMB ($3500) per life year saved, which was acceptable in views of a developing country as China; while strategy C exhibited some loss of life years. Sensitivity analysis suggested the ICER (B-A) was raised more remarkably by a deterioration of PET specificity than by that of its sensitivity. The ICER was turned negative by PET specificity lower than 0.79. Economically, PET cost was proportional to the ICER (B-A), and decrease of palliative therapy cost could reduce both the ICER and overall cost. CONCLUSIONS: The PET/CT strategy is potentially cost-effective for management of NSCLC in China. Patients with nodal-positive CT results are not suggested to be excluded from further PET/CT. Furthermore, maintaining high specificity of PET in clinical scenarios is crucial. Prospective trials are warranted to transfer these results into policy making.

A prospective evaluation of the utility of 2-deoxy-2-[(18) F]fluoro-D-glucose positron emission tomography and computed tomography in staging locally advanced gastric cancer.

BACKGROUND: The aim of this study was to examine prospectively the utility of adding preoperative [(18) F]fluorodeoxyglucose positron emission tomography (FDG-PET)/computed tomography (CT) to routine CT, endoscopic ultrasound (EUS), and laparoscopic staging of localized gastric cancer. METHODS: Patients with locally advanced gastric/gastroesophageal cancer were screened for 2 institutional review board-approved Memorial Sloan-Kettering Cancer Center neoadjuvant chemotherapy protocols. Locally advanced disease was defined as T3 or T4, or lymph node-positive, based on EUS and high-resolution CT scan. All patients underwent both standard FDG-PET/CT and laparoscopy with cytological examination of washings. The sensitivity and specificity of FDG-PET/CT for the identification of metastatic disease not seen on CT was determined. An economic model using Medicare/Medicaid reimbursement charges was developed to assess the cost-effectiveness of these interventions. RESULTS: A total of 113 patients were enrolled from 2003 to 2010. All patients were assessed as having locally advanced disease by CT/EUS. FDG uptake in the primary tumor was associated with male sex, proximal tumors, and nondiffuse Lauren's subtype. 31 (27%) patients had occult metastatic disease detected by PET/CT (n = 11, 10%) and/or laparoscopy (n = 21, 19%), with a single overlap. Economic modeling suggests that the addition of FDG-PET/CT to the standard staging evaluation of patients with locally advanced gastric cancer resulted in an estimated cost savings of ∼US $13,000 per patient. CONCLUSIONS: FDG-PET/CT identifies occult metastatic lesions in approximately 10% of patients with locally advanced gastric cancer. Because of reduced morbidity from fewer futile surgeries and lower patient care costs, PET/CT should be considered as a component of the standard staging algorithm for localized gastric cancer.

Cost-effectiveness of adding FDG-PET or CT to the diagnostic work-up of patients with stage III melanoma.

OBJECTIVE: The aim of this prospective study was to assess predictive value of fludeoxyglucose-positron emission tomography (FDG-PET) and computed tomography (CT) and to analyze their cost-effectiveness in several diagnosis-treatment combinations. BACKGROUND: The incidence of melanoma continues to rise. A proportion will present or recur with lymph node metastases (American Joint Committee on Cancer/Union for International Cancer Control stage III). To detect distant metastases, CT and/or FDG-PET are available. However, few studies have assessed their value and costs in stage III. METHODS: All consecutive patients with melanoma with palpable, proven lymph node metastases (2003-2008) referred for examination with FDG-PET and CT were prospectively included. Sensitivity, specificity, and accuracy, and positive predictive value (PPV) and negative predictive value (NPV) were calculated. In economic evaluation, the costs of diagnostic work-up with and without FDG-PET and CT were compared. RESULTS: Overall, 253 patients with melanoma were included. FDG-PET showed a higher sensitivity than CT: 86.1% compared with 78.2%. Specificity was higher for CT (93.7%) compared with FDG-PET (93.1%). Overall, FDG-PET showed a higher PPV and NPV. Cost-consequence analysis showed that adding CT (True-Positive upstaging in 61 patients) to diagnostic work-up decreased cost by 5.5%, adding FDG-PET (True-Positive upstaging in 68 patients) increased cost by 7.2%, and adding both (True-Positive upstaging in 78 patients) increased cost by 15.1%. CONCLUSIONS: In this study, FDG-PET had higher sensitivity and predictive value, whereas CT had a higher specificity. Adding one of these diagnostic tools improved the staging of stage III patients with less than 10% cost increase. A proposal for stage-specific use of imaging modalities for clinicians caring for patients with melanoma is presented.

New pathways to medicare coverage for innovative PET radiopharmaceuticals: report of a medical imaging & technology alliance (MITA) workshop.

PET and PET/CT have revolutionized the diagnosis, staging, and monitoring of treatment effect or recurrence for a wide range of cancers and shown promise for improving health outcomes for patients with cardiovascular and central nervous system diseases. However, this technology is challenged by insurance coverage policies that hinder patients' access to PET and discourage technologic innovation. Recently, the Medical Imaging & Technology Alliance (MITA), a Washington-based industry association, convened a workshop to consider new pathways for making decisions on Medicare coverage of new PET radiopharmaceuticals and imaging procedures that are currently subject to a national noncoverage decision, or "exclusionary rule." Stakeholders from the government, medical professional societies, academia, patient groups, and industry gathered to brainstorm alternatives to the national noncoverage decision and evaluate their potential to improve access and enhance innovation. Ultimately, MITA, on behalf of the PET community, expects to use the outcomes of the workshop to propose that the Centers for Medicare and Medicaid Services reconsider this current national noncoverage decision for PET and adopt a new framework for coverage.

A pilot study utilizing whole body 18 F-FDG-PET/CT as a comprehensive screening strategy for occult malignancy in patients with unprovoked venous thromboembolism.

BACKGROUND: Approximately 7-10% of patients with unprovoked VTE will be diagnosed with cancer within 12 months. Although cancer screening has been proposed in these patients, the optimal strategy remains unclear. In a pilot study, we prospectively investigated the use of FDG-PET/CT to screen for occult malignancy in 40 patients with unprovoked VTE. MATERIALS/METHODS: Patients were initially screened for occult malignancy with a focused history, physical, and laboratory evaluation. Patients underwent whole body FDG-PET/CT and were followed for up to two years for a new diagnosis of cancer. The total costs of using FDG-PET/CT as a comprehensive screening strategy were determined using 2010 Medicare reimbursement rates. RESULTS: Completion of FDG-PET/CT imaging was feasible and identified abnormal findings requiring additional evaluations in 62.5% of patients. Occult malignancy was evident in only one patient (cancer incidence 2.5%) and FDG-PET/CT imaging excluded malignancy in the remainder of patients. No patients with a negative FDG-PET/CT were diagnosed with malignancy during an average (±SD) follow-up of 449 (±311) days. The use of FDG-PET/CT to screen for occult malignancy added $59,151 in total costs ($1,479 per patient). The majority of these costs were due to the cost of the FDG-PET/CT ($1,162 per patient or 78.5% of total per-patient costs). CONCLUSIONS: FDG-PET/CT may have utility for excluding occult malignancy in patients with unprovoked VTE. The costs of this comprehensive screening strategy were comparable to other screening approaches. Larger studies are needed to further evaluate the utility and cost-effectiveness of FDG-PET/CT as a cancer screening strategy in patients with unprovoked VTE.

Cost-effectiveness of routine (18)F-FDG PET/CT in high-risk patients with gram-positive bacteremia.

UNLABELLED: Gram-positive bacteremia has a high morbidity and mortality rate of approximately 30%. Delayed diagnosis of clinically silent metastatic infectious foci is an important indicator for a complicated outcome. (18)F-FDG PET/CT allows detection of focal infection, resulting in lower relapse rates and mortality. Here, we present a cost-effectiveness analysis associated with introduction of (18)F-FDG PET/CT for patients with gram-positive bacteremia. METHODS: A cost-effectiveness analysis in a prospective (18)F-FDG PET/CT group (n = 115) and matched control group (n = 230) was performed alongside a clinical study, the results of which were previously published. Mortality at 6 mo was considered the final effect outcome and was used in the denominator of the incremental cost-effectiveness ratio. RESULTS: Mortality in the (18)F-FDG PET/CT group was 19%, compared with 32% in the control group (P < 0.01). Incremental costs of (18)F-FDG PET/CT were $9,454 (95% confidence interval [CI], $3,963-$14,947), mainly because of admission (mean, $6,631; 95% CI, $1,449-$11,814). Additional costs were related to echocardiography (P < 0.01), not to (18)F-FDG PET/CT (P = 0.8). The mean incremental costs of the (18)F-FDG PET/CT strategy estimated by stratification for endocarditis were $5,277 per patient (95% CI, $429-$10,123; P = 0.03). The point estimate of the incremental cost-effectiveness ratio is $72,487 per prevented death (95% CI, $11,388-$323,379). CONCLUSION: Introduction of a diagnostic regimen including routine (18)F-FDG PET/CT decreases morbidity and mortality. The cost increase is due to in-hospital treatment of metastatic infectious foci. Costs per prevented death, $72,487, are within the range that is considered to be efficient by Dutch guidelines. Patients with high-risk gram-positive bacteremia therefore should have easy access to (18)F-FDG PET/CT to enable early detection of metastatic infectious disease.

Cost-effectiveness analysis of FDG PET-CT in the management of pulmonary metastases from malignant melanoma.

OBJECTIVES: Most guidelines consider FDG PET-CT to detect occult extra-pulmonary disease prior to lung metastasectomy. A cost-effectiveness analysis, using a Markov model over a 10 year period, was performed to compare two different surveillance programs, either PET-CT or whole-body CT, in patients with suspected pulmonary metastasised melanoma. METHODS: Data from published studies provided probabilities for the model. Complication and care costs were obtained from standardised administrative databases from 19 hospitals identified by DRG codes (reported in 2009 Euros). For the cost calculation of PET-CT we performed a microcosting analysis. All costs and benefits were yearly discounted at respectively 3% and 1.5%. Outcomes included life-months gained (LMG) and the number of futile surgeries avoided. Cost-effectiveness ratios were in Euros per LMG. Univariate and probabilistic sensitivity analyses addressed uncertainty in all model parameters. RESULTS: The PET-CT strategy provided 86.29 LMG (95% CI: 81.50-90.88 LMG) at a discounted cost of euro3,974 (95% CI: euro1,339-12,303), while the conventional strategy provided 86.08 LMG (95% CI: 81.37-90.68 LMG) at a discounted cost of euro5,022 (95% CI: euro1,378-16,018). This PET-CT strategy resulted in a net saving of euro1,048 with a gain of 0.2 LMG. Based on PET-CT findings, 20% of futile surgeries could be avoided. CONCLUSION: Integrating PET-CT in the management of patients with high risk MM appears to be less costly and more accurate by avoiding futile thoracotomies in one of five patients as well as by providing a small survival benefit at 10 years.