Quality-adjusted Life Months Research Articles

Cost-effectiveness analysis in the treatment of heavy menstrual bleeding in Spain

ObjectiveTo compare the effectiveness and costs associated with first-line medical treatments for chronic heavy menstrual bleeding (HMB) in Spain. Study designA cost-effectiveness analysis was conducted comparing the levonorgestrel-releasing intrauterine system (LNG-IUS) with the estradiol valerate/dienogest multiphase oral contraceptive (E2V/DNG), combined oral contraceptives (COC) and progestins (PROG). Study patients were fertile women diagnosed with HMB who initially wished to remain fertile. A Markov model based on reported clinical data and the opinion of a panel of experts was used. The time horizon of the analysis was 5 years. The analysis was conducted from the perspective of the Spanish National Health System (NHS), discounting both costs (€ 2013) and future effects at an annual rate of 3%. One-way sensitivity analyses and probabilistic sensitivity analysis were performed to test the robustness of the results. ResultsIn the analysis at 5 years, the LNG-IUS was associated with a gain of 0.67, 2.22, and 3.53 symptoms free months (SFM) compared with E2V/DNG, COC and PROG, respectively. LNG-IUS contributed more quality-adjusted life months (QALM) than the other treatment alternatives (+1.74 vs. E2V/DNG, +3.33 vs. COC +3.53 vs. PROG). First-line LNG-IUS treatment resulted in savings of € 583, € 988, and € 1891 vs. E2V/DNG, COC and PROG, respectively. These cost benefits, coupled with the greater clinical benefits in terms of SFM and QALM, show that LNG-IUS is the dominant option (less costly and more effective). ConclusionLNG-IUS is the medical treatment of choice and cost-saving option for the control of HMB in Spain.

Decision Analysis of Stereotactic Radiation Surgery Versus Stereotactic Radiation Surgery and Whole-Brain Radiation Therapy for 1 to 3 Brain Metastases

Although whole-brain radiation therapy (WBRT) is effective for controlling intracranial disease, it is also associated with neurocognitive side effects. It is unclear whether a theoretically improved quality of life after stereotactic radiation surgery (SRS) alone relative to that after SRS with adjuvant WBRT would justify the omission of WBRT, given the higher risk of intracranial failure. This study compares SRS alone with SRS and WBRT, to evaluate the theoretical benefits of intracranial tumor control with adjuvant WBRT against its possible side effects, using quality-adjusted life expectancy (QALE) as a primary endpoint. A Markov decision analysis model was used to compare QALE in a cohort of patients with 1 to 3 brain metastases and Karnofsky performance status of at least 70. Patients were treated with SRS alone or with SRS immediately followed by WBRT. Patients treated with SRS alone underwent surveillance magnetic resonance imaging and received salvage WBRT if they developed intracranial relapse. All patients whose cancer relapsed after WBRT underwent simulation as dying of intracranial progression. Model parameters were estimated from published literature. Treatment with SRS yielded 6.2 quality-adjusted life months (QALMs). The addition of initial WBRT reduced QALE by 1.2 QALMs. On one-way sensitivity analysis, the model was sensitive only to a single parameter, the utility associated with the state of no evidence of disease after SRS alone. At values greater than 0.51, SRS alone was preferred. In general, SRS alone is suggested to have improved quality of life in patients with 1 to 3 brain metastases compared to SRS and immediate WBRT. Our results suggest that immediate treatment with WBRT after SRS can be reserved for patients who would have a poor performance status regardless of treatment. These findings are stable under a wide range of assumptions.

Routine HIV Screening in Portugal: Clinical Impact and Cost-Effectiveness

ObjectiveTo compare the clinical outcomes and cost-effectiveness of routine HIV screening in Portugal to the current practice of targeted and on-demand screening.DesignWe used Portuguese national clinical and economic data to conduct a model-based assessment.MethodsWe compared current HIV detection practices to strategies of increasingly frequent routine HIV screening in Portuguese adults aged 18-69. We considered several subpopulations and geographic regions with varying levels of undetected HIV prevalence and incidence. Baseline inputs for the national case included undiagnosed HIV prevalence 0.16%, annual incidence 0.03%, mean population age 43 years, mean CD4 count at care initiation 292 cells/μL, 63% HIV test acceptance, 78% linkage to care, and HIV rapid test cost €6 under the proposed routine screening program. Outcomes included quality-adjusted survival, secondary HIV transmission, cost, and incremental cost-effectiveness. ResultsOne-time national HIV screening increased HIV-infected survival from 164.09 quality-adjusted life months (QALMs) to 166.83 QALMs compared to current practice and had an incremental cost-effectiveness ratio (ICER) of €28,000 per quality-adjusted life year (QALY). Screening more frequently in higher-risk groups was cost-effective: for example screening annually in men who have sex with men or screening every three years in regions with higher incidence and prevalence produced ICERs of €21,000/QALY and €34,000/QALY, respectively.ConclusionsOne-time HIV screening in the Portuguese national population will increase survival and is cost-effective by international standards. More frequent screening in higher-risk regions and subpopulations is also justified. Given Portugal’s challenging economic priorities, we recommend prioritizing screening in higher-risk populations and geographic settings.

A randomized controlled trial of gemcitabine plus cisplatin versus gemcitabine alone in the treatment of metastatic pancreatic cancer

To compare the efficacy and toxicity of single-agent gemcitabine with gemcitabine plus cisplatin (G+C) in patients with metastatic pancreatic cancer Forty-six patients with metastatic pancreatic cancer were randomized to receive gemcitabine alone (n=25; 1,000mgm(-2)) or G+C (n=21; 1,000mgm(-2) gemcitabine and 25mgm(-2) cisplatin). Treatments were administered once a week for 3weeks and repeated every 4weeks. Patient characteristics were comparable between the gemcitabine alone and G+C groups. The gemcitabine dose intensity was similar between the gemcitabine alone and G+C groups (684±32 vs. 617±31mgm(-2)week(-1)). The cisplatin dose intensity was 15.1±0.9mgm(-2)week(-1)×9.9±1.8weeks. Partial response rates were 8% (2/25) for gemcitabine alone and 4.8% (1/21) for G+C (p=1). The median survival and median time to progression were 7.7 and 4.6months for gemcitabine alone and 7.9 and 3.6months for G+C, respectively (p=0.752 and p=0.857, respectively). Clinical benefit was 36% for gemcitabine alone and 29% for G+C (p=0.592). Quality-adjusted life months were 5.6±0.3 for the gemcitabine alone group and 3.8±0.2 for the G+C group (p<0.001). The frequency of grade 3/4 neutropenia (8 vs. 19%) and anemia (8 vs. 10%) and the number of hospitalization days per month of survival (4.7±1.3 vs. 6.3±1.6days; p=0.431) were not significantly different between patients who received gemcitabine alone and those who received G+C. However, patients in the G+C group had a higher rate of thrombocytopenia than did patients in the gemcitabine alone group (62 vs. 24%; p=0.009). Gemcitabine alone and G+C had comparable and modest response rates in metastatic pancreatic cancer, but gemcitabine alone produced less toxicities than did G+C.

The Cost-Effectiveness of Neoadjuvant Chemoradiation is Superior to a Surgery-First Approach in the Treatment of Pancreatic Head Adenocarcinoma

In treating pancreatic cancer, there is no clearly defined optimal sequence of chemotherapy, radiation therapy and surgery. Therefore, cost-effectiveness should be considered. The objective of this study was to compare cost and outcomes between a surgery-first approach versus neoadjuvant chemoradiation followed by surgery for resectable pancreatic head cancer. A decision analytic model was constructed to compare the 2 approaches. Data from the National Cancer Database, National Surgical Quality Improvement Program, and literature populated the surgery-first arm. Data from our prospectively maintained institutional pancreatic cancer database populated the neoadjuvant arm. Costs were estimated by Medicare payment (2011 U.S. dollars). Survival was reported in quality-adjusted life-months (QALMs). The neoadjuvant chemoradiation arm consisted of 164 patients who completed preoperative therapy. Of these, 36 (22 %) did not proceed to surgery; 12 (7 %) underwent laparotomy but had unresectable disease; and 116 (71 %) underwent definitive resection. The surgery-first approach cost $46,830 and yielded survival of 8.7 QALMs; the neoadjuvant chemoradiation approach cost $36,583 and yielded survival of 18.8 QALMs. In the neoadjuvant arm, costs and survival times for patients not undergoing surgery, those with unresectable disease at laparotomy, and those completing surgery were $12,401 and 7.7 QALMs, $20,380 and 7.1 QALMs, and $45,673 and 23.4 QALMs, respectively. Neoadjuvant chemoradiation for pancreatic cancer identifies patients with early metastases or poor performance status, who can be spared an ineffective or prohibitively morbid operation, and is associated with improved survival at significantly lower cost than a surgery-first approach. Neoadjuvant chemoradiation followed by surgery is a strategy that provides more cost-effective care than a surgery-first approach.

Cost-Effectiveness of Gene-Expression Profiling for Tumor-Site Origin

ObjectivesGene-expression profiling (GEP) reliably supplements traditional clinicopathological information on the tissue of origin (TOO) in metastatic or poorly differentiated cancer. A cost-effectiveness analysis of GEP TOO testing versus usual care was conducted from a US third-party payer perspective. MethodsData on recommendation changes for chemotherapy, surgery, radiation therapy, blood tests, imaging investigations, and hospice care were obtained from a retrospective, observational study of patients whose physicians received GEP TOO test results. The effects of chemotherapy recommendation changes on survival were based on the results of trials cited in National Comprehensive Cancer Network and UpToDate guidelines. Drug and administration costs were based on average doses reported in National Comprehensive Cancer Network guidelines. Other unit costs came from Centers for Medicare & Medicaid Services fee schedules. Quality-of-life weights were obtained from literature. Bootstrap analysis estimated sample variability; probabilistic sensitivity analysis addressed parameter uncertainty. ResultsChemotherapy regimen recommendations consistent with guidelines for final tumor-site diagnoses increased significantly from 42% to 65% (net difference 23%; P<0.001). Projected overall survival increased from 15.9 to 19.5 months (mean difference 3.6 months; two-sided 95% confidence interval [CI] 3.2–3.9). The average increase in quality-adjusted life-months was 2.7 months (95% CI 1.5–4.3), and average third-party payer costs per patient increased by $10,360 (95% CI $2,982–$19,192). The cost per quality-adjusted life-year gained was $46,858 (95% CI $13,351–$104,269). ConclusionsGEP TOO testing significantly altered clinical practice patterns and is projected to increase overall survival, quality-adjusted life-years, and costs, resulting in an expected cost per quality-adjusted life-year of less than $50,000.

Cost-effectiveness of Treatment Strategies for Pancreatic Head Adenocarcinoma and Potential Opportunities for Improvement

Generally dismal outcomes have led to a nihilistic attitude toward treating pancreatic cancer, while fiscal constraints have increased scrutiny of treatments costs. Our objective was to compare the cost-effectiveness of various treatment strategies for resectable pancreatic head adenocarcinoma, and to identify opportunities for improved cost effectiveness. A decision model compared 6 strategies: no treatment, radiotherapy only, chemotherapy only, chemotherapy plus radiotherapy, surgery alone, and surgery plus adjuvant therapy. Outcomes and probabilities were identified using the National Cancer Data Base, the American Cancer Society National Surgical Quality Improvement Program, and the literature. Costs were estimated using Medicare payment. Incremental cost-effectiveness ratios (ICERs) were calculated, and sensitivity analyses were performed by varying potentially modifiable parameters of the model. Survival was reported in quality-adjusted life-months (QALMs). Surgery plus adjuvant therapy, chemotherapy alone, and no treatment were the only viable strategies in terms of cost effectiveness. Surgery plus adjuvant therapy versus no treatment demonstrated an incremental cost-effectiveness ratio (ICER) of $7,663/QALM. Theoretically increasing survival in node-negative, margin-negative patients from 14 to 22 QALMs produced the largest reduction in the ICER for surgery plus adjuvant therapy compared to no treatment ($6,386/QALM), whereas reducing the perioperative mortality from 3 to 1% had only a marginal effect. The ICER was significantly lower for high-performing centers ($5,991/QALM) than for low-performing centers ($9,144/QALM). Surgery plus adjuvant therapy for resectable pancreatic head adenocarcinoma extends survival, but at considerable expense. Significant cost reductions could be realized by improving treatment outcomes to levels of high-performing centers and development of increasingly effective adjuvant therapies.

Cost-effective Screening for Acute Hepatitis C Virus Infection in HIV-Infected Men Who Have Sex With Men

We used a Monte Carlo computer simulation to estimate the effectiveness and cost-effectiveness of screening for acute hepatitis C virus (HCV) infection in human immunodeficiency virus (HIV)-infected men who have sex with men. One-time screening for prevalent HCV infection was performed at the time of enrollment in care, followed by either symptom-based screening, screening with liver function tests (LFTs), HCV antibody (Ab) screening, or HCV RNA screening in various combinations and intervals. We considered both treatment with pegylated interferon and ribavirin (PEG/RBV) alone and with an HCV protease inhibitor. Outcome measures were life expectancy, quality-adjusted life expectancy, direct medical costs, and cost-effectiveness, assuming a societal willingness to pay $100000 per quality-adjusted life-year (QALY) gained. All strategies increased life expectancy (from 0.49 to 0.94 life-months), quality-adjusted life expectancy (from 0.47 to 1.00 quality-adjusted life-months), and costs (from $1900 to $7600), compared with symptom-based screening. The incremental cost-effectiveness ratio of screening with 6-month LFTs and a 12-month HCV Ab test, compared with symptom-based screening, was $43 700/QALY (for PEG/RBV alone) and $57 800/QALY (for PEG/RBV plus HCV protease inhibitor). The incremental cost-effectiveness ratio of screening with 3-month LFTs, compared with 6-month LFTs plus a 12-month HCV Ab test, was $129 700/QALY (for PEG/RBV alone) and $229 900/QALY (for PEG/RBV plus HCV protease inhibitor). With HCV protease inhibitor-based therapy, screening with 6-month LFTs and a 12-month HCV Ab test was the optimal strategy when the HCV infection incidence was ≤1.25 cases/100 person-years. The 3-month LFT strategy was optimal when the incidence was >1.25 cases/100 person-years. Screening for acute HCV infection in HIV-infected MSM prolongs life expectancy and is cost-effective. Depending on incidence, regular screening with LFTs, with or without an HCV Ab test, is the optimal strategy.

Neoadjuvant chemoradiation versus surgery first for resectable pancreatic head adenocarcinoma: An economic and outcome analysis.

156 Background: The optimal sequence of treating pancreatic cancer (PC) with chemotherapy, radiation and surgical intervention remains elusive. Thus, cost should be considered. This study was conducted to compare the cost and outcome of a surgery first approach versus neoadjuvant chemoradiation (CRT) followed by surgery. Methods: A decision model was constructed to contrast the 2 treatment strategies. The NCDB (2003-5), ACS NSQIP (2005-9) and literature populated probabilities and outcomes in the surgery first arm, including operative outcome, complication rate, pathologic stage, adjuvant therapy and stage-specific survival based. Data from a prospectively maintained PC database (2002-8) populated the neoadjuvant arm. Costs were based on Medicare reimbursement (2011$). Survival, discounted when appropriate, was reported in quality-adjusted life months (QALM). Results: 164 pts completed neoadjuvant CRT. Of these, 36 (22%) did not proceed to surgery. Failure was due to metastases, 18(50%), prohibitive performance status (PS), 17(47%) and pt choice, 1(3%). 12 pts (7%) proceeded to laparotomy but were deemed unresectable. 116 (71%) pts underwent definitive resection. The surgery first approach cost $95,781 to yield survival of 8.7 QALM, while the neoadjuvant strategy cost $71,416 to achieve 18.8 QALM. In the neoadjuvant population, pts not undergoing surgery, those unresectable at laparotomy and those completing surgery demonstrated a cost of $12,401 to yield 7.7 QALM, $39,112 to yield 7.1 QALM and $92,887 to achieve 23.4 QALM, respectively. Conclusions: Treating pts with neoadjuvant CRT identifies those who develop early metastases or prohibitive PS and can be spared an ineffectual or prohibitively morbid operation. Our data suggest this approach is associated with improved OS at significantly lower cost. Neoadjuvant therapy for resectable PC should be employed more frequently to provide cost-effective care for this lethal disease. [Table: see text]

Cost-effectiveness of semi-annual surveillance for hepatocellular carcinoma in cirrhotic patients of the Italian Liver Cancer population

It was recently shown that semi-annual surveillance for hepatocellular carcinoma (HCC) in cirrhotic patients provides a prognostic advantage over the annual program; however, its cost-effectiveness (CE) in the general cirrhotic population still needs to be defined. A Markov model was built to compare CE of these two strategies, considering literature results and treatment modalities of 918 cirrhotic patients from the Italian Liver Cancer (ITA.LI.CA) database. Results from the Markov model suggest that, compared to annual surveillance, semi-annual surveillance leads to a gain in quality-adjusted life expectancy, in an unselected cirrhotic population, of 1.35 quality-adjusted life-months (QALMs) over 10 years since surveillance start in compensated patients, and of 0.73 QALMs in decompensated patients. Semi-annual surveillance was more cost-effective in compensated than in decompensated cirrhosis, with an incremental CE ratio (ICER) of 1997 and 3814€/QALM, respectively. In compensated cirrhosis, semi-annual surveillance was more cost-effective than the annual program when the annual HCC incidence was ≥3.2% and the relative survival gain after cancer diagnosis was ≥20% with respect to the annual program. In decompensated cirrhosis, semi-annual surveillance was cost-effective in patients amenable to liver transplantation. In both groups, CE of semi-annual surveillance improved with the increase of annual incidence and the survival benefit obtainable with HCC treatment. Both surveillance strategies for HCC in cirrhotic patients can be recommended, according to the individual risk profile for HCC occurrence and the expected survival gain obtainable after tumor diagnosis and therapy.

Should the Arteriovenous Fistula Be Created before Starting Dialysis?: A Decision Analytic Approach

BackgroundAn arteriovenous fistula (AVF) is considered the vascular access of choice, but uncertainty exists about the optimal time for its creation in pre-dialysis patients. The aim of this study was to determine the optimal vascular access referral strategy for stage 4 (glomerular filtration rate <30 ml/min/1.73 m2) chronic kidney disease patients using a decision analytic framework.MethodsA Markov model was created to compare two strategies: refer all stage 4 chronic kidney disease patients for an AVF versus wait until the patient starts dialysis. Data from published observational studies were used to estimate the probabilities used in the model. A Markov cohort analysis was used to determine the optimal strategy with life expectancy and quality adjusted life expectancy as the outcomes. Sensitivity analyses, including a probabilistic sensitivity analysis, were performed using Monte Carlo simulation.ResultsThe wait strategy results in a higher life expectancy (66.6 versus 65.9 months) and quality adjusted life expectancy (38.9 versus 38.5 quality adjusted life months) than immediate AVF creation. It was robust across all the parameters except at higher rates of progression and lower rates of ischemic steal syndrome.ConclusionsEarly creation of an AVF, as recommended by most guidelines, may not be the preferred strategy in all pre-dialysis patients. Further research on cost implications and patient preferences for treatment options needs to be done before recommending early AVF creation.

S86 Quality of life in advanced non-small cell lung cancer, effects of cisplatin dose and carboplatin in combination with gemcitabine: results from BTOG2, a British Thoracic Oncology Group phase III trial in 1363 patients

BackgroundThe standard of care for advanced NSCLC is platinum-based chemotherapy but the optimal dose of cisplatin and comparison with carboplatin is uncertain. With median survival at 8–12 months, the impact...

Withholding Stereotactic Radiotherapy in Elderly Patients with Stage I Non-small Cell Lung Cancer and Co-existing COPD is not Justified: Outcomes of a Markov Model Analysis

Abstract Background and purpose To model outcomes of SBRT versus best supportive care (BSC) in elderly COPD patients with stage I NSCLC. Material and methods A Markov model was constructed to simulate the quality-adjusted and overall survival (OS) in patients ⩾75 years undergoing either SBRT or BSC for a five-year timeframe. SBRT rates of local, regional and distant recurrences were obtained from 247 patients treated at the VUMC, Amsterdam. Recurrence rates were converted into transition probabilities and stratified into four groups according to T stage (1, 2) and COPD GOLD score (I–II, III–IV). Data for untreated patients were obtained from the California Cancer Registry. Tumor stage and GOLD score utilities were adapted from the literature. Results Our model correlated closely with the source OS data for SBRT treated and untreated patients. After SBRT, our model predicted for 6.8–47.2% five-year OS and 14.9–27.4 quality adjusted life months (QALMs). The model predicted for 9.0% and 2.8% five-year OS, and 10.1 and 6.1 QALMs for untreated T1 and T2 patients, respectively. The benefit of SBRT was the least for T2, GOLD III–IV patients. Conclusion Our model indicates that SBRT should be considered in elderly stage I NSCLC patients with COPD.

Pharmacoeconomic Analysis of Capecitabine versus 5-Fluorouracil/Leucovorin as Adjuvant Therapy for Stage III Colon Cancer in Taiwan

ObjectivesTo assess the cost-effectiveness of oral capecitabine compared with intravenous bolus 5-fluorouracil/leucovorin (5-FU/LV) in the adjuvant treatment of stage III colon cancer in Taiwan from payer (Bureau of National Health Insurance [BNHI]) perspectives. MethodsA health state-transition model was developed to estimate the incremental costs and effectiveness of capecitabine versus 5-FU/LV. The time horizons studied were: treatment duration (24 weeks) plus 36 months, 48 months, 60 months, 120 months, and lifetime. Costs were expressed in Taiwanese new dollars (NT$). Clinical outcomes, medical resource use, and utilities were extracted from published sources. Unit costs were estimated from BNHI fee schedules, published sources, and local expert opinion. Outcomes and future costs were discounted at 3%. Cost-effectiveness was expressed as cost per quality-adjusted life-month (QALM). The effects of uncertainty were explored through a one-way sensitivity analysis. ResultsFor the 24-week time period, drug acquisition costs were higher for capecitabine than 5-FU/LV (NT$114,405 vs. NT$4,904 per patient); however, these were offset by the higher administration costs of 5-FU/LV (NT$2,573 vs. NT$204,201 per patient). Overall direct costs for the 24-week treatment period were less with capecitabine than 5-FU/LV (NT$129,327 vs. NT$233,873 per patient). Cost savings with capecitabine were also evident when longer time horizons were considered. Over a lifetime, the projected survival benefit for capecitabine was 7 QALMs. ConclusionsFrom the perspectives of the BNHI and society in Taiwan, capecitabine not only saves costs but also improves health outcomes compared with 5-FU/LV in the adjuvant treatment of stage III colon cancer.

Effectiveness and cost-effectiveness of peri-operative versus post-operative chemotherapy for resectable colorectal liver metastases

BackgroundThe role of neo-adjuvant chemotherapy prior to hepatectomy in patients with resectable colorectal liver metastases is currently a matter of debate. The aim of the present study was to analyse life-expectancy, quality adjusted life-expectancy and cost-effectiveness of the two chemotherapeutic strategies. MethodsA Markov decision model was developed, on the basis of parameters derived from an extensive literature search of the last ten years, to compare outcomes of peri-operative versus post-operative chemotherapy. ResultsLife-expectancy observed for peri-operative chemotherapy was 54.56months and 52.62months with post-operative chemotherapy only; the quality-adjusted life-expectancy with peri-operative chemotherapy was 39.33 quality-adjusted life-months (QALMs) and 37.84 QALMs with post-operative chemotherapy. Peri-operative chemotherapy results in an increase in total costs of 1180€ over ten years and in an incremental cost-effectiveness ratio (ICER) of 791.9€/QALM. The model was more sensitive to the expected 3-year recurrence-free survival (RFS) and cost of hepatic resection: with respect to an expected 3-year RFS⩽25% the peri-operative approach was more cost-effective than post-operative strategy but differences in average cost-effectiveness were small. The relationship between ICER and cost of hepatic resection was inverse because the higher the cost of hepatic resection, the higher the cost saving due to patients becoming unresectable during neo-adjuvant therapy. ConclusionsIn the treatment of resectable colorectal liver metastases, the addition of neo-adjuvant chemotherapy could be cost-effective because it makes it possible to avoid hepatic resection in patients who do not respond to the neo-adjuvant approach; however, the life-expectancy of the two strategies is very similar.

Withholding stereotactic radiotherapy in elderly patients with stage I non-small cell lung cancer and co-existing COPD is not justified: Outcomes of a markov model analysis

Background and purpose To model outcomes of SBRT versus best supportive care (BSC) in elderly COPD patients with stage I NSCLC. Material and methods A Markov model was constructed to simulate the quality-adjusted and overall survival (OS) in patients ⩾75 years undergoing either SBRT or BSC for a five-year timeframe. SBRT rates of local, regional and distant recurrences were obtained from 247 patients treated at the VUMC, Amsterdam. Recurrence rates were converted into transition probabilities and stratified into four groups according to T stage (1, 2) and COPD GOLD score (I–II, III–IV). Data for untreated patients were obtained from the California Cancer Registry. Tumor stage and GOLD score utilities were adapted from the literature. Results Our model correlated closely with the source OS data for SBRT treated and untreated patients. After SBRT, our model predicted for 6.8–47.2% five-year OS and 14.9–27.4 quality adjusted life months (QALMs). The model predicted for 9.0% and 2.8% five-year OS, and 10.1 and 6.1 QALMs for untreated T1 and T2 patients, respectively. The benefit of SBRT was the least for T2, GOLD III–IV patients. Conclusion Our model indicates that SBRT should be considered in elderly stage I NSCLC patients with COPD.

Impact of Cervical Spine Management Brain Injury on Functional Survival Outcomes in Comatose, Blunt Trauma Patients with Extremity Movement and Negative Cervical Spine CT: Application of the Monte Carlo Simulation

Cervical spine (CS) magnetic resonance imaging (MRI) and collar use may prevent quadriplegia, yet create brain injury. We developed a computer model to assess the effect of CS management strategies on outcomes in comatose, blunt trauma patients with extremity movement and a negative CS CT scan. Strategies include early collar removal (ECR), ECR & MRI, late collar removal (LCR), and LCR & MRI. MRI risks include hypoxia, hypotension, increased intracranial pressure (↑ICP), and ventilator-associated pneumonia (VAP). LCR risks include ↑ICP, VAP, and delirium. Model elements include Quadriplegia and Primary, Secondary, LCR, and MRI Brain Injury. The Monte Carlo simulation determines health outcomes (Functional Survival versus Quadriplegia, Severe Brain Disability, or Dead). Utility values are Functional Survival 0.90, Quadriplegia 0.20, Severe Brain Disability 0.10, and Dead 0.00. Years of life expectancy are Functional Survival 39.5, Quadriplegia 20.0, Severe Brain Disability 20.0, and Dead 0.0. Unstable CS rate 2.5%: Functional Survival/1,000: Unstable Patients: ECR 384, LCR 350, LCR & MRI 332, ECR & MRI 331; High-Risk Patients: ECR 161, LCR 151, LCR & MRI 140, ECR & MRI 153; Stable Patients: ECR 596, LCR 587, LCR & MRI 573, ECR & MRI 595. Quality-Adjusted Life Months for Unstable, High-Risk, and Stable Patients are greater with ECR; Stable Patient ECR and ECR & MRI are similar. Unstable CS rate 0.5%: Functional Survival/1000: Unstable Patients: ECR 394, LCR 352, LCR & MRI 332, ECR & MRI 332; High-Risk Patients: ECR 164, LCR 151, LCR & MRI 140, ECR & MRI 152; Stable Patients: ECR 611, LCR 592, LCR & MRI 576, ECR & MRI 598. Quality-Adjusted Life Months for Unstable, High-Risk, and Stable Patients are greater with ECR. LCR and MRI brain injury results in losses of functional survivorship that exceed those from quadriplegia. Model results suggest that early collar removal without cervical spine MRI is a reasonable, and likely the preferable, cervical spine management strategy for comatose, blunt trauma patients with extremity movement and a negative cervical spine CT scan.

Economic modeling of the combined effects of HIV-disease, cholesterol and lipoatrophy based on ACTG 5142 trial data

BackgroundThis study examines the cost and consequences of initiating an ARV regimen including Lopinavir/ritonavir (LPV/r) or Efavirenz (EFV), using data from a recent clinical trial in a previously published model of HIV-disease.MethodsWe populated the Markov model of HIV-disease with data from ACTG 5142 study to estimate the economic outcomes of starting ARV therapy with a PI-containing regimen as compared to an NNRTI-containing regimen, given their virologic and immunologic efficacy and effects on cholesterol and lipoatrophy. CNS toxicities and GI tolerability were not included in the model because of their transient nature or low cost remedies, and therefore lack of economic impact. CD4+ T-cell counts and the HIV-1 RNA (viral load) values from the study were used to assign a specific health state (HS) to each patient for each quarter year. The resulting frequencies used as "raw" data directly into the model obviate the reliance on statistical tests, and allow the model to reflect actual patient behavior in the clinical trial. An HS just below the last observed HS was used to replace a missing value.ResultsThe modeled estimates (undiscounted) for the LPV/r-based regimen resulted in 1.41 quality-adjusted life months (QALMs) gained over a lifetime compared to the EFV-based regimen. The LPV/r-based regimen incurred $7,458 (1.8%) greater cost over a lifetime due to differences in drug costs and survival. The incremental cost effectiveness ratio using the discounted cost and QALYs was $88,829/QALY. Most of the higher costs accrue before the 7th year of treatment and were offset by subsequent savings. The estimates are highly sensitive to the effect of lipoatrophy on Health-related Quality of Life (HRQOL), but not to the effect of cholesterol levels.ConclusionsThe cost effectiveness of ARV regimens may be strongly affected by enduring AEs, such as lipoatrophy. It is important to consider specific AE effects from all drugs in a regimen when ARVs are compared.Trial registration(ClinicalTrials.gov number, NCT00050895http://[ClinicalTrials.gov]).

Economic evaluation of the levonorgestrel-releasing intrauterine system for the treatment of dysfunctional uterine bleeding in Spain

Objective To compare the cost and effectiveness of the levonorgestrel-releasing intrauterine system (LNG-IUS) versus combined oral contraception (COC) and progestogens (PROG) in first-line treatment of dysfunctional uterine bleeding (DUB) in Spain. Study design A cost–effectiveness and cost–utility analysis of LNG-IUS, COC and PROG was carried out using a Markov model based on clinical data from the literature and expert opinion. The population studied were women with a previous diagnosis of idiopathic heavy menstrual bleeding. The analysis was performed from the National Health System perspective, discounting both costs and future effects at 3%. In addition, a sensitivity analysis (univariate and probabilistic) was conducted. Results The results show that the greater efficacy of LNG-IUS translates into a gain of 1.92 and 3.89 symptom-free months (SFM) after six months of treatment versus COC and PROG, respectively (which represents an increase of 33% and 60% of symptom-free time). Regarding costs, LNG-IUS produces savings of € 174.2–309.95 and € 230.54–577.61 versus COC and PROG, respectively, after 6 months–5 years. Apart from cost savings and gains in SFM, quality-adjusted life months (QALM) are also favourable to LNG-IUS in all scenarios, with a range of gains between 1 and 2 QALM compared to COC and PROG. Conclusions The results indicate that first-line use of the LNG-IUS is the dominant therapeutic option (less costly and more effective) in comparison with first-line use of COC or PROG for the treatment of DUB in Spain. LNG-IUS as first line is also the option that provides greatest health-related quality of life to patients.

Routine HIV screening in France: clinical impact and cost-effectiveness.

BackgroundIn France, roughly 40,000 HIV-infected persons are unaware of their HIV infection. Although previous studies have evaluated the cost-effectiveness of routine HIV screening in the United States, differences in both the epidemiology of infection and HIV testing behaviors warrant a setting-specific analysis for France.Methods/Principal FindingsWe estimated the life expectancy (LE), cost and cost-effectiveness of alternative HIV screening strategies in the French general population and high-risk sub-populations using a computer model of HIV detection and treatment, coupled with French national clinical and economic data. We compared risk-factor-based HIV testing (“current practice”) to universal routine, voluntary HIV screening in adults aged 18–69. Screening frequencies ranged from once to annually. Input data included mean age (42 years), undiagnosed HIV prevalence (0.10%), annual HIV incidence (0.01%), test acceptance (79%), linkage to care (75%) and cost/test (€43). We performed sensitivity analyses on HIV prevalence and incidence, cost estimates, and the transmission benefits of ART. “Current practice” produced LEs of 242.82 quality-adjusted life months (QALM) among HIV-infected persons and 268.77 QALM in the general population. Adding a one-time HIV screen increased LE by 0.01 QALM in the general population and increased costs by €50/person, for a cost-effectiveness ratio (CER) of €57,400 per quality-adjusted life year (QALY). More frequent screening in the general population increased survival, costs and CERs. Among injection drug users (prevalence 6.17%; incidence 0.17%/year) and in French Guyana (prevalence 0.41%; incidence 0.35%/year), annual screening compared to every five years produced CERs of €51,200 and €46,500/QALY.Conclusions/SignificanceOne-time routine HIV screening in France improves survival compared to “current practice” and compares favorably to other screening interventions recommended in Western Europe. In higher-risk groups, more frequent screening is economically justifiable.