Mean Quality-adjusted Life Expectancy Research Articles

An Intersectional Approach to Quantifying the Impact of Geographic Remoteness and Health Disparities on Quality-Adjusted Life Expectancy: Application to Australia

ObjectivesAn intersectional multilevel analysis of individual heterogeneity and discriminatory accuracy (MAIHDA) is a novel method for exploring the interaction between sociodemographic characteristics that affect health outcomes. This study explores the interaction between geographic remoteness and socioeconomic status on health outcomes in Australia from an intersectional perspective. MethodsData from a cross-sectional survey were matched with data from the Australian Bureau of Statistics and the Australian Institute of Health and Welfare. To explore the effect of health-related quality of life on life expectancy, quality-adjusted life expectancy (QALE) was estimated through applying utility values derived from the EQ-5D-5L to life table data from the Australian Bureau of Statistics. The effect of geographic remoteness on QALE was quantified using multivariable linear regression. An intersectional MAIHDA was performed to explore differences in mean QALE across strata formed by intersections of age, sex, and Socioeconomic Indexes for Areas score. ResultsBased on multivariable linear modeling, QALE declined significantly with increasing remoteness (inner regional, −1.0 years [undiscounted]; remote/very remote, −3.3 years [undiscounted]) (P < .001). In contrast, life expectancy was only significantly different between participants in remote/very remote areas and major cities (β-coefficient, −2.4; 95% CI −4.4 to −0.4; P = .016). No intersectional interaction effects between strata on QALE were found in the MAIHDA. ConclusionsQALE has considerable value as a metric for exploring disparities in health outcomes. Given that no intersectional interactions were identified, our findings support broad interventions that target the underlying social determinants of health appropriately reduce disparities versus interventions targeting intersectional interactions.

Cost-utility of real-time continuous glucose monitoring versus self-monitoring of blood glucose in people with insulin-treated Type 2 diabetes in Canada.

Aim: Clinical trials and real-world data for Type 2 diabetes have shown that real-time continuous glucose monitoring (rt-CGM) lowers glycated hemoglobin (A1c) and reduces hypoglycemia relative to self-monitoring of blood glucose (SMBG). This analysis examined the long-term health and economic outcomes associated with using rt-CGM versus SMBG in people with insulin-treated Type 2 diabetes in Canada. Materials & methods: Clinical data were sourced from a real-world study, in which rt-CGM reduced A1C by 0.56% versus continued SMBG. The analysis was performed using the IQVIA Core Diabetes Model, from a Canadian payer perspective over a lifetime horizon for a cohort aged 65 years with an A1C of 8.3% at baseline. Future costs and clinical outcomes were discounted at 1.5% annually. Results: Projected total mean lifetime costs were CAD 207,466 for rt-CGM versus CAD 189,863 for SMBG (difference: CAD 17,602) and projected mean quality-adjusted life expectancy was 9.97 quality-adjusted life years (QALYs) for rt-CGM versus 9.02 QALYs for SMBG (difference: 0.95 QALYs), resulting in an incremental cost-utility ratio (ICUR) of CAD 18,523 per QALY gained for rt-CGM versus SMBG. Findings were sensitive to changes in the A1C treatment effect, annual cost and quality of life benefit associated with using rt-CGM, SMBG frequency, and baseline age, but ICURs remained below CAD 50,000 per QALY in all analyses. Conclusion: For people in Canada with insulin-treated Type 2 diabetes and poor glycemic control, use of rt-CGM is likely to be cost-effective relative to SMBG.

Cost-Effectiveness of Hybrid Closed Loop Insulin Pumps Versus Multiple Daily Injections Plus Intermittently Scanned Glucose Monitoring in People With Type 1 Diabetes in The Netherlands.

Hybrid closed loop (HCL) insulin pump systems and intermittently scanned continuous glucose monitoring (IS-CGM) are increasingly used by individuals with type 1 diabetes (T1D). The aim of the analysis was to compare the long-term cost-effectiveness of the MiniMed 670G HCL system versus IS-CGM plus multiple daily injections of insulin (MDI) or continuous subcutaneous insulin infusion (CSII) in adults with T1D in the Netherlands. The analysis was performed using the IQVIA CORE Diabetes Model with clinical input data sourced from observational studies. Simulated patients were assumed to have a baseline HbA1c of 7.8%. Use of the MiniMed 670G system was assumed to reduce HbA1c by 0.4% and confer a quality-of-life (QoL) benefit through reduced fear of hypoglycemia (FoH). The analysis was performed from a societal perspective over a lifetime time horizon; future costs and clinical outcomes pertaining to the Netherlands were used and discounted at 4% and 1.5% per annum, respectively. Use of the MiniMed 670G HCL system was projected to improve mean quality-adjusted life expectancy by 2.231 quality-adjusted life years (QALYs) versus IS-CGM. Total mean lifetime costs were EUR13,683 higher with the MiniMed 670G system resulting in an ICER of EUR6133 per QALY gained. Sensitivity analyses revealed findings to be sensitive to changes in assumptions around severe hypoglycemic event rates and the (QoL) benefit associated with reduced FoH. Over patient lifetimes, for adults with long-standing T1D in the Netherlands, use of the MiniMed 670G system is projected to be cost-effective versus IS-CGM plus MDI or CSII.

Trimodal therapy vs. radical cystectomy for muscle-invasive bladder cancer: A Markov microsimulation model.

Radical cystectomy (RC) is the historic gold standard treatment for muscle-invasive bladder cancer (MIBC), but trimodal therapy (TMT) has emerged as a valid therapeutic option for select patients. Given that prospective clinical trials have been difficult to perform in this area, our aim was to compare these two primary treatment strategies using decision analytic methods. A two-dimensional Markov microsimulation model was constructed using TreeAge Pro to compare RC and TMT for patients with newly diagnosed MIBC. A comprehensive literature search was used to populate model probabilities and utilities. Our primary outcome was quality-adjusted life expectancy (QALE). Secondary outcomes included crude life expectancy (LE) and bladder cancer recurrences. The simulated patient for our model was an adult with MIBC (pT2-4 N0 M0) who was a candidate for either RC or TMT. A total of 500 000 patients were simulated. TMT resulted in an estimated mean QALE of 7.48 vs. 7.41 for RC. However, the average LE for patients treated with TMT was lower compared with RC (10.20 vs. 10.74 years). A sensitivity analysis evaluating the impact of age showed that younger patients treated with RC had greater QALE and longer LE than those treated with TMT; inverse findings were observed for elderly patients. Overall, 39.4% of patients treated with TMT experienced a bladder recurrence. RC results in a longer LE compared to TMT (0.54 years), but with a lower QALE (-0.07 years). The preferred treatment strategy varied with patient age.

Evaluation of the Long-Term Cost-Effectiveness of the Dexcom G6 Continuous Glucose Monitor versus Self-Monitoring of Blood Glucose in People with Type 1 Diabetes in Canada.

BackgroundThe Dexcom G6 real-time continuous glucose monitoring (RT-CGM) system is one of the most sophisticated RT-CGM systems developed to date and became available in Canada in 2019. A health economic analysis was performed to determine the long-term cost-effectiveness of the Dexcom G6 RT-CGM system versus SMBG in adults with type 1 diabetes (T1D) in Canada.MethodsThe analysis was performed using the IQVIA Core Diabetes Model. Based on clinical trial data, patients with mean baseline HbA1c of 8.6% were assumed to have a HbA1c reduction of 1.0% with RT-CGM versus 0.4% reduction with SMBG. RT-CGM was also associated with a quality of life (QoL) benefit owing to reduced incidence of hypoglycemia, reduced fear of hypoglycemia (FoH) and elimination of fingerstick testing. Direct medical costs were sourced from published literature, and inflated to 2019 Canadian dollars (CAD).ResultsDexcom G6 RT-CGM was projected to improve mean quality-adjusted life expectancy by 2.09 quality-adjusted life years (QALYs) relative to SMBG (15.52 versus 13.43 QALYs) but mean total lifetime cots were CAD 35,353 higher with RT-CGM (CAD 227,357 versus CAD 192,004) resulting in an incremental cost-effectiveness ratio (ICER) of CAD 16,931 per QALY gained. Sensitivity analyses revealed that assumptions relating to the QoL benefit associated with reduced FoH and the elimination of fingerstick testing with RT-CGM as well as SMBG usage and change in HbA1c were the key drivers of cost-effectiveness.ConclusionFor adults with T1D in Canada, RT-CGM is associated with improved glycemic control and QoL benefits owing to a reduced FoH and elimination of the requirement for fingerstick testing and over a lifetime time horizon is cost-effective relative to SMBG.

Clinical and economic benefits of integrated pump/CGM technology therapy in patients with type 1 diabetes in Colombia

ObjectiveTo assess the long-term clinical and economic impact of integrated pump/CGM technology therapy as compared to multiple daily injections (MDI), for the treatment of type 1 diabetes (T1D) in Colombia. MethodsThe CORE Diabetes Model was used to simulate a hypothetical cohort of patients with T1D. Mean baseline characteristics were taken from a clinical study conducted in Colombia and a healthcare payer perspective was adopted, with a 5% annual discount rate applied to both costs and outcomes. ResultsThe integrated pump/CGM improved mean life expectancy by 3.51 years compared with MDI. A similar increase occurred in mean quality-adjusted life expectancy with an additional 3.81 quality-adjusted life years (QALYs). Onset of diabetes-related complications was also delayed as compared to MDI, and mean survival time free of complication increased by 1.74 years with integrated pump/CGM. Although this increased treatment costs of diabetes as compared to MDI, savings were achieved thanks to reduced expenditure on diabetes-related complications. The estimated incremental cost-effectiveness ratio (ICER) for SAP was Colombian Pesos (COP) 44,893,950 (approximately USD$23,200) per QALY gained. ConclusionsImproved blood glucose control associated to integrated pump/CGM results in a decreased incidence of diabetes-related complications and improves life expectancy as compared to MDI. Using recommended thresholds from the World Health Organization and previous coverage decisions about health technologies in Colombia, it is a cost-effective alternative to MDI for the treatment of type 1 diabetes in Colombia.

Beneficios clínicos y económicos de la terapia con bomba de insulina integrada a sistema de monitoreo continuo de glucosa en los pacientes diabéticos tipo 1 en Colombia

ObjectiveTo assess the long-term clinical and economic impact of integrated pump/CGM technology therapy as compared to multiple daily injections (MDI), for the treatment of type 1 diabetes (T1D) in Colombia. MethodsThe CORE Diabetes Model was used to simulate a hypothetical cohort of patients with T1D. Mean baseline characteristics were taken from a clinical study conducted in Colombia and a healthcare payer perspective was adopted, with a 5% annual discount rate applied to both costs and outcomes. ResultsThe integrated pump/CGM improved mean life expectancy by 3.51 years compared with MDI. A similar increase occurred in mean quality-adjusted life expectancy with an additional 3.81 quality-adjusted life years (QALYs). Onset of diabetes-related complications was also delayed as compared to MDI, and mean survival time free of complication increased by 1.74 years with integrated pump/CGM. Although this increased treatment costs of diabetes as compared to MDI, savings were achieved thanks to reduced expenditure on diabetes-related complications. The estimated incremental cost-effectiveness ratio (ICER) for SAP was Colombian Pesos (COP) 44,893,950 (approximately USD$23,200) per QALY gained. ConclusionsImproved blood glucose control associated to integrated pump/CGM results in a decreased incidence of diabetes-related complications and improves life expectancy as compared to MDI. Using recommended thresholds from the World Health Organization and previous coverage decisions about health technologies in Colombia, it is a cost-effective alternative to MDI for the treatment of type 1 diabetes in Colombia.

Cost-utility of albiglutide versus insulin lispro, insulin glargine, and sitagliptin for the treatment of type 2 diabetes in the US

Objective To compare the cost-utility of the glucagon-like peptide-1 receptor agonist albiglutide with those of insulin lispro (both in combination with insulin glargine), insulin glargine, and the dipeptidyl peptidase-4 inhibitor sitagliptin, representing treatments along the type 2 diabetes treatment continuum.Methods The Centre for Outcomes Research and Effectiveness (CORE) Diabetes Model was used for the cost-utility analysis. Data from three Phase 3 clinical trials (HARMONY 6, HARMONY 4, and HARMONY 3) evaluating albiglutide for the treatment of patients with type 2 diabetes were used for the baseline characteristics and treatment effects. Utilities and costs were derived from published sources.Results Albiglutide treatment was associated with an improvement in mean quality-adjusted life expectancy of 0.099, 0.033, and 0.101 years when compared with insulin lispro, insulin glargine, and sitagliptin, respectively. Over the 50-year time horizon, mean total costs in the albiglutide arm were $4332, $2597, and $2223 more than in the other respective treatments. These costs resulted in an incremental cost-utility ratio of $43,541, $79,166, and $22,094 per quality-adjusted life-year (QALY) gained for albiglutide vs insulin lispro, insulin glargine, and sitagliptin, respectively. At a willingness-to-pay threshold of $50,000 per QALY gained, there was a 53.0%, 41.5%, and 67.5% probability of albiglutide being cost-effective compared with the other respective treatments.Limitations This analysis was an extrapolation over a 50-year time horizon based on relatively short-term data obtained during clinical trials. It does not take into account potential differences between the respective treatments in adherence and persistence that can influence both effects and costs.Conclusions Albiglutide represents a reasonable treatment option for patients with type 2 diabetes based on its cost-utility, relative to insulin lispro, insulin glargine, and sitagliptin.

Long-term health economic benefits of sensor-augmented pump therapy vs continuous subcutaneous insulin infusion alone in type 1 diabetes: a UK perspective

Aims/hypothesis:Continuous subcutaneous insulin infusion (CSII) is an important treatment option for type 1 diabetes patients unable to achieve adequate glycemic control with multiple daily injections (MDI). Combining CSII with continuous glucose monitoring (CGM) in sensor-augmented pump therapy (SAP) with a low glucose-suspend (LGS) feature may further improve glycemic control and reduce the frequency of hypoglycemia. A cost-effectiveness analysis of SAP + LGS vs CSII plus self-monitoring of blood glucose (SMBG) was performed to determine the health economic benefits of SAP + LGS in type 1 diabetes patients using CSII in the UK.Methods:Cost-effectiveness analysis was performed using the CORE diabetes model. Treatment effects were sourced from the literature, where SAP + LGS was associated with a projected HbA1c reduction of −1.49% vs −0.62% for CSII, and a reduced frequency of severe hypoglycemia. The time horizon was that of patient lifetimes; future costs and clinical outcomes were discounted at 3.5% and 1.5% per annum, respectively.Results:Projected outcomes showed that SAP + LGS was associated with higher mean quality-adjusted life expectancy (17.9 vs 14.9 quality-adjusted life years [QALYs], SAP + LGS vs CSII), and higher life expectancy (23.8 vs 21.9 years), but higher mean lifetime direct costs (GBP 125,559 vs GBP 88,991), leading to an incremental cost-effectiveness ratio (ICER) of GBP 12,233 per QALY gained for SAP + LGS vs CSII. Findings of the base-case analysis remained robust in sensitivity analyses.Conclusions/interpretation:For UK-based type 1 diabetes patients with poor glycemic control, the use of SAP + LGS is likely to be cost-effective compared with CSII plus SMBG.

Evaluating the cost‐effectiveness of reduced mild hypoglycaemia in subjects with Type 1 diabetes treated with insulin detemir or NPH insulin in Denmark, Sweden, Finland and the Netherlands

To estimate short-term cost-effectiveness of insulin detemir vs. NPH insulin based on the incidence of mild hypoglycaemia in subjects with Type 1 diabetes in Denmark, Sweden, Finland and the Netherlands. A model was developed to evaluate cost-effectiveness based on mild (self-treated) hypoglycaemia and pharmacy costs over 1 year. Published rates of mild hypoglycaemia were used for NPH insulin and insulin detemir. Effectiveness was calculated in terms of quality-adjusted life expectancy. Pharmacy costs were accounted using published prices and defined daily doses for both insulins. Costs were expressed in 2010 euros (€). Treatment with insulin detemir was associated with fewer mild hypoglycaemic events than NPH insulin (mean rates of 26.3 vs. 35.5 events per person-year), leading to an improvement in mean quality-adjusted life expectancy of approximately 0.019 (0.030) quality-adjusted life years (standard deviation). Annual costs were € 573.55 (110.42) vs. € 332.76 (62.18) in Denmark for insulin detemir and NPH insulin, respectively. These values were € 545.79 (106.54) vs. € 306.12 (57.78) in Sweden, € 720.10 (140.74) vs. € 408.73 (78.61) in Finland and € 584.01 (109.47) vs. € 359.60 (64.84) in the Netherlands. Incremental cost-effectiveness ratios were approximately € 12,644 (Denmark), € 12,612 (Sweden), € 16,568 (Finland) and € 12,216 (the Netherlands) per quality-adjusted life year gained for insulin detemir vs. NPH insulin. Insulin detemir is likely to be cost-effective vs. NPH insulin in subjects with Type 1 diabetes in Denmark, Sweden, Finland and the Netherlands. Increased pharmacy costs with insulin detemir should not be a barrier to therapy based on these findings.

PD06-02: Cost-Effectiveness Evaluation of the Oncotype DX® Breast Cancer Assay in Clinical Practice in the UK.

Abstract Objective: Optimizing therapeutic regimens for breast cancer patients has an important role to play in improving outcomes and planning the best use of National Health Service resources. Oncotype DX® testing has been shown to provide clinically valuable information in addition to traditional measurements (such as tumor size, tumor grade and lymph node status) to support chemotherapy treatment decision making in women with estrogen receptor positive (ER+), node-negative and up to 3 node-positive breast cancer. The aim of this study was to evaluate the cost-effectiveness of Oncotype DX testing to support adjuvant therapy decision making versus current clinical practice in the treatment of patients with ER+, early-stage breast cancer in the UK. Methods: A Markov model was developed to make long-term projections of distant recurrence, survival, quality-adjusted life expectancy and direct medical costs for patients with ER+, node-negative or micrometastatic (pN1mic) early-stage breast cancer. Scenarios using conventional diagnostic procedures (including Adjuvant! Online and the Nottingham Prognostic Index) or Oncotype DX testing to inform treatment recommendations for adjuvant therapy were modeled. The model relied on data from an ongoing study in Wales for treatment recommendations (with and without Oncotype DX), landmark Oncotype DX studies for the risk of recurrence, and UK-specific life tables for mortality. Costs were derived from published UK sources and expressed in 2010 Pounds Sterling (GBP). Future costs and clinical benefits were discounted at 3.5% annually. Probabilistic and deterministic sensitivity analyses were performed. Results: Oncotype DX was projected to increase mean life expectancy by 0.16 years and mean quality adjusted life expectancy by 0.14 quality-adjusted life years (QALYs) compared with current clinical practice over a 30-year time horizon (see table). Clinical benefits were driven by optimized allocation of adjuvant chemotherapy in the Oncotype DX group. Direct medical costs were estimated to be higher with Oncotype DX testing, leading to an incremental cost-effectiveness ratio (ICER) of approximately GBP 6,232 per QALY gained for Oncotype DX versus current clinical practice in the UK. Sensitivity analysis showed that the cost-effectiveness of Oncotype DX testing was most sensitive to variations in patient age and net changes in chemotherapy for low risk patients. Long-term clinical and cost outcomes with Oncotype DX testing versus current clinical practice Conclusions: Reallocation of adjuvant chemotherapy based on Oncotype DX test results was associated with improvements in survival and quality-adjusted life expectancy in this modeling analysis. At a willingness to pay threshold of GBP 20,000 per QALY (commonly quoted as representing good value for money in the UK), probabilistic sensitivity analysis showed that there was a 99.6% probability that Oncotype DX would be cost-effective versus current clinical practice. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr PD06-02.

Stereotactic Body Radiotherapy Versus Surgery for Medically Operable Stage I Non–Small-Cell Lung Cancer: A Markov Model–Based Decision Analysis

To compare the quality-adjusted life expectancy and overall survival in patients with Stage I non-small-cell lung cancer (NSCLC) treated with either stereotactic body radiation therapy (SBRT) or surgery. We constructed a Markov model to describe health states after either SBRT or lobectomy for Stage I NSCLC for a 5-year time frame. We report various treatment strategy survival outcomes stratified by age, sex, and pack-year history of smoking, and compared these with an external outcome prediction tool (Adjuvant! Online). Overall survival, cancer-specific survival, and other causes of death as predicted by our model correlated closely with those predicted by the external prediction tool. Overall survival at 5 years as predicted by baseline analysis of our model is in favor of surgery, with a benefit ranging from 2.2% to 3.0% for all cohorts. Mean quality-adjusted life expectancy ranged from 3.28 to 3.78 years after surgery and from 3.35 to 3.87 years for SBRT. The utility threshold for preferring SBRT over surgery was 0.90. Outcomes were sensitive to quality of life, the proportion of local and regional recurrences treated with standard vs. palliative treatments, and the surgery- and SBRT-related mortalities. The role of SBRT in the medically operable patient is yet to be defined. Our model indicates that SBRT may offer comparable overall survival and quality-adjusted life expectancy as compared with surgical resection. Well-powered prospective studies comparing surgery vs. SBRT in early-stage lung cancer are warranted to further investigate the relative survival, quality of life, and cost characteristics of both treatment paradigms.

Stereotactic Body Radiotherapy versus Surgery for Medically Operable Stage I NSCLC: A Markov Model Based Decision Analysis

Purpose/Objective(s)To compare the quality-adjusted life expectancy and overall survival in patients with stage I non-small cell lung cancer (NSCLC) treated with either stereotactic body radiation (SBRT) or surgery.Materials/MethodsWe constructed a Markov model to describe health states after either SBRT or lobectomy for stage I NSCLC for a 5-year timeframe. Rates of recurrence and Markov state utilities, consistent with the four stages of the AJCC staging system, were extracted and adapted from the literature. We report various treatment strategy survival outcomes stratified by age, sex, and pack-year history of smoking and compared these to an external outcome prediction tool (Adjuvant! Online).ResultsOverall survival, cancer specific survival, and other causes of death as predicted by our model correlated closely with those predicted by the external prediction tool. Mean quality-adjusted life expectancy ranged from 3.28 to 3.78 years after surgery and 3.35 to 3.87 years for SBRT. The utility threshold for preferring SBRT over surgery was 0.90. Outcomes were sensitive to quality of life, the proportion of local and regional recurrences treated with standard versus palliative treatments, and the surgical and SBRT treatment related mortalities.ConclusionsThe role of SBRT in the medically operable patient is yet to be defined. Our model indicates that SBRT may offer comparable overall survival and quality adjusted life expectancy as compared to surgical resection. Well powered prospective studies comparing surgery versus SBRT in early lung cancer are warranted to further investigate the relative survival, quality of life and cost characteristics of both treatment paradigms. Purpose/Objective(s)To compare the quality-adjusted life expectancy and overall survival in patients with stage I non-small cell lung cancer (NSCLC) treated with either stereotactic body radiation (SBRT) or surgery. To compare the quality-adjusted life expectancy and overall survival in patients with stage I non-small cell lung cancer (NSCLC) treated with either stereotactic body radiation (SBRT) or surgery. Materials/MethodsWe constructed a Markov model to describe health states after either SBRT or lobectomy for stage I NSCLC for a 5-year timeframe. Rates of recurrence and Markov state utilities, consistent with the four stages of the AJCC staging system, were extracted and adapted from the literature. We report various treatment strategy survival outcomes stratified by age, sex, and pack-year history of smoking and compared these to an external outcome prediction tool (Adjuvant! Online). We constructed a Markov model to describe health states after either SBRT or lobectomy for stage I NSCLC for a 5-year timeframe. Rates of recurrence and Markov state utilities, consistent with the four stages of the AJCC staging system, were extracted and adapted from the literature. We report various treatment strategy survival outcomes stratified by age, sex, and pack-year history of smoking and compared these to an external outcome prediction tool (Adjuvant! Online). ResultsOverall survival, cancer specific survival, and other causes of death as predicted by our model correlated closely with those predicted by the external prediction tool. Mean quality-adjusted life expectancy ranged from 3.28 to 3.78 years after surgery and 3.35 to 3.87 years for SBRT. The utility threshold for preferring SBRT over surgery was 0.90. Outcomes were sensitive to quality of life, the proportion of local and regional recurrences treated with standard versus palliative treatments, and the surgical and SBRT treatment related mortalities. Overall survival, cancer specific survival, and other causes of death as predicted by our model correlated closely with those predicted by the external prediction tool. Mean quality-adjusted life expectancy ranged from 3.28 to 3.78 years after surgery and 3.35 to 3.87 years for SBRT. The utility threshold for preferring SBRT over surgery was 0.90. Outcomes were sensitive to quality of life, the proportion of local and regional recurrences treated with standard versus palliative treatments, and the surgical and SBRT treatment related mortalities. ConclusionsThe role of SBRT in the medically operable patient is yet to be defined. Our model indicates that SBRT may offer comparable overall survival and quality adjusted life expectancy as compared to surgical resection. Well powered prospective studies comparing surgery versus SBRT in early lung cancer are warranted to further investigate the relative survival, quality of life and cost characteristics of both treatment paradigms. The role of SBRT in the medically operable patient is yet to be defined. Our model indicates that SBRT may offer comparable overall survival and quality adjusted life expectancy as compared to surgical resection. Well powered prospective studies comparing surgery versus SBRT in early lung cancer are warranted to further investigate the relative survival, quality of life and cost characteristics of both treatment paradigms.

The clinical effectiveness and cost-effectiveness of topotecan for small cell lung cancer: a systematic review and economic evaluation

To assess the clinical effectiveness and cost-effectiveness of topotecan as second-line treatment for small cell lung cancer (SCLC). Bibliographic databases were searched from 1990 to February 2009, including the Cochrane library, MEDLINE (Ovid), EMBASE (Ovid), PREMEDLINE In-Process & Other Non-Indexed Citations. Bibliographies of related papers were assessed and experts were contacted to identify additional references and the manufacturer's submission to NICE was also searched. Two reviewers independently screened titles and abstracts for eligibility. Inclusion criteria were applied to the full text of retrieved papers using a standard form. For the clinical effectiveness review, the studies were randomised controlled trials (RCTs), which included adult participants with relapsed SCLC who responded to first-line treatment and for whom re-treatment with first-line therapy was inappropriate. The treatment was topotecan (oral or intravenous, i.v.) compared with one another, best supportive care (BSC) or other chemotherapy regimens. Outcomes included measures of response or disease progression and measures of survival. For the cost-effectiveness review studies were eligible for inclusion if they reported cost-effectiveness, cost-utility, cost-benefit or cost-consequence analyses. Data extraction and quality assessment of included studies was undertaken by one reviewer and checked by a second. Studies were synthesised through a narrative review with full tabulation of results. An independent economic model estimated the cost-effectiveness of topotecan (oral or i.v.) compared with BSC. The model used survival analysis methods to derive estimates of mean survival for patients treated with topotecan or receiving BSC alone. These were combined with quality of life (QoL) weights to derive estimates of mean quality-adjusted life expectancy for patients receiving BSC alone or topotecan plus BSC. Categories of costs included in the model included drug use, chemotherapy administration and on-treatment monitoring, management of adverse events, monitoring for disease progression and palliative care. A total of 434 references were identified of which five were included in the clinical effectiveness review. In these trials topotecan was compared with BSC, CAV [cyclophosphamide, Adriamycin (doxorubicin) and vincristine] or amrubicin, or oral topotecan was compared with i.v. topotecan. No economic evaluations were identified. There were no statistically significant differences between groups when i.v. topotecan was compared with either CAV or oral topotecan for overall response rate (ORR). Response rate was significantly better in participants receiving i.v. amrubicin than in those receiving a low dose of i.v. topotecan (38% versus 13%, respectively, p = 0.039). There was a statistically significant benefit in favour of oral topotecan compared with BSC (HR 0.61, 95% CI 0.43 to 0.87, p = 0.01). Drug acquisition costs for four cycles of treatment were estimated at 2550 pounds for oral topotecan and 5979 pounds for i.v. topotecan. Non-drug treatment costs accounted for an additional 1097 pounds for oral topotecan and 4289 pounds for i.v. topotecan. Total costs for the modelled time horizon of 5 years were 4854 pounds for BSC, 11,048 pounds for oral topotecan and between 16,914 pounds and 17,369 pounds for i.v. topotecan (depending on assumptions regarding time progression). Life expectancy was 0.4735, 0.7984 and 0.7784 years for BSC, oral topotecan and i.v. topotecan respectively. Total quality-adjusted life-years (QALYs) were 0.2247 and 0.4077, for BSC and oral topotecan respectively, resulting in an incremental cost-effectiveness ratio (ICER) of 33,851 pounds per QALY gained. Total QALYs for i.v. topotecan were between 0.3875 and 0.4157 (depending on assumptions regarding time progression) resulting in an ICER between 74,074 pounds and 65,507 pounds per QALY gained. Topotecan appeared to be better than BSC alone in terms of improved survival, and was as effective as CAV and less favourable than i.v. amrubicin in terms of response. Oral topotecan and i.v. topotecan were similar in efficacy. Topotecan offers additional benefit over BSC, but at increased cost. ICERs for i.v. topotecan, compared with BSC, were high and suggest that it is unlikely to be a cost-effective option. The ICER for oral topotecan is at the upper extreme of the range conventionally regarded as cost-effective from an NHS decision-making perspective. Further research into the QoL of patients with relapsed SCLC could identify the impacts of disease progression and treatment response.

Quality-Adjusted Life-Years and Helmet Use Among Motorcyclists Sustaining Head Injuries

We estimated loss of quality-adjusted life expectancy (QALE) among motorcyclists in Taiwan who sustained head injuries while wearing or not wearing a helmet. Patients with head injuries (n=3328) were grouped into categories representing good and poor outcomes (moderate disability or death) at discharge. After linkage with the National Mortality Registry, survival functions were determined and extrapolated over a 50-year period on the basis of the survival ratio between patients and age- and gender-matched reference populations, as calculated from available Taiwan vital statistics. Survival functions were then multiplied by scores from quality-of-life measures. Percentages of good and poor outcomes were 87.2% and 12.8%, respectively, in the helmeted group and 66.4% and 33.6% in the nonhelmeted group. The mean QALE for helmeted motorcyclists, calculated by weighting percentages of good and poor outcomes, was 31.7 quality-adjusted life-years (QALYs), with an average loss of 5.8 QALYs. For nonhelmeted motorcyclists, the mean QALE was 25.9 QALYs, with a loss of 10.7 QALYs. Helmet use could save approximately 5 QALYs among motorcyclists sustaining head injuries. Future cost-effectiveness analysis can calculate the incremental cost-effectiveness ratio for regulation of helmet use.

Cost-Effectiveness of Switching to Biphasic Insulin Aspart 30 from Human Insulin in Patients with Poorly Controlled Type 2 Diabetes in South Korea

To estimate the cost-effectiveness of switching patients with poorly controlled type 2 diabetes mellitus from human insulin (HI) to biphasic insulin aspart 30 (BIAsp 30) in South Korea. A published and validated diabetes computer simulation model (the IMS CORE Diabetes Model) was used to evaluate the long-term clinical and economic outcomes associated with switching to BIAsp 30, using treatment effects from the South Korean subgroup of the Physician's Routine Evaluation of Safety and Efficacy of NovoMix 30 Therapy study and cost data collected through primary research. Outcomes included life expectancy, quality-adjusted life expectancy, incidence of complications, direct medical costs, and cost-effectiveness. Analyses were performed from a third-party payer perspective over a 30-year time horizon. Future costs and clinical benefits were discounted at 5% per annum. Extensive sensitivity analyses were performed. Switching patients uncontrolled on HI to BIAsp 30 was projected to increase discounted mean life expectancy by 0.15 +/- 0.18 years per patient (8.62 +/- 0.13 years vs. 8.47 +/- 0.13 years) and improve discounted mean quality-adjusted life expectancy by 0.30 +/- 0.12 quality-adjusted life-years (QALYs) per patient (5.68 +/- 0.09 QALYs vs. 5.38 +/- 0.09 QALYs). Conversion to BIAsp 30 was associated with a mean increase in direct costs of South Korean Won (KRW) 1,777,323 +/- 359,209 over patient lifetimes. BIAsp 30 was associated with an incremental cost-effectiveness ratio of KRW5,916,758 per QALY gained versus HI. Switching patients uncontrolled on HI to BIAsp 30 was projected to improve life expectancy and quality-adjusted life expectancy. This analysis suggests that BIAsp 30 could be a cost-effective treatment option in type 2 diabetes patients poorly controlled on HI in South Korea.

Optimal Management of High-Risk T1G3 Bladder Cancer: A Decision Analysis

BackgroundControversy exists about the most appropriate treatment for high-risk superficial (stage T1; grade G3) bladder cancer. Immediate cystectomy offers the best chance for survival but may be associated with an impaired quality of life compared with conservative therapy. We estimated life expectancy (LE) and quality-adjusted life expectancy (QALE) for both of these treatments for men and women of different ages and comorbidity levels.Methods and FindingsWe evaluated two treatment strategies for high-risk, T1G3 bladder cancer using a decision-analytic Markov model: (1) Immediate cystectomy with neobladder creation versus (2) conservative management with intravesical bacillus Calmette-Guérin (BCG) and delayed cystectomy in individuals with resistant or progressive disease. Probabilities and utilities were derived from published literature where available, and otherwise from expert opinion. Extensive sensitivity analyses were conducted to identify variables most likely to influence the decision. Structural sensitivity analyses modifying the base case definition and the triggers for cystectomy in the conservative therapy arm were also explored. Probabilistic sensitivity analysis was used to assess the joint uncertainty of all variables simultaneously and the uncertainty in the base case results. External validation of model outputs was performed by comparing model-predicted survival rates with independent published literature. The mean LE of a 60-y-old male was 14.3 y for immediate cystectomy and 13.6 y with conservative management. With the addition of utilities, the immediate cystectomy strategy yielded a mean QALE of 12.32 y and remained preferred over conservative therapy by 0.35 y. Worsening patient comorbidity diminished the benefit of early cystectomy but altered the LE-based preferred treatment only for patients over age 70 y and the QALE-based preferred treatment for patients over age 65 y. Sensitivity analyses revealed that patients over the age of 70 y or those strongly averse to loss of sexual function, gastrointestinal dysfunction, or life without a bladder have a higher QALE with conservative therapy. The results of structural or probabilistic sensitivity analyses did not change the preferred treatment option. Model-predicted overall and disease-specific survival rates were similar to those reported in published studies, suggesting external validity.ConclusionsOur model is, to our knowledge, the first of its kind in bladder cancer, and demonstrated that younger patients with high-risk T1G3 bladder had a higher LE and QALE with immediate cystectomy. The decision to pursue immediate cystectomy versus conservative therapy should be based on discussions that consider patient age, comorbid status, and an individual's preference for particular postcystectomy health states. Patients over the age of 70 y or those who place high value on sexual function, gastrointestinal function, or bladder preservation may benefit from a more conservative initial therapeutic approach.

Health‐economic comparison of continuous subcutaneous insulin infusion with multiple daily injection for the treatment of Type 1 diabetes in the UK

The aim of this study was to project the long-term costs and outcomes of continuous subcutaneous insulin infusion (CSII) compared with multiple daily injections (MDI) in patients with Type 1 diabetes in the UK. The CORE Diabetes Model is a peer-reviewed, validated model which employs standard Markov/Monte Carlo simulation techniques to describe the long-term incidence and progression of diabetes-related complications. It was used to simulate disease progression in a cohort of patients with baseline characteristics taken from published UK studies (mean age 26 years, duration of diabetes 12 years, mean HbA1c 8.68%). Direct costs for 2003 were calculated from a third-party payer perspective. Discount rates of 3.0% per annum were applied to costs and clinical outcomes. Treatment with CSII was associated with an improvement in mean quality adjusted life expectancy (QALE) of 0.76 +/- 0.19 years compared with MDI (12.03 +/- 0.15 vs. 11.27 +/- 0.14 years). Mean direct lifetime costs were pounds 19,407 +/- 1727 higher with CSII treatment compared with MDI (pounds 80,511 +/- 1257 vs. pounds 61,104 +/- 1249). This produced an incremental cost-effectiveness ratio (ICER) of pounds 25,648 per quality-adjusted life year (QALY) gained with CSII vs. MDI. The results were most sensitive to variation in hypoglycaemia rates and altering improvements in HbA1c associated with CSII therapy compared with MDI. Improvements in glycaemic control associated with CSII over MDI led to improved QALE owing to reduced incidence of diabetes-related complications. CSII was associated with an ICER of pounds 25,648 per QALY gained vs. MDI, representing good value for money by current standards in the UK.

Routine human immunodeficiency virus testing: An economic evaluation of current guidelines

The Centers for Disease Control and Prevention guidelines recommend human immunodeficiency virus (HIV) counseling, testing, and referral for all patients in hospitals with an HIV prevalence of >or=1%. The 1% screening threshold has not been critically examined since HIV became effectively treatable in 1995. Our objective was to evaluate the clinical effect and cost-effectiveness of current guidelines and of alternate HIV prevalence thresholds. We performed a cost-effectiveness analysis using a computer simulation model of HIV screening and disease as applied to inpatients in U.S. hospitals. At an undiagnosed inpatient HIV prevalence of 1% and an overall participation rate of 33%, HIV screening increased mean quality-adjusted life expectancy by 6.13 years per 1000 inpatients, with a cost-effectiveness ratio of 35,400 dollars per quality-adjusted life-year (QALY) gained. Expansion of screening to settings with a prevalence as low as 0.1% increased the ratio to 64,500 dollars per QALY gained. Increasing counseling and testing costs from 53 dollars to 103 dollars per person still yielded a cost-effectiveness ratio below 100,000 dollars per QALY gained at a prevalence of undiagnosed infection of 0.1%. Routine inpatient HIV screening programs are not only cost-effective but would likely remain so at a prevalence of undiagnosed HIV infection 10 times lower than recommended thresholds. The current HIV counseling, testing, and referral guidelines should now be implemented nationwide as a way of linking infected patients to life-sustaining care.