The evolving value assessment of cancer therapies: Results from a modified Delphi study.

The move toward early detection and treatment of cancer presents challenges for value assessment using traditional endpoints. Current cancer management rarely considers the full economic and societal benefits of therapies. Our study used a modified Delphi process to develop principles for defining and assessing value of cancer therapies that aligns with the current trajectory of oncology research and reflects broader notions of value. 24 experts participated in consensus-building activities across 5 months (16 took part in structured interactions, including a survey, plenary sessions, interviews, and off-line discussions, while 8 participated in interviews). Discussion focused on: 1) which oncology-relevant endpoints should be used for assessing treatments for early-stage cancer and access decisions for early-stage treatments, and 2) the importance of additional value components and how these can be integrated in value assessments. The expert group reached consensus on 4 principles in relation to the first area (consider oncology-relevant endpoints other than overall survival; build evidence for endpoints that provide earlier indication of efficacy; develop evidence for the next generation of predictive measures; use managed entry agreements supported by ongoing evidence collection to address decision-maker evidence needs) and 3 principles in relation to the second (routinely use patient reported outcomes in value assessments; assess broad economic impact of new medicines; consider other value aspects of relevance to patients and society).

Cost Effectiveness of Allogeneic Umbilical Cord Blood-Derived Mesenchymal Stem Cells in Patients with Knee Osteoarthritis.

OBJECTIVES: The aim of this study was to assess the cost effectiveness of allogeneic umbilical cord blood-derived mesenchymal stem cells with sodium hyaluronate (hUCB-MSC) compared with microfracture in patients with knee cartilage defects caused by osteoarthritis (OA) in South Korea. METHODS: A partitioned survival model approach was taken consisting of five mutually exclusive health states: excellent, good, fair, poor, and death over a 20-year time horizon. Utility values were obtained from a randomized clinical trial. Cost data were extracted from a database provided by the Health Insurance Review & Assessment Service, and the utilization of healthcare services was estimated from an expert panel of orthopedic surgeons using a structured questionnaire. The incremental cost-effectiveness ratio (ICER) in terms of quality-adjusted life-years (QALY) was calculated. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: In the base case, the incremental costs of US$14,410 for hUCB-MSC therapy along with its associated QALY gain of 0.857 resulted in an ICER of US$16,812 (₩18,790,773) per QALY (95% confidence interval [CI] US$13,408-US$20,828) when compared with microfracture treatment from a healthcare payer perspective. From a societal perspective, the ICER was US$268 (₩299,255) per QALY (95% CI -US$2915 to US$3784). When using a willingness-to-pay threshold of US$22,367/QALY, the probability of hUCB being cost effectiveness compared with microfracture was 99% from the healthcare payer perspective and 100% from the societal perspective. CONCLUSIONS: The study demonstrated that hUCB-MSC therapy was cost effective compared with microfracture when treating patients with knee OA. These findings should inform health policy decision makers about considerations for cost-effective therapy for treating knee OA to ultimately enhance population health.

Use of budget savings from patent expiration of cancer drugs to improve affordability and accessibility.

BACKGROUND: The introduction of generics after the loss of patent exclusivity plays a major role in budget savings by significantly decreasing drug prices. The aims of this study were to estimate the budget savings from off-patent cancer drugs in 2020-2024 and to inform decision makers on how these savings could be used to improve the affordability of innovative cancer treatments in South Korea. METHODS: A model was developed to calculate budget savings from off-patent cancer drug use in Korea over 5 years (2020-2024). Cancer drugs with one or more valid patents that expire between 2020 and 2024 in Korea were selected. Key input parameters in the model included market share of generics, market growth, and prices of originators and generics. To reflect market dynamics after patent expiration, the trends of the off-patent market were estimated using historical sales volume data of IQVIA from 2012 to 2018. The study assumed that the prices of off-patent drugs decreased according to the price regulations set by the Korean government and that the off-patent market sales volume did not grow. Sensitivity analyses were performed to investigate the uncertainty in model input parameters. RESULTS: A total of 24 cancer drugs which met selection criteria were identified. In the base case analysis, patent expiration of cancer drugs between 2020 and 2024 could lead to a spending reduction of ₩234,429 million ($203 million), which was 20% of the cancer drug expenditure in the 5-year period. The savings ranged from ₩157,633 million ($136 million) to ₩434,523 million ($376 million) depending on the scenarios in sensitivity analyses. CONCLUSIONS: The findings indicate that patent loss of cancer drugs could lead to a 20% reduction in spending on cancer drugs over the next 5 years in South Korea. The savings could be used to improve the affordability of innovative, advanced cancer drugs for 94,000 cancer patients by reallocating the budget savings from patent expiration.

International Price Comparisons of Anticancer Drugs: A Scheme for Improving Patient Accessibility.

BACKGROUND: The demand for implementing a new listing scheme to expedite patient access to novel oncology drugs has increased in South Korea. This study was conducted to compare the prices of anticancer drugs between eight countries and to explore the feasibility of a 'pre-listing and post-evaluation' scheme to expedite patient access to oncology drugs. METHODS: This study included 34 anticancer drugs, which were reimbursed between 1 January 2007 and 31 December 2017. The unit price and sales volume of the study drugs were collected from eight countries and IQVIA data, respectively. The prices were adjusted to estimate the ex-factory prices using the discount/rebate rate suggested by the Health Insurance Review Agency (HIRA). The four price indices of Laspeyres, Paasche, Fisher, and the unweighted index were calculated using the price in each country, the average price, and lowest price among the study countries. Each currency was converted using the currency exchange rate and purchasing power parity (PPP). The budget impact of implementing the proposed pre-listing and post-evaluation scheme on payers was calculated. RESULTS: Based on the currency exchange rate, anticancer drug prices were higher in other countries (index range: 1.05-2.78) compared to Korea. The prices in Korea were similar to countries with the lowest prices. When the PPP was applied, prices were higher in the US, Germany, Italy, and Japan than in Korea (range: 1.10-2.13); however, the prices were lower in the UK, France, and Switzerland than in Korea (range: 0.72-0.99). The financial burden of implementing the pre-listing and post-evaluation scheme was calculated at 0.83% of the total anticancer drug sales value in Korea from 2013-2017. CONCLUSIONS: The prices of anticancer drugs in Korea were similar to the lowest prices among the seven other study countries. A pre-listing and post-evaluation scheme should be considered to improve patient access to novel anticancer drugs by reducing the reimbursement review time and uncertainties.

Budget Impact of Switching to Biosimilar Trastuzumab (CT-P6) for the Treatment of Breast Cancer and Gastric Cancer in 28 European Countries.

BACKGROUND: As the economic burden of treating cancer patients has been soaring in European countries, performing a budget impact analysis is becoming one of the requirements for payers' application dossiers. OBJECTIVE: The objective of this study was to estimate the budgetary impact of introducing the biosimilar trastuzumab (CT-P6) from the payer's perspective and to determine the number of additional patients who could be treated with resulting savings in 28 European countries. METHODS: A budget impact model was developed to analyze the financial impact of switching from originator trastuzumab to biosimilar CT-P6 in the treatment of early and metastatic breast cancer and metastatic gastric cancer with a time horizon of 1-5 years. Budgetary savings and the number of patients potentially affected were measured based on epidemiological and sales volume data. The base-case analysis assumed that the price of CT-P6 is 70% of the originator price, the switching rate of originator to CT-P6 in the first year is 20%, and the annual growth in the switching rate for each subsequent year is 5%. RESULTS: For analyses using the base-case scenario following CT-P6 introduction, the total estimated budgetary savings over a 5-year period (depending on the scenario) ranged from €1.13 billion to €2.27 billion based on epidemiological data, or from €0.91 billion to €1.82 billion based on sales volume data. In the first year only, the projected budgetary savings ranged from €58 million to €136 million, and the number of additional patients who could be treated using the savings ranged from 3503 to 7078 by sensitivity analysis. CONCLUSIONS: The conducted budget impact analysis assessing a switch from originator trastuzumab to biosimilar CT-P6 in 28 European countries indicates that budget savings could be between €0.91 billion and €2.27 billion over the next 5 years. These savings could be used to help improve patient access to local biologics in their respective countries while simultaneously strengthening the overall public health landscape across the European Union.

Improving Patient Access to New Drugs in South Korea: Evaluation of the National Drug Formulary System.

This study reviews and evaluates the national drug formulary system used to improve patient access to new drugs by making reimbursement decisions for new drugs as part of the South Korean national health insurance system. The national health insurance utilizes three methods for improving patient access to costly drugs: risk-sharing agreements, designation of essential drugs, and a waiver of cost-effectiveness analysis. Patients want reimbursement for new drugs to be processed quickly to improve their access to these drugs, whereas payers are careful about listing them given the associated financial burden and the uncertainty in cost-effectiveness. However, pharmaceutical companies are advocating for drug prices above certain thresholds to maintain global pricing strategies, cover the costs of drug development, and fund future investments into research and development. The South Korean government is expected to develop policies that will improve patient access to drugs with unmet needs for broadening health insurance coverage. Simultaneously, the designing of post-listing management methods is warranted for effectively managing the financial resources of the national health insurance system.

The association of socioeconomic and clinical characteristics with health-related quality of life in patients with psoriasis: a cross-sectional study.

BACKGROUND: This study aimed to determine the socioeconomic and clinical characteristics affecting health-related quality of life (HRQoL) in patients with psoriasis. METHODS: A cross-sectional study was conducted between March and June 2015 using data obtained via an Internet-based survey completed by a psoriasis patient group in Korea. The survey included items regarding demographic, socioeconomic, and clinical characteristics and HRQoL. Patients' HRQoL impairment was classified as severe if their Dermatology Life Quality Index Scores were ≥ 11. Factors influencing HRQoL impairment were identified using multivariate logistic regression analysis. RESULTS: Of the 299 respondents, 161 (53.8%) exhibited severe HRQoL impairment. The Dermatology Life Quality Index scores were significantly associated with gender, annual income, neck psoriasis, psoriasis-related resignation from work, and use of oral and herbal medications. The severity of HRQoL impairment in women was twice that observed in men (odds ratio [OR] = 2.00, 95% confidence interval (CI): 1.05-3.80). Patients with psoriasis on the neck exhibited significantly greater HRQoL impairment than those with psoriasis on other areas of their bodies (OR = 2.30, 95% CI: 1.20-4.43). With respect to the socioeconomic status, patients who earned > 40 million KRW (approximately 34,000 USD; high-income group) showed less HRQoL impairment compared with those who had lower incomes (OR = 0.47, 95% CI: 0.28-0.80). Patients with severe HRQoL impairment used oral (OR = 2.04, 95% CI: 1.20-3.44) and herbal (OR = 1.86, 95% CI: 1.04-3.34) medications more often relative to patients with less severe HRQoL impairment. CONCLUSIONS: HRQoL in patients with psoriasis was significantly associated with their demographic and socioeconomic characteristics and employment status. The presence of psoriasis on exposed areas of the body was significantly associated with patients' HRQoL and employment status. Further research is required to evaluate the impact of psoriasis on patients' productivity.

Impact of warfarin discharge education program on hospital readmission and treatment costs.

Background Although warfarin is highly effective, management of patients prescribed warfarin is complex due to its narrow therapeutic window. Objective To evaluate the impact of a formal warfarin discharge education program (WDEP) on hospital readmission and treatment costs in patients who received warfarin therapy. Setting Robert Wood Johnson University Hospital Somerset in Somerville, New Jersey, USA. Method In this interventional cohort study, patients were assigned to either the WDEP group or the usual care group. The effects of the WDEP on readmission within 90 days after discharge were analyzed using Cox proportional hazards models. Factors influencing treatment cost were identified using generalized linear model with log-link function and gamma distribution. Main outcome measure Hospital readmission within 90 days and treatment costs associated with hospital readmission. Results Among 692 eligible patients, 203 in each group were matched using propensity scores and there were no statistically significant differences in the patient baseline characteristics between two groups. The risk of all-cause readmission within 90 days was significantly lower in the WDEP group compared to the usual care group (relative risk = 0.46, 95% CI 0.28-0.76). The treatment costs associated with hospital readmission in the WDEP group were 19% lower than those in the usual care group after adjusting for the study variables. Conclusion A formal, individualized WDEP provided by pharmacists resulted in significant reduction of readmission and treatment costs. The economic burden of treatment costs associated with warfarin can be controlled if well-organized warfarin education is provided to patients who received warfarin therapy.

Comparative effectiveness of lipid-lowering treatments to reduce cardiovascular disease.

INTRODUCTION: The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor is a new treatment option for patients with hypercholesterolemia. The objective of this study was to systematically review the cost-effectiveness of lipid-lowering agents. AREAS COVERED: Based on Pubmed, Embase, and Cochrane Database of Systematic Reviews, we identified 29 relevant articles. Studies found statins were cost-effective compared with placebo or no treatment in general. Atorvastatin was reported to be cost-effective against simvastatin. In most cases, rosuvastatin was more cost-effective than atorvastatin or simvastatin. Additionally, ezetimibe was considered to be cost-effective compared with no treatment for statin intolerant patients. For patients not meeting treatment goals with their statins, switching to ezetimibe plus simvastatin was consistently reported cost-effective. The cost-effectiveness of ezetimibe plus a hybrid of a statin varied by the source of clinical data and cost of ezetimibe. Finally, the cost-effectiveness of PCSK9 inhibitor plus a statin against statin monotherapy was uncertain. The PCSK9 inhibitor plus a stain was cost-ineffective compared with ezetimibe plus a statin. EXPERT COMMENTARY: Drug costs and treatment efficacy were the key drivers of the cost-effectiveness results in prior analyses. Future evaluations are warranted to reflect the decreasing drug prices and the long-term treatment effects of PCSK9 inhibitors.

Incremental Treatment Costs Attributable to Overweight and Obesity in Patients with Diabetes: Quantile Regression Approach.

OBJECTIVE: This study aimed to estimate treatment costs attributable to overweight and obesity in patients with diabetes who were less than 65 years of age in the United States. METHODS: This study used data from the Medical Expenditure Panel Survey from 2001 to 2013. Patients with diabetes were identified by using the International Classification of Diseases, Ninth Revision, Clinical Modification code (250), clinical classification codes (049 and 050), or self-reported physician diagnoses. Total treatment costs attributable to overweight and obesity were calculated as the differences in the adjusted costs compared with individuals with diabetes and normal weight. Adjusted costs were estimated by using generalized linear models or unconditional quantile regression models. RESULTS: The mean annual treatment costs attributable to obesity were $1,852 higher than those attributable to normal weight, while costs attributable to overweight were $133 higher. The unconditional quantile regression results indicated that the impact of obesity on total treatment costs gradually became more significant as treatment costs approached the upper quantile. CONCLUSIONS: Among patients with diabetes who were less than 65 years of age, patients with diabetes and obesity have significantly higher treatment costs than patients with diabetes and normal weight. The economic burden of diabetes to society will continue to increase unless more proactive preventive measures are taken to effectively treat patients with overweight or obesity.

Treatment Costs and Factors Associated with Glycemic Control among Patients with Diabetes in the United Arab Emirates.

BACKGROUND: We aimed to estimate the proportion of patients with diabetes who achieved target glycemic control, to estimate diabetes-related costs attributable to poor control, and to identify factors associated with them in the United Arab Emirates. METHODS: This retrospective cohort study used administrative claims data handled by Abu Dhabi Health Authority (January 2010 to June 2012) to determine glycemic control and diabetes-related treatment costs. A total of 4,058 patients were matched using propensity scores to eliminate selection bias between patients with glycosylated hemoglobin (HbA1c) <7% and HbA1c ≥7%. Diabetes-related costs attributable to poor control were estimated using a recycled prediction method. Factors associated with glycemic control were investigated using logistic regression and factors associated with these costs were identified using a generalized linear model. RESULTS: During the 1-year follow-up period, 46.6% of the patients achieved HbA1c <7%. Older age, female sex, better insurance coverage, non-use of insulin in the index diagnosis month, and non-use of antidiabetic medications during the follow-up period were significantly associated with improved glycemic control. The mean diabetes-related annual costs were $2,282 and $2,667 for patients with and without glycemic control, respectively, and the cost attributable to poor glycemic control was $172 (95% confidence interval [CI], $164-180). The diabetes-related costs were lower with mean HbA1c levels <7% (cost ratio, 0.94; 95% CI, 0.88-0.99). The costs were significantly higher in patients aged ≥65 years than those aged ≤44 years (cost ratio, 1.45; 95% CI, 1.25-1.70). CONCLUSION: More than 50% of patients with diabetes had poorly controlled HbA1c. Poor glycemic control may increase diabetes-related costs.

Cost effectiveness of influenza vaccination in patients with acute coronary syndrome in Korea.

BACKGROUND: Influenza can cause cardiovascular abnormalities by inappropriately activating the coagulation cascade. Therefore, influenza vaccination is important because it decreases the risk of hospitalization for and mortality associated with heart disease. In particular, it reduces the occurrence of major adverse cardiovascular events (MACEs) in acute coronary syndrome (ACS) patients. Our study aimed to estimate the disease burden of MACEs and its related direct and indirect costs in ACS patients. METHODS: We estimated the direct and indirect cost of MACEs in ACS patients using a probabilistic model and the Health Insurance Review and Assessment (HIRA)-National Patient Sample (NPS) database. The effect of the influenza vaccination on the rate of MACE in ACS patients was determined using a previous systematic review and meta-analysis. RESULTS: Our study included 682,258 ACS patients obtained from the 2013 NPS database. According to our model, influenza vaccination would prevent 16,514 MACE-related hospitalizations and 2764 premature deaths in Korea per year. The overall reduction in costs would be $86.2 million per year from a societal perspective. Based on the results of sensitivity analysis, most of the estimated values were in the dominant area. CONCLUSIONS: Our findings show that influenza vaccination in ACS patients is highly cost effective in terms of lowering the cost of hospitalization and premature death due to MACE. Therefore, influenza vaccination is recommended as a means of relieving the clinical and socioeconomic burdens associated with ACS.

Costs Attributable to Overweight and Obesity in Working Asthma Patients in the United States.

PURPOSE: To estimate annual health care and productivity loss costs attributable to overweight or obesity in working asthmatic patients. MATERIALS AND METHODS: This study was conducted using the 2003-2013 Medical Expenditure Panel Survey (MEPS) in the United States. Patients aged 18 to 64 years with asthma were identified via self-reported diagnosis, a Clinical Classification Code of 128, or a ICD-9-CM code of 493.xx. All-cause health care costs were estimated using a generalized linear model with a log function and a gamma distribution. Productivity loss costs were estimated in relation to hourly wages and missed work days, and a two-part model was used to adjust for patients with zero costs. To estimate the costs attributable to overweight or obesity in asthma patients, costs were estimated by the recycled prediction method. RESULTS: Among 11670 working patients with a diagnosis of asthma, 4428 (35.2%) were obese and 3761 (33.0%) were overweight. The health care costs attributable to obesity and overweight in working asthma patients were estimated to be $878 [95% confidence interval (CI): $861-$895] and $257 (95% CI: $251-$262) per person per year, respectively, from 2003 to 2013. The productivity loss costs attributable to obesity and overweight among working asthma patients were $256 (95% CI: $253-$260) and $26 (95% CI: $26-$27) per person per year, respectively. CONCLUSION: Health care and productivity loss costs attributable to overweight and obesity in asthma patients are substantial. This study's results highlight the importance of effective public health and educational initiatives targeted at reducing overweight and obesity among patients with asthma, which may help lower the economic burden of asthma.

Cost-effectiveness of cetuximab for colorectal cancer.

INTRODUCTION: Cetuximab is a novel biological agent with superior therapeutic efficacy for colorectal cancer treatment. This study aimed to systematically review the existing evidence related to the cost-effectiveness of cetuximab. Areas covered: Using Medline and Cochrane Database of Systematic Reviews, a total of 12 articles were identified. Previous studies have shown mixed results on the cost-effectiveness of first-line cetuximab combined with FOLFIRI (5-Fluorouracil, leucovorin, irinotecan). However, cetuximab-irinotecan therapy as third-line treatment has consistently been found to be cost-ineffective compared to best supportive care or no third-line therapy. The Kristen-rat-Sarcoma-viral-oncogene (KRAS) testing strategy prior to cetuximab use has been reported as cost-effective compared with the cetuximab-containing strategy without KRAS testing. Expert commentary: The results should be interpreted with consideration of the specific healthcare settings in which cetuximab use was evaluated. Future studies are expected to examine the economic value of cetuximab compared with other newly approved biologic products.

Incidence and treatment costs attributable to medication errors in hospitalized patients.

BACKGROUND: A significant financial burden arises from medication errors that cause direct injury and those without patient harm that represent waste and inefficiency. OBJECTIVE: To estimate the incidence, types, and causes of medication errors as well as their attributable costs in a hospital setting. METHODS: For a retrospective case-control study, data were collected for 57,554 patients admitted to two New Jersey (U.S. State) hospitals during 2005-2006 as well as hospital-specific voluntary error reports from these two hospitals for the same period. Medication errors were classified into categories of stage, error type, and proximal cause, and the incidence was estimated. The costs attributable to medication errors were calculated using both the recycled prediction method, and the Blinder-Oaxaca decomposition method after propensity score matching. RESULTS: Medication errors occurred at a rate of 0.8 per 100 admissions, or 1.6 per 1000 patient days. Most errors occurred at the administration stage of the medication use process. The most frequent types of errors were wrong time, wrong medication, wrong dose, and omission errors. Treatment costs attributable to medication errors were in the range of $8,439 using the Blinder-Oaxaca decomposition method and $8,898 using the recycled prediction method. CONCLUSIONS: Medication errors are associated with significant additional costs, even without patient harm. Considering the substantial costs associated with adverse drug events, the elimination of medication errors should be further emphasized and promoted, and guidelines should be developed to facilitate this goal.

Cost Effectiveness of Monoclonal Antibody Therapy for Rare Diseases: A Systematic Review.

BACKGROUND: Monoclonal antibody (mAb)-based orphan drugs have led to advances in the treatment of diseases by selectively targeting molecule functions. However, their high treatment costs impose a substantial cost burden on patients and society. OBJECTIVES: The study aimed to systematically review cost-effectiveness evidence of mAb orphan drugs. METHODS: Ovid MEDLINE(®), EMBASE(®), and PsycINFO(®) were searched in June 2014 and articles were selected if they conducted economic evaluations of the mAb orphan drugs that had received marketing approval in the USA. The quality of the selected studies was assessed using the Quality of Health Economic Studies (QHES) instrument. RESULTS: We reviewed 16 articles that included 24 economic evaluations of nine mAb orphan drugs. Six of these nine drugs were included in cost-utility analysis studies, whereas three drugs were included in cost-effectiveness analysis studies. Previous cost-utility analysis studies revealed that four mAb orphan drugs (cetuximab, ipilimumab, rituximab, and trastuzumab) were found to be cost effective; one drug (bevacizumab) was not cost effective; and one drug (infliximab) was not consistent across the studies. Prior cost-effectiveness analysis studies which included three mAb orphan drugs (adalimumab, alemtuzumab, and basiliximab) showed that the incremental cost per effectiveness gained for these drugs ranged from $US4669 to $Can52,536 Canadian dollars. The quality of the included studies was good or fair with the exception of one study. CONCLUSIONS: Some mAb orphan drugs were reported as cost effective under the current decision-making processes. Use of these expensive drugs, however, can raise an equity issue which concerns fairness in access to treatment. The issue of equal access to drugs needs to be considered alongside other societal values in making the final health policy decisions.

Clinical outcomes and treatment cost comparison of levalbuterol versus albuterol in hospitalized adults with chronic obstructive pulmonary disease or asthma.

PURPOSE: Results of a prospective study comparing clinical outcomes and costs of levalbuterol versus albuterol therapy for exacerbations of asthma or chronic obstructive pulmonary disease (COPD) are presented. METHODS: In a single-center open-label study, selected adults hospitalized for asthma or COPD exacerbations over a 21-month period were randomly assigned to receive levalbuterol 1.25 mg three times daily (n = 55) or albuterol 2.5 mg four times daily (n = 57); dosage reductions and other respiratory therapies were permitted. Study outcomes included scheduled and rescue nebulizations, total treatment costs, hospital length of stay, and change in heart rate from baseline. RESULTS: The numbers of scheduled nebulizations were similar in the levalbuterol and albuterol groups (mean ± S.D., 19.6 ± 13.4 versus 20.7 ± 14.4; p = 0.692), as were the numbers of rescue nebulizations (mean ± S.D., 0.7 ± 1.4 versus 0.8 ± 2.0; p = 0.849). The mean change from baseline in heart rate did not differ significantly between groups. Mean total treatment costs per patient were significantly greater with the use of levalbuterol ($8003, bootstrap 95% confidence interval [CI], $6628-$9379) versus albuterol ($5772, bootstrap 95% CI, $5051-$6494; p = 0.006). Hospital length of stay was significantly greater in the levalbuterol group (mean ± S.D., 8.5 ± 5.2 days versus 6.8 ± 3.6 days with albuterol use; p = 0.040). CONCLUSION: Clinical outcomes were similar with the use of levalbuterol versus albuterol for exacerbations of COPD or asthma. On average, patients receiving levalbuterol had longer and more costly hospital stays.

Cost-effectiveness of a community-integrated home-based depression intervention in older African Americans.

OBJECTIVES: To test the cost-effectiveness of a home-based depression program: Beat the Blues (BTB). DESIGN: A cost-effectiveness analysis as part of a previously reported randomized controlled trial that compared BTB with a wait-list control group. SETTING: Community. PARTICIPANTS: English-speaking, cognitively intact (Mini-Mental State Examination score ≥24), African Americans aged 55 and older with depressive symptoms (Patient Health Questionnaire score ≥5) (N = 129). INTERVENTION: Participants randomly assigned to BTB received up to 10 home visits over 4 months from licensed social workers who provided care management, referral and linkage, stress reduction, depression education, and behavioral activation to help participants achieve self-identified goals. MEASUREMENTS: Incremental cost-effectiveness ratios (ICERs) of BTB versus wait-list controls during the 4-month study period. The primary ICER was defined as cost per quality-adjusted life year (QALY) using the Euro Quality of Life 5D (EQ-5D) and secondarily using the Health Utilities Index-3 (HUI-3). Additional ICERs were calculated using clinical measures (cost per depression improvement, cost per depression remission). Costs included BTB intervention, depression-related healthcare visits and medications, caregiver time, and social services. RESULTS: BTB cost per participant per month was $146. Base case ICERs were $64,896 per QALY (EQ-5D) and $36,875 per QALY (HUI-3). Incremental cost was $2,906 per depression improvement and $3,507 per remission. Univariate and probabilistic sensitivity analyses yielded a cost/QALY range of $20,500 to $76,500. CONCLUSION: Based on the range of cost-effectiveness values resulting from this study, BTB is a cost-effective treatment for managing depressive symptoms in older African Americans that compares favorably with the cost-effectiveness of previously tested approaches.

Trastuzumab for the treatment of HER2-positive metastatic gastric cancer : a NICE single technology appraisal.

The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of trastuzumab, Roche Pharmaceuticals, to submit evidence for the clinical and cost effectiveness of this drug for the treatment of advanced gastric cancer (aGC), as part of the Institute's single technology appraisal (STA) process. The Centre for Reviews and Dissemination (CRD) and the Centre for Health Economics (CHE) Technology Appraisal Group at the University of York was commissioned to act as the evidence review group (ERG). This article provides a description of the company submission, the ERG report and NICE's subsequent decisions. In the initial appraisal by NICE, trastuzumab was rejected for use in the licensed population. Given this result, the manufacturer submitted additional evidence. In the final appraisal decision, trastuzumab was approved, in accordance with supplementary guidance issued by NICE on appraising life-extending, end-of-life treatments, for patients whose human epidermal growth factor receptor 2 (HER2) status was defined by an immunohistochemistry 3 positive (IHC3+) result. This appraisal highlights the need to fully assess the impact of different approaches to diagnostic testing on the cost effectiveness of targeted treatments. In this appraisal, it was found that the diagnostic strategy influenced the effectiveness and cost of trastuzumab. In the future, different diagnostic strategies should be compared in the incremental cost-effectiveness analysis.