This paper presents a summary of the evidence review group (ERG) report into the evidence for the clinical effectiveness and cost-effectiveness of gemcitabine with paclitaxel for the first-line treatment of metastatic breast cancer (MBC) in patients who have already received chemotherapy treatment with an anthracycline, compared with current standard of care, based upon the manufacturer's submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The clinical evidence for gemcitabine as a treatment for MBC comes from the unpublished JHQG trial (some data commercial-in-confidence): overall survival was 3 months longer for the gemcitabine/paclitaxel arm (18.5 months) than for the paclitaxel arm (15.8 months) (p = 0.0489); gemcitabine/paclitaxel also improved tumour response and time to documented progression of disease compared with paclitaxel monotherapy, but haematological serious adverse events were more common. In the absence of any formal methods of indirect comparison there is insufficient robust evidence to compare the relative effectiveness of gemcitabine/paclitaxel with docetaxel monotherapy or docetaxel/capecitabine combination therapy. The manufacturers used a Markov state transition model to estimate the effect of treatment with five different chemotherapy regimes, adopting a 3-year time horizon with docetaxel monotherapy as the comparator. Health state utilities for different stages of disease progression and for patients experiencing treatment-related toxicity are used to derive quality-adjusted life expectancy with each treatment. The base-case cost-effectiveness estimate for gemcitabine/paclitaxel versus docetaxel is £17,168 per quality-adjusted life-year (QALY). This report contains reference to confidential information provided as part of the NICE appraisal process. This information has been removed from the report and the results, discussions and conclusions of the report do not include the confidential information. These sections are clearly marked in the report. DOI: 10.3310/hta13suppl2/01Gemcitabine for the treatment of metastatic breast cancer 2 When longer survival with docetaxel is assumed in a sensitivity analysis, the incremental costeffectiveness ratio (ICER) is £30,000 per QALY. Probabilistic sensitivity analysis estimates a 70% probability of gemcitabine/paclitaxel being costeffective relative to docetaxel at a willingness-topay threshold of £35,000. There is considerable uncertainty over the results because of the lack of formal quality assessment or assessment of the comparability of the 15 trials included in the input data, and the questionable validity of the indirect comparison method adopted. An illustrative analysis using a different method for indirect comparison carried out by the ERG produces an ICER of £45,811 per QALY for gemcitabine/ paclitaxel versus docetaxel. The guidance issued by NICE in November 2006 as a result of the STA states that gemcitabine in combination with paclitaxel, wit...

Joint military humanitarian missions provide challenges and rewards for mental health nursing not found in the garrison mission. A primary challenge is to develop and implement programs that benefit the various populations inherent in such missions. During Operation Sea Signal, several programs, such as migrant adult day treatment, halfway house, outreach, and inpatient, led to the overall enhancement of mental health nursing care for the Cuban and Haitian migrants. It also gave the participating mental health nursing team of professionals and enlisted technicians the opportunity to develop their nursing expertise and sensitivity in a culturally diverse situation.

This paper presents a summary of the evidence review group (ERG) report into the evidence for the clinical effectiveness and cost-effectiveness of gemcitabine with paclitaxel for the first-line treatment of metastatic breast cancer (MBC) in patients who have already received chemotherapy treatment with an anthracycline, compared with current standard of care, based upon the manufacturer’s submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The clinical evidence for gemcitabine as a treatment for MBC comes from the unpublished JHQG trial (some data commercial-in-confidence): overall survival was 3 months longer for the gemcitabine/paclitaxel arm (18.5 months) than for the paclitaxel arm (15.8 months) (p = 0.0489); gemcitabine/paclitaxel also improved tumour response and time to documented progression of disease compared with paclitaxel monotherapy, but haematological serious adverse events were more common. In the absence of any formal methods of indirect comparison there is insufficient robust evidence to compare the relative effectiveness of gemcitabine/paclitaxel with docetaxel monotherapy or docetaxel/capecitabine combination therapy. The manufacturers used a Markov state transition model to estimate the effect of treatment with five different chemotherapy regimes, adopting a 3-year time horizon with docetaxel monotherapy as the comparator. Health state utilities for different stages of disease progression and for patients experiencing treatment-related toxicity are used to derive quality-adjusted life expectancy with each treatment. The base-case cost-effectiveness estimate for gemcitabine/paclitaxel versus docetaxel is £17,168 per quality-adjusted life-year (QALY). When longer survival with docetaxel is assumed in a sensitivity analysis, the incremental cost-effectiveness ratio (ICER) is £30,000 per QALY. Probabilistic sensitivity analysis estimates a 70% probability of gemcitabine/paclitaxel being cost-effective relative to docetaxel at a willingness-to-pay threshold of £35,000. There is considerable uncertainty over the results because of the lack of formal quality assessment or assessment of the comparability of the 15 trials included in the input data, and the questionable validity of the indirect comparison method adopted. An illustrative analysis using a different method for indirect comparison carried out by the ERG produces an ICER of £45,811 per QALY for gemcitabine/paclitaxel versus docetaxel. The guidance issued by NICE in November 2006 as a result of the STA states that gemcitabine in combination with paclitaxel, within its licensed indication, is recommended as an option for the treatment of MBC only when docetaxel monotherapy or docetaxel plus capecitabine is also considered appropriate.

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106 Background: Costs for cancer patients are not all monetary. For patients with limited life expectancy, such as metastatic breast cancer (MBC) patients, time spent in the hospital or clinic setting can become burdensome. The goal was to evaluate time spent on healthcare among patients receiving treatment for MBC. Methods: This survey-based, cross-sectional study included women ≥18 years with MBC who received treatment at two academic medical centers in Alabama from 2017-2019. Questions regarding employment status, MBC-related hours missed from work, and time spent on healthcare-related activities were used to quantify lost productivity and time. Descriptive statistics included means and standard deviations (SD) or medians and interquartile ranges (IQR) for continuous variables and frequencies for categorical variables. Effect sizes were calculated using Cohen’s d or Cramer’s V. Results: We surveyed 83 female MBC patients with a median age of 59 years (IQR 50-66). Among all respondents, 34% were African American, 41% held a college degree, and 52% had a household income of < $40,000. Patients spent a median 60 minutes (IQR 30-110) traveling from their home to clinic and a median 120 minutes (IQR 60-180) receiving care at a clinic visit. Though not statistically significant, modest differences were found for patients with differing insurance types in travel time. Patients with Medicare had the shortest travel time (median 45 minutes [IQR 30-75]) compared to Medicaid (60 minutes [IQR 60-80]) and private insurance (60 minutes [IQR 30-120]; d = .06).). Patients spent a median 30 minutes (IQR 0-60) on cancer care related activities outside of a clinic visit. Most patients were retired (31%); however, 15% worked full-time, 6% worked part-time, and 20% were on disability. For working women, a median of 8 hours (IQR 1-11) were missed from work in the week. Conclusions: This study highlights productivity losses uncaptured by current patient healthcare cost calculations. Further work is needed to identify and minimize these additional patient costs related to lost productivity during cancer treatment.