Economic evaluation for the US of nab-paclitaxel plus gemcitabine versus FOLFIRINOX versus gemcitabine in the treatment of metastatic pancreas cancer

Background: Nab-paclitaxel plus gemcitabine (NAB-P?+?GEM) and FOLFIRINOX have shown superior efficacy over gemcitabine (GEM) in the treatment of metastatic pancreatic ductal adenocarcinoma (mPDA). Although the incremental clinical benefits are modest, both treatments represent significant advances in the treatment of a high-mortality cancer. In this independent economic evaluation for the US, the aim was to estimate the comparative cost-utility and cost-effectiveness of these three regimens from the payer perspective.

Methods: In the absence of a direct treatment comparison in a single clinical trial, the Bucher indirect comparison method was used to estimate the comparative efficacy of each regimen. A Markov model evaluated life years (LY) and quality-adjusted life years (QALY) gained with NAB-P?+?GEM and FOLFIRINOX over GEM, expressed as incremental cost-effectiveness (ICER) and cost-utility ratios (ICUR). All costs and outcomes were discounted at 3%/year. The impact of parameter uncertainty on the model was assessed by probabilistic sensitivity analyses.

Results: NAB-P?+?GEM was associated with differentials of +0.180 LY and +0.127 QALY gained over GEM at an incremental total cost of $25,965; yielding an ICER of $144,096/LY and ICUR of $204,369/QALY gained. FOLFIRINOX was associated with differentials of +0.368 LY and +0.249 QALY gained over GEM at an incremental total cost of $93,045; yielding an ICER of $253,162/LY and ICUR of $372,813/QALY gained. In indirect comparison, the overall survival hazard ratio (OS HR) for NAB-P?+?GEM vs FOLFIRINOX was 0.79 (95%CI?=?0.59–1.05), indicating no superiority in OS of either regimen. FOLFIRINOX had an ICER of $358,067/LY and an ICUR of $547,480/QALY gained over NAB-P?+?GEM. Tornado diagrams identified variation in the OS HR, but no other parameters, to impact the NAB-P?+?GEM and FOLFIRINOX ICURs.

Conclusions: In the absence of a statistically significant difference in OS between NAB-P?+?GEM and FOLFIRINOX, this US analysis indicates that the greater economic benefit in terms of cost-savings and incremental cost-effectiveness and cost-utility ratios favors NAB-P?+?GEM over FOLFIRINOX.     

Cost drivers for breast,lung, and colorectal cancer care in a commercially insured population over a 6-month episode: an economic analysis from a health plan perspective

Aims: In the absence of clinical data, accurate identification of cost drivers is needed for economic comparison in an alternate payment model. From a health plan perspective using claims data in a commercial population, the objective was to identify and quantify the effects of cost drivers in economic models of breast, lung, and colorectal cancer costs over a 6-month episode following initial chemotherapy.

Research design and methods: This study analyzed claims data from 9,748 Cigna beneficiaries with diagnosis of breast, lung, and colorectal cancer following initial chemotherapy from January 1, 2014 to December 31, 2015. We used multivariable regression models to quantify the impact of key factors on cost during the initial 6-month cancer care episode.

Results: Metastasis, facility provider affiliation, episode risk group (ERG) risk score, and radiation were cost drivers for all three types of cancer (breast, lung, and colorectal). In addition, younger age (p?p?p?p?p?Conclusions: Value-based reimbursement models in oncology should appropriately account for key cost drivers. Although claims-based methodologies may be further augmented with clinical data, this study recommends adjusting for the factors identified in these models to predict costs in breast, lung, and colorectal cancers.     

The real-world cost-effectiveness of adjuvant trastuzumab in HER-2/neu-positive early breast cancer in Taiwan

Background: Trastuzumab was considered a cost-effective adjuvant treatment for HER 2-positive early breast cancer. Since 2010, the Taiwanese National Health Insurance (NHI) has started to reimburse for 1-year adjuvant treatment. This study aims to provide an updated cost-effectiveness analysis from the NHI perspective, which explores assumptions about long-term cardiac toxicity and treatment benefit of 1-year adjuvant treatment sequentially after chemotherapy.

Methods: A Markov model was used to evaluate the cost-effectiveness of 1-year adjuvant trastuzumab for HER-2/neu positive early breast cancer over a 20-year life-time horizon. A probability sensitivity analysis using Monte Carlo simulation was performed to characterize uncertainties in the expected outcomes, which are expressed as an incremental costs effectiveness ratio (ICER, cost/QALY). A willingness-to-pay threshold of 3-times the per capita gross domestic product was adopted according to the WHO definition. The Taiwan per capita gross domestic product in 2015 was US$22,355; thus, a threshold was considered as NT$2,011,950 (US$67 065, 1USD?=30 NTD in 2015).

Results: The model showed that adjuvant trastuzumab treatment in HER-2/neu positive early breast cancer yielded 1.631 quality-adjusted life-years (QALY) compared with no trastuzumab treatment. The ICER was US $51,863 per QALY gained in the base-case scenario. The Monte Carlo simulation by varying all variables simultaneously demonstrated that the probability of cost-effectiveness at the willingness-to-pay threshold of US$67,065 was 50% for 1-year adjuvant trastuzumab.

Conclusions: From this real-world study, 1-year adjuvant trastuzumab treatment is likely to be a cost-effective therapy for patients with HER-2 positive breast cancer at the willingness-to-pay threshold of 3-times GDP per capita in Taiwan.     

特发性肺间质纤维化合并肺癌

特发性肺纤维化是常见的肺间质性疾病,发病率逐年上升,且近年来出现了大量关于特发性肺纤维化合并肺癌肺的报道。多项研究证实,肺纤维化患者的肺癌发病率高而且预后差。本文复习了近期相关的文献,对于特发性肺纤维化合并肺癌的流行病学、发病机理、临床与影像学特点、病理学特点及预后等进行文献复习,旨在提高临床工作者对该病的认识,提高警觉,以期达到特发性肺纤维化合并肺癌肺的早期发现和诊疗。     

Cost of adverse events during treatment with everolimus plus exemestane or single-agent chemotherapy in patients with advanced breast cancer in Western Europe

Objective:

Treatment options for recurrent or progressive hormone receptor-positive (HR+) advanced breast cancer include chemotherapy and everolimus plus exemestane (EVE?+?EXE). This study estimates the costs of managing adverse events (AEs) during EVE?+?EXE therapy and single-agent chemotherapy in Western Europe.

Methods:

An economic model was developed to estimate the per patient cost of managing grade 3/4 AEs for patients who were treated with EVE?+?EXE or chemotherapies. AE rates for patients receiving EVE?+?EXE were collected from the phase III BOLERO-2 trial. AE rates for single-agent chemotherapy, capecitabine, docetaxel, or doxorubicin were collected from published clinical trial data. AEs with at least 2% prevalence for any of the treatments were included in the model. A literature search was conducted to obtain costs of managing each AE, which were then averaged across Western European countries (when available). Per patient costs for managing AEs among patients receiving different therapies were reported in 2012 euros (€).

Results:

The EVE?+?EXE combination had the lowest average per patient cost of managing AEs (€730) compared to all chemotherapies during the first year of treatment (doxorubicin: €1230; capecitabine: €1721; docetaxel: €2390). The most costly adverse event among all patients treated with EVE?+?EXE was anemia (on average €152 per patient). The most costly adverse event among all patients treated with capecitabine, docetaxel, or doxorubicin was lymphocytopenia (€861 per patient), neutropenia (€821 per patient), and leukopenia (€382 per patient), respectively.

Conclusions:

The current model estimates that AE management during the treatment of HR+ advanced breast cancer will cost one-half to one-third less for EVE?+?EXE patients than for chemotherapy patients. The consideration of AE costs could have important implications in the context of healthcare spending for advanced breast cancer treatment.     

体部伽玛刀联合化疗治疗中晚期非小细胞肺癌的临床疗效

目的:评价体部伽玛刀联合化疗治疗中晚期非小细胞肺癌(NSCLC)的临床疗效。方法:观察中晚期NSCLC患者186例,体部伽玛刀治疗单次外周剂量4～5Gy,治疗次数8～12次,总剂量40～50Gy;放疗结束后2周实施化疗,使用吉西他滨(Gemcitabine)1000mg/㎡,第1、8天,顺铂(DDP)30mg/㎡,第1-3天,每21天为1周期,至少完成2周期化疗,伽玛刀治疗结束后3月评价疗效。结果:186例患者均完成治疗,近期疗效评价总有效率(CR+PR)88.17%,随访36与月,1年生存率61.29%,2年生存率42.47%,3年生存率33.87%。随访期内未见严重放射性并发症。结论:采用体部伽玛刀联合化疗治疗中晚期肺癌,具有较高的近期疗效,毒副反应较轻,患者可以耐受     

Economic impact of different preparations of leuprolide acetate in the management of advanced prostate cancer

This study aimed to compare the economic impact of 1-,3-and 6-monthly preparations of leuprolide acetate, a luteinising hormone-releasing hormone agonist (LHRHa), in the treatment of prostate cancer.

Using three published open-label multicentre clinical trials involving the use of each of the three LHRHa preparations, a cost minimisation analysis was undertaken.

The mean annual costs of managing advanced prostate cancer patients with the 1-,3-and 6-monthly preparations were e2,839 (standard deviation (sd) e233), e1,777 (sd e1 95) and e1,567 (sDe204), respectively.

The study concludes that, despite a higher unit price, use of the 6-monthly formulation of leuprolide acetate provides the lowest cost treatment option, the cost driver being the reduction in the number of treatments required. Germany was used as a case study to highlight the impact of health policies on the adoption of such cost optimisation treatment options in prostate cancer patients.     

Consumers’ views of breast care services in Ireland

One Irish woman in 14 develops breast cancer. There are 1700 new cases each year. These rates compare poorly with EU figures. The government indicated in 1995 that it favoured rapid, comprehensive diagnostic facilities, using the triple assessment model of clinical care, to improve survival rates and to diminish the anxiety women experience about breast cancer. Implementation of this policy was delayed until 1999, when a plan for centres of excellence in breast care was conceived. To compliment this plan, the Department of Health and Children wanted consumer views on existing breast care services. The Women’s Health Council was asked by the Department of Health and Children, through the National Cancer Forum, to conduct research on women’s views and reactions as consumers of existing services for symptomatic breast disease. The research team was asked to document women’s views on: diagnostic services; counselling; additional treatment services such as surgery and radiotherapy. The methodology consisted of four strands: questionnaires and focus groups with consumers of breast care services; postal questionnaires to clinic staff and a literature review. Striking aspects were the long delays women experienced before obtaining a completed diagnosis; often chaotic clinic settings which added greatly to women’s shock and anxiety; the lack of support if they received a diagnosis of cancer; and problems relating to limited resources for cancer treatment, including radiotherapy. We explored women’s coping mechanisms and their experiences, in the context of the model of quality of care. Finally, we argue that a centre of excellence must develop a multidimensional model of breast disease care that incorporates the full range of psycho‐social dimensions for women, if it is to earn its claim to excellence.     

Community governance

American politics, especially at the national level, has become dysfunctional; citizens are deeply frustrated with their political leaders and feel that political institutions are unresponsive and corrupted by entrenched power and money. Government leaders must bear the brunt of this anger and distrust, and subsequently feel a sense of disconnection between themselves and those whom they serve. Ironically, at the same time as the ability of local government to solve problems is severely hindered due to this ‘disconnect,' devolution at the federal and state level is forcing local government to take more and more responsibility for resolving local challenges. This essay argues that the solution to this impasse lies in re-inventing the way communities operate—we need to make a shift from government to governance. The dominant model of local politics, which fit the political landscape of the 1940s–1970s, vested decision making authority solely with governmental leadership; citizens voted and governors governed. This essay describes a new mode of operation, one where non-governmental actors are ‘granted a seat at the table.' In this model the goal of political struggles is no longer to defeat your enemy, but to reach collaborative, consensus-based decisions; government, business, community groups and citizens work together; and leaders share power, working to enable others to decide issues.     

Costs of hospital events in patients with metastatic colorectal cancer

Abstract

Background:

In the last decade, the number of new agents, including monoclonal antibodies, being developed to treat metastatic colorectal cancer (mCRC) increased rapidly. While improving outcomes, these new treatments also have distinct and known safety profiles with toxicities that may require hospitalizations. However, patterns and costs of hospitalizations of toxicities of these new ‘targeted’ drugs are often unknown.

Objective:

This study aimed to estimate the costs of hospital events associated with adverse events specified in the ‘Special Warnings and Precautions for Use’ section of the European Medicinal Agency Summary of Product Characteristics for bevacizumab, cetuximab, and panitumumab, in patients with mCRC.

Methods:

From the PHARMO Record Linkage System (RLS), patients with a primary or secondary hospital discharge code for CRC and distant metastasis between 2000–2008 were selected and defined as patients with mCRC. The first discharge diagnosis defining metastases served as the index date. Patients were followed from index date until end of data collection, death, or end of study period, whichever occurred first. Hospital events during follow-up were identified through primary hospital discharge codes. Main outcomes for each event were length of stay and costs per hospital admission.

Results:

Among 2964 mCRC patients, 271 hospital events occurred in 210 patients (mean [SD] duration of follow-up: 34 [31] months). The longest mean (SD) length of stay per hospital admission were for stroke (16 [33] days), arterial thromboembolism (ATE) (14 [21] days), wound-healing complications (WHC), acute myocardial infarction (AMI), congestive heart failure (CHF), and neutropenia (all 9 days; SD 5–15). Highest mean (SD) costs per admission were for stroke (€13,500 [€28,800]), ATE (€13,300 [€18,800]), WHC (€10,800 [€20,500]).

Limitations:

Although no causal link could be identified between any specific event and any specific treatment, data from this study are valuable for pharmacoeconomic evaluations of newer treatments in mCRC patients.

Conclusions:

Inpatient costs for events in mCRC patients are considerable and vary greatly.