Patient and Family Caregiver Considerations When Selecting Early Breast Cancer Treatment: Implications for Clinical Pathway Development.

BACKGROUND: While clinical pathways have been widely adopted to decrease variation in cancer treatment patterns, they do not always incorporate patient and family caregiver perspectives. We identified shared patient and family caregiver considerations influencing treatment preferences/decision making to inform development of a shared decision pathway. METHODS: We conducted qualitative interviews with women who completed initial definitive treatment for stage I-III breast cancer and their family caregivers. As part of a broader interview, we asked participants what they considered when choosing a treatment option for themselves/their loved one. We coded transcribed interviews, analyzed patient and family caregiver datasets separately, and compared findings. Findings Patients' (n = 22) mean age was 55.7 years, whereas family caregivers' (n = 20) mean age was 59.5 years, with most (65%) being patients' spouses/partners. Considerations reported by both groups included cancer status, treatment issues, physical/psychosocial/family consequences, and provider/health care system issues. Data revealed three key tensions that arise during treatment decision making: (1) having enough information to set expectations but not so much as to be overwhelming; (2) balancing the highest likelihood of cure with potential physical/emotional/social/financial consequences of the chosen treatment; and (3) wanting to make data-driven decisions while having a personalized treatment plan. DISCUSSION: Patients and family caregivers identified several considerations of shared relevance reflecting different perspectives. Efforts to balance considerations can produce tensions that may contribute to decision regret if unaddressed. CONCLUSION: Clinical pathways can increase exposure to decision regret if treatment options are selected without consideration of patients' priorities. A shared decision pathway that incorporates patient-centeredness could facilitate satisfactory decision making.

A clinical pathway is a tool used by doctors and nurses to help them plan how they will take care of patients. Clinical pathways do not always include what is important to patients and their families. We spoke with patients with breast cancer and their family members. We wanted to learn what is important to them when they are making decisions about how the patient will be treated for cancer. They reported thinking about the kind of cancer the patient had and about pros and cons of different treatment choices. They also thought about how much is known about different treatment choices. Other patients' stories were important. Patients and family members wanted to know how a treatment would affect their bodies, feelings, normal roles in life, and families. They also thought about their relationship with their doctors and nurses and about how they would pay for their care. It was seen as hard to balance these things when making decisions. Patients and family members wanted to make decisions they would be happy with later. We will use this information to create a new clinical pathway. This tool will help patients with breast cancer, family members, doctors, and nurses work together to make the best decisions about the patient's cancer.

Comparative effectiveness of first-line nab-paclitaxel versus paclitaxel monotherapy in triple-negative breast cancer.

Aim: This observational study evaluated the effectiveness of nab-paclitaxel versus paclitaxel monotherapy as first-line (1L) treatment for metastatic triple-negative breast cancer (mTNBC). Materials & methods: 200 patients from the US Flatiron Health electronic health record-derived database (mTNBC diagnosis, January 2011-October 2016) who received 1L nab-paclitaxel (n = 105) or paclitaxel (n = 95) monotherapy were included. Overall survival and time to next treatment were evaluated. Results: The adjusted overall survival hazard ratio was 0.98 (95% CI: 0.67-1.44), indicating a similar risk of death between groups. Adjusted time to next treatment hazard ratio was 0.89 (95% confidence interval: 0.62-1.29). Conclusion: Nab-paclitaxel and paclitaxel monotherapy showed similar efficacy, suggesting their interchangeability as 1L treatments for mTNBC.

Private sector risk-sharing agreements in the United States: trends, barriers, and prospects.

OBJECTIVES: Risk-sharing agreements (RSAs) between drug manufacturers and payers link coverage and reimbursement to real-world performance or utilization of medical products. These arrangements have garnered considerable attention in recent years. However, greater use outside the United States raises questions as to why their use has been limited in the US private sector, and whether their use might increase in the evolving US healthcare system. STUDY DESIGN: To understand current trends, success factors, and challenges in the use of RSAs, we conducted a review of RSAs, interviews, and a survey to understand key stakeholders' experiences and expectations for RSAs in the US private sector. METHODS: Trends in the numbers of RSAs were assessed using a database of RSAs. We also conducted in-depth interviews with stakeholders from pharmaceutical companies, payer organizations, and industry experts in the United States and European Union. In addition, we administered an online survey with a broader audience to identify perceptions of the future of RSAs in the United States. RESULTS: Most manufacturers and payers expressed interest in RSAs and see potential value in their use. Due to numerous barriers associated with outcomes-based agreements, stakeholders were more optimistic about financial-based RSAs. In the US private sector, however, there remains considerable interest--improved data systems and shifting incentives (via health reform and accountable care organizations) may generate more action. CONCLUSIONS: In the US commercial payer markets, there is continued interest among some manufacturers and payers in outcomes-based RSAs. Despite continued discussion and activity, the number of new agreements is still small.

Targeted erlotinib for first-line treatment of advanced non-small cell lung cancer: a budget impact analysis.

OBJECTIVES: A recent phase III trial showed that patients with advanced non-small cell lung cancer (NSCLC) whose tumors harbor specific EGFR mutations significantly benefit from first-line treatment with erlotinib compared to chemotherapy. This study sought to estimate the budget impact if coverage for EGFR testing and erlotinib as first-line therapy were provided in a hypothetical 500,000-member managed care plan. METHODS: The budget impact model was developed from a US health plan perspective to evaluate administration of the EGFR test and treatment with erlotinib for EGFR-positive patients, compared to non-targeted treatment with chemotherapy. The eligible patient population was estimated from age-stratified SEER incidence data. Clinical data were derived from key randomized controlled trials. Costs related to drug, administration, and adverse events were included. Sensitivity analyses were conducted to assess uncertainty. RESULTS: In a plan of 500,000 members, it was estimated there would be 91 newly diagnosed advanced NSCLC patients annually; 11 are expected to be EGFR-positive. Based on the testing and treatment assumptions, it was estimated that 3 patients in Scenario 1 and 6 patients in Scenario 2 receive erlotinib. Overall health plan expenditures would increase by $0.013 per member per month (PMPM). This increase is largely attributable to erlotinib drug costs, in part due to lengthened progression-free survival and treatment periods experienced in erlotinib-treated patients. EGFR testing contributes slightly, whereas adverse event costs mitigate the budget impact. The budget impact did not exceed $0.019 PMPM in sensitivity analyses. CONCLUSIONS: Coverage for targeted first-line erlotinib therapy in NSCLC likely results in a small budget impact for US health plans. The estimated impact may vary by plan, or if second-line or maintenance therapy, dose changes/interruptions, or impact on patients' quality-of-life were included.

A risk-benefit analysis of factor V Leiden testing to improve pregnancy outcomes: a case study of the capabilities of decision modeling in genomics.

PURPOSE: We sought to assess the benefits, risks, and personal utility of factor V Leiden mutation testing to improve pregnancy outcomes and to assess the utility of decision-analytic modeling for complex outcomes in genomics. METHODS: We developed a model to evaluate factor V Leiden testing among women with a history of recurrent pregnancy loss, including heparin therapy during pregnancy in mutation-positive women. Outcomes included venous thromboembolism, major bleeds, pregnancy loss, maternal mortality, and quality-adjusted life-years. RESULTS: Factor V Leiden testing in a hypothetical cohort of 10,000 women led to 7 fewer venous thromboembolic events, 90 fewer pregnancy losses, and an increase of 17 major bleeding events. Small improvements in quality-adjusted life-years were largely attributable to reduced mortality but also to improvements in health-related quality of life. However, sensitivity analyses indicate large variance in results due to data uncertainty. Furthermore, the complexity of outcomes limited our ability to fully capture the repercussions of testing in the quality-adjusted life-year measure. CONCLUSION: Factor V Leiden testing involves tradeoffs between clinical and personal utility, and additional effectiveness data are needed for heparin use to prevent pregnancy loss. Decision-analytic methods offer somewhat limited value in assessing these tradeoffs, suggesting that evaluation of complex outcomes will require novel approaches to appropriately capture patient-centered outcomes.Genet Med 2013:15(5):374-381.