Unintended Consequences in Cancer Care Delivery Created by the Medicare Part B Proposal: Is the Clinical Rationale for the Experiment Flawed?

PURPOSE: Medicare currently enrolls ≥ 45 million adults, and by 2030 this is projected to increase to ≥ 80 million beneficiaries. With this growth, the Centers for Medicare & Medicaid Services (CMS) issued a proposal, the Medicare Part B Drug Payment Model, to shrink drug expenditures, a major contributor to overall health care costs. For this to not adversely affect patient outcomes, lower-cost alternative medications with equivalent efficacy and no increased toxicity must be available. This is often not true in the treatment of cancer. Herein, we examine the flaws in the rationale of the CMS and the potential unintended consequences of this experiment. METHODS: We identified the top three oncology expenditures (rituximab, bevacizumab, and trastuzumab) and their vetted alternatives (per the National Comprehensive Cancer Network guidelines) to ascertain whether lower-cost equivalent alternatives are available. Drug cost was based on April 2016 average sale price. We explored both efficacy of the agents and, when applicable, toxicity to compare alternatives to these high-dollar medications. RESULTS: For the largest Medicare oncology drug expenditures, there is not a lower-cost option with equal efficacy for their primary indications. Without lower-cost alternatives, the unintended consequence of this CMS experiment may include curtailing access to care or an increase in patient/program costs. CONCLUSION: The CMS proposal, by simply lowering reimbursement for drugs, does not acknowledge the value of these agents and could unintentionally reduce quality of care. Alternative approaches to value-based care, such as the Oncology Care Model and similar frameworks, should be explored.

Safety and treatment patterns of angiogenesis inhibitors in patients with metastatic renal cell carcinoma: evidence from US community oncology clinics.

Safety and treatment patterns of sunitinib and sorafenib in metastatic renal cell carcinoma (mRCC) had been previously reported using retrospective chart review of patients treated in US tertiary centers. Because practice patterns may vary between hospital- and office-based settings, this study examined safety and treatment patterns of these agents in US community oncology clinics. Medical records were retrospectively reviewed for 250 patients with mRCC treated at 18 community oncology clinics. Eligible patients were ≥18 years old and received ≥1 prescription for sunitinib (n = 131) or sorafenib (n = 119) as first-line anti-angiogenic treatment. Rates of adverse events (AEs) and treatment modifications were analyzed; reasons for treatment modifications were examined. Median duration of first-line sunitinib and sorafenib treatment was 5.9 and 5.5 months, respectively. Among patients treated with sunitinib and sorafenib, 86% (30%) and 87% (28%), respectively, experienced ≥1 all-grade (grade 3/4) AE. The most common AEs were fatigue/weakness in sunitinib (all-grade: 42%; grade 3/4: 5%) and skin rash in sorafenib (all-grade: 35%; grade 3/4: 6%). Sixty-two and 64% of patients treated with sunitinib and sorafenib, respectively, had ≥1 treatment modification due to AEs. Recorded AE rates in patients with mRCC treated with angiogenesis inhibitors in community practice tended to be lower than in tertiary centers, possibly due to shorter treatment duration. Rates of treatment modifications due to AEs tended to be higher in community practice. This study provides evidence from an office-based setting of unmet need for agents that may provide improved tolerability in mRCC.

Predictors of response to sequential sunitinib and the impact of prior VEGF-targeted drug washout in patients with metastatic clear-cell renal cell carcinoma.

OBJECTIVE: To identify factors that can be used to identify metastatic clear cell RCC patients more likely to benefit from sequential sunitinib. PATIENTS AND METHODS: We identified patients who failed sorafenib or bevacizumab and subsequently received sunitinib. We looked at objective response rates (ORR), progression-free survival (PFS), and overall survival (OS) to sunitinib in relation to baseline clinical variables. RESULTS: Seventy-one patients received sunitinib sequential therapy. Median duration of follow-up after starting sunitinib was 9.3 months. Median PFS was 5.8 months; median OS was not reached. Significantly higher ORR was seen in patients with normal hemoglobin (25.6%) [defined as >12 gm/dl for female; >13 gm/dl for male]. In addition, a shorter PFS for patients with low hemoglobin, and patients with time from diagnosis to first treatment ≤ 1 year was found. There was a shorter OS for patients ≥ 60 years old, with brain metastasis, low hemoglobin, and time from diagnosis to treatment ≤ 1 year. There was no difference in ORR, PFS, or OS in patients who started sunitinib after or within a 30-day period. CONCLUSIONS: Metastatic clear-cell RCC patients with anemia have less clinical benefit from sequential sunitinib after failure of bevacizumab or sorafenib. Other factors associated with poor outcome include brain metastases, older age, and <1 year between diagnosis and first treatment. Importantly, no difference in outcomes was observed if sequential therapy was initiated within or after 30 days. External validation and prospective evaluation are needed to confirm these findings.

Utility of routine nurse assessment of the risk of chemotherapy-induced febrile neutropenia.

Evidence-based guidelines recommend that patients at high risk (> or = 20%) for febrile neutropenia (FN) should receive prophylactic colony-stimulating factors (Aapro et al., 2006; Kouroukis et al., 2008; National Comprehensive Cancer Network [NCCN], 2008; Smith et al., 2006). We studied the utility of having nurses routinely assess FN risk in new patients before the initiation of chemotherapy. Fifteen nurses used a standardized tool to evaluate FN risk in 150 patients. In 94% of patients studied, nurses detected risk factors that prompted interventions to reduce the incidence of FN. On final evaluation, 67% of nurses said the use of a standardized tool helped them to identify patients at risk for FN, and 73% planned to assess FN risk routinely. Thus, it is feasible and valuable for nurses to assess FN risk using a standardized checklist prior to the initiation of chemotherapy.

Treatment of transfusional iron overload in patients with myelodysplastic syndrome or severe anemia: data from multicenter clinical practices.

BACKGROUND: Patients with myelodysplastic syndrome (MDS) or severe anemia requiring repeated red blood cell (RBC) transfusions risk developing transfusional iron overload, which can reduce survival. Iron chelation therapy (ICT) has been shown to improve survival and quality of life in patients; however, ICT utilization in clinical practices is not well understood. STUDY DESIGN AND METHODS: Medical records of patients diagnosed with MDS or severe anemia at least 6 months before data extraction, aged at least 21 years at diagnosis, and who received at least one RBC transfusion were reviewed. ICT eligibility was defined as at least 20 units of RBCs transfused or at least two serum ferritin levels exceeding 1000 microg/L. Study endpoint was ICT treatment rate among ICT-eligible patients with lower-risk MDS (International Prognostic Scoring System [low or intermediate-1]; World Health Organization [refractory anemia {RA}, refractory anemia with ringed sideroblasts {RARS}, refractory cytopenia with multilineage dysplasia {RCMD}, refractory cytopenia with multilineage dysplasia and ringed sideroblasts, or 5q]; French-American-British [RA/RARS]). RESULTS: Among 78 ICT-eligible patients with lower-risk MDS, 32 (41%) received ICT. At ICT initiation, treated patients received on average 13.3 transfusions (27.6 units) and mean first post-ICT initiation serum ferritin was twice the MDS Foundation recommendation at 1949 microg/L. Median overall survival for all ICT-eligible patients was significantly longer for those ICT-treated patients than untreated patients (8.7 years vs. 4.7 years, log-rank p = 0.02; multivariate hazard ratio 0.372, p = 0.03). CONCLUSION: This study finds only 41% of ICT-eligible patients with lower-risk MDS received ICT in clinical practice, and treatment was initiated later than recommended. Receipt of ICT was associated with significantly longer survival.

Health economic analysis of the burden of infusion reactions on patients, caregivers, and providers.

The cost and efficiency of medical care is an ongoing issue that has a particular effect on patients and caregivers within the community oncology setting. Monoclonal antibody (MoAb) therapy has proven to be effective in the treatment of cancer patients. Although MoAbs are associated with minimal toxicity, they can cause infusion reactions (IRs) in some patients. Managing these infusion reactions leads to an increased burden on patients, caregivers, and providers. Health economic models can quantify the burden that MoAb-induced IRs have on the patient and can help identify ways to maximize the efficiency of providing quality health care. This review identifies the specific burden, including tasks and associated costs, that IRs have on the patient and caregivers, and discusses the importance of using this information to help manage IRs. Nurses are often the first to respond when an IR occurs and the particular impact IRs have on nurses is reviewed. Patients, caregivers, and providers should be aware of the potential burden that MoAb-induced IRs can have on a patient and use this information to help guide clinical decisions.

A retrospective study of quality of life in a community sample of patients with early stage breast cancer.

Few studies have examined the pattern of change in quality of life (QoL) over time among patients with breast cancer, or the impact of disease recurrence on QoL. This retrospective study examined QoL among patients with stage I-IIIB breast cancer. Individual, disease and treatment characteristics were abstracted from the medical record, and linked with QoL data collected as a routine part of patient care. The sample included patients with nonrecurrent (N = 100) and recurrent (N = 19) disease, who completed 1,449 QoL assessments. Linear mixed model analysis showed that disease recurrence significantly and adversely affected QoL across all domains. QoL did not appear to deteriorate before recurrence. The pattern of adjustment after recurrence varied across QoL domains in theoretically consistent ways. Study findings suggest that patients show improvement in some areas after recurrence, but generally do not recover previous levels of QoL.

Implications of IV monoclonal antibody infusion reaction for the patient, caregiver, and practice: results of a multicenter study.

GOALS OF WORK: Targeted monoclonal antibodies (MoAbs) have become a promising treatment option for patients with cancer. However, there is a risk of developing infusion reactions (IRs) with MoAbs. This study was conducted to evaluate the impact of IRs on staff time and costs among patients receiving an initial infusion of cetuximab (Erbitux) and rituximab (Rituxan). PATIENTS AND METHODS: A prospective multicenter study involving time and motion and activity sampling methods was conducted among patients with cancer receiving their first outpatient infusion of cetuximab or rituximab. Patients were observed from initiation of MoAb infusion to the end of the clinic visit. IRs were classified as absent, mild/moderate, and severe/life threatening. Staff time and costs were estimated for preparation and administration of MoAb, other chemotherapy agents, and for management of IRs. Resource costs were compared across IR groups within each MoAb. MAIN RESULTS: Among 161 patients enrolled, 32% of 71 patients on cetuximab and 39% of 90 patients on rituximab experienced IRs. Treatment of patients who experienced IRs required more staff time (31-80% more time) and resulted in higher human resource costs (increase of 17-65 US dollars) than patients who did not experience IRs. CONCLUSIONS: IRs following cetuximab and rituximab administration are common and are associated with measurably increased costs of care. The frequency of IRs suggests the importance of identifying clinical guidelines for intervention and management.

The benefits and challenges of using computer-assisted symptom assessments in oncology clinics: results of a qualitative assessment.

Developed for clinical use in oncology settings, the Patient Assessment, Care & Education (PACE) System is a computer technology tool designed to address the under-identification and treatment of chemotherapy-related symptoms. This system includes general core questions together with the Patient Care Monitor (PCM), a validated questionnaire that assesses patient-reported problems, six symptom burden indices, and one global quality of life index. The system automatically scores the PCM and generates a written report. The objective of this study was to assess the manner in which clinicians use this system and identify the benefits and challenges that oncology clinics may face when adopting this system. The study was part of a larger evaluation of the system that included standardized surveys and chart review. Sixteen providers (physicians, nurses, and physician assistants) at 13 community oncology clinics participated in a 30-minute interview. Responses were coded according to common phrases or concepts. Clinicians indicated that they use the system mainly for symptom assessment or review of systems. The most common benefits identified included the improved ability to identify under-reported symptoms, enhanced communication with patients; increased efficiency; and its ability to highlight patients' most bothersome symptoms. Challenges included patient burden from the frequent need to answer the questionnaires, issues with the wording and formatting of the screening questionnaire, and technical difficulties. In sum, these interviews suggest that electronic symptom assessments offer potential advantages in terms improving the integration of routine assessment of patients' symptoms and health-related quality of life into the daily flow of an oncology clinic. The approach should receive additional research and development attention.

A health economic model of breakthrough pain.

Although the literature adequately addresses the biologic basis, epidemiology, and management of breakthrough pain (BTP), it does not yet describe the full impact of this troubling, widespread phenomenon. The risks of a scanty understanding of BTP impact are failure to take preventive measures, underdiagnosis, undertreatment, and inappropriate management. Studies to date of the impact of BTP have followed pharmacoeconomic approaches. Building on prior efforts, this paper develops a more comprehensive health economic model that encompasses the full spectrum of costs, outcomes, risks and benefits associated with BTP and its management. The authors provide a rubric within which stakeholders--including providers, institutional leaders, administrators, and policymakers--can systematically balance the myriad potential effects of different treatment scenarios to guide decision-making. The paper then extends this model to the population level, providing a template for health economic analysis of alternate strategies for managing BTP, and delineating steps for accomplishing the analysis.

The AIM Higher Initiative: new procedures implemented for assessment, information, and management of chemotherapy toxicities in community oncology clinics.

Chemotherapy-related toxicities are common and often undertreated in routine cancer care. Initiatives to improve toxicity management in practices may not always be effective. Quality improvement programs must engage multiple disciplines of the healthcare team and sustain efforts to institute and maintain procedures that address practice needs. The Assessment, Information, and Management (AIM) Higher Initiative, a quality improvement program undertaken at 15 community oncology practices, was initiated to improve the AIM of chemotherapy-related toxicities in patients with cancer. AIM Higher focuses on improving five chemotherapy-related toxicities: neutropenia, anemia, depression and anxiety, diarrhea and constipation, and nausea and vomiting. Led by a nurse champion at each of the clinics, a variety of new procedures, processes, and tools were implemented to improve quality of care. Nurses and practice administrators can use the quality improvement processes to generate changes in procedures and practices.

Retrospective chart review of severe infusion reactions with rituximab, cetuximab, and bevacizumab in community oncology practices: assessment of clinical consequences.

GOALS OF WORK: Monoclonal antibody (MoAb) treatments can result in severe infusion reactions. Managing infusion reactions in the outpatient setting introduces clinical and resource challenges for patients and providers, but there is little information regarding prevention, management, or outcomes of severe infusion reactions. This study represents one of the first attempts to describe the clinical consequences of severe infusion reactions associated with MoAb treatment. MATERIALS AND METHODS: Clinic staff identified adults treated with rituximab, cetuximab, or bevacizumab who experienced a grade 3 or higher (severe) infusion reaction. Chart reviews from 19 oncology practice sites across the USA captured patient demographics, infusion reaction management procedures, and clinical outcomes. MAIN RESULTS: With an average age of 62 years, the sample comprised of 76 patients who experienced a severe infusion reaction while receiving rituximab (n = 47), cetuximab (n = 24), and bevacizumab (n = 5). The most common pretreatment medications were acetaminophen and antihistamine in the rituximab group and corticosteroids (42%) in the cetuximab group. All cetuximab and the majority of rituximab severe infusion reactions occurred during the first cycle of therapy. Postinfusion reaction management typically included corticosteroids, oxygen, and intravenous fluids. Overall, 22% were hospitalized for a mean of 4 days (range = 2.0 to 6.0 days). Permanent discontinuation of MoAb therapy occurred after the majority of cetuximab (79 to 100%) related severe infusion reactions. CONCLUSIONS: Severe infusion reactions are intensive events that present a serious challenge to patients and oncology practices. Efforts to prevent or reduce such reactions could be of great benefit.

Evaluation of a tablet PC technology to screen and educate oncology patients.

STUDY GOAL: The aim of the study was to evaluate The Patient Assessment, Care and Education (PACE) System-an electronic patient symptom screening and reporting system for oncology. Specifically, the study determined provider and patient opinions of The PACE System and documented evidence as to whether symptom assessment rates increased after this system was implemented. MATERIALS AND METHODS: Ninety-two providers (i.e., physicians, nurse practitioners, and physician assistants) at 16 community oncology clinics were surveyed about their experiences with The PACE System. In addition, 100 patients at two community oncology clinics were surveyed about their perceptions of The PACE System. Finally, at two oncology clinics, 100 patient charts were abstracted in the year before implementation of The PACE System, and 100 patient charts were abstracted in the year after its implementation to evaluate changes in symptom assessment rates. MAIN RESULTS: Providers seemed to value the system. In particular, they reported that the screening and reporting system helped them to identify, track, and document the patients' most important symptoms. The patient survey indicated that the majority of patients at the two sites found the system easy to use and generally helpful and would recommend it to others. The chart review indicated that assessment rates for depression, fatigue, and pain increased after The PACE System was implemented. CONCLUSIONS: The PACE System appears to be a promising approach to addressing the widespread problem of under-identification and under-treatment of symptoms in patients receiving cancer treatment.

Baseline evaluation of the AIM Higher Initiative: establishing the mark from which to measure.

PURPOSE/OBJECTIVES: To collect baseline measurements before the implementation of interventions associated with the AIM (Assessment Information Management) Higher Initiative--a quality improvement program intended to improve symptom assessment, management, and information distribution for five chemotherapy-related symptom groups: anemia, neutropenia, diarrhea and constipation, nausea and vomiting, and depression and anxiety. DESIGN: Subject telephone interviews and chart reviews. SETTING: 15 community oncology clinics in the United States. SAMPLE: 376 adult patients with cancer who visited a healthcare provider before the start of a chemotherapy cycle; patients were enrolled in the study after the initiation of chemotherapy, with at least one chemotherapy cycle remaining. METHODS: Subject interviews and chart reviews to determine the frequency, assessment, and management of and information about target symptoms. MAIN RESEARCH VARIABLES: The frequency of target chemotherapy-related symptoms and occurrence of symptom-specific assessment, information provided, and management. FINDINGS: The five target symptoms had occurred in a considerable proportion of patients with cancer receiving chemotherapy during their most recent chemotherapy cycles. At a substantial number of clinic visits, no documentation of cancer-related symptom assessment, information distribution, or management occurred. CONCLUSIONS: Chemotherapy-related symptoms occur frequently but often are not assessed, managed, or handled with appropriate patient information. IMPLICATIONS FOR NURSING: Findings in the baseline evaluation illustrate the need to improve supportive care--a key responsibility of oncology nurses.

Impact of breakthrough pain on quality of life in patients with chronic, noncancer pain: patient perceptions and effect of treatment with oral transmucosal fentanyl citrate (OTFC, ACTIQ).

OBJECTIVE: To characterize breakthrough pain (BTP), its qualitative impact on quality of life (QoL), and the effects of BTP treatment on QoL. DESIGN: Multicenter patient-reported survey. SETTING: Five pain treatment centers. PATIENTS: Fifty-six adults with chronic noncancer pain using oral transmucosal fentanyl citrate (OTFC, ACTIQ). RESULTS: Forty-three patients qualified for in-depth analysis. BTP had a mean intensity of 9.0 (range 5-10) on an 11-point numerical scale (0 = no pain to 10 = worst possible pain), had a mean duration of 83 minutes, and had an adverse effect on multiple QoL domains. The largest negative QoL impacts were on "general activity level" and "ability to work." OTFC had a positive impact on both controlling BTP and improving QoL. CONCLUSIONS: BTP appears to be a clinically important condition in this population and is associated with an adverse impact on QoL. Understanding those QoL domains most affected by BTP and those potentially improved with treatment should help in developing quantitative QoL assessment tools and other outcome measures for BTP management studies.

Symptom Burden for Patients with Metastatic Colorectal Cancer Treated with First-Line FOLFOX or FOLFIRI with and Without Bevacizumab in the Community Setting.

BACKGROUND: FOLFOX (oxaliplatin/leucovorin/5-fluorouracil) and FOLFIRI (irinotecan/leucovorin/5-fluorouracil) with or without bevacizumab have become standard-of-care regimens in first-line treatment of metastatic colorectal cancer. However, there is a paucity of symptom burden information regarding these regimens from the patient perspective in community oncology. PATIENTS AND METHODS: This retrospective chart review and telephone interview study examined patients with first-line metastatic colorectal cancer from 5 community oncology centers treated with FOLFOX or FOLFIRI with and without bevacizumab. Patientreported outcomes were taken from the Patient Care Monitor 1.0 Revised, a validated tablet computer-based questionnaire that measures symptom burden and several scales of functioning and quality of life. A subset of patients completed structured telephone interviews about the impact of treatment on practical activities and income. RESULTS: Eighty-eight patients with an average age of 62 years were included. Patients completed a median of 8 cycles of treatment. The most common moderate to severe symptom complaint was fatigue. Gastrointestinal symptoms were common but did not cluster in one regimen versus another. Neuropathyrelated symptoms were also common across all regimens except FOLFIRI without bevacizumab. Nausea and neutropenia were common indications for concomitant medications. One third reported work and other activity interference, and care produced outof- pocket expenditures in excess of $1000. CONCLUSION: Although sample size was small in the FOLFIRI-based regimens, patient reports and chart records suggested that there was not a systematic difference between FOLFOX and FOLFIRI regimens in type of symptom. The addition of bevacizumab did not appear to increase symptom burden.

A prospective investigation of chemotherapy-induced neutropenia and quality of life.

This prospective study of chemotherapy-induced neutropenia (CIN) explored the association between the relative grade of neutropenia and symptom burden and quality of life (QOL). Eighty-four adult cancer patients from nine community oncology centers receiving 1 of 13 myelosuppressive chemotherapies were evaluated at days 0, 4, 7, 9, 11, 14, and 21 of their respective first cycle. Neutropenia grade (grade 3/4 vs grades 0 to 2) was determined by serial absolute neutrophil count (ANC) measures. Measures of patient-reported outcomes included the Rotterdam Symptom Checklist (RSCL), Hospital Anxiety and Depression Scale (HADS), Cancer Care Monitor-Medical Isolation Scale (CCM-MIS), and SF-36. Changes in outcomes from baseline to highest grade of neutropenia were evaluated using mixed model-repeated measures for each of 15 outcomes. Compared with grades 0-2, grade 3/4 neutropenia was associated with greater symptom burden and worse QOL for six measures (P < 0.05). The pattern of differences suggested that measures of symptom distress and social functioning were sensitive to patient changes associated with grade 3/4 neutropenia. Worsening of symptom burden and QOL appears to be associated with severe afebrile neutropenia. A causal relationship between neutropenia and worse symptoms and QOL remains difficult to establish due to the confounding of the effects of neutropenia with other adverse effects of chemotherapy.

Impact of less frequent injections on patients, caregivers, and practices.

Many factors can affect decisions about chemotherapy and supportive care, including disease outcome, patient quality of life, and drug toxicities. Chemotherapy and supportive therapy may require numerous medical visits that may significantly affect patients and their caregivers. It has recently been shown that practice resources should also be considered in evaluating the full impact of medical visits. To this end, increasing the efficiency of a practice may help ensure the viability of delivering quality care. Greater efficiency can lead to improvements in the quality of life of patients and their caregivers, lower practice operating expenditures, and increase practice capacity and productivity. Chemotherapy-induced anemia is common in patients with cancer, and erythropoiesis-stimulating proteins (ESPs) can lessen its incidence and severity but may require many additional medical visits. This article discusses the importance of establishing efficiency in the oncology practice and considers the role of coordinating tests and procedures, specifically the role of available scheduling options for growth factors. Synchronizing treatments with ESPs and chemotherapy may increase patient convenience and improve practice efficiencies.

Patient and caregiver time burden associated with anaemia treatment in different patient populations.

GOALS: Cancer patients treated with chemotherapy often develop anaemia. This cross-sectional analysis examined the effect of anaemia treatment on patient and caregiver time and activities. MATERIALS AND METHODS: The analysis included 9,920 patients from 646 US outpatient oncology centres. Patients completed a survey that contained questions about travel time, total time for the visit and other impacts. RESULTS: The mean time taken for a single clinic visit to receive anaemia treatment was 2.2 h. On average, patients receiving epoetin alfa required 17.6 h more than patients receiving darbepoetin alfa to complete a course of anaemia treatment. All patients in the study reported that they had to adjust at least one activity as a result of clinic visits. Older patients, women and patients from low-income areas were more likely to be accompanied during clinic visits. CONCLUSIONS: Reducing the number of clinic visits needed for anaemia treatment by using darbepoetin alfa may benefit patients.