Physician survey of the effect of the 21-gene recurrence score assay results on treatment recommendations for patients with lymph node-positive, estrogen receptor-positive breast cancer.

PURPOSE: To survey the effect of the 21-gene recurrence score (RS) assay results on adjuvant treatment recommendations for patients with lymph node-positive (N+), estrogen receptor-positive (ER+) breast cancer. METHODS: Medical oncologists who ordered the 21-gene RS assay were invited to complete a survey regarding their most recent patient with N+/ER+ breast cancer. We obtained responses from 160 (16%) of the 1,017 medical oncologists. RESULTS: Most of the respondents were in community (71%) versus academic (25%) settings and had practiced for a median of 11 years. T1, T2, or T3 disease was reported in 62%, 35%, and 3% of patients, respectively. One, two, three, or ≥ 4 nodes were reported in 69%, 18%, 6%, and 3% of patients, respectively. Eighty-six percent of the oncologists made treatment recommendations before obtaining the RS; 51% changed their recommendations after receiving the RS. In 33%, treatment intensity decreased from chemotherapy plus hormonal therapy to hormonal therapy alone. In 9%, treatment intensity increased from hormonal therapy alone to chemotherapy plus hormonal therapy. In 8%, treatment recommendations changed in a way that did not fit the definition of either increased or decreased intensity. CONCLUSION: In this survey of physician practice, the RS result was used to guide adjuvant treatment decision making in N+/ER+ breast cancer more often in patients with tumors less than 5 cm in size and one to three positive lymph nodes than in patients with larger tumors and four or more positive nodes and yielded an overall reduction in recommendations for chemotherapy.

Cost and utilization of COPD and asthma among insured adults in the US.

OBJECTIVES: This study evaluates the burden of concomitant chronic obstructive pulmonary disease (COPD) + asthma, two highly prevalent and costly conditions. PATIENTS AND METHODS: The authors identified commercial enrollees from a large health plan database who were aged > or =40 years with medical and pharmacy benefits and medical claims with diagnosis codes for COPD or asthma between January 1, 2004 and December 31, 2004. We assigned patients to COPD or COPD + asthma cohorts, excluding all others. A patient index date was the first evidence date of COPD or COPD + asthma. We excluded those with one outpatient COPD or asthma claim or who were not continuously enrolled during the 12 months before and after index date. After controlling for differences, postindex respiratory-related emergency department (ED) visits and/or hospitalizations and costs were compared between cohorts. RESULTS: We identified 24,935 patients, 17,394 (70%) in the COPD cohort and 7,541 (30%) in the COPD + asthma cohort. COPD + asthma patients were younger (58 versus 60 years; p < 0.0001) and more were females (62% vs 45%; p < 0.0001). COPD + asthma patients were 1.6 times more likely to have respiratory-related EDs and/or hospitalizations than COPD patients (95% CI 1.5, 1.8), and had $1987 (SE = $174, p < 0.0001) more respiratory-related healthcare costs. Mean adjusted respiratory-related healthcare costs were $3803 for COPD and $5790 for COPD + asthma. Limitations include a potential for misclassification due to misdiagnosis or coding errors as well as traditional biases of observational studies including the potential for omitted variable bias. CONCLUSION: COPD + asthma patients are more costly and use more services than those with COPD, and may be more unstable and require more intensive treatment.

Adherence and persistence with omalizumab and fluticasone/salmeterol within a managed care population.

Asthma control requires adherence with pharmacologic therapy. A medication's mode of delivery may affect adherence. The purpose of this study was to compare medication persistence and adherence between patients newly treated with either an inhaled or injected asthma medication. Using a propensity-score-matched retrospective cohort study, we evaluated medication persistence and adherence over 1 year in adult asthma patients newly treated with omalizumab or fluticasone (500 microg)/salmeterol (50 microg) (FSC 500/50). Kaplan-Meier analysis was conducted to compare persistence between users of FSC 500/50 and omalizumab using the log-rank test. We conducted four sensitivity analyses. After propensity matching, the study sample included 213 omalizumab patients and 426 FSC 500/50 patients, with no statistically significant differences between groups on baseline measures. Mean adherence rates were 64.6% for omalizumab and 29.5% for FSC 500/50 (p < 0.0001). Fifty-four percent of omalizumab users were persistent at 1 year compared with 18.5% of FSC 500/50 users (p < 0.0001). In sensitivity analyses, we stratified patients by evidence of allergy and the results did not change. Adherence was more than twice as high and persistence was almost twice as high among omalizumab compared with FSC 500/50 users. The direction of our findings was consistent across all sensitivity analyses. In both omalizumab and FSC 500/50 cohorts, persistence decreased substantially over 1 year. Our study suggests that injected medications may have advantages in asthma treatment. A comprehensive program to improve adherence should address not just administration route but also patient factors that prevent proper medication use.

Economic burden in direct costs of concomitant chronic obstructive pulmonary disease and asthma in a Medicare Advantage population.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a highly prevalent disease whose sufferers consume a large amount of resources. Among community-dwelling Medicare beneficiaries, 12% reported that they had COPD in 2002. For clinicians, differentiating COPD from asthma may be difficult, but among patients with COPD and asthma, approximately 20% have both conditions. The economic impact of concomitant asthma and COPD is potentially large but has not been studied. OBJECTIVE: To assess the cost burden of asthma in patients with COPD in a Medicare Advantage population. METHODS: We reviewed the database of a large health plan that contained information from more than 30 distinct plans covering approximately 25 million members. We identified Medicare beneficiaries aged 40 years or older with medical and pharmacy benefits and medical claims with International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes for COPD or asthma over a 1-year identification period (calendar year 2004). We assigned patients to 2 cohorts based on diagnoses on medical claims (any diagnosis field) during 2004; the COPD cohort had at least 1 medical claim for COPD, and the COPD + asthma cohort had at least 1 claim for COPD and at least 1 claim for asthma. A patient's index date was the first date during 2004 in which there was a medical claim with a diagnosis code for COPD or asthma. To confirm diagnosis, each patient was required to have at least 1 additional claim for COPD (COPD cohort) or at least 1 claim for COPD and at least 1 claim for asthma (COPD + asthma cohort) during the 24-month period from 12 months before through 12 months after the index date. We excluded patients who (1) were not continuously enrolled during the 12 months before and after the index date and (2) did not have at least 1 pharmacy claim for a drug of any type (to verify pharmacy benefits). Outcome measures included the use of emergency room (ER) and hospital services, and cost (net provider payment after subtraction of member cost share), categorized as all-cause, non-respiratory, and respiratory-related. ER use and inpatient hospital stays were identified using place-of-service codes. A minimum of 2 consecutive dates of service (length of stay [LOS] of at least 1 day) was required to indicate an inpatient hospitalization. An LOS of at least 1 day was required to distinguish inpatient services from other services (e.g., procedures or tests) reported on claims with an inpatient place of service. Multivariate analyses adjusted for age, gender, census region, and Charlson Comorbidity Index (CCI). Ordinary least squares regression was used to predict respiratory-related total health care costs, and logistic regression was used to predict the occurrence of at least 1 acute event, defined as use of either an ER or an inpatient hospital. All 2-way interactions were considered, and only those with significant results were included in the models. All reported P values were 2-sided with a 0.05 significance level. RESULTS: During 2004, 68,532 individuals within the database were enrolled in a Medicare Advantage plan. After application of the other inclusion criteria, we excluded approximately 11% of the patients who did not have 1 pharmacy claim of any type. There were 8,086 patients (11.8%) who had at least 1 medical claim with diagnosis codes for COPD and at least 1 other medical claim for either COPD or asthma and were continuously enrolled for at least 24 months. The COPD + asthma cohort numbered 1,843 patients (22.8%), and the COPD cohort numbered 6,243 patients (77.2%). Compared with COPD patients without asthma, patients with COPD + asthma were slightly younger, and a higher proportion was female. There were differences between the 2 cohorts in geographic distribution, and the COPD + asthma cohort had a higher disease severity with a mean CCI score of 2.6 (standard deviation [SD], 2.1) compared with the COPD cohort (2.3 [2.3], P < 0.001). Respiratory-related pharmacy costs were a relatively small part of total respiratory-related health care costs: approximately 5.7% for the COPD cohort and 8.8% for the COPD + asthma cohort. Respiratory-related costs accounted for 22.0% of total all-cause health care costs for the COPD cohort and 28.7% for the COPD + asthma cohort. Mean ([SD], median) unadjusted respiratory-related health care costs were $7,240 ([$15,057], $1,957) for the COPD + asthma cohort and $5,158 ([$11,881], $808) in the COPD cohort. After adjusting for covariates, patients in the COPD + asthma cohort were more likely to have at least 1 acute event (e.g., ER visits and hospitalizations) than patients in the COPD cohort (adjusted odds ratio, 1.6; 95% CI, 1.4-1.7) and had $1,931 (37.1%) greater adjusted respiratory-related health care costs--$7,135 versus $5,204 for the COPD cohort (P < 0.001). CONCLUSION: Medicare beneficiaries with COPD and asthma incur higher health care costs and use more health care services than those with COPD without asthma.

An evaluation of patient preference for an alternative insulin delivery system compared to standard vial and syringe.

BACKGROUND: Diabetes mellitus (DM) affects over 18.2 million Americans and diabetes-related medical costs exceed 132 billion dollars per year, totaling more than 12% of the United States healthcare budget. The Diabetes Control and Complications Clinical Trial demonstrated that intensive insulin therapy and the control of plasma glucose can significantly reduce the incidence of late diabetic complications and delay the progression of existing conditions in type 1 diabetes. Optimal glycemic control often requires intensive insulin therapy to maintain a hemoglobin A(1C) (A1C) of less than 7% as recommended by the American Diabetes Association. It is estimated that more than half of the approximately 7 million Americans using insulin do so with suboptimal treatment and while administering one or two insulin injections per day. Non-adherence may be a contributing factor in suboptimal treatment. For a variety of reasons, many patients diagnosed with diabetes and treated with insulin are non-adherent. SCOPE: The primary objective of this study was to evaluate preference for an insulin delivery system comparing a disposable doser (InnoLet) to the standard vial/syringe. In a prospective, randomized, open-label, two-period, crossover study, 260 patients were enrolled (age > or = 18 years, with type 1 or 2 diabetes, and receiving NPH or regular or 70/30 insulin for at least 6-months). A total of 162 patients completed both treatment arms. Excluded were those unable to read/write English or administer their own injections, pregnant/lactating women, those using antipsychotics, and those with a history of alcohol abuse or cognitive impairment. Patients completed the eight-item Diabetes Fear of Self-Injection Questionnaire at baseline, week 12 and week 24. Items were rated on a 4-point Likert scale (1 = almost never; 4 = almost always) with a maximum fear score of 32. At week 24, patients completed a preference survey. FINDINGS: Of the 162 patients completing both treatment arms, 89 (55.0%) were in the vial/syringe to disposable doser treatment arm, 50% were female and mean age was 60 +/- 11 years. Patients in both treatment arms displayed little significant differences in baseline characteristics. Patients reported significantly lower fear of self-injection after using the disposable doser compared to vial/syringe (mean +/- SEM: 9.5 +/- 0.2 vs. 11.2 +/- 0.4; p < 0.0001). Most patients (71.5%) indicated a preference for the disposable doser compared to the vial/syringe method (p < 0.0001). CONCLUSION: The majority of patients preferred the disposable doser, and reported significantly less fear of self-injection using this delivery system. There are some potential limitations to consider. A randomization bias may have been present, patients who enrolled in this study were those who were actively seeking medical treatment for diabetes, insulin pens and cartridges are not available for all types of insulin regimens, pre-filled pens and cartridges may not be altered and, in general, alternative insulin delivery systems tend to be more costly than insulin sold in traditional vials. However, insulin may have greater patient acceptance and less psychological distress when administered via an alternative delivery system.