Tanya Burton

Aim: We investigated the healthcare resource utilization and costs of patients with dose escalations beyond recommended levels of long-acting octreotide for persistent carcinoid syndrome (CS) symptoms. Materials & methods: A retrospective study of US health insurance claims included 358 adults with ≥1 medical claim for CS and ≥6 claims for long-acting octreotide (10–30 mg) between 1 July 2006 and 31 December 2013. Results: Pre-escalation per-patient per-month outcomes and costs were lower versus post-escalation, including vascular conditions (0.11 vs 0.21), metastasis/secondary neoplasms (0.45 vs 0.74), total all-cause costs (US$4116 vs US$8305; p < 0.001) and CS-related costs (US$3156 vs US$7101; p < 0.001). Conclusion: Higher mean pre-escalation per-patient per-month resource use and costs post-escalation primarily attributable to CS-related ambulatory care suggests continuing challenges in managing CS despite octreotide dose escalation.

Background: Guidelines recommend that women with hormone receptor–positive/human epidermal growth factor receptor 2–negative (HR+/HER2–) metastatic breast cancer (mBC) initiate hormonal therapy before chemotherapy. This study compared outcomes of women with mBC who received chemotherapy first vs hormonal therapy. Methods: A retrospective cohort study of women with mBC was conducted using a large US commercial health plan database between January 1, 2008–April 30, 2013. Subjects had evidence of a HR+/HER2– tumor sub-type in a cancer registry and use of chemotherapy or hormonal therapy in claims. Subjects were continuously enrolled for ≥6 months after metastasis and assigned to cohorts for receiving chemotherapy only or hormonal therapy only during first-line (CT-1L vs HT-1L). Adjusted incidence rates of clinically significant events were compared using a negative binomial model, and adjusted healthcare costs were compared using a generalized linear model. Results: Three hundred and twenty-four women with HR+/HER2– mBC met the selection criteria; 179 (55%) received CT-1L and 145 (45%) received HT-1L. Mortality rates did not differ between cohorts (unadjusted incidence rate ratio (IRR) = 1.67, 95% CI = 0.82–3.46; adjusted IRR = 0.64, 95% CI = 0.32–1.27). Adjusted average total all-cause healthcare costs were $11 090 for women with CT-1L and $6743 for women with HT-1L (cost ratio =1.64, 95% CI =1.36–1.99). Conclusions: Observed use of first-line chemotherapy (>50%) was higher than expected given the HR + molecular profile of the tumors. Chemotherapy use during first-line did not appear to be associated with a survival benefit, but was associated with significantly higher costs compared with the use of hormonal therapy during first-line; however, this comparison is limited by demographic and baseline characteristic differences between the two cohorts. This study contributes to understanding real-world treatment patterns and the associated clinical and economic outcomes of using chemotherapy vs hormonal therapy as a first-line treatment option for the HR+/HER2– mBC population.

Purpose Incidence and prevalence estimates of acromegaly in the United States (US) are limited. Most existing reports are based on European data sources. The objective of this study was to estimate the annual incidence and prevalence of acromegaly in a large US managed care population, overall and stratified by age, sex, and geographic region, using data from 2008 to 2012. Methods Using administrative claims data, commercial health plan enrollees were identified with acromegaly if they had two or more medical claims with an acromegaly diagnosis code (ICD-9-CM: 253.0×) or one medical claim with an acromegaly diagnosis code in combination with one other claim for a pituitary tumor or pituitary procedure. The first date for an acromegaly-related claim set the index year. Incidence rates for each year were calculated by dividing the number of new acromegaly cases by the calculated person-time at risk. Annual prevalence estimates were calculated by dividing the number with any evidence of acromegaly by the total number of health plan enrollees enrolled for at least 1 day during each calendar year. Incidence and prevalence estimates were stratified by age (0–17, 18–44, 45–64, 65+ years), sex (male, female), and US geographic region of the health plan (Midwest, Northeast, South, West). Results Overall annual incidence rates of acromegaly were relatively constant across 2008–2012 with ~11 cases per million person-years (PMPY). Rates increased with age, ranging from 3–8 cases PMPY among children aged 0–17 years old to 9–18 cases PMPY among adults aged 65 and older. Females had 12 cases PMPY on average compared to 10 cases PMPY among men. On average, the Midwest had the lowest incidence rates (7 cases PMPY) compared to the Northeast, South and West (14, 12, and 10 cases PMPY, respectively). The overall annual prevalence of acromegaly was relatively constant across the 5 years from 2008 to 2012 with approximately 78 cases per million each year. Annual prevalence estimates increased with age, ranging from 29–37 cases per million among children aged 0–17 years old to 148–182 cases per million among adults aged 65 years and older. Males and females were similarly affected; each with approximately 77 cases per million each year. The Northeast and South had the highest prevalence estimates (92 and 89 cases per million, respectively); while the estimates for the West and Midwest were lower (65 and 57 cases per million, respectively) each year. Conclusion This study examined 5 years of recent data to estimate the incidence and prevalence of acromegaly in a large geographically-diverse managed care population. The incidence rates were higher on average than published rates outside the US (11 vs. 3.3 PMPY), but prevalence estimates were consistent with previous reports. Incidence and prevalence both increased by age, did not differ for males and females, and varied slightly by US geographic region. The age and sex distribution of the selected population matched the known epidemiology of the disease. Using a claims-based approach, this analysis only captured acromegaly cases with an acromegaly-related medical claim. As a result, these estimates may underestimate the incidence and prevalence of acromegaly in US commercial health plans as they did not include individuals who were undiagnosed, in remission, undertreated, or not monitored during the study period. At the same time, these estimates may be viewed as an upper bound on the incidence of acromegaly in the US as the estimates did not include individuals who were in other health plans or uninsured during the study period. Additional evaluations are needed to identify the full extent of acromegaly in the US.

Purpose This study aimed to develop an algorithm to identify patients with CD, and quantify the clinical and economic burden that patients with CD face compared to CD-free controls. Methods A retrospective cohort study of CD patients was conducted in a large US commercial health plan database between 1/1/2007 and 12/31/2011. A control group with no evidence of CD during the same time was matched 1:3 based on demographics. Comorbidity rates were compared using Poisson and health care costs were compared using robust variance estimation. Results A case-finding algorithm identified 877 CD patients, who were matched to 2631 CD-free controls. The age and sex distribution of the selected population matched the known epidemiology of CD. CD patients were found to have comorbidity rates that were two to five times higher and health care costs that were four to seven times higher than CD-free controls. Conclusion An algorithm based on eight pituitary conditions and procedures appeared to identify CD patients in a claims database without a unique diagnosis code. Young CD patients had high rates of comorbidities that are more commonly observed in an older population (e.g., diabetes, hypertension, and cardiovascular disease). Observed health care costs were also high for CD patients compared to CD-free controls, but may have been even higher if the sample had included healthier controls with no health care use as well. Earlier diagnosis, improved surgery success rates, and better treatments may all help to reduce the chronic comorbidity and high health care costs associated with CD.

198 Background: Prostate cancer is the most commonly diagnosed malignancy among men in the US; mortality rates are highest among those with castration-resistant prostate cancer (CRPC). Observational data on CRPC are limited. This study examined CRPC treatment patterns relative to NCCN guidelines in a large US health plan. Methods: This was a retrospective claims database analysis of commercial and Medicare Advantage enrollees with evidence of prostate cancer (ICD-9: 185.xx) between 07/01/06 – 03/31/11. CRPC patients were then identified based on prostate-specific antigen (PSA) progression (≥2 PSA increases based on ≥3 PSA values) and/or use of chemotherapy: docetaxel (DOC), mitoxantrone (MIT), estramustine (EST), or cabazitaxel (CAB). The CRPC index date was the first date of PSA progression or chemotherapy. Patients were continuously enrolled for 6 months before (baseline) and ≥6 months after the index date until 09/30/2011 or until death, if sooner (follow-up). Results: A total of 1651 patients met the CRPC selection criteria. Mean (SD) age was 70 ± 9 years, 1085 (66%) received DOC on the index date, and 467 (28%) died during follow-up. A third of patients with DOC received additional CRPC therapy during follow-up: 160 (15%) received MIT, EST, or CAB, and 239 (22%) received a secondary hormonal therapy (SHT: antiandrogens, aminoglutethimide, GnRH/LHRH antagonists, estrogen, or abiraterone acetate). Among 566 patients without DOC, 99 (17%) received a different chemotherapy (MIT = 45; EST = 52; CAB = 2), and 178 (31%) received a SHT. More than half 311 (55%) without DOC did not receive any other CRPC therapy during follow-up, of which 40 (13%) received bone-directed therapy (BDT: denosumab = 0; bisphosphonates = 27; radiation = 13). Conclusions: Consistent with NCCN guidelines, DOC was the most commonly used therapy. However, two-thirds of patients with DOC and over half of patients without DOC did not receive additional CRPC therapy after the index date. In addition, only 13% of patients with no CRPC therapy received any follow-up BDT. Additional research is warranted to understand whether clinical rationale, patient preference, or access to care may have resulted in patients not receiving additional therapy.

Acromegaly is a rare, chronic, and debilitating disease that results from excessive growth hormone production. Clinically, this disease is associated with enlargement of soft tissue, excessive skeletal growth, and increased risk of cardiovascular disease. Acromegaly is often diagnosed late, when a wide range of comorbidities may already be present. First-line therapy for acromegaly is typically surgery; but a number of highly-specific pharmacological agents have recently enabled a more aggressive medical management of acromegaly. Since surgical cure of acromegaly is low for macroadenomas, medical control of active acromegaly is an important component of treatment. There are no published US data currently available regarding real-world rates of comorbidities and treatment patterns among patients with acromegaly. This retrospective study examined the comorbidities and treatment patterns of 949 health plan enrollees, who had acromegaly diagnosis and/or procedure codes in an administrative claims database from July 1, 2002 through June 30, 2010. Acromegaly was associated with high rates of hypertension and diabetes along with a number of other comorbidities. The incidence of comorbidities was highest among patients with acromegaly-related treatment, which may have resulted, in part, from inadequate disease management and/or poor disease control. Unexpectedly, 55 % of patients identified with acromegaly received no treatment for acromegaly (i.e., surgery, radiotherapy, and medication) and only 28 % received a medication treatment during the observation period. However, some patients may have received a curative surgery prior to the observation period, which may have reduced the use of other acromegaly-related treatments during the study period. Of those treated with medications, the most common first medications were octreotide, cabergoline, and bromocriptine. Given the high incidence of serious comorbidities associated with active acromegaly, earlier diagnosis and treatment, along with appropriate follow-up care, may potentially avoid the life-long consequences of uncontrolled disease.

Background: Being overweight or obese increases risk for cardiometabolic disorders. Although both body mass index (BMI) and waist circumference (WC) measure the level of overweight and obesity, WC may be more important because of its closer relationship to total body fat. Because WC is typically not assessed in clinical practice, this study sought to develop and verify a model to predict WC from BMI and demographic data, and to use the predicted WC to assess cardiometabolic risk. Methods: Data were obtained from the Third National Health and Nutrition Examination Survey (NHANES) and the Atherosclerosis Risk in Communities Study (ARIC). We developed linear regression models for men and women using NHANES data, fitting waist circumference as a function of BMI. For validation, those regressions were applied to ARIC data, assigning a predicted WC to each individual. We used the predicted WC to assess abdominal obesity and cardiometabolic risk. Results: The model correctly classified 88.4% of NHANES subjects with respect to abdominal obesity. Median differences between actual and predicted WC were − 0.07 cm for men and 0.11 cm for women. In ARIC, the model closely estimated the observed WC (median difference: − 0.34 cm for men, +3.94 cm for women), correctly classifying 86.1% of ARIC subjects with respect to abdominal obesity and 91.5% to 99.5% as to cardiometabolic risk. The model is generalizable to Caucasian and African-American adult populations because it was constructed from data on a large, population-based sample of men and women in the United States, and then validated in a population with a larger representation of African-Americans. Conclusions: The model accurately estimates WC and identifies cardiometabolic risk. It should be useful for health care practitioners and public health officials who wish to identify individuals and populations at risk for cardiometabolic disease when WC data are unavailable.

(2012). One-year follow-up healthcare costs of patients hospitalized for transient ischemic attack or ischemic stroke and discharged with aspirin plus extended-release dipyridamole or clopidogrel. Journal of Medical Economics: Vol. 15, No. 6, pp. 1217-1225.