Variation in Care for Patients with Irritable Bowel Syndrome in the United States.

OBJECTIVES: Irritable bowel syndrome (IBS) affects nearly one in seven Americans. Significant national variations in care may exist, due to a current lack of standardized diagnosis and treatment algorithms; this can translate into a substantial additional economic burden. The study examines healthcare resource utilization in patients with IBS and in the subset of IBS patients with constipation (IBS-C) and analyzes the variation of IBS care for these patients across the United States (US). METHODS: Healthcare resource use (HRU), including gastrointestinal (GI) procedures and tests, all-cause and intestinal-related medical visits, GI specialist visits, and constipation or diarrhea pharmacy prescriptions for IBS patients enrolled in a large US administrative claims database (2001-2012) were analyzed for the 24-month period surrounding first diagnosis. Multivariate regression models, adjusting for age, gender, year of first diagnosis, insurance type, and Charlson comorbidity index, compared HRU across states (each state vs. the average of all other states). RESULTS: Of 201,322 IBS patients included, 77.2% were female. Mean age was 49.4 years. One in three patients had ≥3 distinct GI medical procedures or diagnostic tests; 50.1% visited a GI specialist. Significant HRU differences were observed in individual states compared to the national average. IBS-C patients had more medical visits, procedures, and pharmacy prescriptions for constipation/diarrhea than IBS patients without constipation. CONCLUSIONS: This study is the first to identify considerable regional variations in IBS healthcare across the US and to note a markedly higher HRU by IBS-C patients than by IBS patients without constipation. Identifying the reasons for these variations may improve quality of care and reduce the economic burden of IBS.

Psoriasis and risk of diabetes-associated microvascular and macrovascular complications.

BACKGROUND: Psoriasis's effect on diabetes onset is well documented, but its effect on course of diabetes is poorly understood. OBJECTIVE: We sought to compare risks of developing microvascular and macrovascular complications between diabetic patients with and without psoriasis. METHODS: Adults with 2 or more diabetes diagnoses selected from MarketScan databases (Truven Health Analytics Inc, Ann Arbor, MI) (2000-2006) were classified into 2 cohorts: 2 or more psoriasis diagnoses and without psoriasis diagnosis. Patients with psoriasis were matched using propensity score, and exactly matched using age, sex, and diabetes characteristics with patients without psoriasis. Outcomes were compared between cohorts using Cox regression models. RESULTS: In all, 6164 diabetic patients with psoriasis (27% moderate to severe) were matched to 6164 diabetic patients without psoriasis. Patients with psoriasis were significantly more likely to develop microvascular events than patients without psoriasis overall (hazard ratio [HR] 1.14, P < .001) and by psoriasis severity (mild: HR 1.13, P = .004; moderate to severe: HR 1.16, P = .038). Risk of macrovascular events was higher for patients without psoriasis overall (HR 1.13, P = .001) and those with mild psoriasis (HR 1.15, P = .003), but not for moderate to severe cases (HR 1.10, P = .210). LIMITATIONS: Psoriasis to diabetes association may be underestimated. CONCLUSION: Among diabetic patients, psoriasis is generally associated with higher rates of microvascular and macrovascular complications. Greater psoriasis severity did not increase risk of diabetic complications.

Brain metastases in patients with ALK+ non-small cell lung cancer: clinical symptoms, treatment patterns and economic burden.

OBJECTIVE: Brain metastases (BM) are highly prevalent among anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC) patients; yet little is known about their real-world treatment patterns and clinical and economic burdens. This study aimed to describe these patients' treatment patterns, symptoms, and costs. RESEARCH DESIGN AND METHODS: Retrospective study pooling data from three large administrative databases in the US (08/2011-06/2013). ALK+ NSCLC patients with BM and continuous enrollment for ≥ 60 days before and ≥ 30 days after the first observed BM diagnosis were identified by pharmacy records for crizotinib among patients with lung cancer and BM diagnostic codes. MAIN OUTCOME MEASURES: Treatment patterns, symptoms, healthcare resource utilization, and costs, before and after BM diagnosis. RESULTS: Of the 213 crizotinib patients with BM diagnoses meeting the selection criteria, 23.0% had BM prior to NSCLC diagnosis; 47.4% had BM prior to crizotinib initiation; 19.2% during crizotinib treatment; and 10.3% post-crizotinib treatment. For those diagnosed with BM after NSCLC diagnosis, the median time between the NSCLC and BM diagnoses was 88 days. Following the first observed BM diagnosis, 88.7% used chemotherapy, 63.4% had radiotherapy, and 31.9% had stereotactic radiosurgery. The prevalence of BM-related symptoms substantially increased post-BM-diagnosis: fatigue (from 15% to 39%), headaches (from 5% to 24%), and depression (from 5% to 15%). Monthly costs per patient averaged $5983 before the BM diagnosis and $22,645 after diagnosis. Patients' resource utilization increased significantly post-BM-diagnosis, with a 3-fold increase in OP visits and a 6-fold increase in IP stays. Post-BM-diagnosis costs were driven by pharmacy (42.0%), inpatient (29.6%), and outpatient costs (26.0%). LIMITATIONS: The study sample was limited to crizotinib-treated patients. CONCLUSIONS: Post-BM-diagnosis, patients experience high symptom burden. Post-BM-diagnosis, treatment is highly variable and costly: average monthly costs per patient almost quadrupled post-BM-diagnosis.

Impact of low-grade adverse events on health-related quality of life in adult patients receiving imatinib or nilotinib for newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase.

OBJECTIVE: Chronic myeloid leukemia (CML) treatment relies on tyrosine kinase inhibitors (TKIs), but their use can be associated with low-grade adverse events (AEs). This analysis aimed to identify the low-grade AEs which significantly impact the Health Related Quality of Life (HRQoL) of CML patients in chronic phase (CP) and to compare the incidence of such AEs among nilotinib- and imatinib-treated patients. RESEARCH DESIGN AND METHODS: Data from the 48 month ENESTnd trial were used (N = 593 patients). HRQoL was assessed using generic (SF-36) and leukemia-specific (FACT-Leu) HRQoL surveys. AEs were categorized into 26 system organ classes. RESULTS: In the adjusted regression model, five low-grade AE categories - gastrointestinal disorders, blood and lymphatic system disorders, general disorders and administration site conditions, musculoskeletal disorders, and psychiatric disorders - significantly impaired at least one HRQoL score. The incidence rate of these five AE categories was either significantly lower for nilotinib than imatinib or not different between the two drugs. The AE categories with lower incidence for both nilotinib 300 mg BID and 400 mg BID versus imatinib 400 mg daily were gastrointestinal, blood and lymphatic system, and musculoskeletal; nilotinib 300 mg BID had lower incidence than imatinib for general disorders. LIMITATIONS: Low-grade AEs were grouped and analyzed by system organ class category, so the effect of some rare individual AEs on HRQoL may have been missed. CONCLUSIONS: The impact of low-grade AEs on HRQoL should be taken into account, along with other factors, when selecting the optimal treatment for patients newly diagnosed with CML-CP.

Comparing nilotinib with dasatinib as second-line therapies in patients with chronic myelogenous leukemia resistant or intolerant to imatinib -- a retrospective chart review analysis.

INTRODUCTION: This study compared progression, progression-free survival (PFS), overall survival (OS), and treatment changes among chronic myelogenous leukemia patients in chronic phase (CML-CP) receiving nilotinib or dasatinib as second-line therapy. PATIENTS AND METHODS: Information on CML-CP patients switched from imatinib to nilotinib or dasatinib as second-line therapy was collected retrospectively from 122 US hematologists and oncologists through an online medical chart review. Progression, PFS, and OS were compared using multivariate Cox proportional hazard models, and treatment changes using chi-square tests. RESULTS: Of 597 imatinib resistant or intolerant patients, 301 initiated nilotinib and 296 dasatinib as second-line therapy. Nilotinib was associated with a lower risk of progression (hazard ratio [HR] = 0.27; p = 0.021) and longer PFS (HR = 0.48; p = 0.030) than dasatinib, with a median follow-up time of 11 months for nilotinib and 10 months for dasatinib. Nilotinib patients had a lower estimated hazard of mortality than dasatinib patients, though not statistically significant (HR = 0.46; p = 0.067). When treatment changes were classified by the physicians' justifications, fewer nilotinib patients had treatment changes due to ineffectiveness (2.0% vs. 5.1%, p = 0.041) or drug holidays due to intolerance (0.0% vs. 1.7%, p = 0.024) than dasatinib patients. CONCLUSIONS: Among CML-CP patients in this retrospective chart review who switched from imatinib to either nilotinib or dasatinib, nilotinib was associated with a significantly lower risk of progression and longer PFS than dasatinib. Nilotinib patients were also less likely than dasatinib patients to subsequently have treatment changes due to ineffectiveness or drug holidays due to intolerance. These findings could be subject to unobserved confounders.

Loss of treatment response to infliximab maintenance therapy in Crohn's disease: a payor perspective.

OBJECTIVES: To assess the incidence and economic implications of loss of treatment response among patients with Crohn's disease (CD) treated with infliximab maintenance therapy. METHODS: This was a retrospective observational study of infliximab response and costs among patients with CD using a large health-care claims database. Patients with CD receiving infliximab maintenance therapy with an initial response were selected from the Integrated Healthcare Information Services claims database (1999-2005). Patients' claim histories were used to identify patterns of response to infliximab treatment. Incidence of loss of response was estimated using Kaplan-Meier method. Annual total health-care and CD-related costs were estimated and adjusted for inflation to 2005 US dollars. Generalized linear model was used to assess the impact of loss of response on treatment costs. RESULTS: The study sample included 262 patients with CD with an initial response to infliximab therapy. Within 24 months of therapy initiation, 77% of patients lost treatment response. Upward dose adjustment, a new drug therapy for CD, and CD-related emergency room or inpatient visits were the three most common indicators of loss of response. Both annual total and CD-related health-care costs for patients who lost treatment response during the first year were found to be approximately one-third higher than for those who did not lose response. CONCLUSIONS: The majority of patients who had initial responses to infliximab maintenance treatment subsequently lost response within 2 years. Loss of response was associated with a significant increase in total health-care and CD-related costs.

The costs of Crohn's disease in the United States and other Western countries: a systematic review.

OBJECTIVE: To conduct a critical and systematic literature review of the costs of Crohn's disease (CD) in Western industrialized countries. RESEARCH DESIGN AND METHODS: Studies published in English that described the cost of CD in Western industrialized countries were identified using three major databases (Medline, EMBASE, and ISI Web of Science). Studies were reviewed and rated based on their relevance to cost of illness and the reliability of the estimates. All costs were adjusted for inflation to 2006 values. RESULTS: Estimated direct medical costs were $18,022-18,932 per patient with CD per year in the United States, and euro 2898-6960 in other Western countries. Hospitalizations accounted for 53-66% of direct medical costs, with an average cost-per-hospitalization of $37,459 in the United States. Estimated indirect costs accounted for 28% of the total cost in the United States and 64-69% in Europe. Costs differed greatly by disease severity. Costs of patients with severe disease were 3- to 9-fold higher than patients in remission. Direct medical costs in the United States for patients in the top 25% of total costs averaged $60,582 per year; costs of patients in the top 2% averaged more than $300,000 per year. Combining prevalence rates, the total economic burden of CD was $10.9-15.5 billion in the United States and euro 2.1-16.7 billion in Europe. LIMITATIONS: This review is limited by the research quality and variations of the individual studies reviewed, and only includes English articles. CONCLUSIONS: This updated literature synthesis demonstrated the substantial total cost burden of CD, of which hospitalizations accounted for more than half of direct medical costs.