Resource utilization before and during infliximab therapy in patients with inflammatory bowel disease.

OBJECTIVE: Although Remicade (infliximab) is costly relative to non-biologic therapy, its impact on healthcare resource utilization and mucosal healing may make it a cost-effective option. This study aimed to compare gastrointestinal (GI)-related healthcare resource utilization and severity of mucosal damage before and during infliximab therapy in Crohn's disease (CD) or ulcerative colitis (UC) patients. METHODS: A retrospective chart review was conducted at 14 gastroenterology practices from across the country, which varied in practice sizes and types. Patients were aged ≥18 years, diagnosed with CD or UC, and had an infliximab index date between January 1, 2005 and September 30, 2007. GI-related utilization 12 months before and 12 months after the index date was compared. Endoscopic disease severity was categorized based on blinded review of abstracted reports. RESULTS: Results from 268 patients indicated significantly lower rates of surgery (29.7% to 9.9%, p < 0.0001, CD; 24.4% to 12.8%, p = 0.042, UC) and colonoscopy (54.4% to 17.6%, p < 0.0001, CD; 50.0% to 22.1%, p = 0.0007, UC) during infliximab therapy. The rates of hospitalizations in UC (15.1% to 3.5%, p = 0.0124) and radiology assessments in CD (23.1% to 10.4%, p = 0.006) also decreased. Based on severity data from 183 procedures, greater proportions of patients had normal or mild ratings during infliximab treatment compared with pre-treatment. LIMITATIONS: This retrospective descriptive study is limited by the type and quantity of information available in patient charts from 14 gastroenterology clinics during the first year of infliximab treatment. In addition, the number of patients with pre-treatment and post-treatment disease severity information was too small to make comparisons among disease severity groups. Further information about the severity of disease and the extent of mucosal healing could be helpful in determining the effect of therapy on resource utilization in future research. CONCLUSIONS: GI-related resource utilization was significantly lower and attenuation of mucosal damage severity was observed during infliximab treatment compared with the pre-treatment period.

Stability of infliximab dosing in inflammatory bowel disease: results from a multicenter US chart review.

OBJECTIVE: Infliximab dosing for inflammatory bowel disease (IBD) is based on patient weight and treatment response. Understanding dosing patterns may provide insight into treatment response and predictability of treatment cost. The purpose of this medical record review was to assess dose and dose frequency of infliximab maintenance treatment in patients with IBD using patient chart data. METHODS: A retrospective chart review was conducted at 14 community gastroenterology clinics (GI clinics). Patients were aged ≥18 years, diagnosed with Crohn's disease (CD) or ulcerative colitis (UC), and had a first infliximab administration (index date) between January 1, 2005 and September 30, 2007. At least 24 months of continuous data availability were required with dosing data collected for 12 months after initiation of infliximab therapy. Patients with biologic use and/or participation in an IBD clinical trial within 12 months before the index date were excluded. RESULTS: Charts from 182 CD patients and 86 UC patients were analyzed. About half of the patients were female. Over 90% of patients initiated treatment with infliximab 5 mg/kg. Among CD patients and UC patients, respectively, 79% and 61% continued receiving this dose for maintenance therapy at stable intervals. LIMITATIONS: This retrospective descriptive study is limited by the type and quantity of information available in patient charts from 14 GI clinics during the first year of infliximab treatment. Further, non-anti-tumor necrosis factor medication data were intermittently collected in some charts and, therefore, did not allow for analysis. CONCLUSIONS: Weight-based dosing and, presumably, patient response enabled providers to find the effective infliximab dose for IBD patients. The maintenance dose and administration frequency remained stable during the initial year.

The National Oncology Working Group (NOW) initiative: payer and provider collaborations in oncology benefits management.

Payers recognize the need to expand benefits management for oncology but struggle to find effective solutions amid the complexity of available therapies and skepticism from oncologists, who are facing their own set of economic pressures. An effort called the National Oncology Working Group (NOW) Initiative is trying to change the sometimes adversarial relationship between payers and oncologists through a collaborative model. The group, which is supported by pharmaceutical manufacturer sanofi-aventis, is developing patient-centered strategies for successful and sustainable oncology benefits management. The focus includes finding consensus between payers and providers and devising solutions for oncology management such as decreasing variability of cancer care and improving end-of-life care for patients with terminal illness. NOW is designing tools that will be tested in small-scale regional demonstration projects, which NOW participants anticipate will set an example for successful oncology benefits management that can be replicated and expanded.

Quality improvement initiatives: the missed opportunity for health plans.

BACKGROUND: The increase in healthcare cost without direct improvements in health outcomes, coupled with a desire to expand access to the large uninsured population, has underscored the importance of quality initiatives and organizations that provide more affordable healthcare by maximizing value. OBJECTIVES: To determine the knowledge of managed care organizations about quality organizations and initiatives and to identify potential opportunities in which pharmaceutical companies could collaborate with health plans in the development and implementation of quality initiatives. METHODS: We conducted a survey of 36 pharmacy directors and 15 medical directors of different plans during a Managed Care Network meeting in 2008. The represented plans cover almost 74 million lives in commercial, Medicare, and Medicaid programs, or a combination of them. RESULTS: The responses show limited knowledge among pharmacy and medical directors about current quality organizations and initiatives, except for quality organizations that provide health plan quality accreditation. The results also reveal an opportunity for pharmaceutical companies to collaborate with private health plans in the development of quality initiatives, especially those related to drug utilization, such as patient adherence and education and correct drug utilization. CONCLUSION: Our survey shows clearly that today's focus for managed care organizations is mostly limited to the organizations that provide health plan quality accreditation, with less focus on other organizations.

Assessment of drug therapy management and the prevalence of heart failure in a managed care population with hypertension.

OBJECTIVES: To (1) determine the prevalence of heart failure (HF) and cardiovascular risk factors within a hypertensive managed care population, (2) measure blood pressure goal attainment in patients with concurrent HF and hypertension (HTN), and (3) assess the use of drug therapy for diabetic and nondiabetic patients with concurrent HF and HTN, particularly regarding the use of angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs). METHODS: Eligible patients were identified through a review of medical and pharmacy claims data from 10 managed care organizations (MCOs) and 2 specialty medical groups (4.6 million total members) from June 1998 through July 2001. From approximately 850,000 members in the claims database identified as hypertensive, 7,226 were randomly selected for medical chart review. Of these, 6,935 medical charts had a confirmed diagnosis of HTN but not HF, and 291 (4%) had confirmed HTN and HF. The study population--291 patients with HTN and HF--provided information on demographic characteristics, prevalence of cardiovascular risk factors and relevant comorbidities, and systolic and diastolic blood pressure. Current antihypertensive therapy prescription fill rate was evaluated using pharmacy claims. RESULTS: Patients with diagnoses of HTN and HF confirmed in the medical chart (N=291) were included in the present analysis. HF prevalence among hypertensive patients was 4% (291 of 7,226). Mean age of the study patients was 68.3 years, and 52.9% of the patients were female. Key cardiovascular risk factors included gender (men and postmenopausal women) (89.3%), age > 60 years (73.5%), hyperlipidemia (47.4%), and diabetes (38.8%). Of the total sample, only 30.1% of the diabetic (34 of 113) and 26.4% of the nondiabetic (47 of 178) patients with HF had their blood pressure controlled to the goal level of < 130/85 mm Hg recommended by the Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, the national guideline in effect at the time. Overall, 64.7% of HF patients for whom we had pharmacy claims were receiving an ACE inhibitor or an ARB. CONCLUSIONS: The study results indicate a deficit in the treatment of HTN among HF patients with and without diabetes, including failure to achieve blood pressure goals (< 130/85 mm Hg at the time of this study period). More aggressive quality improvement programs are necessary to educate providers and patients on the importance of treating blood pressure to nationally accepted goal using antihypertensives proven beneficial for hypertensive patients with HF.

The hypertension management program: identifying opportunities for improvement.

To date, relatively few programs have been evaluated that were designed to affect the clinical practice patterns of primary care physicians who treat patients with hypertension. In particular, studies that have evaluated blood pressure control as a clinical outcome before and after an intervention are lacking. The Hypertension Management Program, developed by Applied Health Outcomes, is a quality improvement program designed to improve the medical management of hypertension in population-based health care settings. This program is in the process of continuing to collect baseline data from health maintenance organizations, conducting physician-focused interventions designed for improving clinical care, and collecting postintervention data between 6 and 12 months after the intervention is completed to determine its effect. The authors present the rationale for conducting large-scale hypertension management programs that measure outcomes, as well as preliminary baseline and postintervention data from the Hypertension Management Program, based on a current database of more than 1.9 million individuals enrolled in eight health care plans.