Recent real-world treatment patterns and outcomes in US patients with relapsed/refractory multiple myeloma.

BACKGROUND: In patients with relapsed/refractory multiple myeloma (RRMM) previously receiving 1-3 therapy lines, newer agents demonstrated improved outcomes versus older agents. Real-world treatment pattern data are limited. We assessed real-world treatment patterns and outcomes in patients with RRMM (≥2 prior therapy lines). RESEARCH DESIGN AND METHODS: An electronic medical record (EMR) analysis and chart review were conducted using International Oncology Network (ION) EMR data. Patients ≥18 years old initiating first-line MM treatment 1 January 2011, to 31 May 2017, were stratified into older/newer treatment cohorts (approval date before vs during/after 2012). Treatment patterns and outcomes were described; no statistical tests were performed. RESULTS: In the EMR analysis (n = 1601) and chart review (n = 456), bortezomib, lenalidomide, and bortezomib-lenalidomide combinations dominated first-line treatment. Median real-world progression-free survival (rwPFS) was 12.0 to 3.5 months (first- to fifth-line), and median real-world overall survival (rwOS) was 48.2 to 5.8 months. A trend for increased rwPFS/rwOS with newer versus older treatments was observed. Most common AEs were fatigue, bone pain, and anemia. EXPERT OPINION: Real-world data describing treatment patterns in relapsed/refractory multiple myeloma are limited. Evaluation of new treatments on patient outcomes will influence treatment patterns and patient outcomes in the real-world setting. CONCLUSIONS: Although a trend for improved rwPFS and rwOS with newer versus older treatments was suggested, additional treatment options to improve patient outcomes are needed.

Two comparative assessments of intravenous immunoglobulin therapy switching patterns in the treatment of chronic inflammatory demyelinating polyneuropathy in the US.

Purpose: For chronic inflammatory demyelinating polyneuropathy (CIDP) patients, each branded intravenous immunoglobulin (IVIG) treatment differs in production processes, virus elimination, formulation, and composition. Given the limited availability of real-world data comparing IVIGs for CIDP, this study evaluated switching patterns between IVIG products in 2 separate retrospective databases. Patients and methods: Two independent analytic teams retrospectively evaluated IVIG treatment-naïve patients with an ICD diagnosis code for CIDP. Study 1 used integrated healthcare claims from IMS LifeLink PharMetrics Plus™ and Study 2 used the Truven MarketScan® Database. All analyses were descriptive, with outcomes assessed during the 2-year post-index period. Results: One-quarter of IVIG patients switched therapies within the 2-year study period. In both studies, switching rates were lowest for IVIG-G (Gamunex®-C) (Study 1: 9.8%, Study 2: 8.9%), followed by IVIG-F (Flebogamma®) (Study 1: 25.0%, Study 2: 18.2%), and highest for IVIG-other (Octagam®/Gammaplex®) (Study 1: 50.0%, Study 2: 33.3%). When patients were switched, most switched to IVIG-G (Study 1: 51.6%, Study 2: 54.3%). Conclusion: The small proportion of CIDP switchers in 2 independent studies suggests that IVIG therapy is generally well tolerated. However, differences existed in switch rates for different IVIG products. The reason for low switching rates could not be assessed in this study; therefore, further studies are required to detect possible relevant differences in effectiveness and tolerability.

Real-world treatment patterns and outcomes of patients with small cell lung cancer progressing after 2 lines of therapy.

OBJECTIVES: To evaluate treatment patterns, physician-assessed overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) among third-line (3L)-plus small cell lung cancer (SCLC) patients. MATERIALS AND METHODS: Retrospective analysis of a United States (US)-based community oncology electronic medical record (EMR) database was conducted. Target sample included SCLC patients ≥18 years of age whose disease progressed after at least 2 prior treatments. Treatment patterns captured systemic therapy and best supportive care (BSC) in 3L, fourth-line (4L), and fifth-line (5L) settings. ORR, PFS, and OS were evaluated for each line of systemic therapy and OS was also evaluated for BSC. RESULTS: 334 3L SCLC patients received systemic therapy (n = 249) or BSC (n = 85). Mean age (standard deviation [SD]) was 63.7 (9.5), with 72% having extensive disease at initiation of first-line therapy. Of 3L patients, 41% and 12% went on to 4L and 5L, respectively. ORR for systemic therapy in 3L and 4L averaged around 21% while 5L was 12%. Median PFS in 3L systemic therapy was 2.3 months (95% confidence interval [CI]: 1.9, 2.5), which decreased in 4L and 5L. Median OS for 3L systemic therapy was 4.4 months (95% CI: 4.0, 5.5), with 6- and 12-month survival rates of 37% and 11%, respectively. In contrast, median OS for 3L BSC was 0.9 months (95% CI: 0.6, 1.2), with 9% survival rate at 6 months. CONCLUSION: Current treatments utilized in the 3L-plus setting yield limited survival benefit. Furthermore, patients left untreated and placed on BSC typically live less than 1 month. New therapeutic options are thus needed for these patients, where no approved options exist.

COPD affects worker productivity and health care costs.

Purpose: This study aimed to measure the true burden of COPD by calculating incremental direct and indirect costs. Direct medical resource use, productivity metrics, and COPD-specific resource use and costs were also evaluated. Patients and methods: This was a retrospective, observational, matched cohort study using administrative claims data from the Truven Health MarketScan® Commercial Claims and Encounters and the Health and Productivity Management databases (2007-2010). Working-age (18-65 years) patients with COPD were identified as having at least one hospitalization or one emergency department visit or two outpatient visits. Patients in the non-COPD cohort did not have a diagnosis of COPD during the study period. Outcomes were evaluated in the first full calendar year after the year of identification (index). Results: Of the 5,701 patients with COPD identified, 3.6% patients were frequent exacerbators (≥2), 10.4% patients were infrequent exacerbators (1), and 86% patients were non-exacerbators (0). When compared with the 17,103 patients without COPD, the incremental direct cost of COPD was estimated at $6,246/patient/year (95% confidence interval: $4,620, $8,623; P<0.001). Loss in productivity was significantly greater in patients with COPD, with an average of 5 more days/year of absence from work and incremental indirect costs from short-term disability of $641 (P<0.001). Direct costs for frequent exacerbators ($17,651/year) and infrequent exacerbators ($14,501/year) were significantly higher than those for non-exacerbators ($11,395, P<0.001). Conclusion: Working-age patients with COPD incur statistically significantly higher direct and indirect costs and use more resources compared with those who do not have COPD.

Hospitalization Costs for Patients Undergoing Orthopedic Surgery Treated With Intravenous Acetaminophen (IV-APAP) Plus Other IV Analgesics or IV Opioid Monotherapy for Postoperative Pain.

INTRODUCTION: To assess the impact on hospitalization costs of multimodal analgesia (MMA), including intravenous acetaminophen (IV-APAP), versus IV opioid monotherapy for postoperative pain management in patients undergoing orthopedic surgery. METHODS: Utilizing the Truven Health MarketScan® Hospital Drug Database (HDD), patients undergoing total knee arthroplasty (TKA), total hip arthroplasty (THA), or surgical repair of hip fracture between 1/1/2011 and 8/31/2014 were separated into postoperative pain management groups: MMA with IV-APAP plus other IV analgesics (IV-APAP group) or an IV opioid monotherapy group. All patients could have received oral analgesics. Baseline characteristics and total hospitalization costs were compared. Additionally, an inverse probability treatment weighting [IPTW] with propensity scores analysis further assessed hospitalization cost differences. RESULTS: The IV-APAP group (n = 33,954) and IV opioid monotherapy group (n = 110,300) differed significantly (P < 0.0001) across baseline characteristics, though the differences may not have been clinically meaningful. Total hospitalization costs (mean ± standard deviation) were significantly lower for the IV-APAP group than the IV opioid monotherapy group (US$12,540 ± $9564 vs. $13,242 ± $35,825; P < 0.0001). Medical costs accounted for $701 of the $702 between-group difference. Pharmacy costs were similar between groups. Results of the IPTW-adjusted analysis further supported the statistically significant cost difference. CONCLUSIONS: Patients undergoing orthopedic surgery who received MMA for postoperative pain management, including IV-APAP, had significantly lower total costs than patients who received IV opioid monotherapy. This difference was driven by medical costs; importantly, there was no difference in pharmacy costs. Generalizability of the results may be limited to patients admitted to hospitals similar to those included in HDD. Dosing could not be determined, so it was not possible to quantify utilization of IV-APAP or ascertain differences in opioid consumption between the 2 groups. This study did not account for healthcare utilization post-discharge.

Comorbidity and health care visit burden in working-age commercially insured patients with diabetic macular edema.

PURPOSE: To examine the comorbidity profile and update estimates of health care resource utilization for commercially insured, working-age adults with diabetic macular edema (DME) relative to a matched comparison group of diabetic adults without DME. Additional comparisons were made in the subgroup of pseudophakic patients. PATIENTS AND METHODS: A retrospective matched-cohort study of commercially insured diabetic adults aged 18-63 years was conducted using medical and outpatient pharmacy claims (July 1, 2008-June 30, 2013). Outcomes included diabetes-related and ocular comorbidities and health care resource utilization (any health care visit days, outpatient visit days, inpatient visit days, emergency room visits, eye care-related visit days, unique medications) in the 12-month post-index period. RESULTS: All diabetes-related and ocular comorbidities were significantly more prevalent in DME cases versus non-DME controls (P<0.05). A significantly greater proportion of DME cases utilized eye care-related visits compared with non-DME controls (P<0.001). DME cases had almost twice the mean number of total health care visit days compared to non-DME controls (28.6 vs 16.9 days, P<0.001), with a minority of visit days being eye care-related (mean 5.1 vs 1.5 days, P<0.001). Similar trends were observed in pseudophakic cohorts. CONCLUSION: This working-age DME population experienced a mean of 29 health care visit days per year. Eye care-related visit days were a minority of the overall visit burden (mean 5 days) emphasizing the trade-offs DME patients face between managing DME and their overall diabetic disease. Insights into the complex comorbidity profile and health care needs of diabetic patients with DME will better inform treatment decisions and help optimize disease management.

First-Line Treatment with Bevacizumab and Platinum Doublet Combination in Non-Squamous Non-Small Cell Lung Cancer: A Retrospective Cohort Study in US Oncology Community Practices.

BACKGROUND: Real-world evidence is lacking on the impact of bevacizumab added to carboplatin/paclitaxel (Bev + CP) therapy versus CP alone for patients with non-squamous non-small cell lung cancer (NS-NSCLC), particularly in those excluded from clinical trials. METHODS: This is a retrospective electronic medical record analysis of patients who received first-line therapy with Bev + CP or CP between 1 October 2006 and 30 June 2013. We identified four subsets: elderly patients (≥65 years), patients with brain/central nervous system (CNS) metastases, patients with Eastern Cooperative Oncology Group performance status (ECOG PS) ≥2, and patients receiving anticoagulation. We used descriptive statistics to describe patient characteristics and treatment patterns and evaluated progression-free survival (PFS) and overall survival (OS) using survival analyses. RESULTS: The study included 431 patients (Bev + CP: 231; CP: 200). The Bev + CP cohort was more likely to receive four or more cycles of induction therapy (72 vs. 50 %) and was more likely to receive maintenance therapy (45 vs. 21 %) than patients receiving CP. In the overall population, median PFS and OS were significantly longer in the Bev + CP cohort than in the CP cohort: 6.7 vs. 5.1 months (hazard ratio [HR] 0.74; 95 % confidence interval [CI] 0.59-0.92; p = 0.008) and 11.9 vs. 9.0 months (HR 0.57; 95 % CI 0.44-0.73; p < 0.001), respectively. Treatment with Bev + CP in patients aged ≥65 years and in those with brain/CNS metastases was also associated with a significant risk reduction in PFS (35 and 51 %, respectively; p < 0.05 for both) and OS (46 and 62 %, respectively; p < 0.05 for both) compared with CP alone. CONCLUSION: Bev + CP is associated with a significant improvement in PFS and OS in patients with NS-NSCLC and in subsets with brain/CNS metastases and those aged ≥65 years.

Treatment patterns of chronic obstructive pulmonary disease in employed adults in the United States.

BACKGROUND: This study evaluated patterns of pharmacotherapy in chronic obstructive pulmonary disease (COPD) as they relate to recommended guidelines in a prevalent COPD patient population with employer-sponsored health insurance in the US. METHODS: Health care claims data from 2007 and 2008 were retrospectively analyzed for the study population defined as patients aged 40 years and older, continuously enrolled during the study period, and having at least one inpatient or one emergency department (ED) visit, or at least two outpatient claims coded with COPD (International Classification of Diseases, 9th Revision, Clinical Modification code 491.xx, 492.xx, 496.xx). Rates of any pharmacotherapy (both maintenance and reliever), long-acting maintenance pharmacotherapy in patients with an exacerbation history, and short-term treatment of acute exacerbations of COPD were evaluated in the overall population, newly diagnosed, and previously diagnosed patients (including maintenance-naïve and maintenance-experienced). Stratified analyses were also conducted by age group (40-64 years, ≥65 years) and physician specialty. RESULTS: A total of 55,361 patients met study criteria of whom 39% were newly diagnosed. The mean age was 66 years, and 46% were male. Three-fourths (74%) of all COPD patients had some pharmacotherapy (maintenance or reliever) with less than half (45%) being treated with maintenance medications. The combination of an inhaled corticosteroid and a long-acting beta-agonist was the most prevalent drug class for maintenance treatment followed by tiotropium. Only 64% of patients with an exacerbation history had a prescription for a long-acting maintenance medication, and short-term treatment with oral corticosteroids or antibiotics was higher for hospitalization exacerbations compared to ED visit exacerbations (68% vs 44%). In general, the rates of pharmacotherapy were highest in patients who were maintenance-experienced followed by newly diagnosed and maintenance-naïve. CONCLUSION: The majority of COPD patients received maintenance or reliever COPD medications, but less than half received guideline-recommended care, especially those with an exacerbation history or receiving short-term treatment for acute exacerbations.

Observational study of the outcomes and costs of initiating maintenance therapies in patients with moderate exacerbations of COPD.

BACKGROUND: There are limited data describing patients with moderate COPD exacerbations and evaluating comparative effectiveness of maintenance treatments in this patient population. The study examined COPD patients with moderate COPD exacerbations. COPD-related outcomes were compared between patients initiating fluticasone propionate-salmeterol 250/50 mcg (FSC) vs anticholinergics (ACs) following a moderate COPD exacerbation. METHODS: This retrospective observational study used a large administrative claims database (study period: 2003-2009) to identify and describe patients with an initial, moderate COPD exacerbation. A descriptive analysis of patients with moderate COPD exacerbations was done evaluating maintenance treatment rates, subsequent COPD exacerbation rates, and COPD-related costs during a 1-year period. A cohort analysis compared COPD exacerbation rates and associated costs during a variable-length follow-up period between patients initiating maintenance therapy with FSC or ACs. COPD exacerbations were reported as rate per 100 patient-years, and monthly costs were reported (standardized to USD 2009). COPD exacerbation rates between cohorts were evaluated using Cox proportional hazards models, and costs were analyzed using generalized linear models with log-link and gamma distribution. RESULTS: 21,524 patients with a moderate COPD exacerbation were identified. Only 25% initiated maintenance therapy, and 13% had a subsequent exacerbation. Annual costs averaged $594 per patient. A total of 2,849 treated patients (FSC = 925; AC = 1,924) were eligible for the cohort analysis. The FSC cohort had a significantly lower rate of COPD exacerbations compared to the AC cohort (20.8 vs 32.8; P = 0.04). After adjusting for differences in baseline covariates, the FSC cohort had a 42% significantly lower risk of a COPD exacerbation (HR = 0.58; 95% CI: 0.38, 0.91). The FSC cohort incurred significantly higher adjusted pharmacy costs per patient per month by $37 (95% CI: $19, $72) for COPD-related medications vs the AC cohort. However, this increase was offset by a significant reduction in adjusted monthly medical costs per patient for the FSC vs the AC cohort ($82 vs $112; P < 0.05). Total monthly COPD-related costs, as a result, did not differ between cohorts. CONCLUSIONS: Only a quarter of patients with a moderate COPD exacerbation were subsequently treated with maintenance therapy. Initiation of FSC among those treated was associated with better clinical and economic outcomes compared to AC.

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.

Predicted coronary heart disease risk reduction and dual blood pressure/cholesterol goal attainment in patients with hypertension treated in real-world clinical practice.

Hypertension and dyslipidemia are highly co-prevalent, but often poorly controlled, coronary heart disease (CHD) risk factors. A retrospective cohort study was conducted between January 2004 and April 2008 to compare estimated 10-year CHD risk reduction and dual blood pressure and low-density lipoprotein cholesterol goal attainment (Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure and Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults [Adult Treatment Panel III]) in patients with a first prescription for amlodipine monotherapy, co-prescribed amlodipine + statin, or single-pill amlodipine/atorvastatin. In total, 2739 patients were prescribed amlodipine monotherapy, 653 were co-prescribed amlodipine + statin, and 227 were prescribed single-pill amlodipine/atorvastatin. Baseline CHD risk was similar in all 3 cohorts (11.0%-12.5%). Relative CHD risk reduction was greater in those prescribed single-pill amlodipine/atorvastatin (24.5%) compared with amlodipine monotherapy (14.4%, P<.01), and co-prescribed amlodipine + statin (18.4%, P=.01). The findings were driven by greater dual goal attainment for patients prescribed single-pill amlodipine/atorvastatin (50.2%) compared with amlodipine monotherapy (31.7%, P<.05) and co-prescribed amlodipine + statin (37.5%, P<.05).

Better Asthma Management with Advanced Technology: Creation of an Asthma Utilization Rx Analyzer (AURA) Tool.

With nearly 23 million people affected by asthma each year, optimizing care among patients with persistent disease is a constant challenge for health care providers. The Asthma Utilization Rx Analyzer (AURA) tool enables health plan managers to evaluate quality and resource utilization for its members with asthma by analyzing medical and pharmacy claims. Customizable quality measures allow users of the tool to generate results from specific plans in order to optimize asthma disease management.

Economic and clinical evaluation of fondaparinux vs. enoxaparin for thromboprophylaxis following general surgery.

PURPOSE: Patients undergoing general surgical procedures are at increased risk for venous thromboembolism (VTE). Compliance rates with established guidelines for VTE thromboprophylaxis in patients at moderate-to-high risk are notably low. Recent literature has demonstrated that fondaparinux is associated with lower costs and fewer VTEs than enoxaparin in patients undergoing major orthopedic surgery (MOS), but data are limited in patients undergoing general surgery. This study was conducted to evaluate the cost implications and relative real-world effectiveness of fondaparinux vs. enoxaparin in general surgery patients. METHODS: Data were obtained from inpatient billing records from over 500 hospitals using Premier's Perspective Comparative Database. Patients hospitalized for general surgery between July 1, 2003 and January 31, 2006 were eligible for inclusion. Eligible patients were included if they received fondaparinux or enoxaparin after their general surgery date. Patients were excluded if they received both anticoagulants on their first day of therapy, were <18 years of age on the surgery date, or did not have data 6 months prior and 1 month post hospitalization. Included patients were stratified into two cohorts based on their first anticoagulant, fondaparinux or enoxaparin. Patients were matched in each group on 1:1 case-control matching based on propensity scores. RESULTS: A total of 5364 patients were included (n = 2682 for each cohort) from 326 unique hospitals. Average total costs per patient for the fondaparinux group were significantly lower than the enoxaparin group ($15 156 vs. 17 741, p < 0.0001). Patients receiving fondaparinux were significantly less likely to experience a VTE (2.80 vs. 3.77%, p = 0.046, a 35% relative risk reduction). No significant differences in bleeding events between the cohorts were observed (p = 0.6047), and no significant differences in all-cause inpatient death were noted (p = 0.3673). CONCLUSION: Fondaparinux was associated with significantly lower costs and fewer VTEs compared to enoxaparin without an increase in bleed rates or all-cause inpatient mortality. The findings from this study are limited by the retrospective study design and should only be generalized to a similar patient population.

Consequences of major bleeding in hospitalized patients with non-ST segment elevation acute coronary syndromes receiving injectable anticoagulants.

OBJECTIVE: To evaluate the burden of major bleed in patients with non-ST segment elevation acute coronary syndromes (NSTE ACS) receiving injectable anticoagulation from the hospital perspective. METHODS: Retrospective analysis of inpatient medical and pharmacy data from the Premier Perspective Comparative Database between 1/1/2003 and 3/31/2006. Hospitalized patients aged >or=18 years with a diagnosis of UA or NSTEMI who received an injectable anticoagulant agent during the same hospital stay were stratified into two cohorts: those who experienced a major bleed during hospitalization and those who did not, defined by the presence of >or=1 pre-specified ICD-9 codes. Length of hospital stay (LOS), inpatient mortality, 30-day readmissions, and hospitalization costs over 30 days were assessed between the cohorts using statistical models to control for covariates which may have impacted the outcomes. RESULTS: Patients with a major bleed had significantly longer length of stay (13.8 days vs 5.6 days), higher readmission rates (31.3% vs 14.7%), and increased all-cause mortality (15.0% vs 4.5%) compared with patients who did not bleed. After controlling for covariates, major bleeding was significantly associated with increased length of stay, readmission rate, and mortality. Adjusted costs were $13,856 higher on average for patients with a major bleed (95% CI: $13,828-$18,884; p < 0.0001). Subanalyses conducted on patients aged >or=65 years and those undergoing invasive procedures demonstrated higher occurrence of bleed than the general population and a similar impact on outcomes assessed. CONCLUSION: In conclusion, the study showed that patients with UA or NSTEMI who experience a major bleed have significantly longer hospital stays, higher readmission rates, increased costs, and increased mortality than those without a major bleed. These data emphasize the importance of considering the safety profile in context of the efficacy of the recommended agents. The findings from this study are limited by the retrospective study design and certain endpoints, such as readmissions, may have been underreported.

Impact of a pentavalent combination vaccine on immunization timeliness in a state Medicaid population.

BACKGROUND: Use of combination vaccines has been associated with improved coverage rates, but their effect on timeliness remains to be explored. This study assessed the effect of diphtheria-tetanus-acellular pertussis/hepatitis B/inactivated polio vaccine (DTaP/HepB/IPV) on the timeliness of vaccine administration. METHODS: This retrospective cohort study used administrative claims data from the Georgia Medicaid program. Children with 24 months of continuous enrollment and at least 4 vaccine-related office visits were stratified into 2 cohorts: those with at least 3 DTaP/HepB/IPV doses (DTaP/HepB/IPV cohort) and those with at least 3 doses of DTaP but no doses of DTaP/HepB/IPV (reference cohort). Children who received any dose of HepB/Hib were excluded to isolate the effect of the study vaccine. Timeliness was measured as the percentage of children who received their vaccines on time and the cumulative days undervaccinated. RESULTS: There were 2880 children in the DTaP/HepB/IPV cohort and 2672 in the reference cohort. After controlling for covariates, receipt of DTaP/HepB/IPV was associated with significantly improved timeliness for 3 doses of DTaP (on-time rates: 66.3% vs. 60.8%, P < 0.0001; cumulative days undervaccinated: 29.5 vs. 70.4 days, P < 0.0001). Significantly improved timeliness was also observed in the DTaP/HepB/IPV cohort for IPV, HepB, Hib, 4 DTaPs, and the combination series assessed (P < 0.001 for all comparisons). CONCLUSIONS: Use of DTaP/HepB/IPV in this Medicaid population was associated with improved on-time vaccination and fewer undervaccinated days. These findings, along with previous research associating combination vaccines with improved coverage rates, provide quantitative data to support the ACIP, AAP, and AAFP preference for combination vaccines.

Treatment modalities, health care resource utilization, and costs in patients diagnosed with interstitial cystitis.

OBJECTIVE: The aim of this study was to examine treatment modalities, health care resource utilization, and costs in patients diagnosed with interstitial cystitis (IC). STUDY DESIGN: Patients with a diagnosis of IC were identified from a national managed care administration claims database and classified into treatment cohorts. All-cause health care resource utilization and costs were calculated by treatment cohort. RESULTS: Patients treated with narcotics plus nonnarcotic analgesics were associated with higher mean health care costs. Patient cohorts treated with some of the more common oral therapies for interstitial cystitis, including pentosan polysulfate sodium, amitriptyline, and hydroxyzine, were associated with lower costs. Physician visits were fewest among patients treated with pentosan polysulfate sodium plus amitriptyline and hydroxyzine. Physician visits were higher for cohorts that included dimethyl sulfoxide plus cystoscopy or bladder irrigation, or narcotics plus nonnarcotic analgesics. CONCLUSION: Interstitial cystitis is associated with substantial costs and health care resource utilization.

Combination vaccine use and vaccination quality in a managed care population.

OBJECTIVE: To evaluate the impact of a pentavalent combination vaccine on childhood immunization coverage rates and timeliness within a managed care organization. STUDY DESIGN: Retrospective matched-cohort analysis of encounter data from administrative claims and a state immunization registry. METHODS: Children were stratified into 2 demographically matched cohorts (combination and reference), based on receipt of the DTaP/HepB/IPV combination vaccine. Children were followed until 24 months of age, and coverage rates and on-time rates were assessed. Outcomes were measured for the HEDIS Combination 2 vaccine series (4 doses of diphtheria/tetanus/pertussis, 3 doses of polio, 1 dose of measles/mumps/rubella, 3 doses of Haemophilus influenzae type b, 3 doses of hepatitis B, and 1 dose of varicella) and each vaccine series individually. RESULTS: Children in the combination cohort were significantly more likely to be fully vaccinated for the HEDIS Combination 2 series by 2 years of age and to be vaccinated within the recommended age ranges. In the combination cohort 86.9% (752/865) of patients were fully covered compared with only 74.1% (641/865) of the reference cohort (P <.001). In the combination cohort 45.2% (391/865) of patients received vaccinations on time versus 37.5% (324/865) of the reference cohort, P = .001. CONCLUSIONS: Receipt of DTaP/HepB/IPV was associated with improved coverage and age-appropriate immunization in a managed care population.

Use of combination vaccines is associated with improved coverage rates.

BACKGROUND: The number of shots represented by the routine childhood immunization schedule poses a logistical challenge for providers and a potential deterrent for parents. By reducing the number of injections, use of combination vaccines could lead to fewer deferred doses and improved coverage rates. OBJECTIVE: To determine the effect of combination vaccines on coverage rates. METHODS: This was a retrospective study of administrative claims data from the Georgia Department of Community Health Medicaid program conducted from January through September of 2003. Coverage rates were compared between children who received at least 1 dose of HepB/Hib (COMVAX) or DTaP/HepB/IPV (PEDIARIX) (the combination cohort) and children who received no doses of either combination (the reference cohort). Infants with fewer than 4 vaccination visits were excluded from the analysis. Multivariate logistic regression was performed on the whole study population to assess the effect of combination vaccines while controlling for potential confounders. Hepatitis B and pneumococcal conjugate vaccine coverage rates were not included as outcomes. RESULTS: The study population consisted of 18,821 infants, 16,007 in the combination cohort and 2814 in the reference cohort. Unadjusted coverage rates for DTaP, IPV and the 4 DTaP:3 IPV:1 MMR, 4 DTaP: 3 IPV: 1 MMR: 3 Hib: 1 varicella, and 3 DTaP:3 IPV: 3 Hib series were higher in the combination cohort. Receipt of at least 1 dose of a combination vaccine was independently associated with increased coverage for each of these vaccines and vaccine series when controlling for gender, birth quarter, race, rural versus urban residence and historical provider immunization quality. CONCLUSIONS: Use of combination vaccines in this Medicaid population was associated with improved coverage rates. Additional studies are warranted, including those examining private sector populations and outcomes such as timeliness and cost.