H Waters

S2 Statistical Solutions, Cincinnati, Ohio, United States

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Publications (47)268.81 Total impact

  • G. David · N. Tandon · H.C. Waters · C. Gunnarsson · A. Kavanaugh
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    ABSTRACT: Introduction: This study analyzed the impact of biologics on total hip replacement (THR) and total knee replacement (TKR) in rheumatoid arthritis (RA) patients. Study Design: A retrospective analysis was performed using 1993 to 2008 data from the Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project. Methods: A coding algorithm was used to identify all 1,742,935 patients having THR or TKR procedures, 58,036 of whom had a diagnosis of RA. Difference-in-differences methodology was utilized to examine the potential effect of biologic agents on the likelihood that RA was the primary reason for receiving THR or TKR by comparing 3 groups of patients: RA patients after introduction of biologics, RA patients before introduction of biologics, and patients without a diagnosis of RA. All models controlled for patient demographics and comorbidities. Results: The number of annual THR procedures more than doubled between 1993 and 2008 (25,987 to 56,478), and the number of annual TKR procedures more than tripled (38,136 to 125,881). Patients with RA as a primary or secondary diagnosis had a statistically significant (P <.01) 28% decrease in THR or TKR surgeries following introduction of the tumor necrosis factor inhibitors etanercept, infliximab, and adalimumab. Conclusions: Since introduction of biologics for treatment of RA, there has been a reduction in THR and TKR surgeries among RA patients. This consistent and robust finding suggests that the availability of biologic agents, as well as other changes in the therapeutic approach to RA, may confer long-term benefits to both RA patients and healthcare systems. © 2014, Managed Care and Healthcare Communications. All Rights Reserved.
    No preview · Article · Nov 2014 · American Journal of Pharmacy Benefits
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    N. Tandon · S. Haas · H. C. Waters · W. Olson · S. Bolge · C. Gunnarsson
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    ABSTRACT: Background Rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) are chronic autoimmune diseases that result in destructive inflammation of the joints, as well as other organs. Golimumab, adalimumab, and etanercept are subcutaneous biologic therapies indicated for the treatment of moderately to severely active RA, PsA, and AS in adults. Objectives To understand real world persistence in patients who receive golimumab, adalimumab and etanercept using administrative claims data. Methods This study used the MarketScan® Research Database from Thomson Reuters. Patients were diagnosed with RA, PsA, or AS and aged ≥18 years at index date, with continuous enrollment for 6 months prior to and 364 days following the initial medication fill. Patients had ≥2 fills and a 28-31 day supply of study drug (golimumab, adalimumab, or etanercept) for all fills during the 365 day study period. Matches for golimumab patients were obtained using propensity score matching for a range of demographic characteristics and 1:1 matching for prior biologic experience. Duration of therapy was calculated as the minimum of (1) the number of days between the date of last dose within the study window and the date of first dose plus the days supply for the last dose; and (2) 365 days. Treatment persistence was defined as: (duration/365) × 100. Results Prior to matching, there were significant differences between the golimumab, adalimumab, and etanercept cohorts in terms of age, gender, geographic region, previous biologic use, last biologic previous to the index biologic, primary diagnosis, and psoriasis comorbidity. Golimumab patients were older than adalimumab or etanercept patients (mean age =52.09 vs. 50.52 and 50.07, p=0.028) and more likely to be female (74.3% vs. 65.7% and 71.3%, p=0.002). Golimumab patients were also more likely to have previous biologic experience than adalimumab or etanercept patients (79.1% vs. 32.0% and 19.8%, p<0.001). In the matched cohorts, no significant differences were found in duration of therapy between the golimumab (259.73 days; 95% CI: 247.20-272.26) and adalimumab (268.75 days; 95% CI: 256.03-281.47) patients or persistence (71.16% [95% CI: 67.73%>74.59%] vs. 73.63% [95% CI: 70.16%>77.10%]). Likewise, there were no significant differences in duration of therapy (267.82 [95% CI: 253.81-281.83] vs. 276.26 days [95% CI: 261.68-290.84]) or persistence (73.38% [95% CI: 69.54-77.22] vs. 75.69% [95% CI: 72.59-78.79]) between the golimumab and etanercept cohorts. Conclusions The mean treatment persistence among golimumab patients is over 70%, and when matched to patients taking adalimumab or etanercept, both duration of therapy and persistence are numerically equivalent between cohorts. Future research is needed to assess the impact of persistence on clinical and economic outcomes. Disclosure of Interest N. Tandon Employee of: Janssen Scientific Affairs, LLC, S. Haas Consultant for: Janssen Scientific Affairs, LLC, H. Waters Consultant for: Janssen Scientific Affairs, LLC, W. Olson Employee of: Janssen Scientific Affairs, LLC, S. Bolge Employee of: Janssen Scientific Affairs, LLC, C. Gunnarsson Consultant for: Janssen Scientific Affairs, LLC
    Full-text · Article · Jan 2014 · Annals of the Rheumatic Diseases
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    ABSTRACT: Meta-analyses of clinical trials have shown that using statins to lower low-density lipoprotein cholesterol (LDL-C) reduces cardiovascular events, and more intensive lowering of LDL-C further decreases the risk of occlusive vascular events. Lipoprotein studies suggest treating patients more aggressively when low-density lipoprotein particle (LDL-P) number is discordantly high in the presence of normal LDL-C levels. Failure to manage LDL-P numbers may lead to additional direct and indirect costs. This analysis modeled direct and indirect costs associated with cardiovascular events due to suboptimal treatment resulting from discordance between LDL-C and LDL-P levels. The analysis was conducted from the payer perspective and the employer perspective, respectively, over a 3-year time period. Clinical data were obtained from the Multi-Ethnic Study of Atherosclerosis, a community-based population study. The employer perspective included indirect costs and quality-adjusted life years in addition to the direct costs and cardiovascular disease events considered in the payer analysis. All costs are reported in 2011 dollars. From the payer perspective, managing LDL-C and LDL-P in comparison with LDL-C alone reduced costs ($21,212) and cardiovascular events (9 events). Similar patterns were observed for managing LDL-P alone in comparison with LDL-C. From the employer perspective, managing both LDL-P alone or in combination with LDL-C also resulted in lower costs, fewer cardiovascular disease events, and increased quality-adjusted life years in comparison with LDL-C. This analysis indicates that the benefits of additional testing to optimally manage LDL-P levels outweigh the costs of more aggressive treatment. These favorable results depended on the cost of drug therapy.
    No preview · Article · Nov 2013 · Journal of Clinical Lipidology
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    ABSTRACT: The primary objective of this study was to estimate the occurrence and costs of medical errors from the hospital perspective. Methods from a recent actuarial study of medical errors were used to identify medical injuries. A visit qualified as an injury visit if at least 1 of 97 injury groupings occurred at that visit, and the percentage of injuries caused by medical error was estimated. Visits with more than four injuries were removed from the population to avoid overestimation of cost. Population estimates were extrapolated from the Premier hospital database to all US acute care hospitals. There were an estimated 161,655 medical errors in 2008 and 170,201 medical errors in 2009. Extrapolated to the entire US population, there were more than 4 million unique injury visits containing more than 1 million unique medical errors each year. This analysis estimated that the total annual cost of measurable medical errors in the United States was $985 million in 2008 and just over $1 billion in 2009. The median cost per error to hospitals was $892 for 2008 and rose to $939 in 2009. Nearly one third of all medical injuries were due to error in each year. Medical errors directly impact patient outcomes and hospitals' profitability, especially since 2008 when Medicare stopped reimbursing hospitals for care related to certain preventable medical errors. Hospitals must rigorously analyze causes of medical errors and implement comprehensive preventative programs to reduce their occurrence as the financial burden of medical errors shifts to hospitals.
    Full-text · Article · Mar 2013 · Value in Health
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    Chureen T Carter · Heidi C Waters · Daniel B Smith
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    ABSTRACT: To assess the impact of a continuous measure of adherence with infliximab maintenance treatment in Crohn's disease (CD) during the first year of treatment on CD-related health care utilization, CD-related hospitalizations, inpatient costs, and length of hospital stay. A retrospective claims analysis using the IMS LifeLink Health Plan Claims Database (September 1, 2004, to June 30, 2009) was conducted. Continuous enrollment for 12 months before and 12 months after the index date was required. Patients were required to have at least two claims with an International Classification of Diseases, 9th Revision, Clinical Modification diagnosis code for CD (555.xx) pre-index and be aged ≥ 18 years at index. Patients with three infusions during the first 56 days post-index and at least one infusion following day 56 post-index were considered to have maintenance therapy. Adherence and nonadherence were defined as a medication possession ratio of ≥ 80% and < 80%, respectively. Four hundred forty-eight patients were included in the analysis (mean age, 42.6 years; 56% female; mean ± standard deviation [SD] and median number of infliximab infusions, 7.35 ± 1.60 and 8). The number of patients who met the definition of adherence was 344 (77%). CD-related health care utilization was not significantly impacted by adherence except for ancillary services and radiology. Fewer adherent patients were hospitalized compared with nonadherent patients (9% versus 16%; P = 0.03). Adherent patients had fewer mean ± SD and median days in the hospital (5.5 ± 3.4 and 5 days) compared with nonadherent patients (13.1 ± 14.2 and 8 days; P = 0.01). Mean ± SD and median hospital costs were significantly greater for nonadherent patients ($40,822 ± $49,238 and $28,864) compared with adherent patients ($13,704 ± $10,816 and $9938; P = 0.002). Adherence with maintenance infliximab over 12 months was associated with lower rates of CD-related hospitalizations and inpatient costs and a shorter length of hospital stay.
    Preview · Article · Jun 2012 · Patient Preference and Adherence
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    J.A. Rizzo · P. Mallow · H. Waters · A. Cirrincione

    Preview · Article · Jun 2012 · Value in Health
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    J.A. Rizzo · P. Mallow · H. Waters · A. Cirrincione

    Preview · Article · Jun 2012 · Value in Health
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    J.A. Rizzo · P. Mallow · H. Waters · A. Cirrincione

    Preview · Article · Jun 2012 · Value in Health
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    ABSTRACT: 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. 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 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. 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. GI-related resource utilization was significantly lower and attenuation of mucosal damage severity was observed during infliximab treatment compared with the pre-treatment period.
    No preview · Article · Feb 2012 · Journal of Medical Economics
  • Chureen T Carter · Heidi C Waters · Daniel B Smith
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    ABSTRACT: Few published reports have described the impact of adherence with biologic agents on hospitalizations and inpatient costs in Crohn's disease (CD). A retrospective claims analysis using the IMS LifeLink Health Plan Claims Database between September 1, 2004 and June 30, 2009 was conducted. Continuous enrollment for 12 months before and 12 months after the index date was required. Patients were required to have ≥2 claims with an International Classification of Diseases, 9th Edition, Clinical Modification diagnosis code for CD (555.xx) preindex, be ≥18 years of age at index, and have ≥4 infliximab infusions with a gap no greater than 12 weeks between each infusion. Patients with 7-9 infliximab infusions (12 months postindex) were considered adherent; patients with 4-6 infliximab infusions were considered nonadherent. In total, 638 patients were included in the analyses (mean age, 43 years; 58% female in the adherent group and 53% in the nonadherent group). The number of patients who met the definition of adherence was 466 (73%). A smaller proportion of adherent patients had a CD-related emergency room visit, compared with nonadherent patients (11% vs. 17%, P=0.029). A smaller proportion of adherent patients required CD-related hospitalization, compared with nonadherent patients (8% vs. 12%, P=0.117). Among those hospitalized, adherent patients had fewer mean [median] days in the hospital (5.9 [5] days), compared with nonadherent patients (12.8 [8] days, P=0.015). Mean [median] hospital costs were significantly lower for adherent patients ($13,427 [$9,352]), compared with nonadherent patients ($37,783 [$28,864], P=0.001). Multivariate analyses confirmed lower inpatient (P<0.001) costs for adherent versus nonadherent patients. Adherence with infliximab therapy during the first year of treatment in patients with CD was associated with a shorter hospital length of stay and lower inpatient costs compared with nonadherent patients. Strategies for increasing adherence rates to infliximab maintenance therapy may be valuable in reducing hospitalizations and inpatient costs in patients with CD.
    No preview · Article · Aug 2011 · Advances in Therapy
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    ABSTRACT: To assess infliximab infusion patterns in ulcerative colitis (UC) and assess the impact of persistence with infliximab maintenance therapy on UC-related hospitalizations, lengths of stay, and inpatient costs. Retrospective analysis of medical claims for UC patients newly initiating infliximab treatment. Patients were aged >18 years and had 2 UC diagnosis codes, an infliximab index date between September 1, 2005, and January 31, 2008, and continuous enrollment for >12 months before and >14 months after the index date. Infliximab induction (first 56 days postindex) and maintenance (>56 days and <12 months postinduction) patterns were evaluated. Of patients with maintenance treatment, persistence was defined as a medication possession ratio (MPR) of >80%, and this group was compared with those without persistence (<80% MPR). Overall, 420 patients were included in the analysis; 84.3% (n = 354) continued to maintenance therapy. Maintenance infusion patterns were consistent with recommended prescribing information. A smaller proportion of patients with maintenance therapy persistence required hospitalization compared with patients without persistence (3.0% vs 20.4%; P <.001). Hospitalized patients with maintenance therapy persistence had significantly lower mean inpatient costs ($14,243 vs $32,745; P = .046), with a trend toward shorter mean lengths of stay (6.67 vs 9.71 days; P = .147) than patients without persistence. Infliximab maintenance therapy persistence in UC was associated with significantly fewer hospitalizations. Once hospitalized, patients with therapeutic persistence had significantly decreased inpatient costs.
    No preview · Article · Jun 2011 · The American journal of managed care
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    ABSTRACT: 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. 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. 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. 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. 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.
    No preview · Article · May 2011 · Journal of Medical Economics
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    ABSTRACT: Plaque psoriasis is a chronic, inflammatory skin disease that can be difficult to treat. Traditional systemic agents, topical agents, phototherapy and biologic therapies can be used for patients with psoriasis. The authors reviewed published results from a variety of sources in order to better understand the effects of psoriasis treatments on patient satisfaction, patient adherence, healthcare resource utilization and productivity. Patients with psoriasis consider many factors when evaluating therapies, including the time for the therapy to be effective, cosmetic issues common with topical therapies and travel to and from phototherapy centers. Satisfaction with and adherence to biologic therapies appears to be greater than for traditional therapies. Although biologic therapies are generally more expensive than are traditional, these agents may contribute to decreased healthcare utilization and increased productivity.
    No preview · Article · Feb 2011 · Journal of drugs in dermatology: JDD
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    ABSTRACT: Crohn's disease is a chronic condition that often presents in early adulthood. To evaluate health care costs and costs per quality-adjusted life year (QALY) for Crohn's disease. A Markov model was developed using administrative claims data for patients aged > or = 18 years with > or = 3 years of continuous enrolment from 2000 to 2008 and > or =2 Crohn's disease claims. Disease states (remission, mild-moderate, moderate-severe, and severe-fulminant) were defined using the American College of Gastroenterology treatment guidelines criteria. Transition probabilities were calculated from consecutive 6-month periods. Costs were determined from paid claims and QALY utilities were obtained from the literature. The model assumed a 30-year-old patient at the time of entry into the model. There were 40 063 patients identified, with a total of 420 773 cycles [remission (197 111; 46.8%), mild-moderate (44 024; 10.5%), moderate-severe (132 695; 31.5%), severe-fulminant (46 925; 11.2%)]. The costs/QALY for remission, mild-moderate, moderate-severe, and severe-fulminant disease states respectively were $2896, $8428, $11 518 and $69 277 for males and $2896, $8426, $22 633 and $69 412 for females. Overall, health care costs for patients with Crohn's disease increased with disease severity. Although the probabilities of transitioning from other health states to the severe-fulminant disease state were low, the cost/QALY was high.
    Full-text · Article · Aug 2010 · Alimentary Pharmacology & Therapeutics
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    ABSTRACT: Psoriasis is a chronic autoimmune condition that affects over 7 million Americans, approximately 1-3 percent of the population. Although there are a number of treatment options currently available, little is known about the treatment patterns of patients. Using data from 1,006 psoriasis sufferers, the aim of the present study was to analyze patients' treatment timeline, as well as their perceptions about these treatments. Most respondents were white, female and had health insurance. The results suggested that over-the-counter (OTC) and prescription topicals were the most common initial treatments, but systemic orals and biologics were the most common treatments for patients who required a third-line or fourth-line treatment (and for patients with greater severity). Treatment dissatisfaction was relatively high, with very few positive attributes associated with the current treatment options. Overall, this study suggests that treatment options vary (at a statistically significant level) as a function of severity, and many patients, despite the choices in the number and quality of treatment options, are generally dissatisfied.
    No preview · Article · Aug 2010 · Journal of drugs in dermatology: JDD
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    ABSTRACT: Background: Patient preference has been recognized as being of increasing importance when choosing a drug therapy for chronic conditions for which there are no cures and for which long-term treatment is needed. Objective: To quantify treatment preferences and priorities of patients with Crohn’s disease (CD). Methods: This was a prospective Internet-based survey of adult participants with moderate to severe CD who were recruited through two national survey panels in the US. The survey included questions about diagnostic and treatment histories, attitudes and perceptions related to CD, and CD therapy. In a discrete-choice-based conjoint exercise, respondents selected a preferred biologic treatment option from each of 16 pairs of drug profiles that systematically varied efficacy, convenience, and product history attributes. A hierarchical Bayes probit model was utilized to estimate respondent-level ‘utility scores’ for each of the attribute levels. In a separate exercise, respondents also directly ranked each specific attribute. Two-tailed tests were conducted to determine statistical significance at p < 0.05. Results: A total of 252 participants were surveyed, 202 (80%) of whom were biologic naive. Mean age was 44.1 years and mean disease duration was 11.6 years. The majority (71.8%) were female. In the conjoint exercise, the three attributes of greatest importance in accounting for patients’ biologic therapy preference were (greater) proportion of patients achieving lasting remission, (decreased) frequency of medication administration, and (higher) proportion of patients responding in 2 weeks. In the direct ranking exercise, the proportion of CD patients achieving lasting remission was selected as the most important attribute by the most respondents (27%), followed by the proportion of CD patients responding in 2 weeks (23%). Conclusion: Achievement of lasting remission and a rapid clinical response were the biologic treatment characteristics highly valued by respondents in this survey. It is critical that physicians provide patients with balanced information regarding the benefits and risks, convenience, and medication history of each treatment option available to them in order for patients to make informed therapy choices that reflect their personal priorities.
    No preview · Article · Jun 2010 · The patient
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    A Naim · KV Nair · J Van Den Bos · K Draaghtel · H Waters

    Full-text · Article · May 2010 · Value in Health
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    R Bailey · H Waters · F. R. Ernst · B Johnson · RS McKenzie

    Full-text · Article · May 2010 · Value in Health
  • Heidi C. Waters · Chureen Carter · Paula Smith · Daniel B. Smith

    No preview · Article · May 2010 · Gastroenterology

  • No preview · Article · May 2010 · Gastroenterology

Publication Stats

190 Citations
268.81 Total Impact Points

Institutions

  • 2014
    • S2 Statistical Solutions
      Cincinnati, Ohio, United States
  • 2011
    • The Harvard Drug Group
      Ливония, Michigan, United States