A value-based analysis of hemodynamic support strategies for high-risk heart failure patients undergoing a percutaneous coronary intervention.

BACKGROUND: The economic burden of heart disease is heavy and growing. As advanced technologies for treating heart disease become available, decision makers need to be able to assess the relative value of such options against existing standards of care. OBJECTIVES: To compare the clinical and economic benefits of a percutaneous ventricular assist device (pVAD) versus an intra-aortic balloon pump (IABP) observed during the 90-day duration of the PROTECT II clinical trial, and to supplement these findings with a simulation of the longer-term value of this technology through the use of a Markov model to estimate the incremental cost-effectiveness of a pVAD relative to an IABP, in terms of quality-adjusted life-years (QALYs). METHODS: Hospital bills were collected for patients enrolled in the PROTECT II trial who received hemodynamic support for high-risk percutaneous coronary intervention (PCI) provided by a pVAD (Impella 2.5) versus a conventional IABP during a 90-day episode of care (EOC). Length of stay, charges, and costs were analyzed for the index admissions, intensive care unit confinements, readmissions, and overall EOC. In addition, a probabilistic Markov model was used to project these parameters and their impact on a patient's quality of life for up to 10 years in relation to a pVAD versus an IABP. RESULTS: Hospital costs for the index admission were lower for the IABP compared with the pVAD ($33,684 vs $47,667; P <.001), whereas readmission length of stay and costs were lower for the pVAD versus the IABP (5 days vs 7 days; and $11,007 vs $21,834, respectively; P <.001). The total 90-day hospital charges were similar for the pVAD and the IABP ($172,564 vs $172,758, respectively; P = .785); however, the total 90-day EOC cost was lower for the IABP than for the pVAD ($44,032 vs $53,171, respectively; P <.001). The median hospital days for the entire EOC were 7 days for the pVAD versus 9 days for the IABP (P = .008). Critical care stays were considerably shorter for a pVAD than for an IABP on readmissions (3.88 days vs 7.00 days; P = .145). Reduction in major adverse cardiovascular and cerebrovascular events resulted in a projected gain of 0.26 QALYs over 10 years, yielding an incremental cost-effectiveness ratio of $39,389/QALY. CONCLUSIONS: For high-risk patients with advanced heart failure undergoing PCI, the new pVAD reduced major adverse events, critical care and readmission length of stay, and readmission cost over the 90-day EOC, and was determined to be cost-effective over the long-term. These findings can assist decision makers in forming value-based judgments with regard to new hemodynamic support strategies.

Historical clinical and economic consequences of anemia management in patients with end-stage renal disease on dialysis using erythropoietin stimulating agents versus routine blood transfusions: a retrospective cost-effectiveness analysis.

OBJECTIVE: To determine whether Medicare's decision to cover routine administration of erythropoietin stimulating agents (ESAs) to treat anemia of end-stage renal disease (ESRD) has been a cost-effective policy relative to standard of care at the time. METHODS: The authors used summary statistics from the actual cohort of ESRD patients receiving ESAs between 1995 and 2004 to create a simulated patient cohort, which was compared with a comparable simulated cohort assumed to rely solely on blood transfusions. Outcomes modeled from the Medicare perspective included estimated treatment costs, life-years gained, and quality-adjusted life-years (QALYs). Incremental cost-effectiveness ratio (ICER) was calculated relative to the hypothetical reference case of no ESA use in the transfusion cohort. Sensitivity of the results to model assumptions was tested using one-way and probabilistic sensitivity analyses. RESULTS: Estimated total costs incurred by the ESRD population were $155.47B for the cohort receiving ESAs and $155.22B for the cohort receiving routine blood transfusions. Estimated QALYs were 2.56M and 2.29M, respectively, for the two groups. The ICER of ESAs compared to routine blood transfusions was estimated as $873 per QALY gained. The model was sensitive to a number of parameters according to one-way and probabilistic sensitivity analyses. LIMITATIONS: This model was counter-factual as the actual comparison group, whose anemia was managed via transfusion and iron supplements, rapidly disappeared following introduction of ESAs. In addition, a large number of model parameters were obtained from observational studies due to the lack of randomized trial evidence in the literature. CONCLUSIONS: This study indicates that Medicare's coverage of ESAs appears to have been cost effective based on commonly accepted levels of willingness-to-pay. The ESRD population achieved substantial clinical benefit at a reasonable cost to society.

Surgical site infection: incidence and impact on hospital utilization and treatment costs.

BACKGROUND: Surgical site infections (SSIs) are serious operative complications that occur in approximately 2% of surgical procedures and account for some 20% of health care-associated infections. METHODS: SSI was identified based on the presence of ICD-9-CM diagnosis code 998.59 in hospital discharge records for 7 categories of surgical procedures: neurological; cardiovascular; colorectal; skin, subcutaneous tissue, and breast; gastrointestinal; orthopedic; and obstetric and gynecologic. Source of data was the 2005 Healthcare Cost and Utilization Project National Inpatient Sample (HCUP NIS). Primary study outcomes were rate of SSI by surgical category and impact of SSI on length of stay and cost. Results were projected to the national level. RESULTS: Among 723,490 surgical hospitalizations in the sample, 6891 cases of SSI were identified (1%). On average, SSI extended length of stay by 9.7 days while increasing cost by $20,842 per admission. From the national perspective, these cases of SSI were associated with an additional 406,730 hospital-days and hospital costs exceeding $900 million. An additional 91,613 readmissions for treatment of SSI accounted for a further 521,933 days of care at a cost of nearly $700 million. CONCLUSION: SSI is associated with a significant economic burden in terms of extended length of stay and increased costs of treatment. Our analysis documented nearly 1 million additional inpatient-days and $1.6 billion in excess costs.

Can managed care organizations partner with manufacturers for comparative effectiveness research?

OBJECTIVE: To describe 2 published pragmatic or practical clinical trials (PCTs) as case studies illustrating successful partnerships between managed care organizations (MCOs) and pharmaceutical manufacturers. STUDY DESIGN: In today's environment, there is increasing concern about the comparative effectiveness of medical interventions. Various opinion leaders and stakeholders lament the dearth of such evidence and are calling for the public and private sectors to invest up to billions of dollars to create better comparative evidence. METHODS: We selected 2 PCTs conducted at different points in the drug life cycle to highlight strengths, limitations, and policy implications. The phase IV study compared fluoxetine hydrochloride vs 2 generic tricyclic antidepressants in selected primary care clinics of a health maintenance organization from 1992 through 1994. The phase IIIb study compared daily budesonide via dry powder inhaler vs triamcinolone acetonide metered-dose inhaler in adult patients with persistent asthma in 25 MCOs from 1995 through 1998. RESULTS: Both PCTs were successfully sponsored and funded by pharmaceutical manufacturers in collaboration with MCOs and provided potentially useful evidence of real-world effectiveness and evidence of value to healthcare decision makers. CONCLUSIONS: Industry-sponsored PCTs in managed care are feasible when manufacturer and MCO incentives align and can provide real-world evidence of comparative effectiveness and value for money. These trials can be conducted successfully in the phase IIIb and phase IV environments.

The costs of treating acute heart failure: an economic analysis of the SURVIVE trial.

OBJECTIVE: To estimate the incremental cost per life year gained with levosimendan relative to dobutamine in treatment of acute heart failure based on the Survival of Patients with Acute Heart Failure in Need of Intravenous Inotropic Support (SURVIVE) trial. METHODS: SURVIVE enrolled 1,327 patients (levosimendan 664, dobutamine 663) from nine nations with 180-day survival from date of randomisation as the primary endpoint. Hospital resource utilisation was determined via clinical case reports. Unit costs were derived from hospital payment schedules for France, Germany and the UK, and represent a third-party payer perspective. Cost-effectiveness analysis was performed for a subset of the SURVIVE patient population selected in accordance with current levosimendan labeling. RESULTS: Mortality in the levosimendan group was 26 versus 28% for dobutamine (hazard ratio 0.91, 95% confidence interval 0.74-1.13, p=0.40). Initial hospitalisation length of stay was identical (levosimendan 14.4, dobutamine 14.5, p=0.98). Slightly lower rates of readmission were observed for levosimendan relative to dobutamine at 31 (p=0.13) and 180 days (p=0.23). Mean costs excluding study drug were equivalent for the index admission (levosimendan euro5,060, dobutamine euro4,952; p=0.91) and complete episode (levosimendan euro5,396, dobutamine euro5,275; p=0.93). CONCLUSION: At an acquisition cost of euro600 per vial, there is at least 50% likelihood that levosimendan is cost effective relative to dobutamine if willingness to pay is equal to or greater than euro15,000 per life year gained.

Increasing the use of arteriovenous fistula in hemodialysis: economic benefits and economic barriers.

The Fistula First Initiative set a goal of 66% arteriovenous (AV) fistula-based access among US hemodialysis patients. This study modeled the impact of achieving the target AV fistula placement rate on Medicare expenditures and on dialysis patient survival and also reviewed economic disincentives for providers that will inhibit achieving this target. The model projects lifetime costs and survival in the US 2003 incident hemodialysis population. Annual treatment costs were estimated from previous analyses of Medicare expenditures by access modality. Patient survival by mode of access was derived from the Dialysis Morbidity and Mortality Study (DMMS). These parameters were applied to a cohort of patients who meet the 66% AV fistula target and an identical cohort with the current vascular access case mix. Comparison of outcomes yields estimates of differential total expenditures and total patient life-years. If prevalence AV fistula-based access in the 2003 incident hemodialysis cohort were 66% rather than the observed 35%, then the Center for Medicare and Medicaid Services would save $840 million in access-attributed expenditures over the expected lifetime of these patients. However, population survival would increase by 35,000 additional life-years, increasing total lifetime expenditures by a net of $1.4 billion. Relative to the current mix of access modality, the shift to 66% AV fistula would be achieved at a net incremental cost of $40,000 per year of life gained. Economic barriers to reaching this goal include financial disincentives to providing adequate predialysis care, performing AV fistula surgical procedures, and monitoring vascular access flow. Achievement of the 66% AV fistula target is cost-effective. Financial incentives in the form of higher reimbursement to encourage wider use of AV fistula placement also could be cost-effective.

Cost-effectiveness of intrathecal baclofen therapy for the treatment of severe spasticity associated with cerebral palsy.

Spasticity is relatively common among children with cerebral palsy. This condition can be painful, can severely impair a child's ability to perform basic tasks, and can place an enormous emotional and financial burden on the family. Intrathecal baclofen delivered via an implantable pump is an effective treatment option for children unresponsive to oral medication and needing generalized motor control. However, the initial investment for the delivery device and its surgical placement can be a barrier to access. A cost-effectiveness analysis of intrathecal baclofen for adults in the British health care system concluded that intrathecal baclofen offered good value for the money. No similar analysis of intrathecal baclofen has been conducted in the context of the US health care system, and no study has specifically examined cost-effectiveness of intrathecal baclofen in a pediatric population. The aim of this article is to assess the cost-effectiveness of intrathecal baclofen among children with severe spasticity of cerebral origin who have not responded to less invasive treatments such as oral medications relative to alternative medical and surgical therapy. The authors used mathematical modeling and computer simulation to estimate the incremental cost per quality-adjusted life-year for identical cohorts of children treated with intrathecal baclofen or alternative therapy over a 5-year episode of treatment. Data on treatment costs representative of these children were derived from a health insurance claims database that included both commercial and Medicaid data. Utility values used to construct quality-adjusted life-years were obtained from a panel of expert clinicians who used the Health Utilities Index-2 to rate health states associated with the course of treatment. On average, intrathecal baclofen therapy increased the 5-year cost of treatment by $49 000 relative to alternative treatment. However, this was accompanied by an average gain of 1.2 quality-adjusted life-years. The net result was an incremental cost-effectiveness ratio of $42 000 per quality-adjusted life-year, a figure well within the $50 000 to $100 000 range that is widely accepted as offering good value for the money.

Practice patterns for managing Helicobacter pylori infection and upper gastrointestinal symptoms.

OBJECTIVE: To assess adherence with guidelines for testing and treatment of Helicobacter pylori infection and upper gastrointestinal symptoms. STUDY DESIGN: Retrospective longitudinal cohort analysis of patient-level medical and pharmacy claims from 75 US managed care plans. METHODS: Persons with new claims for antisecretory medication, H pylori tests, or endoscopies were selected from among 2 million plan members continuously enrolled from 2001 to 2004 and were grouped by initial clinical diagnosis (3456 with peptic ulcer disease [PUD], 14,593 with nonulcer dyspepsia [NUD], and 36,233 with gastroesophageal reflux disease [GERD]). Diagnostic procedures, medications received, and sequencing of specific procedures and medications were examined relative to published guidelines by initial diagnosis, age, and physician specialty. RESULTS: While guidelines recommend testing before treatment, one third of persons receiving antibiotics for H pylori infection had not first been tested for the infection. In one third of all posttreatment testing, primary care practitioners incorrectly used serologic tests, despite their inability to distinguish cured from active infection. Eighteen percent of patients with GERD were tested for H pylori, although there is no causal link between them. Only two thirds of patients aged 50 to 64 years with presumed PUD underwent endoscopy, which guidelines recommend for older adults; yet one third of patients with PUD aged 18 to 49 years, for whom prompt endoscopy is generally not recommended, had an endoscopy within 30 days of their index date. CONCLUSIONS: Substantial noncompliance with widely disseminated guidelines calls for better understanding of appropriate indications for H pylori testing and endoscopy to improve patient care and conserve healthcare resources.

A taxonomy and economic consequences of nursing home falls.

BACKGROUND: Falls are a primary cause of injury and disability in the nursing home environment and can be costly to treat. We propose a taxonomy of nursing home falls that accounts for both the severity of fall consequences and the duration of the treatment episode. No other systematic approach of this kind has been previously described. METHODS: We defined a 9-level taxonomy of fall types and outcomes. Components of each fall category include resource use during the acute, convalescent, and long-term phases of treatment. Three variants of each category describe typical, best-case and worst-case fall episodes. Treatment costs were estimated for each fall category by applying unit costs from national databases and published sources to projected medical resource utilisation. Long-term costs reflect adjustment in Medicare per diem reimbursement rates associated with change in patient status subsequent to the fall. RESULTS: The most common and least costly fall category was category 1 -- non-injurious, which accounted for 30% of falls and a 1-year cost of US dollars 319 per event (range US dollars 71-550). The least common and most costly was fall category 9 -- multiple injuries, which accounted for 1% of falls and a 1-year cost of US dollars 22,368 (range US dollars 9,969-64,382). CONCLUSIONS: The falls taxonomy represents a unique approach to estimating the cost of nursing home falls and offers a tool for evaluating the cost-effectiveness of fall prevention strategies. A validation study should be performed to confirm the magnitude of fall frequency and cost estimates.

Cost effectiveness of cardiac resynchronization therapy in the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial.

OBJECTIVES: The analysis goal was to estimate incremental cost-effectiveness ratios (ICERs) for the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial patients who received cardiac resynchronization therapy (CRT) via pacemaker (CRT-P) or pacemaker-defibrillator (CRT-D) in combination with optimal pharmacological therapy (OPT) relative to patients with OPT alone. BACKGROUND: In the COMPANION trial, CRT-P and CRT-D reduced the combined risk of all-cause mortality or first hospitalization among patients with advanced heart failure and intraventricular conduction delays, but the cost effectiveness of the therapy remains unknown. METHODS: In this analysis, intent-to-treat trial data were modeled to estimate the cost effectiveness of CRT-D and CRT-P relative to OPT over a base-case seven-year treatment episode. Exponential survival curves were derived from trial data and adjusted by quality-of-life trial results to yield quality-adjusted life-years (QALYs). For the first two years, follow-up hospitalizations were based on trial data. The model assumed equalized hospitalization rates beyond two years. Initial implantation and follow-up hospitalization costs were estimated using Medicare data. RESULTS: Over two years, follow-up hospitalization costs were reduced by 29% for CRT-D and 37% for CRT-P. Extending the cost-effectiveness analysis to a seven-year base-case time period, the ICER for CRT-P was 19,600 dollars per QALY and the ICER for CRT-D was 43,000 dollars per QALY relative to OPT. CONCLUSIONS: For the COMPANION trial patients, the use of CRT-P and CRT-D was associated with a cost-effectiveness ratio below generally accepted benchmarks for therapeutic interventions of 50,000 dollars per QALY to 100,000 dollars per QALY. This suggests that the clinical benefits of CRT-P and CRT-D can be achieved at a reasonable cost.

Misdiagnosed patients with bipolar disorder: comorbidities, treatment patterns, and direct treatment costs.

OBJECTIVE: The purpose of this study was to examine comorbidities, treatment patterns, and direct treatment costs of patients with bipolar disorder who are misdiagnosed with unipolar depression. METHOD: This study is a retrospective analysis of data from the MarketScan Commercial Claims and Encounters (CCE) database. Logistic regressions and analyses of variance were used to compare the misdiagnosis cohort to 3 age- and gender-matched comparison cohorts (recognized bipolar, depression, and no psychiatric disorders based on ICD-9-CM criteria) during the year 2000. RESULTS: Each cohort had 769 individuals (68.0% female; mean age of roughly 42 years). The misdiagnosis cohort had higher rates of several psychiatric comorbidities than the depression cohort (e.g., personality disorders, alcohol abuse, psychotic disorder) and the bipolar cohort (e.g., generalized anxiety disorder, panic) but a lower rate of psychotic disorders than the bipolar cohort (p < .05). Compared with the bipolar cohort, the misdiagnosis cohort was more likely to receive antidepressants, but less likely to receive anticonvulsants, antipsychotics, or lithium (all p < .001). Antidepressant rates were similar among the misdiagnosis and depression cohorts. Group differences were found in mean annual costs for anticonvulsants, antipsychotics, lithium, antidepressants, and total treatment costs: bipolar (USD $442, $310, $67, $497, $8600); misdiagnosis (USD $221, $185, $20, $704, $8761); depression (USD $70, $74, $5, $657, $7288). CONCLUSION: Misdiagnosed bipolar patients received inappropriate and costly treatment regimens involving overuse of antidepressants and underuse of potentially effective medications. Patterns of psychiatric comorbidity suggest one possible strategy for improving recognition of bipolar disorder among patients presenting with depressive symptoms. Patients who present with the observed pattern of comorbidities may benefit from additional screening for bipolar disorder. It is recommended that steps be taken to minimize misdiagnosis in clinical settings.

Weighing the evidence: trends in managed care formulary decision making.

Health plans, pharmacy benefit managers, and other organizations use drug formularies to promote quality care while controlling costs. However, restrictive formularies are often viewed as constraints on physician practice and potential barriers to optimal patient care. Reluctance to add new drugs to an established formulary is rational economic behavior. Innovative compounds may have unknown properties with uncertain outcomes and therefore may impose costs in the form of risk. Products that seemingly duplicate drugs already on formulary may increase transaction costs without additional benefit. In evaluating new products, formulary managers face the task of identifying, assembling, and synthesizing a wide range of complex information. Manufacturers, who may be in the best position to supply that information, have been severely restricted by U.S. Food and Drug Administration (FDA) regulations that limited marketing communications to findings from well-controlled clinical trials. The FDA Modernization Act of 1997 eased these restrictions somewhat by acknowledging that sophisticated purchasers such as organized health plans were capable of weighing the quality and impartiality of manufacturer-supplied evidence. The Academy of Managed Care Pharmacy (AMCP) created a standardized template that formularies can use to request comprehensive information about specific drugs from manufacturers. Widespread adoption of the AMCP format by health plans and manufacturers will greatly increase access to information about new drugs, speeding the process of formulary committee deliberation, and instilling greater confidence in the outcome of those decisions. Wider access to new drugs may result.

Economic implications of nesiritide versus dobutamine in the treatment of patients with acutely decompensated congestive heart failure.

Pooled data from trials comparing nesiritide with dobutamine for treatment of acute decompensated congestive heart failure were combined with national hospital cost data in an economic model. Results indicate that the acquisition cost of nesiritide is fully offset by decreased hospital costs.

Economic evaluation of enoxaparin as prophylaxis against venous thromboembolism in seriously ill medical patients: a US perspective.

OBJECTIVE: To determine the cost and cost effectiveness of adding venous thromboembolism (VTE) prophylaxis with enoxaparin, a low-molecular-weight heparin, to standard care for acutely ill, hospitalized medical patients. METHODS: A pharmacoeconomic model was developed to simulate the 6- to 14-day course of enoxaparin prophylaxis evaluated in the MEDENOX trial in a US healthcare setting. Clinical results as reported for the trial were applied to resource use and treatment costs in a US healthcare environment. The model projects hospital length of stay and cost for an acute medical admission from a third-party payer perspective, as well as costs for the course of enoxaparin. RESULTS: VTE prophylaxis with enoxaparin would account for 1.2% to 2.4% of the cost of a hospital admission, with an additional $23 +/- $28 to $99 +/- $122 to complete the course of prophylaxis out of hospital. Incremental cost effectiveness of VTE prophylaxis relative to no prophylaxis ranges from $1249 to $3088 per VTE avoided. Venous thromboembolism prophylaxis appears to be a break-even intervention, with the cost recouped through avoided treatment, if the rate of treated VTE without prophylaxis is at least 3-4%. DISCUSSION AND CONCLUSIONS: The MEDENOX trial demonstrated that prophylaxis with enoxaparin substantially decreases the risk of VTE among acutely ill, hospitalized medical patients. Economic analysis indicates that this protection represents a small increase in current treatment costs. Prophylaxis is cost effective in terms of incremental cost per VTE avoided. Furthermore, there is a reasonable likelihood that the cost of prophylaxis will be offset by avoided future VTE treatment.

Management of acute proximal deep vein thrombosis: pharmacoeconomic evaluation of outpatient treatment with enoxaparin vs inpatient treatment with unfractionated heparin.

OBJECTIVES: A landmark Canadian randomized controlled clinical trial compared treatment of acute proximal vein thrombosis via low-molecular-weight heparin (LMWH) [enoxaparin] administered primarily at home with IV unfractionated heparin (UH) in the hospital. Results demonstrated equivalent safety and efficacy for home care with enoxaparin with a reduction in cost. Our objective was to validate these findings in the routine practice setting of a US health maintenance organization. DESIGN: Retrospective analysis of medical and administrative records of health-plan members meeting inclusion-exclusion criteria of the Canadian trial during the period from 1995 to 1998. SETTING: Staff-model health maintenance organization serving New Mexico. PATIENTS: Persons presenting as outpatients from 1995 to 1996 or from 1997 to 1998 with acute, proximal deep vein thrombosis (DVT) diagnosed by duplex ultrasonography. INTERVENTIONS: Initial anticoagulant therapy of IV UH administered in the hospital (from 1995 to 1996 group, n = 64) or subcutaneous LMWH (enoxaparin) administered primarily at home (from 1997 to 1998 group, n = 65), followed by warfarin therapy. RESULTS: No statistically significant differences were observed in the number of recurrent venous thromboembolic events (p = 0.36) or bleeding events (p = 1.0). Mean +/- SD cost per patient was 9,347 dollars +/- 8,469 in the enoxaparin group compared with 11,930 dollars +/- 10,892 in the UH group, a difference of - 2,583 dollars (95% bootstrap-adjusted asymmetrical confidence interval, - 6,147 dollars, + 650 dollars). CONCLUSIONS: Retrospective replication of the Canadian study in a US routine (managed) care setting found similar clinical and economic outcomes. Treatment of acute proximal DVT with enoxaparin in a primarily outpatient setting can be accomplished safely and yields savings through avoidance or minimization of inpatient stays.

Willingness to pay for complete symptom relief of gastroesophageal reflux disease.

BACKGROUND: Over $6 billion per year is spent on prescription medication for gastroesophageal reflux disease (GERD). This study is an economic analysis of patients' willingness to pay for a prescription medication that offers complete relief of GERD symptoms. METHODS: The study was a cross-sectional, nonrandomized design recruiting patients from 5 clinical sites. A computer-administered discrete-choice questionnaire was used to explore patients' willingness to pay for various attributes (time to relief, amount of relief, side effects, and out-of-pocket cost) associated with GERD treatment. Patients chose between 2 different combinations of attributes by indicating which scenario they preferred. Data were gathered on health status, health-related quality of life, and sociodemographic characteristics. RESULTS: Two hundred five patients completed the discrete-choice questionnaire with a consistency rate of 99.5%. All attributes were relevant to patient decision making. Respondents were willing to pay up to $182 to obtain complete relief in a short period of time without side effects. Patients with less severe GERD symptoms were willing to pay more to avoid side effects ($58.25 vs $38.43). Older patients were less willing to pay for better relief than younger patients. CONCLUSIONS: Results demonstrate that patients are willing to pay more per month for a medication that provides more complete and faster relief from GERD symptoms. This information can guide clinicians and formulary committees in evaluating optimal treatment for GERD.