Rethinking the laryngopharyngeal reflux treatment algorithm: Evaluating an alternate empiric dosing regimen and considering up-front, pH-impedance, and manometry testing to minimize cost in treating suspect laryngopharyngeal reflux disease.

OBJECTIVES/HYPOTHESIS: Empiric proton pump inhibitor (PPI) trials for laryngopharyngeal reflux (LPR) are common. A majority of the patients respond to acid suppression. This work intends to evaluate once-daily, 40 mg omeprazole and once-nightly, 300 mg ranitidine (QD/QHS) dosing as an alternative regimen, and use this study's cohort to evaluate empiric regimens prescribed for LPR as compared to up-front testing with pH impedance multichannel intraluminal impedance (MII) with dual pH probes and high-resolution manometry (HRM) for potential cost minimization. STUDY DESIGN: Retrospective cohort review and cost minimization study. METHODS: A chart review identified patients diagnosed with LPR. All subjects were treated sequentially and outcomes recorded. Initial QD/QHS dosing increased after 3 months to BID if no improvement and ultimately prescribed MII and HRM if they failed BID dosing. Decision tree diagrams were constructed to determine costs of two empiric regimens and up-front MII and HRM. RESULTS: Ninety-seven subjects met the criteria. Responders and nonresponders to empiric therapy were identified. Seventy-two subjects (74%) responded. Forty-eight (67% of responders and 49% of all) improved with QD/QHS dosing. Forty-nine (51%) subjects escalated to BID dosing. Twenty-four subjects (33% of responders and 25% of all) improved on BID therapy. Twenty-five subjects (26%) did not respond to acid suppression. Average weighted cost was $1,897.00 per patient for up-front testing, $3,033.00 for initial BID, and $3,366.00 for initial QD/QHS. CONCLUSIONS: An alternate QD/QHS regimen improved the majority who presented with presumed LPR. Cost estimates demonstrate that the QD/QHS regimen was more expensive than the initial BID high-dose PPI for 6 months. Overall per-patient cost appears less with up-front MII and HRM. LEVEL OF EVIDENCE: 4. Laryngoscope, 127:S1-S13, 2017.

BRAVO esophageal pH monitoring: more cost-effective than empiric medical therapy for suspected gastroesophageal reflux.

INTRODUCTION: Early referral for catheter-based esophageal pH monitoring is more cost-effective than empiric proton-pump inhibitor (PPI) therapy to diagnose gastroesophageal reflux disease (GERD). We hypothesize that BRAVO wireless pH monitoring will also demonstrate substantial cost-savings compared to empiric PPI therapy, given its superior sensitivity and comfort. METHODS: We reviewed 100 consecutive patients who underwent wireless pH monitoring for suspected GERD at our institution. A cost model and a cost equivalence calculation were generated. Cost-saving analyses were performed for both esophageal and extraesophageal symptoms. RESULTS: Eighty-seven patients were available for analysis. Median PPI use prior to referral was 215 weeks (range 0-520). Forty-three patients (49 %) had BRAVO results diagnosing GERD; 98 % of these had esophageal symptoms. Patients with negative BRAVO studies had a median of 113 (0-520) weeks of unnecessary PPI therapy. Cost-savings ranged from $1048 to $15,853 per patient, depending on sensitivity (75-95 %), PPI dosage, and brand. Maximum cost-savings occurred in patients with extraesophageal symptoms ($2948-$31,389 per patient). The PPI cost equivalence of BRAVO placement was 36 and 6 weeks for low- and high-dose therapy, respectively. CONCLUSIONS: BRAVO wireless pH testing is more cost-effective than prolonged empiric medical management for GERD and should be incorporated early in the treatment algorithm.

Early referral for esophageal pH monitoring is more cost-effective than prolonged empiric trials of proton-pump inhibitors for suspected gastroesophageal reflux disease.

INTRODUCTION: The most cost-effective diagnostic algorithm for gastroesophageal reflux disease (GERD) remains controversial. We hypothesized that prompt referral for esophageal pH monitoring is more cost-effective than prolonged empiric courses of proton-pump inhibitors (PPIs). DISCUSSION: A cost model was created based on a cohort of 100 patients with possible GERD who underwent pH monitoring. The additional costs incurred from pH monitoring were compared to the potential savings from avoiding unnecessary PPI usage in patients with a negative pH study. The costs of PPI therapy reach equivalence with pH monitoring after 6.4 to 23.7 weeks, depending on the PPI regimen. A total of 21,411 weeks of PPIs were prescribed beyond the recommended 8-week trial, of which 32 % were for patients who had a negative 24-h pH monitoring study. If the sensitivity of pH monitoring was 96 %, early referral for pH monitoring would have saved between $1,197 and $6,303 per patient over 10 years. This strategy remains cost-effective as long as the sensitivity of pH monitoring is above 35 %. Prompt referral for pH monitoring after a brief empiric PPI trial is a more cost-effective strategy than prolonged empiric PPI trials for patients with both esophageal and extraesophageal GERD symptoms.

High economic burden of caring for patients with suspected extraesophageal reflux.

OBJECTIVES: Extraesophageal symptoms are common manifestations of gastroesophageal reflux disease (GERD). Lack of a definitive diagnostic or treatment standards complicate management, which often leads to multiple specialty consultations, procedures, pharmaceuticals and diagnostic tests. The aim of this study was to determine the economic burden associated with extraesophageal reflux (EER). METHODS: Direct costs of evaluation were estimated for patients referred with symptoms attributed to EER between 2007 and 2011. Medicare payment for evaluation and management and pharmaceutical prices was used to calculate first year and overall costs of evaluating and treating extraesophageal symptoms attributed to reflux. RESULTS: Overall, 281 patients were studied (cough (50%), hoarseness (23%), globus/post-nasal drainage (15%), asthma (9%), and sore throat (3%)). Over a median (interquartile range) of 32 (16-46) months follow-up, patients had a mean (95% confidence interval) of 10.1 (9.4-10.9) consultations with specialists and underwent 6.4 (3-9) diagnostic procedures. Overall, the mean initial year direct cost was $5,438 per patient being evaluated for EER. Medical and non-medical components contributed $5,154 and $283. Of the overall cost, 52% were attributable to the use of proton pump inhibitors. During the initial year, direct costs were 5.6 times higher than those reported for typical GERD ($971). A total of 54% of patients reported improvement of symptoms. Overall cost per improved patient was $13,700. CONCLUSIONS: EER contributes substantially to health-care expenditures. In this cohort, the cost for initial year's evaluation and treatment of EER symptoms was quintuple that of typical GERD. Prescription costs and, in particular, proton pump inhibitors were the single greatest contributor to the cost of EER management.

Unsedated peroral wireless pH capsule placement vs. standard pH testing: a randomized study and cost analysis.

BACKGROUND: Wireless capsule pH-metry (WC) is better tolerated than standard nasal pH catheter (SC), but endoscopic placement is expensive. AIMS: to confirm that non-endoscopic peroral manometric placement of WC is as effective and better tolerated than SC and to perform a cost analysis of the available esophageal pH-metry methods. METHODS: Randomized trial at 2 centers. Patients referred for esophageal pH testing were randomly assigned to WC with unsedated peroral placement or SC after esophageal manometry (ESM). Primary outcome was overall discomfort with pH-metry. Costs of 3 different pH-metry strategies were analyzed: 1) ESM + SC, 2) ESM + WC and 3) endoscopically placed WC (EGD + WC) using publicly funded health care system perspective. RESULTS: 86 patients (mean age 51 ± 2 years, 71% female) were enrolled. Overall discomfort score was less in WC than in SC patients (26 ± 4 mm vs 39 ± 4 mm VAS, respectively, p = 0.012) but there were no significant group differences in throat, chest, or overall discomfort during placement. Overall failure rate was 7% in the SC group vs 12% in the WC group (p = 0.71). Per patient costs ($Canadian) were $1475 for EGD + WC, $1014 for ESM + WC, and $906 for ESM + SC. Decreasing the failure rate of ESM + WC from 12% to 5% decreased the cost of ESM + WC to $991. The ESM + SC and ESM + WC strategies became equivalent when the cost of the WC device was dropped from $292 to $193. CONCLUSIONS: Unsedated peroral WC insertion is better tolerated than SC pH-metry both overall and during placement. Although WC is more costly, the extra expense is partially offset when the higher patient and caregiver time costs of SC are considered. TRIAL REGISTRATION: Clinicaltrials.gov Identifier NCT01364610.

Wireless pH capsule--yield in clinical practice.

Wireless pH monitoring is one of the recent technologies that focus on improving the diagnosis of gastroesophageal reflux disease (GERD). The capsule, which is fixed within the esophagus, transmits data via telemetry to an external receiver. The capsule is usually inserted 6 cm above the squamocolumnar junction during an upper endoscopy. The standard recording duration is 48 hours but this can be extended to 96 hours. The wireless capsule has been shown to be at least as accurate as the conventional catheter for the monitoring of esophageal pH. Normal pH values have been established in three different series. The use of a wireless capsule provides an increased diagnostic yield for GERD compared with the conventional catheter. The increased yield is the result of higher sensitivity to detect both abnormal acid esophageal exposure and positive symptom-reflux association. This may be related both to the prolonged recording duration and to fewer dietary modifications and restrictions on activities. Several studies have shown that the pH capsule was better tolerated by patients than the conventional pH catheter. Mild-to-moderate chest pain represents the main side effect of the pH capsule: severe chest pain requiring endoscopic removal of the capsule is rare. The main indication for wireless capsule application is monitoring of distal esophageal pH for diagnostic purpose, particularly in patients with a normal endoscopic examination. The capsule technique has some limitations: costs are higher than conventional pH monitoring, misplacement may occur, and the sampling rate is lower. Finally, compared with pH-impedance monitoring, only acid reflux events can be evaluated.

Timely confirmation of gastro-esophageal reflux disease via pH monitoring: estimating budget impact on managed care organizations.

BACKGROUND: Current guidelines recommend the use of pH monitoring to confirm the diagnosis of acid reflux in patients with a normal endoscopy. This analysis evaluated the financial impact of pH monitoring with the wireless pH capsule on a managed care organization (MCO) in the United States. METHODS: A decision model was constructed to project total 1-year costs to manage GERD symptoms with and without the adoption of wireless pH capsules in a hypothetical MCO with 10 000 eligible adult enrollees, of whom 600 presented with GERD-like symptoms. Costs of GERD diagnosis, treatment, and symptom management for those in whom a GERD diagnosis was ruled out by pH monitoring were assessed. The incremental per-member-per-month (PMPM) and per-treated-member-per-month (PTMPM) costs were the primary outcomes. Data sources included literature, expert input, and standardized fee schedules. RESULTS: An increase of 10 percentage points in the use of pH monitoring with wireless pH capsules yielded incremental PMPM and PTMPM costs of $0.029 and $0.481, respectively. The costs of proton pump inhibitor (PPI) therapy to the plan dropped to $236,363 from $238,086, while increases were observed in pH monitoring (from $16 739 to $21 973) and non-GERD therapy costs (from $1392 to $1740). The results were sensitive to the percentage of patients requiring repeat endoscopy before wireless pH monitoring and the cost of PPIs. CONCLUSIONS: Timely and increased use of pH monitoring as recommended in published guidelines leads to less unnecessary use of PPIs with a modest budgetary impact on health plans.