Early pH monitoring reduces unnecessary PPI use

Early referral for 24-hour esophageal pH monitoring in patients with suspected gastroesophageal reflux disease who fail to respond to proton pump inhibitor therapy can lead to substantial health care cost savings, according to findings from a retrospective study.

Although most guidelines recommend an empiric 8-week trial of PPIs in symptomatic patients, many remain on treatment for much longer than that, Dr. David Kleiman explained at a press briefing held in advance of the annual Digestive Disease Week, where the findings will be presented.

In fact, in 100 patients who underwent 24-hour pH monitoring, 21,411 weeks of PPI therapy were prescribed beyond the recommended 8-week trial, and nearly a third (32%) of those were in patients who had a negative 24-hour pH monitoring study, said Dr. Kleiman of New York Presbyterian Hospital–Weill Cornell Medical College, New York.

Based on a cost model created from a third-party payer perspective over a 10-year period, that equals excess costs of between $1,966 and $7,825 per patient, assuming 100% sensitivity of pH monitoring. The range represents costs from low-dose generic PPIs to high-dose name-brand PPIs.

Based on the average wholesale unit prices of PPIs as reported in the 2012 Micromedex Redbook, and the cost of 24-hour pH monitoring and manometry (which was used to determine esophageal function and for appropriate positioning of the pH probe) as determined by 2012 Medicare fees, the weekly cost of PPIs ranged from $29.06 to $107.70 and the cost of monitoring was $690, Dr. Kleiman said.

Depending on the PPI regimen used, the costs of PPI therapy and the costs of monitoring equalized between 6.4 and 23.7 weeks; Patients with esophageal GERD symptoms reported a median of 208 weeks of therapy prior to referral for 24-hour pH monitoring; those with extraesophageal GERD symptoms reported a median of 52 weeks of PPI use before referral.

Sensitivity of 24-hour pH monitoring ranges from 30% to 96%, according to a review of the literature. As long as the sensitivity of pH monitoring is above 35%, the strategy of prompt referral after an 8-week PPI trial will be cost-effective, Dr. Kleiman said.

These findings demonstrate "surprisingly convincing" benefits of performing pH monitoring.

"By utilizing pH monitoring we were able to identify a large percentage of patients who were taking PPIs without having any signs of GERD," he said.

Given that an estimated 25%-40% of Americans experience daily heartburn – which may or may not be associated with GERD – the findings have important implications for patient management, he said, noting that the overuse of PPIs in the general population has been garnering increasing attention in recent years.

A "shocking"$9.4 billion is spent on PPIs just in the United States each year, he said.

"And these numbers, every time they come out, keep increasing. More and more papers are acknowledging that there is a great deal of inappropriate use of PPIs in patients that really do not need to be taking them. I think raising the awareness of this issue is really critical to optimizing the care that we provide for our patients," he said.

As for which patients should undergo pH testing, the best scenario has yet to be identified, and while it is clear that not every single person who experiences reflux occasionally – or even more than occasionally – needs to undergo pH monitoring, the available data suggest that those who continue to experience symptoms after an 8-week PPI trial most likely have another disorder that is being overlooked, Dr. Kleiman said.

"I think those patients, certainly, should be considered to have this testing sooner than they would have previously," he said.

Dr. Kleiman has no financial conflicts relevant to this study.*

*Correction 05/20/2013: An earlier version of this story misstated Dr. Kleiman's financial declaration.

Early referral for 24-hour esophageal pH monitoring in patients with suspected gastroesophageal reflux disease who fail to respond to proton pump inhibitor therapy can lead to substantial health care cost savings, according to findings from a retrospective study.

Although most guidelines recommend an empiric 8-week trial of PPIs in symptomatic patients, many remain on treatment for much longer than that, Dr. David Kleiman explained at a press briefing held in advance of the annual Digestive Disease Week, where the findings will be presented.

In fact, in 100 patients who underwent 24-hour pH monitoring, 21,411 weeks of PPI therapy were prescribed beyond the recommended 8-week trial, and nearly a third (32%) of those were in patients who had a negative 24-hour pH monitoring study, said Dr. Kleiman of New York Presbyterian Hospital–Weill Cornell Medical College, New York.

Based on a cost model created from a third-party payer perspective over a 10-year period, that equals excess costs of between $1,966 and $7,825 per patient, assuming 100% sensitivity of pH monitoring. The range represents costs from low-dose generic PPIs to high-dose name-brand PPIs.

Based on the average wholesale unit prices of PPIs as reported in the 2012 Micromedex Redbook, and the cost of 24-hour pH monitoring and manometry (which was used to determine esophageal function and for appropriate positioning of the pH probe) as determined by 2012 Medicare fees, the weekly cost of PPIs ranged from $29.06 to $107.70 and the cost of monitoring was $690, Dr. Kleiman said.

Depending on the PPI regimen used, the costs of PPI therapy and the costs of monitoring equalized between 6.4 and 23.7 weeks; Patients with esophageal GERD symptoms reported a median of 208 weeks of therapy prior to referral for 24-hour pH monitoring; those with extraesophageal GERD symptoms reported a median of 52 weeks of PPI use before referral.

Sensitivity of 24-hour pH monitoring ranges from 30% to 96%, according to a review of the literature. As long as the sensitivity of pH monitoring is above 35%, the strategy of prompt referral after an 8-week PPI trial will be cost-effective, Dr. Kleiman said.

These findings demonstrate "surprisingly convincing" benefits of performing pH monitoring.

"By utilizing pH monitoring we were able to identify a large percentage of patients who were taking PPIs without having any signs of GERD," he said.

Given that an estimated 25%-40% of Americans experience daily heartburn – which may or may not be associated with GERD – the findings have important implications for patient management, he said, noting that the overuse of PPIs in the general population has been garnering increasing attention in recent years.

A "shocking"$9.4 billion is spent on PPIs just in the United States each year, he said.

"And these numbers, every time they come out, keep increasing. More and more papers are acknowledging that there is a great deal of inappropriate use of PPIs in patients that really do not need to be taking them. I think raising the awareness of this issue is really critical to optimizing the care that we provide for our patients," he said.

As for which patients should undergo pH testing, the best scenario has yet to be identified, and while it is clear that not every single person who experiences reflux occasionally – or even more than occasionally – needs to undergo pH monitoring, the available data suggest that those who continue to experience symptoms after an 8-week PPI trial most likely have another disorder that is being overlooked, Dr. Kleiman said.

"I think those patients, certainly, should be considered to have this testing sooner than they would have previously," he said.

Dr. Kleiman has no financial conflicts relevant to this study.*

*Correction 05/20/2013: An earlier version of this story misstated Dr. Kleiman's financial declaration.

Early referral for 24-hour esophageal pH monitoring in patients with suspected gastroesophageal reflux disease who fail to respond to proton pump inhibitor therapy can lead to substantial health care cost savings, according to findings from a retrospective study.

Although most guidelines recommend an empiric 8-week trial of PPIs in symptomatic patients, many remain on treatment for much longer than that, Dr. David Kleiman explained at a press briefing held in advance of the annual Digestive Disease Week, where the findings will be presented.

In fact, in 100 patients who underwent 24-hour pH monitoring, 21,411 weeks of PPI therapy were prescribed beyond the recommended 8-week trial, and nearly a third (32%) of those were in patients who had a negative 24-hour pH monitoring study, said Dr. Kleiman of New York Presbyterian Hospital–Weill Cornell Medical College, New York.

Based on a cost model created from a third-party payer perspective over a 10-year period, that equals excess costs of between $1,966 and $7,825 per patient, assuming 100% sensitivity of pH monitoring. The range represents costs from low-dose generic PPIs to high-dose name-brand PPIs.

Based on the average wholesale unit prices of PPIs as reported in the 2012 Micromedex Redbook, and the cost of 24-hour pH monitoring and manometry (which was used to determine esophageal function and for appropriate positioning of the pH probe) as determined by 2012 Medicare fees, the weekly cost of PPIs ranged from $29.06 to $107.70 and the cost of monitoring was $690, Dr. Kleiman said.

Depending on the PPI regimen used, the costs of PPI therapy and the costs of monitoring equalized between 6.4 and 23.7 weeks; Patients with esophageal GERD symptoms reported a median of 208 weeks of therapy prior to referral for 24-hour pH monitoring; those with extraesophageal GERD symptoms reported a median of 52 weeks of PPI use before referral.

Sensitivity of 24-hour pH monitoring ranges from 30% to 96%, according to a review of the literature. As long as the sensitivity of pH monitoring is above 35%, the strategy of prompt referral after an 8-week PPI trial will be cost-effective, Dr. Kleiman said.

These findings demonstrate "surprisingly convincing" benefits of performing pH monitoring.

"By utilizing pH monitoring we were able to identify a large percentage of patients who were taking PPIs without having any signs of GERD," he said.

Given that an estimated 25%-40% of Americans experience daily heartburn – which may or may not be associated with GERD – the findings have important implications for patient management, he said, noting that the overuse of PPIs in the general population has been garnering increasing attention in recent years.

A "shocking"$9.4 billion is spent on PPIs just in the United States each year, he said.

"And these numbers, every time they come out, keep increasing. More and more papers are acknowledging that there is a great deal of inappropriate use of PPIs in patients that really do not need to be taking them. I think raising the awareness of this issue is really critical to optimizing the care that we provide for our patients," he said.

As for which patients should undergo pH testing, the best scenario has yet to be identified, and while it is clear that not every single person who experiences reflux occasionally – or even more than occasionally – needs to undergo pH monitoring, the available data suggest that those who continue to experience symptoms after an 8-week PPI trial most likely have another disorder that is being overlooked, Dr. Kleiman said.

"I think those patients, certainly, should be considered to have this testing sooner than they would have previously," he said.

Dr. Kleiman has no financial conflicts relevant to this study.*

*Correction 05/20/2013: An earlier version of this story misstated Dr. Kleiman's financial declaration.