Monitoring the Esophagus Eliminates Unnecessary PPIs

Caroline Helwick

May 29, 2013

ORLANDO, Florida — Early pH monitoring of the esophagus in patients on proton pump inhibitors (PPIs) for suspected gastroesophageal reflux disease (GERD) could eliminate unnecessary treatment and save healthcare dollars, according to a cost-effectiveness study.

"We compared the cost-effectiveness of 2 strategies for the early management of suspected GERD, and found that early referral for pH monitoring saved $6600 per patient over 10 years," said David Kleiman, MD, a research fellow in the Department of Surgery at New York Presbyterian Hospital in New York City.

"Many patients remain on PPIs for years after the trial period, without any confirmation that they are being treated for the right diagnosis. A prompt pH monitoring test could help clinicians accurately diagnose GERD, increase healthy outcomes for patients, and save people money," Dr. Kleiman said during a news conference here at Digestive Disease Week (DDW) 2013.

Although patients suspected of having acid reflux are often empirically treated with PPIs, studies have shown that many actually have no measurable signs of disease, he noted.

Most guidelines recommend an 8-week trial of PPIs to reduce acid secretion, followed by observation to see if symptoms subside.

Dr. Kleiman and his team created a cost model to represent the perspective of a third-party payer over a 10-year period using average wholesale unit prices of generic and name-brand PPIs.

For the low and high ends of the cost spectrum, they used low-dose 20 mg/day generic PPIs and high-dose 40 mg twice daily name-brand PPIs, respectively. They based the costs of pH monitoring and manometry on 2012 Medicare fees.

Early referral for pH monitoring saved $6600 per patient over 10 years.

The researchers retrospectively reviewed type of symptoms and duration of PPI use for 100 patients who subsequently underwent pH monitoring. To evaluate cost-effectiveness, they subtracted the cost of unnecessary PPIs from the cost of pH monitoring for all patients.

The weekly cost of PPIs ranged from $29.06 to $107.70, and the cost of 24-hour pH monitoring was $690.00.

"The cohort was prescribed 21,411 weeks of PPIs beyond the initial 8-week trial, of which 6764 weeks of treatment, or 32% of all prescriptions, were for patients with negative 24-hour pH monitoring studies, who therefore received treatment unnecessarily," Dr. Kleiman reported.

Assuming a sensitivity of pH monitoring of 100%, the cost model showed that pH monitoring for all patients after an 8-week PPI trial would have saved from $1966 to $7285 per patient over 10 years, he said.

However, this assumes a perfect pH monitoring study and use of the most expensive PPI. According to the researchers, $6600 is the most realistic cost-saving estimate.

Prior to the study, the duration of PPI therapy was highly variable; some patients took an acid-reducing medication for more than 20 years without evidence of reflux.

"We set a 10-year window as representative of the cost estimate, but if you narrowed this down over 1 year, there would still be a cost saving, just not as much," Dr. Kleiman acknowledged.

The cost of PPI therapy reached equivalence with pH monitoring after 6.4 to 23.7 weeks, depending on the PPI regimen.

The researchers recommend that all patients undergo pH monitoring after an 8-week trial of PPIs.

Costly Overuse

"We conclude that early identification of patients who do not have GERD enables physicians to continue to seek the true cause of symptoms and to identify potentially serious alternative diagnoses. This improves outcomes and saves money," Dr. Kleiman said.

In a separate session at DDW, John Inadomi, MD, from the University of Washington School of Medicine in Seattle, discussed the overuse of PPIs. He said gastroenterologists should care about PPI overuse because of costs, "which are small for the individual, but large for the healthcare system," and the risk for adverse events, which are "rare for the individual, but potentially substantial for the population."

The economic costs of PPI use in the United States are huge, he said, and are estimated to be more than $10 billion a year. They are overused for heartburn and dyspepsia that are not responsive, and for heartburn and stress ulcer prophylaxis, for which there is no indication, he said.

"Simply put, we should use a PPI when it is indicated, and stop it if it is not working," he said.

Dr. Inadomi pointed out that pH monitoring in a patient not responding to a PPI can reveal a very low rate of acid production, so the pH study might not be helpful. "Still, as opposed to doing additional expensive testing downstream, it's preferred," he told Medscape Medical News.

For early pH monitoring to truly be cost-effective, the patient must not go back on the PPIs, Dr. Inadomi emphasized. "Patients need to believe a negative test and not continue on the PPI anyway. The test is not useful if you don't act on it."

Dr. Kleiman and Dr. Inadomi have disclosed no relevant financial relationships.

Digestive Disease Week (DDW) 2013. Abstract 201. Presented May 19, 2013.


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