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First Finding of Landmark Program to Get Better Value for Medicare: Drugs as Good as Surgery for 'GERD'

DECEMBER 15, 2005 -- Drugs can be as effective as surgery for one of the most common health conditions affecting older Americans, gastroesophageal reflux disease (GERD), said a study released Wednesday under a landmark federal program aimed at comparing the effectiveness and price of medical treatments.

The study is the first of 10 that the federal Agency for Healthcare Research and Quality (AHRQ) will release in coming weeks. Subjects that will be examined in the upcoming reports include treatments for conditions that are common in the Medicare population—depression, the off-label use of certain anti-psychotic drugs, diabetes, and different types of breast imaging.

The studies were funded under the new "Effective Health Care Program," authorized under section 1013 of the Medicare overhaul law (PL 108-173). The law authorizes $50 million per year in spending on the program, but its fiscal 2005 funding totaled $15 million, the same level of funding expected for fiscal 2006. There are no indications that funding will be increased in fiscal 2007.

Studies in fiscal 2005 and fiscal 2006 are to focus on the Medicare population, but AHRQ will soon begin planning for a round of studies affecting enrollees in Medicaid and the State Children's Health Insurance Program.

AHRQ Administrator Carolyn M. Clancy emphasized at a Wednesday morning press briefing that AHRQ is making no treatment recommendations based on the findings. She also noted that Medicare cannot use findings of the program alone as the basis for coverage or non-coverage decisions.

Clancy noted that the GERD findings showed that 10 to 65 percent of surgery patients resumed use of medications. Asked whether the study shows that there is any reason to get surgery, Clancy said "that would depend on the severity of the symptoms," among other factors.

United Healthcare, Consumer Reports and other organizations have said they will disseminate the GERD findings to consumers, Clancy said. Aetna and the insurance lobby America's Health Insurance Plans also have expressed interest in disseminating the findings, Clancy said.

Treatment with "proton pump inhibitor" drugs appeared to be as effective as a $36,000 surgical procedure for lessening symptoms of GERD, Clancy said.

Known as "PPIs," the drugs, which include such products as Prilosec and Nexium, were more effective in treating GERD symptoms than "H2 receptor antagonist" drugs such as Pepcid, Zantac, and Tagamet, the study found. But PPIs have more side effects than the H2 drugs, Clancy noted.

GERD occurs when stomach acid enters the esophagus, causing heartburn and potential damage to the esophagus. The disease affects up to 7 percent of the U.S. adult population and its treatment costs about $10 billion a year, Clancy said.

The condition, also known as "acid regurgitation," disrupts sleep and causes belching.

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