The Agency for Healthcare Research & Quality's study on the effectiveness of proton pump inhibitors could lead to more difficulties for brand companies in seeking formulary placement.

AHRQ's "Comparative Effectiveness of Management Strategies for Gastroesophageal Reflux Disease" study released Dec. 14 found that PPIs "can be as effective as surgery in relieving the symptoms and improving quality of life."

However, the study, authored by the Tufts-New England Medical Center Evidence-based Practice Center, also concluded that "PPIs appear to have similar clinical effectiveness when compared to one another for treating GERD."

The findings could exacerbate brand manufacturers' challenges in negotiating coverage.

AHRQ's analysis of three systematic, comparative efficacy reviews of PPIs and H2-receptor antagonists found that for acute treatment of symptoms and esophagitis at eight weeks there was no comparative difference between omeprazole (AstraZeneca's Prilosec and generics), lansoprazole (TAP's Prevacid ), pantoprazole (Wyeth's Protonix ) and rabeprazole (Eisai's Aciphex ).

The AHRQ study incorporated a meta-analysis of data from 14 trials of PPIs that reported on resolution of symptoms at four weeks. This meta-analysis found that, with the exception of AstraZeneca's Nexium (esomeprazole) 40 mg versus omeprazole 20 mg, risk differences in rates of complete symptom resolution were non-significant in the rest of the comparisons.

The meta-analysis also found that all PPIs were effective at healing esophagitis and that with the exception of Nexium 40 mg versus omeprazole 20 mg, risk differences for healing at four and eight weeks were non-significant in the rest of the comparisons.

On the differences between Nexium and omeprazole, AHRQ noted that the study found that "some statistically significant differences have been reported, but these differences are modest and the clinical implications are unclear."

"The doses of various PPIs that would be considered pharmacologically equivalent have not been established and thus it is possible that all the various PPIs could be equivalent when administered at certain doses," the study stated.

Nexium's label includes the comparative study with omeprazole, and the data is a key part of AstraZeneca's message about the product's value, but Nexium has been a frequent target for critics, including FDA Center for Drug Evaluation & Research Office of Medical Policy Director Robert Temple (¹ Also see "Intra-Class Comparisons Could Help Drugs With Safety Issues – FDA’s Temple" - Pink Sheet, 4 July, 2005., p. 12).

AHRQ also concluded that for maintenance treatment of six months to one year, PPIs at a standard dose were more effective than at a lower dose in preventing relapse of symptoms and esophagitis.

The study also affirmed that PPIs were more effective than H2-receptor antagonists but have more side effects.

Although the report did not include cost considerations, in suggestions for future research the study's authors urge that data should be gathered on the cost-effectiveness of empiric acid-suppression therapy prescribed for patients with GERD symptoms to confirm diagnosis.

Representatives from TAP, AstraZeneca and Eisai contributed to the peer review of the GERD comparative effectiveness study.

The GERD study is the first of 10 comparative effectiveness studies on "priority conditions" for the Medicare population that AHRQ expects to release over the next three months (² Also see "AHRQ Drug Effectiveness Comparisons Will Focus On 10 “Priority Conditions”" - Pink Sheet, 20 December, 2004., p. 11). The next one will be issued in January.

Funding for the studies - which will include analyses of the effectiveness of epoetin and darbepoetin in managing cancer treatment induced anemia, as well as evidence for off-label use of atypical antipsychotics - was authorized in the Medicare Modernization Act.

AHRQ will initiate a new process next year for creating additional comparative effectiveness studies that are broader in scope. The agency will hold a public listening session on Jan. 11 and keep a docket open to solicit suggestions for areas of research that affect all populations covered by CMS, including beneficiaries covered by Medicaid and the State Children's Health Insurance Program.

PPIs Get AHRQ Stamp Of Approval Vs. Surgery; Generics Could Be Big Winners

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