Drugmakers submit substandard data for analysis, study finds

July 23, 2007

The opportunity for drug companies to voluntarily compare their new drugs with relevant treatment alternatives occurs only 17% of the time, according a study that examined how closely information submitted to formulary committees at managed healthcare systems and PBMs complies with national guidelines from AMCP.

The opportunity for drug companies to voluntarily compare their new drugs with relevant treatment alternatives occurs only 17% of the time, according a study that examined how closely information submitted to formulary committees at managed healthcare systems and PBMs complies with national guidelines from AMCP. The study of 155 submissions by drugmakers found that drug companies voluntarily provided economic or cost-effectiveness analyses about 46% of the time. When economic analyses were submitted, they had relatively low levels of compliance with industry standards. "The take-away message here is that the guidelines contained in AMCP's Format for Formulary Submissions provide an opportunity for health plans to evaluate various drugs' clinical and economic information," said Peter J. Neumann, ScD, senior author of the study and director of the Center for the Evaluation of Value and Risk in Health at Tufts-New England Medical Center. "But concerns persist about the quality of the information submitted, and continued vigilance and caution is warranted." The study was a joint effort by researchers at Tufts-New England Medical Center, the University of Washington, and Washington-based Premera Blue Cross.

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