Drug-Company Evidence Submitted to Health Plans is of Variable Quality, Study Finds.

Drug Companies Voluntarily Compare Their New Drugs to Relevant Treatment Alternatives Only 17 Percent of the Time

BOSTON & MOUNTLAKE TERRACE, Wash. -- An opportunity for drug companies to voluntarily provide detailed evidence of their products' cost-effectiveness compared to existing alternatives is showing promise-but still far from successful.

That's one conclusion of a study looking at how closely information submitted to formulary committees at managed health care systems and pharmacy benefit management companies (PBMs) complies with national guidelines from the Academy of Managed Care Pharmacy (AMCP).

The findings of the joint study by researchers at Tufts-New England Medical Center, the University of Washington, and Washington-based Premera Blue Cross, are published in the July issue of The American Journal of Managed Care.

"We reviewed the quality of economic analysis in dossiers submitted to Premera Blue Cross-a large health insurer serving 1.7 million people-between 2002 and 2005," said Peter J. Neumann, ScD, senior author of the study and director of the Center for the Evaluation of Value and Risk in Health (CVER) at Tufts-New England Medical Center. "We also examined the clinical studies included in the submissions made to Premera in 2003.

"What we found was that the quality of information that drug companies submitted was of relatively poor quality, including sub-standard economic analyses," Neumann said.

The FDA does not consider cost-effectiveness a condition of approval. But health insurers and PBMs can ask for such information. Premera routinely requests the information to design benefits that reward consumers for purchasing the most cost-effective and high-quality drugs.