Tufts Medical Center Researchers and Colleagues Find Drug Company Evidence Submitted to Health Plans is of Variable Quality
Boston, Mass. -- 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 by researchers at Tufts Medical Center and colleagues that looks 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 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 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.”
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.
The study of 115 submissions by drug makers found that drug companies voluntarily provided economic or cost-effectiveness analyses about 46 percent of the time. When economic analyses were submitted, they had relatively low levels of compliance with industry standards. In analyzing cost-effectiveness, only 17 percent of the 115 submissions by drug makers compared their new drugs to the most relevant or cost-effective treatment alternatives.
The researchers did find that economic analyses of high-value or innovative products had higher compliance with recommended practices. The study team also found substantial amounts of evidence submitted by drug makers in support of various off-label uses, but the information was less extensive and of poorer quality than for labeled indications.
“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. But concerns persist about the quality of the information submitted, and continued vigilance and caution is warranted,” Neumann said.
Co-authors of the study included Sean Sullivan, Ph.D. of the University of Washington, John Watkins of Premera Blue Cross, and Jennifer A. Palmer, MS, and Kathleen Bungay, both of Tufts Medical Center’s Institute of Clinical Health Policy and Research Studies. The study’s lead author, Harvard doctoral student Fernando Colmenero, MD, passed away in April 2006. The study was funded by the AHRQ in an award to the Harvard School of Public Health.
###