McClellan Says More Drug Comparisons Coming Under Medicare Rx

Federal regulators are preparing to conduct much more thorough examinations of drug products as part of an evidence-based approach to medicine that will drive the implementation of the Medicare Rx benefit, which is slated to take effect next year.

With this goal in mind, the Centers for Medicare & Medicaid Services (CMS) intends to conduct close comparisons of similar drugs in the same class to better determine the advantages and disadvantages of particular products, CMS Administrator Mark McClellan told the World Health Care Congress meeting in Washington, D.C.

CMS already performs some analyses of drug classes, including price comparisons of similar drugs, under the Medicare drug card. However, McClellan said that by taking an evidence-based approach to drug products, such as comparing clinical data of similar drugs, CMS will improve drug safety, lower drug costs, and improve healthcare services.

"We need to do a lot more after drugs are approved to learn about how well they work in particular kinds of beneficiaries," said McClellan, who spoke during the conference's keynote sessions. "That is something that we built into the drug benefit -- the capacity and interest in developing more evidence on what works and doesn't work for particular beneficiaries."

The information that emanates from the drug comparisons may also reveal data that could be used to provide early warnings on drug safety, he said. "We need a 21st century [system] for postmarket monitoring of drug safety and effectiveness," McClellan said. "We're relying on overworked doctors and health professionals to report when there is a problem. It's not the kind of systematic or adequate approach that we need to be taking in order to develop better evidence on what drugs work in the postmarket environment."