In the rush to write the rules for the new Medicare prescription drug benefit, one aspect of the program has been overlooked:
the vast amount of data it will create. Medicare expects to be covering more than 40 percent of all prescriptions in the United
States, noted Mark McClellan, administrator of the Centers for Medicare and Medicaid Services (CMS), in a recent speech. As
a result, McClellan believes it is critical for Medicare to address important questions on drug safety and utilization, and
about how prescribing decisions affect health outcomes and costs.
In pursuit of that goal, he plans to link reimbursement data from Medicare prescription drug plans (PDPs) with existing Medicare
hospitalization and physician-care databases. The result will be an unprecedented collection of data on the prescription drug
use of millions of elderly patients. Both as a tool and a challenge for pharma, Medicare's new knowledge base promises to
have a major impact on the industry.
Links to Outcomes
In order to be reimbursed under the prescription drug program, PDPs have to submit electronically to CMS extensive information
(36 data elements) for each prescription filled under Part D, including the particular drug form, dosage, quantity and refill
The FDA Connection
"This will be the largest scale implementation ever of such electronic data on prescription drugs, by far," McClellan predicted,
explaining that it will have an even greater impact through links to existing Medicare databases on hospital and physician
services. The program, he said, will "provide insights about the association of drug use with overall outcomes and costs of
care." This will address a number of specific purposes:
Identifying drug adverse events Medicare already provides FDA with information related to safety issues that emerge for those drugs covered by Medicare Part
B, such as data on what kinds of patients use a certain treatment and possible long-term complications. Integrated outpatient
drug use data will help identify drug safety issues more broadly, which may involve rare but potentially important adverse
events. This could enhance FDA post-market surveillance activities by reducing reliance on spontaneous reporting of adverse
events by healthcare providers. McClellan anticipates that FDA will be able to determine much more quickly if certain drugs
are associated with important complications in particular kinds of patients. Drug manufacturers and prescribers ideally will
use such information to target drugs to patients who don't have such side effects, and may truly benefit.
Augmenting post-market studies By monitoring patients for longer periods—and on a much larger scale than occurs in pre-approval clinical trials—Medicare
can help pharma companies gain information more quickly and cheaply on many issues now addressed through costly Phase IV studies.
Assessing off-label risks and benefits Medicare drug information can provide evidence for marketers seeking to expand indications. Utilization and safety data may
better answer questions involving subpopulations with different demographics, co-morbidities, risk factors, and baseline therapeutic
regimens than those studied in clinical trials. The flip side, of course, is that Medicare data may reveal negative side effects
and added risks from off-label use.
Comparing treatment costs and effectiveness Part D data combined with other health information will help determine whether certain medication management techniques or
treatment approaches lead to best results and lower costs for certain types of patients. McClellan envisions studies to show
» which drugs keep patients with complex diseases out of hospitals or how certain treatments can reduce side effects. Such
analysis, which would be conducted by outside experts and research organizations, would support decisions on best practices
in using medications to improve outcomes and lower overall costs of care.