Articles on Pharmacy Benefit Management

Featured HBD Story October 12, 2007

New Law Now Gives FDA Sweeping New Authority over the Safety of Marketed Prescription Drugs

Reprinted from DRUG BENEFIT NEWS, biweekly news, data and business strategies for health plans, PBMs and pharmaceutical companies.

President Bush on Sept. 27 signed a law that gives the FDA sweeping new authority over the safety of marketed prescription drugs. While most of the onus falls on pharmaceutical manufacturers, some provisions in the law will affect health plans and PBMs, according to pharmacy executives and observers. These include calls to establish an "active" surveillance system that scans insurers' drug claims data for potential safety signals and a new public database containing the results of all drug clinical trials — a development that could shed new light on the comparative effectiveness of medications and provide a better foundation for formulary decisions.

Some 200 drug safety provisions are included in the 156-page FDA Amendments Act, H.R. 3580, which, among other things, reauthorizes the FDA to collect industry user fees. One of the key drug-safety provisions that could affect plans and PBMs calls for an "active post-market risk identification and analysis."

Under this provision, Sec. 905, HHS will establish a system to "link and analyze safety data from multiple sources." The provision aims to obtain unidentified drug data from at least 25 million patients by July 1, 2010, and at least 100 million patients by July 1, 2012. Today, the FDA "passively" gathers adverse drug safety events through reporting to its Adverse Events Reporting System. Only about one in 10 adverse events are reported, according to the FDA. By contrast, the proposed active system will use advanced data-mining techniques to scan electronic medical databases for signals of potential problems, the FDA says. The system would use the following data sources:

• Federal health-related electronic data (such as data from the Medicare program and the health systems of the Department of Veterans Affairs);
• Private-sector health-related electronic data (such as pharmaceutical purchase data and health insurance claims data); and
• Other data as the HHS Secretary deems necessary to create a robust system to identify adverse events and potential drug safety signals.

The law allocates $25 million annually for fiscal years 2008 through 2012 to help implement this system.

Plans See Opportunities to Improve Quality

Tim Antonelli, clinical program manager for Blue Cross Blue Shield of Michigan (BCBSM), says the requirement to link and analyze safety data from multiple sources — including private-sector sources — creates new opportunities to improve the quality of U.S. health care.

"This approach will permit the FDA to execute post-market surveillance of prescription drugs on a large scale that is likely to yield data results, allowing the FDA to take appropriate actions on approved products," Antonelli tells DBN. "This includes actions to pursue additional post-market clinical studies, restrict prescribing authority to physicians with special training, or remove a product from the market due to safety reasons."

The FDA used the surveillance technique three years ago on a smaller database to identify cardiac risks associated with Merck's pain killer Vioxx (rofecoxib). Based on these results, Merck withdrew Vioxx, and the subsequent fallout led to the current focus on drug safety.

Kaiser Permanente already works with the FDA on a more intensive basis than submitting raw data to assess the safety of particular drugs used by Kaiser members, says Anthony A. Barrueta, vice president of government relations at Kaiser Foundation Health Plan, Inc.

"Given the wide variety of utilization patterns in different systems of care, the FDA's design of an active surveillance system should leave room for what already exists - involving integrated providers in the study design and analysis, rather than simply creating a large database that can subsequently be mined," he tells DBN.

Barrueta acknowledges there would be value in such a database. "But there is greater value in taking advantage of the context of what is known about actual prescribing of the drug, and that involves more than just pharmacy and PBM databases," he adds. "To the extent additional clinical information is available, it should be taken advantage of. However, given the different models of care, the best way to do that is to collaborate with providers and health plans proactively."

Trials Database Will Provide Useful Information

Another area that could prove useful to health plans and PBMs is the provision that requires drug manufacturers to make publicly available the results of all clinical trials. In the past, critics have assailed pharmaceutical companies for making available only the clinical trials that showed their products in the best light possible.

Jeff Wollitz, director of federal relations for Blue Cross and Blue Shield of Florida, cautions that it's still too early to evaluate the full implications of the provision on clinical trials, as the level of disclosure has yet to be determined.

"It's going to depend on what kinds of information will be allowed to be posted," he tells DBN. "Certainly there is potential for data to be posted that would allow providers, hospitals and other players in the system to get a feel for the efficacy of certain drugs as they come to market, and the impacts they're having on patients — are there side effects or not?"

Others say the posting of all clinical trial data could help pharmacy and therapy (P&T) committees design formularies at PBMs and health plans.

"It will inform the decision-making process," says Judith Cahill, executive director of the Academy of Managed Care Pharmacy (AMCP). "Whether that results in greater or lesser drugs being listed on formularies, it's really a function of what the information tells the clinicians that are making the decisions."

Antonelli says the law will provide access to drug-study information that perhaps would not have been available or widely known. "Depending on the available study results, this new information could work to assist [P&T] committee members to best select formulary placement, whether preferred or non-preferred status," Antonelli says. "In addition to formulary placement, such information can play an important role in a health plan designing utilization management programs."

Another provision that could affect health plans is the FDA's new authority to require post-market clinical trials (i.e., Phase IV studies), rather than just request the studies as had been the case. The agency now has the power to fine drug companies for not completing Phase IV studies.

Cahill points to a scenario in which a drug has been approved, but the FDA is concerned about its use with geriatric patients. The agency can now require a Phase IV study as a condition of approval, she says. "Insofar as [the manufacturer] would want to work with a large database of patients, they might choose to contract with a health plan to look at the effects in whatever the target population is for that particular study."

This would, in turn, benefit health plans, Cahill adds. "If they're able to get a better fix on how a product actually plays itself out with a patient population, it's going to provide them with information that will allow them to fine-tune their protocols for medication use, for alternative therapies. It's an opportunity to better inform the knowledge base around a product through its maturing life cycle."

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