Patient Compliance

Increasingly, managed care executives are receptive toward value-added programs that enhance patient compliance. Some believe greater efforts should be focused on improving patient compliance. For example, patients who only take 50 percent of a drug's intended dosage may never realize the health benefits behind the drug.

Because of patients' tendencies toward therapy noncompliance, P&T committees are looking very favorably at medications that offer one or fewer doses per day. "With the number of medications our patients are receiving now, we would lean toward those that have fewer doses per day," Bender says. Also, "The more doses a patient receives, the greater the likelihood that the nurse administering that medication or the pharmacist dispensing it will make a mistake," he says. The flipside, however, is that if the patient misses that one dose, he or she will have lost a day of therapy. "It's a double-edged sword, and one that has the most impact in outpatient populations."

Early Strategizing

P&T committees urge pharma companies to involve them early on in product development. "Asking us how they should design their Phase III trials is intriguing to me and something I appreciate," says David Calabrese, director of pharmacy, Provider Service Network. "That way, when it comes time for a product to launch, they know they've built the right outcomes measures and pharmacoeconomics into their companies' studies."

Some pharma companies are wary of asking for input from P&T committees, even if they are requesting objective and unbiased information. But Pigg says that setting up one-on-one meetings with committee members can be beneficial. "If they give us a heads up, we'll be fairly forthright with our thoughts and options." Still, there seems to be confusion about whether these meetings are allowed under the OIG guidelines.

"The onus is largely on the pharmaceutical companies because each company interprets guidelines differently. Some keep drug information very close to the vest and will only share it in an advisory type of setting," Calabrese says.

There are several reasons to explain their conservatism. One is a fear of divulging key information, which, if leaked to competitors, may result in a loss of competitive edge at launch time. A second reason may be the fairly rigid FDA guidelines regarding sharing of such information.

"FDA and PhRMA should collaborate to establish more lenient guidelines for the sharing of pre-FDA-approval data with P&T Committees," Calabrese says. "It is essential that the P&T decision makers are well-informed of pipeline clinical developments so that drug and drug-class reviews can be conducted in a more proactive, well-rounded fashion, post-approval."

Alana Klein is Pharmaceutical Executive's senior associate editor. She can be reached at aklein@advanstar.com

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