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."
At companies like Cigna, where they assume responsibility for the medical risk of patients, there is every incentive to make
sure the patient is taking their medication. "The most expensive medication patients receive is the one they don't take,"
Pigg says. The nuances between once- or twice-a-day dosages, she says, are negligible. But, "With three or more doses, then
you start affecting compliance."
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 firstname.lastname@example.org
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