Marketing to Professionals: Penetrating P&T

As a result of the rapid innovations in drug technology, and the increasing complexities surrounding drugs' safety, cost, and efficacy, the demand for extensive formulary reviews is growing. To keep pace, Pharmacy & Therapeutics (P&T) committees have been ardently reviewing medications to determine which ones deserve inclusion and preferred placements in health plans and formularies. While there are many factors that influence the committees' decisions, with some carrying more weight than others, pharmaceutical execs complain that there is no accurate way to predict which drugs will make the cut.

Alana Klein

But there are certain measures pharmaceutical companies can take to better position their products. A handful of P&T committee members, who spoke at Pharmaceutical Executive's Marketing Summit last April, offered insight into their decision-making processes.

The Cost vs. Quality Question

The P&T review process is multi-faceted, and while there's an obvious focus on ensuring a drug's clinical safety and efficacy, there is also the question of cost efficiency. "Years ago, the decision was purely based upon cost and they didn't really look at non-clinical, non-value driven issues," says Fredrick Bender, director of pharmacy, Greenville Memorial Hospital. Now, he says, the committee's focus has shifted. "The P&T committee is looking a lot more at outcomes and quality of care. It's a much more objective and value-driven process." While cost is still a factor in the mix, he says, "it's third or fourth on the list in terms of important criteria to look at."

Steven Arnold [far left] and Cynthia Pigg discuss how to get a drug onto the committee's radar screen, at Pharmaceutical Executive's annual Marketing Summit, held last April.

But the mere task of assessing a drug's value can be a challenge in itself. Many committee members agree that it's important to differentiate what is the marketing and sales pitch from what the clinical evidence says about the quality of the product. The challenge often becomes figuring out what's fact and what's perception.

Looking at a drug's comparative value is key, says Cynthia Pigg, the newly appointed executive director for the Foundation for Managed Care Pharmacy and former vice president of pharmacy, Cigna Healthcare. "We are looking for drugs that actually are going to treat the given condition better, not ones that are just clinically neutral," she says. Ninety percent of the drugs she sees fall into the clinically neutral category, she says.

Often, the committee will take a look at the drug's market position. "Sometimes, we will prefer to have a market leader. In that case, if the price is competitive, we'll pay a bit more for it," she says. If a drug proves to be superior, she says, cost is not a component. "Cost is a factor in the value equation, quality is a factor in the value equation," she says. "But as our process will show, and if I may steal an old phrase from Ford, quality is definitely job one."

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."

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."

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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