On the eve of Lipitor’s patent expiration this month, its innovator, Pfizer Inc., is pursuing an aggressive strategy to keep its prize statin product on the radar screen as it loses patent protection and faces generic competition.

During a Nov. 1 conference call to discuss third-quarter financial results, Pfizer CEO Ian Read said Pfizer is considering FDA approval for an over-the-counter (OTC) version, pursuing deals with PBMs and providing discounts to patients in order to persuade them to stick with the brand form. But offering patients discounts is a strategy that some industry consultants and health plan executives say will only partially work.

“From a plan sponsor view, the self-insured plan sponsor, the question is about where is the savings return to the health plan or PBM client?” Randy Vogenberg, principal at the Institute for Integrated Healthcare, tells DBN.

Contract savings and rebates should flow back to the client or be shared between the client and PBM, Vogenberg says. “This is an example of where alignment between vendor, health plan, PBM and the client, including employer, union and municipality, is not in sync.”

George Van Antwerp, senior vice president and general manager of pharmacy solutions for Silverlink Communications, Inc., predicts that “if the Pfizer rebates lower the cost of the brand drug below the generic price during the exclusivity period, some PBMs will move Lipitor to the first tier.” Van Antwerp tells DBN that this would be good for both the consumer, who will see no change, and the payer, which will see a lower cost. “But it can be confusing when a brand drug is treated as a generic,” Van Antwerp says.

He contends that in general, health plans have been skeptical of covering OTC products such as Claritin and Prilosec. “While I think there is a clear case for an OTC strategy, it would typically require the use of OTC prescriptions for them to be covered products,” Van Antwerp says. “OTC prescriptions are not a normal process for physicians to write and pharmacies to process. Therefore, I’m skeptical that health plans would cover an OTC statin.”

At BlueCross BlueShield of Tennessee, clients are given a choice when a prescription drug such as a non-sedating antihistamine or ulcer drug goes OTC. One option is that “if the prescription drug goes OTC, we’re not going to cover that at all. It’s on the individual to go and purchase that product at its full price,” Elaine Manieri, vice president of pharmacy management at the Tennessee Blues plan, tells DBN.

The other option for employer clients, Manieri explains, is to say, “We’ll cover the OTC version of these drugs at a lesser copay, because usually they are priced less than what the prescription was.”

Both Vogenberg and Manieri see low odds of Pfizer getting FDA approval for an OTC version of Lipitor. Vogenberg cites the regulatory environment in Washington. And Manieri points out that “it takes years and years for these drugs to work, and I think you should be under a doctor’s supervision because even though they’re rare, they can produce some pretty severe problems.”

The track record, so far, for statins making a successful transition from prescription to OTC isn’t very good. In 2008, the FDA rejected Merck & Co.’s request to have its statin Mevacor (lovastatin) receive OTC status.

Manieri says that Pfizer, like other manufacturers, wants to strike the best deal for its product as it goes generic.

“Sometimes the rebates do outweigh what the generic is going to be priced at, especially in the first six months, because typically the generic is priced 10% to 20% less than the brand,” she says. “And so in many cases, you can get a better deal on your brand drug with the rebate as opposed to that generic.”

But at the Tennessee Blues plan, “we do not have Lipitor in a preferred status. And we go to our generic alternative as well as other brand-name products that we got a better deal on,” Manieri says.

Almost a year ago, Pfizer began giving out $4 copay cards for a month’s supply of Lipitor as a part of its “Lipitor for You” program (DBN 9/9/11, p. 5).

Manieri says that couponing is intended to allow the drug company to build up brand loyalty so that patients remain on the brand even after generics become available. She notes that Lipitor now is offering a coupon for patients to receive about a $50 rebate. “It’s a good deal for the patient because they are receiving the medication at a lower cost, but for the health plan and for the payer, we’re still paying a higher cost for that non-preferred drug.”

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