WellPoint Would Take A Mulligan On Antihistamine Petition In Hindsight

If it could do it all over again, WellPoint Health Networks Chief Pharmacy Officer Robert Seidman said the insurer would use an alternate approach to requesting forced over-the-counter switches of certain classes of drugs through a FDA citizen petition.

"I would not necessarily recommend to anyone following the specific steps that WellPoint took" in petitioning FDA to force switches, Seidman stated at a recent Rx-to-OTC switch conference.

"The simplest way to describe it is we were somewhat naïve," said Seidman. "From a societal perspective and a cost perspective, we had a responsibility to provide broad access to affordable pharmaceuticals, and [the petition] seemed like a good idea."

Seidman emphasized the need for partnerships across industries in pursuing future switches.

"The most important thing is that it really isn't appropriate for a health plan to file a petition. If you're going to be in this business, you want to form a coalition or consortium of employers, Fortune 500 companies - people who have skin in the game."

WellPoint filed citizen petitions in 1998 and 2002 requesting Rx-to-OTC switches of certain low- and non-sedating antihistamines, including Schering-Plough's Claritin (loratadine) and Clarinex (desloratadine), Aventis' Allegra (fexofenadine) and Pfizer's Zyrtec (cetirizine).

The insurer recently announced it would not sue FDA if the petitions are denied.

Seidman said the onslaught of direct-to-consumer advertising for non-sedating antihistamines was the primary impetus for the petition, a point he made to an FDA advisory committee in 2001 (¹ (Also see "Antihistamine DTC Ads Demonstrate Suitability Of OTC Use, WellPoint Says" - Pink Sheet, 21 May, 2001.), p. 13).

"I really think it was the DTC that broke the camel's back on this. It was very painful for me to get up in the morning and go to bed at night seeing these commercials 25 times a day saying these drugs had side effects similar to a sugar pill."

"We didn't know or think FDA was going to take us seriously," he continued. "Obviously, we were quite surprised that they did. And the incredible negative press that we received really took us by surprise."

Seidman further noted that Rx drug expenses "are increasing at a rate that's not sustainable," and advocated more switches to control managed care costs.

"At the end of the day, the goal is to provide easier access to lower cost pharmaceuticals," he stated. "We've got prescription drug trends running 20% a year. In five years, [expenses] will double, and we're very concerned that employer groups are going to opt out of providing broader access to prescription drugs."

"I think somehow...pharmaceutical manufacturers, managed care employer groups [and] providers need to really sit down and figure out how to tame this madness."

Seidman said he remains "perfectly comfortable" with forced switches of products "masquerading" as prescription medications. However, he recognizes "there are really very few therapeutic classes" that would qualify.

"All of the products and classes that are potential candidates for Rx-to-OTC [switches] have nuances or baggage," said Seidman, citing cholesterol-lowering statins as a recent example. Johnson & Johnson/Merck is currently pursuing a switch to "pharmacy status" for its Zocor 10 mg (simvastatin) in the UK (² (Also see "J&J/Merck Seeking Zocor Switch In UK; Mevacor Still Lead U.S. Candidate" - Pink Sheet, 24 Nov, 2003.), p. 3) where patent protection ran out in May.

"There's going to be much greater due diligence on the part of the [FDA], consumer groups, pharmaceutical manufacturers. There has to be much greater discussion on how these products could be converted...OTC."

"The advent of OTC statins for primary prevention is something that, yes, does come with some risk," he acknowledged. "But I'm not comfortable with what I define as the 'white coat model' today, where you have to see your physician" in order to obtain a statin prescription. "I don't think that we're treating our patients as well as we could be in the current model, so I'm somewhat intrigued with an OTC alternative."

Seidman is optimistic that with proper educational efforts, consumers "will know how to take an OTC statin, and will know when to consult their physicians."

Seidman further notes that with a potential statin switch, "the UK, European nations, Canada are setting the stage for a much broader embracing of Rx-to-OTC conversions."