It's finally happening. Pfizer has placed the ball at the line of scrimmage. And based on the X's and O's to come out of its Lipitor OTC actual-use study, Pfizer will be making its run with its eye on the ultimate prize — a successful Rx-to-OTC switch of a statin.
Only this time, the Food and Drug Administration may not be as quick to sack Pfizer's switch attempt. With the advances and pervasion of health technology in the self-care space by way of smartphones and tablets; with the evolution of the pharmacist as a healthcare professional able to practice at the top of their license; and with the adoption of diagnostic tests like a cholesterol panel that can be physically administered in the pharmacy, consumers may finally get it right when self-selecting a statin.
Because it's the consumer actual-use studies that have scuttled just about every statin switch attempt in the past. In the last switch of Mevacor, FDA advisory panelists determined the statin was safe enough for the self-care space. And it was effective. It's just that the consumers who would be right for an OTC statin didn't appropriately self-select. And if they can't appropriately self-select, what's the point, really?
But that may change with this switch attempt. In fact, the FDA has already seen how technology can improve the self-selection process when it comes to statins. Two years ago, before a panel of FDA officials who were exploring how to expand what conditions would be considered appropriate in the self-care space, GlaxoSmithKline presented a prototypical healthcare kiosk that channeled a patient through nine algorithms and assisted him or her in making an appropriate treatment decision for use of an OTC statin, in this case Mevacor — branded Cardiocare. It was the kind of proof-of-concept presentation that helped showcase to FDA what the next generation of switch might look like.
Then there's the expanded switch paradigm factor. FDA just came off of a year in which it created two categories never-before-seen in the nonprescription space — overactive bladder and nasal corticosteroids. And with Merck's Oxytrol, indicated for overactive bladder, the FDA even went against the advice of its advisory panel, the simple majority of which had voted that overactive bladder was not appropriate for OTC (six were opposed, five were in favor). Proponents of the switch argued that women with overactive bladders may go years before consulting a physician and that an OTC option might encourage therapy sooner. That may be one of the tipping points for FDA — medicines available OTC, for certain conditions, may represent a greater good for the public.
And don't forget that as part of the Affordable Care Act, there is a significant cost associated with keeping statins as prescription only. You can bet the folks over at the Centers for Medicare and Medicaid Services and Tricare will be rooting for this statin switch. But then again, that's something that DSN has been saying all along. Here's what we wrote in 2011: "Under ObamaCare, the country becomes a much larger healthcare payer in 2014. OTC Lipitor could lower the cost of therapy from $4 to $5 per pill to a fraction of that — even cheaper than a generic version when you factor out the cost of the doctor visit that would be saved. The federal government stands to save a lot of money here if the Food and Drug Administration could change the way it thinks about an OTC statin."
At the end of the day, a Lipitor switch would be a significant boon to purveyors of the OTC category. Some analysts have predicted that an OTC Lipitor would become the first de facto blockbuster drug in the nonprescription space, which is defined as having sales in excess of $1 billion. Pfizer is only at the very beginning in its drive for the ultimate switch touchdown, but it's likely Pfizer will be posting seven points on the board when it's all said and done.