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Who Stands To Gain With FDA Approval Of OTC Lipitor?
Lipitor, the LDL-cholesterol lowering statin, is the biggest selling drug of all time with annual sales of almost $13 billion dollars at its peak in 2006. It is also a drug that has been studied in a number of randomized clinical trials involving tens of thousands of patients dosed for multiple years. These studies have demonstrated the importance of this drug in the treatment of cardiovascular disease (CVD) and, as a result, it has become a cornerstone of any CVD treatment regimen.
 
The patent on Lipitor expired in the U.S., Europe and other parts of the world, and Pfizer’s sales of this blockbuster are only about 15% of where they were at their peak. As reported by the Wall Street Journal’s Peter Loftus, Pfizer is seeking to commercialize an over-the-counter (OTC) version of its prized statin. As Loftus points out, OTC Lipitor would “be a boon to Pfizer by helping to recapture a portion of the market it has lost since low-cost generic versions hit the market beginning in late 2011.”
 
Historically, the FDA has approved the conversion of a number of prescription drugs to OTC status. For example, anti-ulcer/heartburn drugs such as the histamine H2 antagonist, Zantac, and the proton pump inhibitor, Prilosec – drugs first marketed more than 25 years ago – are readily available OTC. The same can be said for anti-allergy medications such as Claritin and Zyrtec. In general, these prescription-to-OTC switches are for drugs that have been used extensively, have a well understood side-effect profile, and are deemed by the FDA as being relatively safe.
 
Pfizer believes that Lipitor fits these criteria and is willing to run yet another clinical study to support this belief. Pfizer has started a 1,200 patient trial to determine if consumers taking OTC Lipitor will get their own blood tests at the pharmacy to see if the drug is improving their cholesterol profile. The trial will then measure if patients make the right health decisions based on their results. Most of the OTC drugs, such as pain relievers, heartburn drugs and anti-allergy agents, all relieve symptoms quickly and patients know whether the drug is helping them. High LDL-cholesterol, while harmful in the long term, is symptomless, and the FDA doesn’t want patients taking a drug that isn’t providing benefit – thus the need for periodic blood testing for cholesterol levels. Will patients be motivated to get their blood tested? That’s a goal of Pfizer’s study.
 
There’s no guarantee that, even if the Pfizer study is successful, the FDA will allow the OTC switch. Previously, Merck tried to get FDA approval to make its statin, Mevacor, available OTC, but this was rejected. However, Lipitor has been far more extensively studied than Mevacor. Furthermore, Pfizer is seeking OTC approval only for the lowest prescribed dose, 10 mg. Prescriptions doses can be as high as 80 mg. The FDA might be comfortable with this strategy.
Certainly, Pfizer stands to gain should the FDA approve OTC Lipitor. Goldman Sachs estimates that it could bring in $1 billion in sales each year. But generic companies also will benefit. Pfizer will get three years of exclusivity for OTC Lipitor based on the provisions of the Waxman-Hatch Act, provided that the FDA agrees that the clinical trial run by Pfizer met FDA guidelines. But after this time, generic companies are free to market their own OTC versions which would have to be called by Lipitor’s generic name, atorvastatin. Thus, they would be winners in this scenario as well as their patient pool would also be expanded.
 
However, insurance companies will also be big winners, as medical insurance doesn’t cover OTC medications. Insurers will no longer need to pay for 10 mg Lipitor prescriptions and, eventually, 10 mg generic atorvastatin prescriptions as well. Furthermore, in all likelihood, insurers will lobby hard to convert as many statin users as possible to OTC Lipitor. In doing so, they will perhaps shift as much as $1 billion of costs that they now have onto consumers.
Is there a benefit to patients? Perhaps. Based on the new cholesterol guidelines, patients can use the risk calculator to determine if they are at risk for having a heart attack or a stroke. The new guidelines no longer treat to a specific target; rather, they focus on patients’ overall risk assessment. Thus, if patients are able to determine they are at risk, then they can readily get 10 mg of OTC Lipitor and not worry about reaching a specific target. That should make things easier for them.
 
There is no doubt that people will be following Pfizer’s gambit closely. OTC Lipitor could not only impact Pfizer’s fortunes, but those in other parts of the healthcare delivery chain as well. Pfizer’s trial should finish by the end of the year. Perhaps an OTC statin could be available to consumers as early as 2016.