The Opportunity to Go OTC

We recently have heard that Pfizer is considering asking the US Food and Drug Administration (FDA) to approve an over-the counter (OTC) formulation of Lipitor, its blockbuster drug that is losing its patent later this year. Drug manufacturers have made this type of request before. We have seen it with allergy medications such as Claritin and Zyrtec. Prilosec became available as an OTC medication after its loss of patent. In the case of Lipitor, the request will be for this drug to be available “behind the counter” but without the need for a prescription from a doctor.

This model is not novel. Merck attempted 3 times to move Mevacor to OTC status, and Bristol-Myers Squibb made this request in 2000 on behalf of its medication pravastatin. The 2000 request by Bristol-Myers Squibb was denied due to both safety and appropriateness-of-use concerns. Now, 11 years later, Pfizer is making a similar request for a drug in a similar class that treats the same condition: hypercholesterolemia. This prompted me to ponder the question of whether it would be a good thing for the FDA to approve an OTC formulation of Lipitor. Who would gain value from this approval? Patients? Payers?

The 1 constituency most likely to benefit from the approval would be the manufacturer. Lipitor, which is the most prescribed drug in the United States, has been an unquestionable success for Pfizer. It is clear that Pfizer will miss this revenue when it loses its patent. Later this year, a generic version of this very popular drug will become available. Even during the generic exclusivity period, there will be significant movement from branded Lipitor to the generic atorvastatin. The generic will be less expensive than the brand while maintaining equivalent effectiveness. By offering a drug with great name recognition without a physician’s prescription, Pfizer hopes to maintain a share of this very lucrative drug class.

Would having Lipitor available OTC (actually behind the counter) extend value to healthcare consumers? Some might say that with the obesity epidemic in the United States and how that affects the cardiovascular system, we should just put it in the water system for all citizens. All joking aside, is there value in this model for a person with hypercholesterolemia? I know that we have a physician shortage in some places in this country that may make access to care an issue, but I have not heard of access being a barrier to consumers getting their cholesterol medication. In fact, with all the work that I have done over the last 7 years on medication adherence, I have not heard of physician access being a major reason for nonadherence with this class of medications.

The other issues needing evaluation are questions concerning safety and appropriateness. Is there an adequate alternative system in place to address these issues without active participation of healthcare consumers’ physicians? Such a system does exist in some other countries (eg, the United Kingdom, where statins are available without a prescription), but I would suggest that such a system does not exist at this time in the United States. This is not to say that it could not be developed. Another thing to be considered is whether the drug would be covered by insurance. There are some examples of OTC medications being covered by the pharmacy benefit, although it is not extremely common. In my next column, I will look at the use of OTC medications within a drug benefit.

In the meantime, we would love to hear your thoughts regarding the potential OTC availability of Lipitor specifically and drugs like it more generally. Is the United States ready for a behind-the-counter OTC system?