Pfizer said it will no longer pursue over-the-counter status for Liptor, citing disappointing results from its actual-use study.

Manufacturers seeking to switch from prescription to OTC status must study how patients actually take the drug without physician guidance. The FDA reviews that data and determines whether prescription status is still required before a new drug application is submitted. Bristol-Myers Squibb and Merck, two other statin manufacturers, previously failed in their attempts at launching an OTC cholesterol drug.

In its Q2 2015 quarterly financials report, the company said:

A Phase 3 “actual use” trial intended to simulate the OTC use of Lipitor (atorvastatin calcium) 10 mg was completed in December 2014. The study did not meet its primary objectives of demonstrating patient compliance with the direction to check their low-density lipoprotein cholesterol (LDL-C) level and, after checking their LDL-C level, take appropriate action based on their test results. Based on dialogue with the FDA about the program and the analysis of this data, the program was terminated.

The trial, which started in October 2013 and had enrolled 1,311 patients, also examined how many patients consulted with a pharmacist or physician before taking the OTC medication.

“It is apparent that a patient needs to sit down with a physician and be told that he/she needs to get their LDL-C under control with a statin when diet and exercise are not working,”said former Pfizer R&D head John LaMattina in Forbes. “Relying on the patient to be motivated to do this on their own is wishful thinking.”

Our Take: It isn’t surprising that patients wouldn’t take the initiative to actively check their cholesterol. Patients with high cholesterol aren’t symptomatic. People with headaches or allergies, on the other hand, get an immediate response from the medication they take. Those drugs were simply easier to confer OTC status to.

ACOs will be disappointed by the results as they want their patient populations accountable for their healthcare. Payers, too, would like to see an OTC statin; despite generic availability of most statins, it still affects their bottom line.

On the other hand, what they are paying for generics is pennies compared to the cost of Praluent, the first-in-class PCSK9-inhibitor, approved last week by the FDA. Developed by Sanofi and Regeneron, its wholesale acquisition cost is $14,600/year. The companies have defended the price of the injectable drug, saying that it “reflects the potential that it can provide to individual patients with uncontrolled elevated LDL cholesterol, and its overall total value to the healthcare system.”

The total market for the drug, which is used for patients with unusually high or uncontrollable bad cholesterol, is estimated at 8-10 million people in the US.


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