When federal advisory committees meet later this week to decide if
cholesterol drug Mevacor can be sold without a prescription, they may be taking the next step in putting more health care responsibility into the hands of patients -- or more money in the pockets of drugmakers and insurers.
Since the mid-1970s, efforts to switch drugs from so-called status Rx to over the counter (OTC) have been couched in terms of patient empowerment and consumer savings. "OTC medicines continue to be an extremely cost-effective option for the millions of consumers who are following the trend of self-reliance," says the Consumer Healthcare Products Association, which represents over-the-counter product makers.
"The FDA's goal is to increase Rx-to-OTC switches by 50% on average," the Food and Drug Administration said in a budget request for the recently completed fiscal year. The FDA said it should become "more proactive in recommending" switches "that could result in further consumer empowerment in self-medication as well as provide an expedient way to significantly reduce consumer health care costs for certain ailments."
But neutral observers say the switches are essentially motivated by companies trying to wring extra profits out of flagging prescription products and by insurers and managed-care companies trying to cut costs.
"Maintaining sales post-patent expiry is a key driver of the implementation of an Rx-to-OTC switch," said Adele Schulz, a health care analyst at Datamonitor, a London-based health care strategy firm. Companies often wait until a prescription product is near its patent expiration date, then they seek to switch the drug to "capitalize on hard-earned brand equity even after patent expiry," Schulz said.
"Switching drugs to over-the-counter availability reduces insurers' prescription drug costs but increases the costs for most patients," says a recent study by the Tufts Center for the Study of Drug Development at the Tufts University School of Medicine in Boston. "However, some
will benefit, particularly uninsured patients, who previously had to pay the full retail prescription price and the cost of physicians' visits."
The Tufts study, published in the Jan. 1 edition of the
British Medical Journal
, added that "insured patients faced with high co-payments on their prescriptions may also benefit financially from over-the-counter availability."
Switching drugs from Rx to OTC status "is an evolution," Joshua P. Cohen, senior research fellow for the Tufts Center for the Study of Drug Development, said in an interview. "It's based on a combination of clinical factors, consumer responsibility and the changing role of the FDA."
Cohen expects another flurry of Rx-to-OTC switches in the next few years amid an environment of rising drug costs, insurance company pressure and patent expirations on big-selling drugs. "It is, for the most part, cost-driven," he said.
Since the mid-1970s, changing physician, regulator and patient attitudes have affected the marketing of antihistamines, pain relievers, heartburn remedies, hair-loss treatments and smoking-cessation drugs. Some of the most famous prescription names of yesteryear -- Claritin, Rogaine, Pepcid, Zantac, Nicorette, Prilosec -- are all now sold without a prescription.
Is Mevacor next? Four years ago,
Merck asked the FDA to make it a nonprescription drug, but FDA advisory committees said Merck failed to prove the drug could be used safely by consumers without a prescription. The FDA also rejected an attempt by
to get the cholesterol drug Pravachol approved for OTC use. Bristol-Myers Squibb
recently submitted another request for OTC Pravachol, but only Mevacor is scheduled for an FDA advisory committees' review on Jan. 13 and 14.
When companies switch drugs, consumer savings often depend on whether the out-of-pocket cost for an OTC drug is lower than the co-payment someone makes to his insurer for an Rx drug.
"There is a lot more to consider than just the cost of prescription co-payments, which vary greatly," says the Consumer Products Healthcare Association. "Other circumstances must be factored in, such as the fee for the doctor's visit, travel costs and time off from work."
Tufts School of Medicine researchers say switches can reduce choices and raise prices for managed-care clients. They interviewed 12 top managed-care organizations and found "a strong tendency" to remove the switched drugs from their formularies -- a list of approved drugs -- and to raise co-payments on similar prescription medications.
"Increasing the co-payments of prescription drugs in the same class gives patients further financial incentive to take the over-the-counter drug," said the Tufts study in the
British Medical Journal
Researchers found that each managed-care firm removed loratadine from its formularies when the drug went OTC and raised co-payments for similar prescription antihistamines. Loratadine is the generic name for
Claritin. The researchers said one-third of the HMOs are removing all other similar antihistamines from their formularies.
The managed-care firms acted similarly with omeprazole, the generic name for
Prilosec, which belongs to the proton pump inhibitor class. Eight removed omeprazole from their formularies, and seven raised the co-payments for prescription proton pump inhibitors.
Drug industry observers say Claritin is a good illustration of how a drug company responds to its economic interests.
In 1998, the managed-care company
took the unusual step of asking the FDA to recommend that three prescription antihistamines, including Claritin, become OTC products.
Schering-Plough opposed WellPoint's petition. Two days before a May 11, 2001, meeting of two federal advisory committees, Schering-Plough issued a press release saying OTC Claritin "would force patients to self-diagnose, self-treat and pay the entire cost of their allergy medications." It said the WellPoint petition, "while good for the insurance company, would not be in patients' best interests."
Although the advisory committee supported the WellPoint petition, the FDA didn't act on the request. The agency cannot force a company to switch a prescription drug to OTC status.
By early 2002, "after losing a protracted patent litigation," Schering-Plough changed its view, said the Tufts Center for Drug Development. "To expand the brand name's viability," Schering-Plough sought and received FDA approval for OTC Claritin.
OTC Claritin "represents an important new treatment option for the estimated 20 million Americans who currently choose to treat their allergies with a non-prescription medication," Schering-Plough said in November 2002 news release, after the FDA approved the drug. Claritin went over the counter shortly after Schering-Plough introduced a cousin, Clarinex, to the prescription market.
Neither Merck nor Bristol-Myers has said much about turning their cholesterol drugs into OTC products. Mevacor has long since lost patent protection; its U.S. sales are being swamped by generic competitors. Pravachol loses U.S. patent protection in April 2006. It is the third-ranked drug in the statin class of cholesterol drugs.
Lipitor is the leader, followed by Merck's Zocor, which loses its U.S. patent in mid-2006.
Zocor is the world's first statin to be switched to OTC status, having reached U.K. pharmacies in July. "In general, the switch has been well-received in the U.K.," said Paula Fryans, senior cardiovascular analyst for Datamonitor.