Flip the switch

An OTC statin could forever change the 
switch model — Lipitor could be the first


As the clock winds down on the patent exclusivity of the industry’s biggest blockbuster drug in November, speculation continues to grow that Pfizer will look to flip the switch on an OTC version of Lipitor (atorvastatin) before generic competition whittles away at the $7 billion behemoth. 


And while there is a long and unsuccessful history of pharma companies trying to switch statin drugs from Rx to OTC status, it appears that things could be different this time for Lipitor. For one thing, recent OTC switches like Alli and Plan B may have helped create an atmosphere that would be more permissive of a Lipitor switch by leveraging the expertise of the pharmacist to help mitigate patient safety fears.


For another, 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. But ObamaCare also creates new tax burdens for branded drug makers like Pfizer, creating yet another compelling reason for the company to find new revenue streams for its biggest drug.


Even still, it won’t just be all about money. Regardless of how much Pfizer can make or payers can save, if a Lipitor switch were to be successful, it would have to clear the same consumer-usage hurdles that prior applicants failed to clear — that is, the ability to prove safe and appropriate self-selection by consumers.


When Merck and GlaxoSmithKline last pitched an OTC switch of Mevacor (lovastatin) in 2007, the companies submitted the best consumer usage studies to date. Based on consumers’ knowledge of their LDL levels, 98% of subjects appropriately chose not to take the medicine — however, only 16% of those who chose to take the medicine did so appropriately. That marked the fourth time a statin switch had been rejected by the FDA: three times for Mevacor and one failed attempt by Bristol-Myers Squibb’s Pravachol in 2000.


But an improved usage study no longer may be the lone cost of entry for an OTC statin. With more states expanding pharmacists’ immunizing authority beyond just flu shots, the role of the pharmacist has evolved significantly in recent years — a trend that promises to continue, particularly as community pharmacy finds its natural place in medication therapy management. And as many pharmacies already offer cholesterol screenings, many believe there is a role here for the pharmacist to play in patient assessment.


“From pharmacy’s perspective, not only are there immunization regulations in all states, most states also have collaborative care agreements,” Randy Juhl, vice chancellor for research conduct and compliance for the University of Pittsburgh and one-time chairman of the FDA Nonprescription Drugs Advisory Committee, told Drug Store News. “The possibility that pharmacists are involved in cholesterol management already exists. The mechanisms are there.”


In addition, there are those that believe that some of the more complex switches of the past decade may have served as critical building blocks for future switches once thought improbable, including statin drugs.


In the 1990s, OTC nicotine-replacement therapies helped establish precedents for limited channel distribution, restricting sales by age and mandating educational materials. The emergency contraceptive Plan B and weight-loss aid Alli took the idea of channel distribution further by creating a behind-the-counter OTC classification, without necessarily creating an actual, codified third class of drugs.


At press time, Pfizer executives still would not confirm that the company is considering a switch for Lipitor, though several reports said the company has assembled a team of experts to explore future options for Lipitor, including assessing the feasibility of a switch. Logic dictates Pfizer will try. It is projected that OTC Lipitor could be the first $1 billion OTC brand.


A statin switch also would redefine what quantifies as a sales success in the OTC arena. “Cholesterol is chronic,” noted Steve Francesco, CEO of Francesco International. “If you look at that in terms of tablet consumption, you’re taking Lipitor 365 days of the year. How often do you take an allergy pill?” he asked. “Tablet consumption will be huge compared to your everyday OTC product.”


Francesco and others believe that a successful statin switch would open the doors of the self-care market to a plethora of new disease states, including hypertension, mild asthma, osteoporosis, arthritis, migraine or incontinence. According to Francesco, there are numerous chronic and recurrent therapy drugs that will seek to switch over the next five years that have great potential if drug makers can prove that the drugs are safe in an OTC setting. Such new technologies as electronic prescription cards that allow patients to be monitored without direct physician supervision and new mobile phone applications will help pave the way for a series of new Rx-to-OTC switches that once were unlikely; something Francesco called “OTC-Es” — that’s “e” as in “enabled.”


There is little doubt that this is the future of health care in America — a consumer-directed model with patients taking more responsibility for managing costs, more self-care options to treat a wider range of conditions and an expanded role for the pharmacist. And there is little doubt that in that kind of a future, OTC Lipitor would do quite well. The question is: Can Pfizer get there in time to save Lipitor from the patent cliff? Will it try?


This much is certain, if Pfizer successfully can flip the switch on an OTC version of Lipitor, it will forever flip the script on the Rx-to-OTC switch model.

Comments

- 11:08 PM
mjbelitz says

As long as US law permits any and all OTC's to be sold in any retail outlet, you will have the "16% of those who chose to take the medicine did so appropriately", which means there is a 84% failure rate. With such poor results it is no wonder that authorities may not allow the RX-OTC switch. I suggest that the regulatory authorities look to Canada with its 3 classes of OTC medications. Class 1 is pharmacist only sale of products that are kept behing the counter. Class 2 is drugstore only sale and the product must be kept for self selection in an area close to the pharmacy/dispensing area. Class 3 are products that can be sold anywhere. Class 1 and 2 protect the public since class 1 products must have pharmacist approval for the sale (Lipitor OTC would be a good example) and, class 2 would provide ready access to a pharmacist if the customer has a question. An actual, codified third class of drugs would solve the problem for manufacturers and regulators.

- 11:08 PM
mjbelitz says

As long as US law permits any and all OTC's to be sold in any retail outlet, you will have the "16% of those who chose to take the medicine did so appropriately", which means there is a 84% failure rate. With such poor results it is no wonder that authorities may not allow the RX-OTC switch. I suggest that the regulatory authorities look to Canada with its 3 classes of OTC medications. Class 1 is pharmacist only sale of products that are kept behing the counter. Class 2 is drugstore only sale and the product must be kept for self selection in an area close to the pharmacy/dispensing area. Class 3 are products that can be sold anywhere. Class 1 and 2 protect the public since class 1 products must have pharmacist approval for the sale (Lipitor OTC would be a good example) and, class 2 would provide ready access to a pharmacist if the customer has a question. An actual, codified third class of drugs would solve the problem for manufacturers and regulators.

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