Best to Market - Pharmaceutical Executive


Best to Market

Pharmaceutical Executive

Strength in Numbers

Jeffrey Stewart, VP
Enbrel doesn't have an indication for Crohn's disease, and Remicade never established a foothold in dermatology, so Humira's full coverage of all three represents a distinct advantage. But perhaps one of the most valuable cards in Humira's deck is the numbers, in the form of long-term clinical studies. "We've kept a lot of our studies going on for an extended period of time," says Stewart. "In RA, we're proud to be able to highlight eight years of showing that the joints are stable, that the joints don't deteriorate over time. That's a substantial time frame, unique to Humira, and that allows our representatives to frame out why Humira might be the best option for patients." Stewart says the management of clinical data collected over time is beneficial for all stakeholders. "Years ago, these biologics were somewhat mysterious, but I think that because of the breadth of our clinical program, and the huge safety database that we have, no matter who you are—a payer, or a prescriber, or a patient—the fact that we have that data gives them comfort," says Stewart. "These are severe diseases, and patients are often in rough shape, so that extensive database, going back to 1997, when we enrolled the first patients, is a significant asset."

Stewart points to dermatology as an example of how managing and communicating the data translates into better sales figures. "There's never been head-to-head trials between Enbrel and J&J's Stelara (approved in 2009 for moderate to severe plaque psoriasis), but if you look at the perception among doctors, and you look at the market research, the skin clearance that we see in our pivotal trials—the ability to clear plaque psoriasis from 75 percent of the body—it's pretty much universally viewed as very impressive efficacy data," says Stewart. "That helps us out with the overall perception of Humira as a safe biologic, in addition to the experience in the marketplace since 2003, even with other indications. In 2011, we became the new prescription and the total prescription market share leader in dermatology, and gained almost three share points. The market is rewarding us for our profile and our ability to communicate the Humira data."

Fear Factor

Humira is not without serious potential side effects, though, which holds true for the rest of the anti-TNF class. They all carry FDA's sternest safety warning—the Black Box—which can be hair-raising for patients. Virginia Ladd, president and executive director of the American Autoimmune Related Diseases Association (AARDA), says patients have a real "fear factor" when it comes to the anti-TNF class. "Lymphoma—they hear that, they hear cancer in the advertisements, life-threatening infection, tuberculosis ... you have to be pretty brave," says Ladd.

In a forthcoming paper and patient brochure, AARDA will reveal the results of a study conducted among 1,000 autoimmune patients, and how they make the decision to receive treatment. Ladd says most pharmaceutical companies she deals with do a pretty good job of educating patients on the risks and benefits of a drug, and Abbott "does an excellent job—they have websites, they have webinars, and all kinds of things that are patient-friendly, that help patients." However, the study results showed that pharmaceutical companies aren't too high on the list of trustworthy sources of information. Ladd says this isn't entirely pharma's fault. "Many patients with autoimmune diseases do not actually trust their doctors," says Ladd. "The reason for this is that most have had a difficult time being diagnosed. They saw several doctors, and over 40 percent were told—these were patients with serious autoimmune diseases—that they were chronic complainers or too concerned with their health." Symptoms such as fatigue and joint pain, and the fact that RA in particular affects women disproportionately, has led to problems with diagnosis. "These women are told they're too busy or too stressed, or they're depressed. So when they actually do get a diagnosis they're grateful ... but when the doctor tells them, 'I want you to take this TNF-inhibitor,' they see the ads, and there's a level of mistrust to begin with," says Ladd.

For physicians, Ladd has some advice: Tell the patient what the side effects of their illnesses are, in addition to drug side effects. During the study, Ladd said AARDA tested responses to physicians' instructions, in terms of how patients behaved. In each scenario, a patient has been diagnosed with RA, and given a script for an anti-TNF. In the first scenario, the doctor says, "Here's your prescription; see me in three months." In a different test, the doctor says, "Here's your prescription for rheumatoid arthritis, which we hope will prevent the crippling that could cause a disability in you." In the latter instance, "compliance shot up," says Ladd. "I call it three-second compliance. If a physician adds three seconds, patients know what the drug is going to do for them. If it's going to halt something, if it's going to stop progression—that was very important to patients."

When diagnosed early, RA patients who receive anti-TNF treatment immediately can prevent crippling and disability, and that's one of the best aspects of the drugs, says Ladd. Biologics like Humira "are the only really new medications to come along for most autoimmune diseases in 50 years ... they represent a real advance in the treatment of these conditions," says Ladd.


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