Articles on Pharmacy Benefit Management

Compliance With Ulcerative Colitis Therapy Can Cut Costs, Improve Outcomes

Reprinted from the Jan. 5, 2007, issue of DRUG BENEFIT NEWS, biweekly news, data and business strategies for health plans, PBMs and pharmaceutical companies.

Although therapy compliance is certainly important in any condition, data from recent studies are making the case for early compliance especially with ulcerative colitis (UC) treatments to reduce hospitalizations.

UC affects about 500,000 people in the United States, and the disease varies among them in terms of its severity. About 20,000 annual hospitalizations and 250,000 physician visits are tied to UC.

A recent study analyzed 2002-2004 data for 1,057 UC patients who were covered under a self-insured employer, which was not identified, with approximately 500,000 covered lives. When health care costs for the UC patients were compared with those of non-UC claimants, the study found:

• Mean annual unadjusted UC patient costs were $14,486, compared with $6,158 for the control group.
• When the data were divided up by UC severity, the severe UC group "had a two-fold increase of mean total cost as compared to the mild and moderate groups" — $26,875 versus $12,443.

"What we know is these patients have significant symptoms," says William Sandborn, M.D., professor of medicine at the Mayo Clinic College of Medicine and lead study investigator. The problems not only can impact patients' health, but also can affect their quality of life and ability to perform a job. UC patients can experience four or five stools per day, as well as the need to "urgently rush to the bathroom," says Sandborn. Other symptoms include cramping and passing blood — and "this is the mild version" of UC, he adds.

Sunanda Kane, M.D., associate professor of medicine at the University of Chicago, says the majority of UC patients fall under the mild-to-moderate category, "but what one person's mild is, is another's severe." She adds that "we know if we don't treat these patients, they won't get better. Spontaneous remission does happen, but it is rare.…Without medication, they are not curbing the inflammatory response."

First-line therapy for mild to moderate UC consists of 5-aminosalicylic acid (5-ASA) therapy. Short-term treatment with corticosteroids — which are "not accepted long term because of their toxicity," says Sandborn — is the next step, and then immunosuppressants. While costs vary depending on the drug and the dosing, they are usually in the range of $200 to $400 per month. Historically, he says, patients who were still not responding at this level had surgery as their only other option.

There are two surgical options. Neither, however, may guarantee success, says Sandborn. "The lore has been that patients are cured when they had surgery, but there is increasing evidence that this is not true," he says.

According to Sandborn, within five years 50% of those patients will develop pouchitis, an inflammation in the small intestine. Ten years out, 50% of patients will require reoperation. Patients also have the potential to develop cancer or dysplasia, which may indicate a precancerous condition, so yearly endoscopies and biopsies may be needed as well, he says. Infertility may also be an issue for some of these patients.

UC Treatment Costs Are High

But in 2005, FDA approved a biologic drug to treat moderate to severe UC cases. Remicade (infliximab) is a specialty pharmaceutical that has UC among its various indications. Other indications include rheumatoid arthritis and Crohn's disease. The drug, which is administered through a two-hour infusion, costs approximately $1,400 per patient per month. And because UC is a chronic condition, Remicade is a long-term treatment.

According to Sandborn, who cites an additional study's findings, "two-thirds of patients [on Remicade] will respond with a meaningful clinical response." One-third will experience complete remission. Rates of hospitalization were reduced by half for patients on Remicade therapy, he says, and "data are being pulled together now" that would indicate whether the drug ultimately will reduce surgery rates. Sandborn contends that "it likely will" cut those rates. Remicade manufacturer Centocor, Inc. financially supported the studies.

"If insurance providers believe that by avoiding Remicade, they will save money in the long term, this is not the case," contends Sandborn. "Remicade is not cheap.but a number of patients do well on it. But surgery is not cost-efficient."

Sandborn says that Remicade compliance is pretty good because it's administered by a physician every eight weeks. He also points to a not-yet-approved Shire Pharmaceuticals Group drug, Mesavance (mesalamine), which is a "reformulation of 5-ASAs in a high-strength pill" of 1,200 mg taken twice per day. The drug offers a delayed, sustained response, he says. The drug "should help with compliance," he adds. Jan. 21 is the FDA action date for issuing a decision on approval of Shire's drug.

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