Roxanne Nelson

May 26, 2011

May 26, 2011 — The high cost of many oncology drugs is affecting patient compliance. Up to 10% of cancer patients abandon their initial prescriptions for oral oncolytic therapy, according to a study conducted by Avalere Health.

The researchers also found that 23% of patients reversed their newly initiated oral drug and followed-up with a different prescription, causing a potential delay in therapy.

The study was published simultaneously in the May issue of the Journal of Oncology Practice and in the May supplement of the American Journal of Managed Care, and will be presented at the upcoming American Society of Clinical Oncology 2011 Annual Meeting.

The failure to fill initial prescriptions for oral oncolytic therapy was primarily the result of 2 factors — high cost sharing and the complexity of drug therapy — the authors report. Out-of-pocket expenses, in particular, played a significant role in the likelihood of a patient failing to fill their initial prescription. One in 4 patients who filled prescriptions with cost-sharing amounts over $500 "abandoned the prescription and did not follow-up with another oncology medication within 90 days," they note.

"Many studies have shown that there is a relationship to out-of-pocket costs and treatment compliance," said study coauthor Michael Johnsrud, PhD, who leads the Health Economics and Outcomes Research Group at Avalere Health. "As you increase the cost sharing, patient adherence to therapy tends to decline. The goal is to remove as many barriers as possible to treatment."

"One of the most important conclusions to come out of this study is the need for more research in this area to look at other factors that might be driving noncompliance, such as clinical variables," Dr. Johnsrud told Medscape Medical News. "We need to expand research and find other drivers that we can address to reduce abandonment."

Cost and its relation with compliance is an issue that physicians increasingly have to address. "To the degree that it is possible, those discussions have to be held," said Dr. Johnsrud.

Type of Insurance and Income

The type of insurance coverage correlated strongly with the amount of cost sharing that the patient had to pay out of pocket. The authors note that patients who were enrolled in Medicare plans that included prescription drug plans and Medicare Advantage Prescription Drug plans tended to have higher cost-sharing expenditures than those insured by commercial insurance plans.

The association between cost sharing and abandonment rate has been previously investigated, but Dr. Johnsrud and colleagues identified other factors that significantly increased the likelihood of abandoning their prescriptions. Specifically, those with higher concurrent prescription activity were more likely to abandon their first oral oncolytic prescription at the pharmacy, they report.

Higher abandonment rates were also associated with a lower annual household income, although this relation did not reach statistical significance after other confounders were controlled for.

Dr. Lee Schwartzberg

Study coauthor Lee Schwartzberg, MD, oncologist and medical director of The West Clinic in Memphis, Tennessee, told Medscape Medical News that he believes these results are generally applicable to the population at large. "They represent a large national database, and they are contemporary data with currently used oral oncolytics," he said. "Physicians in general and oncologists in particular are beginning to factor cost into the treatment decision, especially when an oral drug is considered."

Healthcare reform must address this growing problem.

"Our results show that many patients will not even fill the prescription, primarily because of out-of-pocket cost or having other drugs to purchase," Dr. Schwartzberg added. "Healthcare reform must address this growing problem."

High Cost of Cancer Drugs

The rising cost of cancer therapy, especially for some of the new oral agents, has become a cause of ever increasing concern among physicians, payers, lawmakers, and patients.

Two years ago, a report issued by the Kaiser Family Foundation and the American Cancer Society outlined how cancer patients, even those with private insurance, are at high risk for huge medical debts, personal bankruptcy, and delaying or forgoing treatment.

"Cancer patients too often find out that their insurance doesn't protect them when they need care the most," John R. Seffrin, PhD, national chief executive officer of the American Cancer Society, said at the time.

Spending for Medicare Part B, which covers drugs administered in the setting of a physician's office (of which cancer treatments make up a large proportion), rose from $3 billion in 1997 to $11 billion in 2004, according to a study published in the New England Journal of Medicine (2009;360:626-633).

The cost of cancer care has risen because of advances in diagnostic and surgical techniques and pharmaceutical innovations. But study author Peter Bach, MD, associate attending physician at Memorial Sloan-Kettering Cancer Center in New York City, told Medscape Medical News at the time that "there's no question that the key driver is the cost of the drugs. When drugs cost thousands of dollar a month, treatment can get very expensive."

Variations Across Groups

In their study, Dr. Johnsrud and colleagues calculated the abandonment rate of oral oncolytic medications and identified factors that could influence the likelihood of abandonment.

They used administrative claims data from the Wolters Kluwer Dynamic Claims Lifecycle Database, a source of nationally representative pharmacy utilization data, and identified 20,607 patients for whom at least 1 pharmacy claim was adjudicated for an oral oncolytic agent between January 1, 2007 and June 30, 2009.

From this cohort, there were 10,508 patients who met the final inclusion criteria for the analysis. About half of the patients were younger than 65 years of age, and patients were slightly more likely to be female and to have an income between $40,000 and $75,000. The majority of patients were covered by a commercial insurance plan.

Of the 8 oral oncolytics that were reviewed in the study, capecitabine accounted for more than one third of the sample. Imatinib, lenalidomide, erlotinib, and temozolomide were also commonly used medications. The remaining 3 drugs — sorafenib, sunitinib, and lapatinib — were less commonly used.

Two thirds (67%) of the claims were adjudicated and paid for by the patient and/or pharmacy benefit plan; the remaining one third were reversed. Of the total number of reversed claims, 23% of patients followed-up with a different drug within 90 days; the remaining 10% of patients had no follow-up, abandoning the oral oncolytic agent.

There were also differences across age groups and types of insurance. Patients older than 80 years were more likely to abandon their initial oral drug than those 40 years or younger (13% vs 10%; P < .05). Patients covered by Medicare were also significantly more likely to abandon their oral oncolytic than those covered by commercial insurance (16% vs 9%; P < 0.05).

Medicare Equals Higher Out-of-Pocket Costs

Medicare patients were less likely to have out-of-pocket costs of $100 or less than those covered by commercial plans (35% vs 80%). Similarly, Medicare patients were more likely to have out-of-pocket costs totaling $500 or higher than those who were commercially insured (46% vs 11%).

Lower annual household income was associated with higher abandonment rates. Those with incomes below $40,000 per year had an abandonment rate of 11%, which decreased to 10% for incomes between $40,000 and $75,000 and 9% for incomes above $75,000 (P < .05). But in multivariate analysis, age and annual income were no longer significant predictors.

Finally, prescription activity was significantly associated with an increased incidence of abandonment rates. Almost one quarter (23%) of patients submitted more than 5 claims for nononcolytic medications in the month previous to initiating anticancer therapy; 29% had no concurrent prescription activity. Those with more than 5 claims in the previous month had an abandonment rate of 12%, compared with 9% for patients with no other claims (P < .05).

Dr. Johnsrud and coauthors Sonya Blesser Streeter, MPP, MPH, and Nadia Husain, ScM, are employees of Avalere Health.

American Society of Clinical Oncology (ASCO) 2011 Annual Meeting: Abstract 82120. To be presented June 6, 2011.

J Oncol Pract. 2011;7(3S):46s-51s. Abstract

Am J Manag Care. 2011;17(5 Spec No.):SP38-SP44.

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