October 4, 2016
Significant out-of-pocket costs that cancer patients can face before Medicare insurance drug benefits kick in may delay the patients’ treatment with a novel class of targeted therapies, according to a study led by researchers at the University of North Carolina Lineberger Comprehensive Cancer Center.
In the study, published online Oct. 3 in the Journal of Clinical Oncology, researchers report that nearly one-third of a group of patients with chronic myeloid leukemia, and who have federally-funded Medicare health insurance, did not start treatment within six months of diagnosis with any of three targeted drugs that have led to dramatic improvements in survival for the disease. However, patients who had access to subsidies to help cover those drug costs had a shorter median time before starting the drugs.
“There are two troubling findings here,” said Aaron Winn, the study’s lead author and a doctoral student in health policy and management at the UNC Gillings School of Global Public Health. “First, we are seeing that more than 30 percent of people aren’t starting therapy within six months. Second, we are seeing long delays in starting drugs for people without subsidies. This is very concerning, as these delays may be an indicator that the patient is trying to find funds to pay for their first treatment.”
Drugs known as tyrosine kinase inhibitors, such as Gleevec, have led to dramatic improvements in mortality rates for chronic myelogenous leukemia (CML), a type of blood cancer that typically occurs in people who are middle-aged or older. The median age of diagnosis is age 64, according to the National Cancer Institute.
Orally administered cancer medications, such as Gleevec, can be costly. Previous studies have found that patients insured through Medicare Part D see out of-pocket costs of nearly $3,000 for the first month’s supply of a tyrosine kinase inhibitor.
The researchers say that the high up-front costs are due to the Medicare Part D benefit design, which requires patients to pay a larger share of medication costs until they have paid at least $4,840 out-of-pocket in a given year. After that, patients pay 5 percent of the monthly drug costs. While that may sound reasonable, annual out-of-pocket costs have been found to reach a median of approximately $8,500 for patients using Gleevec, according to a Kaiser Family Foundation report.
The foundation also found that only about 30 percent of Medicare Part D enrollees qualify for subsidies to lower their drug costs, so the researchers said cost may be a common problem for many patients who need high-cost specialty drugs. In their study, 40 percent of the population qualified for the subsidies. In 2016, an individual must have an annual income of less than $17,820 and assets of less than $13,640 to qualify for Medicare Part D’s low-income subsidy.
“Once you’re on Medicare Part D, there really aren’t ways to minimize these out-of-pocket costs, other than subsidies,” said the study’s senior author Stacie Dusetzina, PhD, assistant professor of health policy and management at the Gillings School and in the UNC Eshelman School of Pharmacy and UNC Lineberger member. “When the Medicare benefit was designed, these very expensive therapies weren’t considered. The benefit design makes a lot more sense when you’re looking at drugs that cost several hundred dollars versus several thousand dollars or more. We really need to think carefully about how much these high out-of-pocket costs are making an impact on patients’ access to life-saving drugs.”
Researchers found that nearly one-third – or 32 percent– of CML patients in the study who were insured by Medicare Part D plans had not started on one of the three tyrosine kinase inhibitor drugs that are approved as first-line treatments for the disease within six months of diagnosis. Researchers examined time to starting for the three drugs for 393 people ages 66 years and older, diagnosed between 2007 and 2011, and enrolled in Medicare Part D.
For people who had access to subsidies to cover the cost, median time for starting treatment was 50 days shorter – 58 days, as compared to 108.
While the gap between the two groups widened after diagnosis, patients without subsidies eventually did “catch up,” Dusetzina said. Ninety days from diagnosis, 48 percent of Medicare recipients without subsidies had started the treatments, as compared to 63 percent of people with subsidies, according to unadjusted data. At six months, 64 percent of Medicare Part D enrollees without subsidies had started the drugs, compared to 65 percent of people with subsidies. Dusetzina said patients without subsidies could be catching up as they find the financial resources to help cover those initial costs.
Overall, however, patients with subsidies were 35 percent more likely to start the drugs faster.
“We recognize that people have a high cost even to start therapy, and this study really demonstrates the difference between people with and without a subsidy in initiating therapy,” Dusetzina said. “The out-of-pocket costs may be delaying people starting these life-saving drugs.”
Nancy L. Keating, MD, MPH, professor of health care policy and medicine at Harvard Medical School and a physician at Brigham and Women’s Hospital, is also a co-author.
The study was supported by the Comparative Effectiveness Research Strategic Initiative of the University of North Carolina Clinical and Translational Science Award, the UNC School of Medicine, the NIH Building Interdisciplinary Research Careers in Women’s Health K12 Program, the North Carolina Translational and Clinical Sciences Institute, the Royster Society of Fellows at UNC-Chapel Hill, and the National Cancer Institute.