CHAPEL HILL -- 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 University of North Carolina Lineberger Comprehensive Cancer Center-led study.
In the study published in the Journal of Clinical Oncology, researchers report that nearly a 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 to starting the drugs.
"There are two troubling findings here," said Aaron Winn, the study's lead author and a doctoral student 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 these tyrosine kinase inhibitors like 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 high up-front costs are due to the Medicare Part D benefit design, the researchers say, which requires patients to pay a larger share of medication costs until they have paid at least $4,840 out-of-pocket in a 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 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. An individual must have an annual income of less than $17,820 and assets of less than $13,640 in 2016 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, a UNC Lineberger member and assistant professor in the UNC Eshelman School of Pharmacy and UNC Gillings School of Global Public Health. "One of the challenges is that when the Medicare benefit was designed, I don't think they were really considering these very expensive therapies. 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 impacting patients' access to life-saving drugs."
Researchers found that nearly a third - or 32 percent- of CML patients they studied 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 aged 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 to when they started treatment was 50 days shorter, 58 days compared to 108.
While the gap between the two groups widened after diagnosis, eventually, patients without subsidies did "catch" up, Dusetzina said. Ninety days from diagnosis, 48 percent of Medicare recipients without subsidies had started the treatments, 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.
But overall, patients with subsidies were 35 percent more likely to start the drugs faster.
"We recognize that people have a high cost to even 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."
In addition to Winn and Dusetzina, Nancy L. Keating of the Harvard Medical School and Brigham and Women's Hospital co-authored the report.
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.