CML Patients on Medicare Delaying TKIs Due to Cost

Stacie Dusetzina, PhD

Stacie Dusetzina, PhD

A recent study has found that nearly one-third of patients with chronic myelogenous leukemia (CML) insured by Medicare opted to delay their recommended treatment with tyrosine kinase inhibitors (TKIs) that are known to improve survival. The reason: the medications’ high costs.

Researchers at the University of North Carolina (UNC) Lineberger Comprehensive Cancer Center analyzed SEER-Medicare data for patients with CML from 2007 to 2011 to calculate the time interval between when patients were diagnosed and when they initiated their TKI therapy.

Of 393 patients studied, 31.8% had not started on TKI therapy—either imatinib (Gleevec), nilotinib (Tasigna), or dasatinib (Sprycel)—within 6 months of their diagnosis.

To combat the high costs of drugs, Medicare offers subsidies for those enrollees who qualify. For patients who received these cost-sharing subsidies, the median time to starting TKI treatment after diagnosis was 58 days, compared with 108 days among beneficiaries who did not have the subsidies (P = .04).¹

Overall, patients with access to subsidies were 35% more likely to start on the drugs faster than their counterparts. This delay for patients without subsidies, according to researchers, suggests they are attempting to find funds to pay for their first treatments.

“There are two troubling findings here,” noted Aaron Winn, the study’s lead author and a doctoral student at the UNC Gillings School of Global Public Health, in a statement. “First, we are seeing that more than 30% percent of people aren’t starting therapy within 6 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.”

Clinical guidelines recommend that patients with CML start on these drugs immediately after diagnosis. Additionally, according to the study, failing to adhere to these drugs can negatively impact treatment response, leading to worse clinical outcomes, an increased risk of needing stem-cell transplantation, and possibly decreased life expectancy.

This issue is becoming more and more prevalent as the number of oral anticancer agents rises. Patients on Medicare Part D needing a TKI had an out-of-pocket cost of $3000 for the first month’s supply, the researchers noted.

With the design of the Medicare Part D program, patients pay a larger share of medication costs until they reach the annual out-of-pocket spending threshold — currently $4840 for the year 2016. Once that threshold has been reached, patients are then responsible for 5% of the monthly drug costs (approximately $11,000 for TKIs), resulting in a monthly out-of-pocket expenditure of $550 for patients insured by Medicare after they reach the spending threshold. The Kaiser Family Foundation calculated that the median annual out-of-pocket costs for patients on imatinib, for example, to be $8500.²

The researchers noted that insofar as cost-sharing subsidies represent the only relief system available—and only 30% of Medicare beneficiaries qualify for them—the subsidies program is not well suited for the more expensive therapies.

As senior study author Stacie Dusetzina, PhD, explained in a statement, “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.” Dusetzina is a member of UNC Lineberger and an assistant professor in the UNC Eshelman School of Pharmacy and UNC Gillings School of Global Public Health.

While the gap between the two groups widened after diagnosis, eventually, patients without subsidies did “catch up,” Dusetzina added: 90 days from diagnosis, 48% of Medicare recipients without subsidies had started the treatments versus 63% of those with subsidies, according to unadjusted data.

At 6 months, 64% of Medicare Part D enrollees without subsidies had started the drugs, compared with 65% of individuals with subsidies. Dusetzina said patients without subsidies could be catching up as they find the financial resources to help cover those initial costs.

Nevertheless, “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.”

Reference

• Winn AN, Keating NL, Dusetzina SB. Factors Associated With Tyrosine Kinase Inhibitor Initiation and Adherence Among Medicare Beneficiaries With Chronic Myeloid Leukemia [published ahead of print October 3, 2016]. J Clin Oncol.
• Hoadley J, Cubanski J, Neuman T. “It Pays to Shop: Variation in Out-of-Pocket Costs for Medicare Part D Enrollees in 2016.” A report of the Kaiser Family Foundation. http://kaiserf.am/1NJvWnQ. Accessed October 6, 2016.