ALEXANDRIA, VA. – Higher out-of-pocket costs for oral tyrosine kinase inhibitors (TKIs) were linked to inferior survival in patients with advanced, biomarker-positive lung cancers in an analysis of state-level registry data, an investigator reported at a press conference ahead of the Quality Care Symposium, sponsored by the American Society of Clinical Oncology.
Higher out-of-pocket cost burden was also linked to lower numbers of TKI prescriptions and shorter duration of TKI therapy in the study, which included patients diagnosed with EGFR- and ALK-positive non–small cell lung cancer (NSCLC) between 2010 and 2016.
The findings would suggest a need for a review of coverage for these effective medications, according to, a thoracic oncologist and health services researcher at the University of Washington and Fred Hutchinson Cancer Research Center, both in Seattle.
“Making sure that the cost to the patients is affordable could mitigate this financial toxicity, and hopefully help patients stay on therapy and derive the survival benefit that these medications are supposed to offer,” Dr. Goulart said in an interview.
The study included data on 106 patients with EGFR- and ALK-positive stage IV NSCLC in the Washington Surveillance, Epidemiology, and End Results registry who had at least one oral TKI prescription. Investigators linked that registry data with commercial and Medicare claims, then divided this patient cohort into quartiles based on out-of-pocket costs.
In the top quartile, the median monthly out-of-pocket cost for TKI treatment was $2,888, compared with just $1,431 in the other three quartiles – essentially half the cost, Dr. Goulart said.
Median survival in the patients in the top out-of-pocket cost quartile was just 9 months, compared with 22 months in the lower three quartiles, he added.
“That difference is remarkable,” Dr. Goulart said, adding that the survival in the top-cost quartile reflects a survival that might be expected with conventional, nontargeted chemotherapy, while survival in the remaining patients mirrored what might be expected based on clinical trials of TKIs in this setting.
Patients in the high-cost quartile were 2.31 times as likely to die as patients in the lower quartiles, according to results of a multivariable analysis that adjusted for patient, disease-specific, and financial characteristics including qualification for low-income subsidies.
The mean medication possession ratio, a measure of medication adherence, was lower in the high-cost quartile (1.06 vs. 1.20 for the lower three quartiles; P = .02), and median duration of therapy was likewise lower in the high-cost quartile (4 vs. 8 months; P less than .01), according to data reported in the study abstract.
While multiple previous studies have linked out-of-pocket costs to decreased adherence and duration of therapy, the present study is one of the few to evaluate the link between cost of oral cancer medications and survival, according to Dr. Goulart.
In one other recent study showing a relationship between financial toxicity and survival, researchers at Fred Hutchthat Washington cancer patients who filed for bankruptcy were more likely to die, compared with cancer patients not filing for bankruptcy, even after adjustment for a variety of patient characteristics.
The present study results raise a “serious concern” that some patients are unable to afford their medications, which is having a detrimental effect on survival, Dr. Goulart said. Alternatively, the out-of-pocket costs may not have an effect on survival; rather, they may be a “marker of very poor insurance coverage” that reflects higher costs for multiple other aspects of their care.
“The out-of-pocket cost for these drugs can be pretty astronomical, and we have at least a plausible hypothesis that they are taking a toll on patient’s survival,” he added.
If the findings of this study are confirmed in more and larger studies, there could be important implications for health policy and oncology practice, according to Dr. Goulart.
“The biggest action would be to involve patient advocates and physician groups such as ASCO, and advocate for changes in policy for coverage and out-of-pocket costs for these oral TKIs, at least for the patients that have the mutations,” he explained.
Another action, according to Dr. Goulart, would be to try to equip oncology clinics everywhere with patient financial-assistance programs to link patients to entities that can help them afford the cost of TKIs.
“Patients who attend small, remote cancer clinics might not have access to a financial specialist who can help them navigate these costs,” he said.
Funding for the study came from the National Institutes of Health. Dr. Goulart reported disclosures related to Flatiron Health (travel, accommodations, and expenses).
SOURCE: Goulart BHL et al. SCS 2019, .