MBC Treatment Not Aligned With NCCN Guidelines Leads to Higher Patient Cost Responsibility

Patients on Medicare with metastatic breast cancer who receive treatment that is discordant with NCCN guidelines bear a greater burden of patient cost responsibility than patients who do receive care according to treatment guidelines.

What is the impact on the patient responsibility portion of cancer treatment when it is not aligned with care guidelines?

In the case of metastatic breast cancer (MBC), it is already known that treatment that is not in concordance with the National Comprehensive Cancer Network (NCCN) is linked to higher healthcare utilization and patient costs. A study published this month from the JNCCN—Journal of the National Comprehensive Cancer Network extends those findings, and says that that patients on Medicare with MBC who receive treatment that is discordant with NCCN guidelines bear a greater burden of patient cost responsibility than patients who do receive care according to treatment guidelines.

The previous work found that about one-fifth of Medicare beneficiaries with MBC have received treatment discordant with NCCN guidelines; while there was no overall survival difference seen between patients with and without guideline-concordant care, patients without had almost $2000 higher Medicare spending per month.

The additional data comes as those who work in oncology, from providers to social workers, are increasingly discussing the issue of financial toxicity with their patients, as new treatments are increasingly more expensive, the authors noted. Financial toxicity is linked to negative patient outcomes and psychological stress, and adults over the age of 65 may be particularly sensitive to this issue given the likelihood of that they live on a fixed income.

In an interview with The American Journal of Managed Care® (AJMC®), lead author Courtney P. Williams, MPH, Division of Hematology and Oncology, O’Neal Comprehensive Cancer Center at the University of Alabama, Birmingham, said this is the first study to look specifically at patient cost responsibility and was conducted to fill in some gaps unanswered by the earlier study.

SEER-Medicare data, which the retrospective study used, does not provide true out-of-pocket costs, Williams said, but it does show copayments, co-insurance, and deductible. However, that information alone isn’t enough to tell if patients paid for that themselves, or if it was picked up by a supplemental Medicare plan or charity.

The researchers examined patient costs for 3709 women diagnosed with MBC between 2007 and 2013 who survived at least a year after diagnosis. Treatment regimens were matched to the version of the NCCN breast cancer guidelines that were available at the time of treatment. Out of the 3709, 17.6%, or 651, received guideline-discordant treatment.

Compared with patients receiving guideline-concordant care, those receiving discordant treatment were younger and were more often Medicare/Medicaid dual-eligible, hormone receptor (HR)-negative, and human epidermal growth factor receptor 2 (HER2)-positive.

Researchers reviewed treatment regimens for discordance and grouped them into separate categories, including:

  • Therapy mismatched with HR or HER2 status
  • HER2-targeted therapy without chemotherapy
  • Nonapproved bevacizumab use
  • Adjuvant regimens received in the metastatic setting
  • Miscellaneous reasons for guideline discordance, which included nonapproved agents or regimens usually received in cancers other than MBC, trastuzumab in nonapproved combinations, and approved agents or regimens received in nonapproved year

In the year after diagnosis, median patient cost responsibility was significantly higher for guideline-discordant versus -concordant care: $7421, (interquartile range [IQR] $4359—$12983) vs $5171 [IQR, $3006–$8483]; P <.001).

In adjusted models, guideline-discordant treatment was significantly associated with $1841 higher patient costs in the first year from diagnosis (95% CI, $1280—$2401) compared with guideline-concordant care.

Patient cost responsibility differed by category of guideline discordance, with those receiving nonapproved bevacizumab having the highest cost responsibility (β = $3330; 95% CI, $1711—$4948).

“I think that guidelines exist for a reason and even though out-of-pocket costs are not considered when creating the guidelines, these are evidence-based physician-recommended treatments that ideally have better outcomes for patients and that’s why they are included as guideline-based therapy,” Williams said. While noting that there may be situations where off-guideline treatment is appropriate, she said she thinks the study adds to the knowledge that in addition to better outcomes for patients, using guidelines-based treatment leads to the liklihood that there is reduced financial toxicity.

The issue of financial toxicity is not a problem that is expected to go away in Medicare beneficiaries, she said. "I think that looking at cost to patients in this population is important because in this population, financial toxicity will continue to be a growing problem because these patients are increasing in survival based on these new treatments and also these new treatments are becoming more and more expensive.”


Phillips C, Azuero A, Kenzik KM, et al. Guideline discordance and patient cost responsibility in Medicare beneficiaries with metastatic breast cancer. J Natl Compr Canc Netw. 2019;17(10) doi: 10.6004/jnccn.2019.7316.

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