Overcoming ctDNA MRD Payer Gaps and Operational Hurdles in Bladder Cancer

Navigating the financial and operational landscape of circulating tumor DNA (ctDNA) minimal residual disease (MRD) testing in bladder cancer reveals significant logistical hurdles. In an interview with CancerNetwork®, Kirollos Hanna, PharmD, BCPS, BCOP, explained that clinicians currently face severe heterogeneity in payer coverage, with uniform policies noticeably lacking.

Currently, wide payer coverage sits at only 40% to 50%, forcing institutions to navigate extensive administrative hurdles and appeals for the remaining patient share. While recent NCCN guideline updates and FDA-approved assays provide critical leverage during the appeal process, operational challenges persist. Specifically, the oncology community lacks standardized protocols dictating optimal testing frequency during surveillance for tracking early signs of recurrence and treating patients who convert from ctDNA-positive to ctDNA-negative status.

To overcome these coverage gaps and effectively manage off-label pathways, Hanna expressed that institutions must build robust, cross-functional infrastructure that adapts as clinical evidence and guideline frameworks mature.

Hanna is the director of Pharmacy at Minnesota Oncology, an assistant professor of Pharmacy at the Mayo Clinic Alix School of Medicine, and an editorial advisory board member of the journal ONCOLOGY®.

CancerNetwork: From a pharmacy, therapeutics, and institutional operational perspective, what are the primary challenges in securing financial clearance and reimbursement for serial ctDNA MRD testing in bladder cancer, and how should institutions build pathways to handle off-label requests when a patient converts from ctDNA negativity to ctDNA positivity during surveillance?

Hanna: We are seeing heterogeneity in payer coverage, to be honest. There is not a uniform coverage policy across payers, which is a challenge when physicians want to test for ctDNA status. It becomes challenging when there is pushback from payers. I think the NCCN guideline update, along with having an FDA-approved test, helps when appealing a payer's decision or coverage policy, but it is still not something we are widely seeing. I would say we are seeing anywhere from 40% to 50% coverage for the test, with the remaining share requiring more hurdles to jump through to get coverage.

The other challenge is, when patients convert to [ctDNA negativity], how often do we need to be checking ctDNA status if patients remain negative [or if] there will be [early] signs of recurrence? There are no uniform standards around testing, whether they converted from ctDNA positive to ctDNA negative [disease], how often they test, or, in general, how often patients on surveillance should be tested [or managed]. There are still a lot of challenges with frequency and coverage gaps, but as we learn more, and with the guideline updates, we should have some tools in our toolbox to navigate some of these more difficult payer policies.