Healthcare leaders are grappling with mounting operational complexities as they implement value-based cancer care initiatives, particularly around biosimilar adoption and prior authorization processes that create significant resource burdens for oncology practices.
Jason Bergsbaken, PharmD, MBA, BCOP, interim manager of oncology pharmacy at UW Health and clinical assistant professor at the University of Wisconsin-Madison School of Pharmacy, highlighted how varying definitions of value across stakeholders complicate implementation efforts. "Value may be different to different stakeholders within a very complex health system and health care environment," Bergsbaken noted during a recent Institute for Value-Based Medicine® event.
Biosimilar Mandates Create Inventory Challenges
The adoption of biosimilars, while providing significant benefits, has introduced operational hurdles that require substantial coordination. Bergsbaken identified payer-specific product mandates as a primary challenge, explaining that "we often see payer-specific mandates for a specific biosimilar, which—on the health system side—then requires us to be able to operationally support that mandate, which may be a different drug for a different patient, inventory considerations, and all the things that follow."
Clayton Irvine, PharmD, MBA, MS, senior manager of oncology cancer care at Mayo Clinic in Rochester, Minnesota, echoed these concerns, noting that biosimilar formulary inconsistencies across payers "created a huge challenge in academic centers and infusion centers, primarily because there's a lot of specific payers that want a certain biosimilar. It creates inventory issues for pharmacies, and pharmacies having to keep all the drugs on formulary."
Prior Authorization Complexity Impacts Patient Care
Both experts emphasized how increasingly complex prior authorization processes are straining healthcare resources and potentially compromising patient care. Bergsbaken described the challenge as "increasingly complex," noting that "our prior authorization teams are trying to understand and implement increasing requirements on the payer side in terms of the complexities of how we actually go about getting approvals."
Irvine highlighted the downstream effects, explaining that manual prior authorization processes "creates delays and inefficiencies and also sometimes leads to financial toxicity, not just for institutions, but for patients." He emphasized that financial implications often get "passed downstream to patients," representing a conversation that "we don't talk about enough."
Technology Solutions Show Promise
To address these operational challenges, experts are exploring integrated digital solutions. Irvine suggested leveraging "integrated platforms like CoverMyMeds or other AI-based solutions" and noted that "there's prior authorization software out there" that could be integrated into workflows to provide value and benefit.
Balancing Standardization with Personalization
Healthcare systems are developing sophisticated approaches to maintain pathway adherence while accommodating personalized treatment needs. Bergsbaken's institution maintains "pretty tight institutional controls in terms of our formulary process," looking to National Comprehensive Cancer Network (NCCN) and FDA guidance while conducting due diligence through "multiple multi-disciplinary groups."
However, recognizing the need for flexibility, his institution employs "a process where regimens could be reviewed on more of a patient-specific fashion" to address "increasingly personalized complexities that might challenge the standard paradigm." This involves peer review validation of efficacy and safety before treatment delivery.
Irvine emphasized that pathways "really should have an off-label component or an off-label arm" with clearly defined documented exceptions. He stressed the importance of having representative stakeholders review pathways "in a frequent and regular cadence" because "guidelines are changing, and practices are changing."
AI and Clinical Decision Support
Looking toward future solutions, Irvine highlighted the potential of molecular tumor boards and AI-driven clinical decision support tools. "There's a lot of work being done right now with AI helping to augment and support this approach, and that's a really exciting field," he noted, suggesting that significant advances may emerge within five years.
The dual approach described by these experts aims to preserve the safety and consistency of standardized care while maintaining flexibility for individualized treatment decisions, particularly important in rare or late-line cancer settings where personalized, biomarker-informed treatment becomes increasingly critical.
