- October 2025
- Volume 31
- Issue 11
- Pages: SP791
Advancing Value-Based Oncology Through Pharmacy Leadership and Precision Medicine
Key Takeaways
- Value-based oncology care requires balancing rapid innovation with operational sustainability, equitable access, and patient-centered outcomes.
- Pharmacy and precision medicine operations are crucial, necessitating coordination between academic and community settings and integration of real-world evidence.
A session explores how value-based oncology integrates pharmacy, precision medicine, and real-world evidence to enhance lung cancer care and patient outcomes.
The transition toward value-based oncology care continues to challenge health systems to balance rapid clinical innovation with operational sustainability, equitable access, and patient-centered outcomes. As new cancer therapies enter the market at unprecedented speed—driven by advances in immunotherapies, targeted therapies, and precision diagnostics—health systems are looking to integrate these options without compromising affordability or efficiency. At the same time, the shift toward risk-sharing and performance-based reimbursement requires evidence-based decision-making, alignment with payer expectations, and strategies to mitigate disparities in care delivery.
Two domains sit at the center of these challenges: pharmacy and precision medicine operations. Pharmacy teams are navigating increasingly complex supply chains, payer requirements, and care-delivery models, while precision medicine specialists aim to ensure that patients receive timely biomarker testing and appropriate, targeted interventions. Both areas rely on robust coordination between academic and community settings, innovative site-of-care strategies, and the integration of real-world evidence into clinical and operational pathways.
Speakers explored these themes in depth during discussions at an Institute for Value-Based Medicine (IVBM) event in Milwaukee, Wisconsin. In one panel, speakers examined the role of pharmacy decision-making in oncology, and in another, panelists focused on advancements in precision medicine in lung cancer. These discussions offered a comprehensive view of how operational and clinical strategies can converge to improve outcomes and optimize resources.
The pharmacy panel was moderated by Clayton Irvine, PharmD, MBA, MS, who was then senior manager of oncology cancer care at Mayo Clinic in Rochester, Minnesota. Panelists included Justin Konkol, PharmD, BCPS, DPLA, executive director of acute care and oncology pharmacy services at Froedtert Health and a clinical assistant professor at the Medical College of Wisconsin in Milwaukee; Jason Bergsbaken, PharmD, MBA, BCOP, interim manager of oncology pharmacy, pharmacy coordinator of regional oncology services, and program director of PGY2 oncology pharmacy residency at UW Health in Madison, Wisconsin; and Peter Stuessy, PharmD, BCOP, clinical pharmacy manager – oncology Midwest region for Advocate Health in Milwaukee. The panel discussed integrating real-world evidence into treatment decisions, optimizing academic-community partnerships, navigating payer-driven site-of-care shifts, managing biosimilar adoption, and balancing standardized protocols with individualized patient care in value-based oncology.
The precision medicine in lung cancer panel featured a conversation between panel moderator Irvine and panelist Jonathan Thompson, MD, MS, a thoracic medical oncologist at the Medical College of Wisconsin in Milwaukee. The discussion addressed advances in biomarker testing, targeted therapy integration, and immunotherapy sequencing, with a focus on overcoming systemic and socioeconomic barriers to care.
Integrating Real-World Evidence Into Pharmacy Decision-Making
Irvine opened the pharmacy panel by framing a central tension in oncology around the use of data from randomized controlled trials (RCTs) vs real-world evidence to guide oncology decision-making. RCTs remain the gold standard for establishing safety and efficacy, but Irvine noted that these data cannot answer every question that arises in real-world clinical practice. Bergsbaken noted that RCTs often enroll highly selected patient populations under controlled conditions, whereas real-world settings involve more heterogeneity in comorbidities, adherence, and demographic characteristics. These differences can significantly affect treatment performance, toxicity profiles, and patient-reported outcomes.
Stuessy tied this discussion to the increasing reliance on the FDA’s accelerated approval pathway, which expedites market entry for therapies based on surrogate end points or limited clinical data. Although such approvals can provide rapid access for patients with limited treatment options, they also create uncertainty about long-term benefit.
“One of the things that [highlights] how things have changed in our practice is with the accelerated approval pathway being used more and more these days,” Stuessy said during the panel discussion. “We’ve seen quite a few approvals be removed in the oncology space over the last several years. So, do we hesitate any further if a drug is accelerated approved?”
Stuessy explained further that his institution may be more cautious about the uptake of an accelerated approved drug for competitive indications.
“I’d say we’re still usually pretty quick to adopt at my institution. However, if it’s an accelerated approval for a space where we might have a regular approval drug, right now, it definitely seems to have a little bit less of a push to get in front of our formulary committee or to try to find a space for that particular therapy at the time.”
Irvine added that real-world evidence can help guide therapy sequencing, especially when confirmatory trial data are lacking. He offered the example of immunotherapy in various perioperative settings, where multiple pathways may recommend similar approaches despite differences in disease stage, tumor biology, or patient comorbidities. Real-world evidence, he explained, may be able to refine these recommendations pending the results of confirmatory studies.
Academic-Community Partnerships
The pharmacy panel then turned to the operational and financial complexities of coordinating care between academic medical centers and community oncology practices. Konkol emphasized the importance of meeting patients where they are—geographically and clinically—while balancing the need for early-cycle safety monitoring with long-term convenience. At Froedtert Health, high-risk therapies are often initiated at the academic campus, allowing providers to assess tolerance and manage early toxicities before transferring care closer to the patient’s home, according to Konkol. However, such transitions frequently require new prior authorizations and assurance that the receiving site is equipped to administer the drug safely.
Stuessy recalled that during recent national drug shortages, collaboration between systems became essential. In some cases, institutions shared drug inventory or arranged for patients to receive therapy at alternative infusion sites, prioritizing timely and appropriate treatment over institutional boundaries.
“I was heavily involved in some of the drug shortages over the last several years, and knock on wood, we’re doing really [well] right now,” Stuessy said. “During that time, we very often talked with other systems and discussed how their inventory looked, how everything looked, because what really mattered was making sure our patients got the best therapy and the most appropriate therapy for them. If that was our center and we had it available, that’s wonderful. If it’s not, what chair availability is there? Is there any way we could get this patient there? That’s definitely one area where I’ve seen partnerships in the past.”
According to Stuessy, Advocate Health has larger centers with a greater number of chairs and smaller centers with fewer chairs.
“We’ll start patients on less familiar therapies at some of our larger centers, where we do our initial education and everything, and then start branching out. We have a lot of more rural infusion areas as well in some areas in northern Wisconsin, where patients are driving for several hours just to get to a smaller infusion center. Then we oftentimes collaborate with very small hospitals that are actually closer to their home to make sure they’re familiar, if they are a posttransplant patient or if they are a patient who’s on a more novel therapy that that particular center might not be as familiar with, to just kind of help take care of that patient the best we can.”
Bergsbaken agreed that proximity to home is a high priority for patients, but he stressed the complexity of these decisions. According to Bergsbaken, site-of-care choices should consider regimen complexity, insurance restrictions, provider preferences, and changing operational conditions.
Navigating Site-of-Care Decisions
The pharmacy panelists acknowledged that payer efforts to steer patients toward lower-cost care settings are reshaping infusion delivery models. Konkol described Froedtert’s multipronged infusion strategy, which designates certain geographic areas for hospital outpatient departments when high oversight is required, others for pharmacy-based infusion suites when less intensive monitoring is sufficient, and, in select scenarios, home infusion. Yet he cautioned that nursing shortages and the time-intensive nature of specific infusions limit the scalability of home-based administration.
Irvine provided a case study from Mayo Clinic’s pilot program in home-based chemotherapy, noting that the model was funded by grants rather than a sustainable reimbursement structure. The program revealed significant care fragmentation, as contracted home infusion nurses lacked electronic health record (EHR) access and had to rely on triage calls for patient information.
Patient preference also influences site-of-care strategy. Konkol noted internal survey data showing that 60% of patients receiving home infusion preferred to return to in-office care, citing camaraderie with other patients and the reassurance of being within a full clinical environment.
Adoption of New Formulations and Biosimilar Utilization
The discussion shifted to operational considerations in adopting subcutaneous (SC) formulations. Stuessy noted that chair-time savings can be decisive in high-volume infusion centers, but adoption depends on payer coverage, acquisition costs, and patient acceptance. Some patients resist SC injections, perceiving them as less comfortable than intravenous (IV) infusions.
“One of the issues we have had is some of our patients have preferred the IV agents. When we’ve talked with them and worked with them, they’re like, ‘Well, I’m just uncomfortable with it going into my belly like that,’” Stuessy explained. To address this, Stuessy and his team worked with vendors to train nurses in administration techniques that minimize discomfort.
Biosimilar adoption has also introduced operational burdens, according to Konkol. He described the “firehose” effect of managing multiple preferred biosimilars across payers, settings, and product lines.
“We have to carry 16 different biosimilar line items, because in this market, these are the 2 or 3 preferred on the outpatient side, but then there’s 2 or 3 that are more financially viable on the acute care side. It is a full time job,” Konkol said. “There are actually roles out there, full-time biosimilar coordinators and other things that are developing with the complexities, and so I don’t know—it’s killing me.”
Stuessy further detailed the complexity of maintaining separate inpatient and outpatient preferred biosimilar products and numerous insurance-mandated alternatives. Ensuring the correct product–billing code pairing is essential to avoid reimbursement losses, prompting EHR vendors to build additional safeguards into ordering systems, according to Stuessy.
Standardization, Personalization, and the Pharmacist’s Role
Moving on to standardized pathways, Bergsbaken explained that although standardization improves safety and value, flexibility remains essential for rare or late-line cases. His institution employs internal peer review for nonstandard requests, ensuring that deviations are evidence based and resource conscious. The other panelists agreed that pharmacists often
act as negotiators and navigators, balancing clinical appropriateness, operational feasibility, and payer requirements.
Irvine also called for more collaboration with industry, not only to improve diversity in clinical trials but also to streamline operational processes such as therapy start-up protocols, which can be slowed by redundant portals and approval steps.
“I think we can also partner with industry to look at rural partnerships for those types of projects, going back to real-world data, real-world evidence, and also quality improvement initiatives, [which can] answer some of the questions, gaps, and barriers that we’ve talked about tonight.”
Precision Medicine in Lung Cancer: The Role of NGS and Targeted Therapy
Transitioning to the lung cancer panel, Thompson described precision medicine as a cornerstone of modern lung cancer care, driven by the integration of next-generation sequencing (NGS) for genomic profiling and the deployment of targeted therapies and immunotherapies across disease stages. He stressed that comprehensive NGS should be performed for all patients with non–small cell lung cancer (NSCLC), regardless of stage, to identify actionable mutations.
Further, despite consensus in guidelines, testing gaps persist, according to Thompson. He identified provider awareness as the main barrier, with some institutions still relying on sequential single-gene tests that consume limited biopsy material. Implementing reflex NGS at diagnosis could standardize practice and prevent delays caused by variable ordering habits, Thompson explained.
Overcoming Payer and Operational Barriers to Testing
Although payer denials for NGS are uncommon for his patient population, Thompson noted occasional resistance in early-stage disease. Repeat testing is most valuable in driver-mutated cases to detect resistant mutations, such as in EGFR-positive disease, enabling the use of subsequent targeted agents. Thompson explained that the yield of repeat testing is generally low in patients without known driver mutations.
Operationally, delays between biopsy and treatment initiation are challenging, particularly when tissue samples are insufficient for comprehensive testing. Thompson’s team increasingly uses blood-based circulating tumor DNA (ctDNA) assays in metastatic disease.
“We do a lot of blood-based testing, especially in the metastatic setting, looking for ctDNA answers to the NGS question,” Thompson said. “That does shave off some barriers for that population, but…remains a challenge for the earlier-stage groups.”
Immunotherapy: Duration, Sequencing, and De-escalation
For patients without actionable mutations, immunotherapy is now a standard backbone of treatment. Thompson discussed the role of perioperative chemo-immunotherapy, citing impressive 5-year overall survival rates of 95% among patients achieving a pathologic complete response to neoadjuvant chemotherapy plus nivolumab (Opdivo; Bristol Myers Squibb). In such cases, his institution omits adjuvant immunotherapy, avoiding unnecessary cost and toxicity.
“I think that does give us the opportunity to avoid an additional adjuvant immune checkpoint inhibitor, or you’ll again be costing money to the health care system. You’re also exposing the patient to therapy that’s probably not benefiting them and only exposing them to toxicity rather than efficacy,” Thompson said. “I think that’s probably our best opportunity, at least right now, to potentially de-escalate therapy.”
In metastatic settings, Thompson noted he supports time-limited therapy, often discontinuing after 2 years if the disease remains controlled. This is consistent with RCT evidence that approximately half of patients can maintain durable responses off therapy. Toxicity severity, timing of recurrence, and prior treatment exposure guide re-treatment decisions, according to Thompson, with certain immune-related adverse events (IRAEs), such as high-grade pneumonitis or cardiac toxicity, precluding rechallenge.
Thompson noted that in the neoadjuvant setting, significant IRAEs are rare, with most being manageable endocrine events. In metastatic disease, where therapy duration is longer, higher-grade toxicities occur more frequently. Management at his institution is guided by protocols developed in collaboration with pharmacists and supported by a dedicated immunotherapy toxicity team.
Addressing Disparities in Precision Oncology
Socioeconomic status, insurance coverage, and geographic location significantly influence access to biomarker testing and targeted therapy. Thompson described how patients from lower-income backgrounds may face barriers in transportation, insurance eligibility, and continuity of care.
“A large portion of the lung cancer population comes from less advantaged socioeconomic status. Along those lines, we see issues with whether or not they have insurance—whether it’s Medicaid or what have you—those throw barriers in terms of where they can receive treatment within health care systems,” Thompson said.
Solutions include expanding clinic and infusion center locations, providing transportation assistance through social work, and selectively decentralizing clinical trials to community sites to reduce travel burdens.
“We do have social workers who help try to find rides. We do have ways of getting them signed up for insurance or payment plans, things along those lines, but again, not anything that universally catches everything,” Thompson said.
The Central Message: Test and Act
Thompson concluded with a firm directive to his peers: Failing to perform appropriate biomarker testing risks mismanaging patients.
“When we’re talking about lung cancer, I’m beating a dead horse, but if you don’t do the right biomarker testing, you’re going to be probably mismanaging the patient,” Thompson said. “I think that would be my message to everybody I talk to about lung cancer––do the testing and pay attention to the testing.”
He added that performing NGS testing without acting on the results is equally problematic. The full benefit of precision medicine can only be realized when genomic data directly inform treatment selection, according to Thompson.
Conclusion
The IVBM discussions in Milwaukee underscore that the future of value-based oncology care depends on the seamless integration of clinical innovation with operational pragmatism. Pharmacy leaders and oncologists alike are navigating an environment in which rapid therapeutic advances—spanning immunotherapy, targeted agents, and precision diagnostics—must be balanced against payer constraints, resource limitations, and the imperative to deliver equitable, patient-centered care. The pharmacy panel highlighted how real-world evidence, thoughtful site-of-care strategies, biosimilar adoption, and academic-community partnerships can collectively enhance efficiency and outcomes. The lung cancer precision medicine panel reinforced that timely biomarker and NGS testing and the appropriate use of targeted and immunotherapeutic agents remain foundational to
optimizing survival.
Across both conversations, a common theme emerged: multidisciplinary collaboration, informed by data and attuned to the realities of patient access, is essential to delivering sustainable, high-value oncology care. By aligning operational strategies with evolving clinical standards, health systems can better position themselves to deliver on the promise of precision medicine while meeting the demands of value-based reimbursement.
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