Balancing Innovation and Equity in Oncology Value-Based Care: Panel Discussions

During a series of panel discussions featuring top experts from The University of Texas Southwestern Medical Center, Texas Oncology, and other leading institutions, breakthroughs in cancer treatment and care delivery took center stage at the Institute for Value-Based Medicine^® event in Dallas, Texas. From leveraging CDK 4/6 inhibitors and genomics in breast cancer to advancing precision medicine in lung cancer, panelists examined how cutting-edge therapies are transforming outcomes. Discussions also delved into the complexities of value-based oncology care, the growing role of real-world data, and strategies to improve access to care in hematology. Across all sessions, a common theme emerged: the need to balance innovation with patient-centered, equitable, and sustainable care models.

"Innovations in Breast Cancer Treatment"

Ina Patel, DO | Image credit: UT Southwestern

The panel, moderated by Ina Patel, DO, assistant professor, The University of Texas Southwestern Medical Center, focused on several important topics in the management of early-stage and metastatic breast cancer. The first discussion centered around the use of CDK 4/6 inhibitors as adjuvant therapy for hormone receptor-positive, HER2-negative early-stage breast cancer. The panelists highlighted the need to balance the potential benefits of agents such as abemaciclib (Verzenio) and ribociclib (Kisqali) against their adverse effect profiles and duration of treatment.

Dawn Klemow, MD | Image credit: UT Southwestern

Dawn Klemow, MD, medical oncologist at The University of Texas Southwestern Medical Center, explained the differences between both therapies and how treatment duration factors into her decision for each patient. Abemaciclib has been FDA-approved for longer, and it’s indicated for node-positive cancer. Ribociclib was recently approved, providing a CDK4/6 treatment option for patients with node-negative cancer.

“If I'm very concerned about the potential risk for relapse, I definitely use the CDK4/6 inhibitor, and they have criteria; you can see the criteria of who is eligible or not…” she said. “I know positive patients for Verzenio; for that reason, it's a year shorter duration of treatment and I think the important thing to remember when you think about the diarrhea is that Verzenio works even at low dose. It's not necessary to give full dose Verzenio, which is where you see most of the toxicity with diarrhea. So, Verzenio is still my first choice unless they're high-risk, node-negative, and then it is ribociclib.”

Rochelle Horadam, RPh, BCOP | Image credit: UT Southwestern

Ribociclib stands out as the only CDK 4/6 inhibitor with overall survival data, yet all 3 agents—ribociclib, palbociclib, and abemaciclib—have roles depending on patient profiles, according to Rochelle Horadam, RPh, BCOP, oncology pharmacist at The University of Texas Southwestern Medical Center. She prefers palbociclib for elderly patients with bone-only metastases due to its lower risk of liver toxicity, despite some manageable neutropenia. Abemaciclib, effective in both early-stage and metastatic breast cancer, offers flexibility at lower doses, although it may cause diarrhea and increase serum creatinine, requiring alternative renal function tests. Ribociclib, with a category 1 indication in the National Comprehensive Cancer Network (NCCN) guidelines, is effective but poses challenges with liver toxicity, drug interactions, and the need for EKG monitoring.

“Drug interactions, to me—it's a huge part of my job having to identify them and patients that are on antidepressants, which a lot of these patients are on, it's really sometimes difficult to manage some of the interactions,” Horadam explained. “So I think picking the appropriate drug—I think it's really based on the patient profile, including performance status.”

Next, Patel focused the discussion on genomic integration. For premenopausal patients receiving ribociclib, ovarian suppression is necessary to pair the treatment with an aromatase inhibitor effectively, she explained. Regarding the integration of genomics into breast cancer care, the panelists discussed the critical role of molecular biomarkers in guiding treatment strategies. In metastatic breast cancer, next-generation sequencing (NGS) for targetable mutations is often performed at the time of first metastatic diagnosis to optimize initial treatment plans. However, some clinicians may delay testing until disease progression or after a biopsy of the progression site, depending on the clinical context.

Ashwani K. Agarwal, MD | Image credit: Texas Oncology

“This is interesting because most of these metastatic breast cancer patients these days are going through 5, 6, 7 lines of treatment,” said Ashwani K. Agarwal, MD, medical oncologist and hematologist with Texas Oncology. “So it's become a game of chess.”

He explained that at Texas Oncology, all patients with metastatic breast cancer undergo upfront biomarker testing and additional testing at any point of disease progression. The team prioritizes accessible biopsy sites, such as liver metastases, while avoiding lung biopsies due to the risk of pneumothorax. Liquid biopsies are used aggressively, with tests like Guardant360 performed every 3 to 6 months to monitor for key mutations such as ESR1 and PIK3CA. Regular liquid biopsies help detect mutations early, informing treatment decisions and guiding adjustments to therapy over time.

The value of comprehensive next-generation sequencing, both at diagnosis and at progression, was emphasized by the panelists in order to identify targetable mutations and guide treatment decisions, including access to clinical trials. They also noted the challenges in obtaining sufficient tissue for testing and the growing role of liquid biopsies in this setting.

Regarding the use of antibody-drug conjugates (ADCs) in breast cancer, the speakers highlighted their evolving role, particularly in HR-positive and ultra-low HR-positive disease. They discussed the need to balance efficacy and toxicity when selecting targeted therapies and the challenges in accurately identifying ultra-low HR-positive patients.

Finally, the panel touched on promising areas of research in metastatic breast cancer, including the shift towards more targeted treatments, the potential of CAR T-cell therapies and vaccines, and the importance of de-escalating chemotherapy cycles to improve patient outcomes and quality of life.

“I think, always, we try to evaluate bone marrow and other avenues in which we could target therapy,” Patel said. “I know there's always talk of also vaccines, particularly in the triple-negative space for breast cancer, which has shown some promise of preventing recurrence from happening or progression in metastatic disease. I know we have a trial at [University of Texas], the Flamingo trial, where we're looking at vaccines to prevent HER2 positive disease after someone has already done chemo for HER2 disease.”

The following panel discussion, “Access to Care in Hematology,” touched on this topic.

"Access to Care in Hematology"

Farrukh T. Awan, MD, MS, MBA | Image credit: UT Southwestern

The panel, moderated by Farrukh T. Awan, MD, MS, MBA, The University of Texas Southwestern Medical Center, focused on the challenges and opportunities in defining clinically meaningful endpoints for rare hematologic diseases, as well as the role of real-world data and value-based care models in oncology.

The panelists, Hycienth Ahaneku, MD, PhD, Texas Oncology, and from The University of Texas Southwestern Medical Center, Adeel Khan, MD, MPH, MS, and Praveen Ramakrishnan, MD, discussed the difficulties in establishing appropriate end points for rare diseases, where traditional measures like overall survival or progression-free survival may not be feasible or practical.

Awan began by sharing a story about his early experience with systemic mastocytosis, a rare disease he encountered shortly after completing training. Despite limited knowledge about the condition at the time, he became deeply involved in a trial that ultimately led to the approval of midostaurin. He highlighted the difficulties of defining meaningful end points for rare diseases, such as addressing quality of life, symptom burden, and specific issues like rashes or anaphylactic reactions.

"The problem is, what we face with some of these diseases, again, creating a trial, as [Awan] said, in these rare diseases, is good," Ramakrishnan responded. "You have to be a kind of center of excellence to pull people in and have meaningful endpoints. Some of these may not be just scans alone... Response rates you can't really look at, like survival, are the only endpoint in some of these rare diseases... To get these drugs approved, you need to have novel solutions and novel targets as your end points, and not just focus on response rates or just survival. So patient-reported outcomes definitely come to mind, and improvement in quality of life, I think, are paramount to some of these disorders."

The panel also highlighted the growing influence of real-world data in clinical practice and its impact on NCCN guidelines. Some noted that the rigidity of guidelines can sometimes limit clinicians' ability to provide personalized, patient-centered care, particularly for complex or rare conditions. The panelists stressed the need for more nimble and flexible approaches that prioritize the individual patient's needs.

Ahaneku shared that he's happy that NCCN is looking into real-world data, because the data can translate to the practice of clinicians that see patients in the community.

"Those things that come back from phase 4 clinical trials, the side effects profile and things like that, they eventually help to refine how we practice, you know, especially with respect to side effects profile," he said. "So, doing more real-world data evaluation helps the clinicians better in my estimation. I'm not saying that [phase 3 clinical trials] are not important, but real-world data and the feedback we get from them enhances our management of patients a lot."

Regarding the Inflation Reduction Act (IRA) and its potential impact on health care, the panelists reflected on how it has helped improve access to targeted therapies for their patients, particularly those on Medicare or Medicaid. They discussed the potential benefits of the Act's provisions, such as Medicare's ability to negotiate drug prices and the challenges in balancing cost-effectiveness with patient-centered care.

Adeel Khan, MD, MPH, MS | Image credit: UT Southwestern

Kahn addressed the longstanding inability of CMS to negotiate prices and highlighted the tension between pharmaceutical companies' need for profitability and patients' need for affordable access. Using lenalidomide as an example, he pointed out that even after becoming generic, the drug remains expensive due to factors like the REMS program and historical context dating back to thalidomide. He pointed out the phased model used by the UK's NHS, which structures price reductions over time instead of the sharp transitions seen in the US.

"So, instead of the brand name generic, with the sharp transition that we have here in the US, a faded model allowed for more equitable pricing and ultimately for expanded access," Kahn said. "That seems so simple and so brilliant, but we just haven't done it here."

The panel also delved into the complexities of value-based care models in oncology, with the panelists sharing their experiences in navigating the transition from fee-for-service to value-based reimbursement. They discussed the difficulties in managing both payment structures simultaneously and the importance of maintaining a consistent, high-quality standard of care across all patient populations.

"Value-Based Oncology Care within the US"

Lalan Wilfong, MD, senior vice president, Value-Based Care, Thyme Care, moderated a conversation on value-based care in the US, featuring Travis Brewer, vice president, payer and public health strategy/relations, and R. Stephen Paulson, MD, CEO, both of Texas Oncology, and Barry Russo, MBA, CEO for The Center for Cancer and Blood Disorders. They discussed the opportunities and challenges in shifting from fee-for-service to value-based care models.

Lalan Wilfong, MD | Image credit: LinkedIn

One of the primary challenges Wilfong first brought up was the need to manage both fee-for-service and value-based care models simultaneously within a practice.

"We know that cost of care is really high. Outcomes for patients, especially in the United States, are lagging other countries. There's a lot of issues with inappropriate treatment at the end of life, you know, inappropriate therapies being given, other decisions driving what we do outside of value," he said to the panelists. "So, as you're thinking about value-based care models, what metrics and outcomes do you think are important that we incorporate into those."

Barry Russo, MBA | Image credit: Center for Cancer and Blood Disorders

Russo emphasized the importance of focusing on outcomes, including efficacy, toxicity, and financial toxicity, when defining value-based care metrics. The use of pathways and the need to consider the cost of treatments, in addition to their clinical efficacy, when making treatment decisions was also discussed.

"In my mind, the barometers of looking at outcomes are really about overall survival, progression-free survival, quality of life metrics, and such," Paulson said. "So, using patient-generated ePROs (electronic patient-reported outcomes) to sort of assess their overall quality of life, I think is incredibly important."

The panel also addressed the complexity of value-based care models in oncology, with Brewer noting that many previous attempts at implementing these models in the oncology space had failed due to overly ambitious goals. The panelists suggested a more modular, disease-specific approach may be more successful in the future.

"I mentioned before we're well positioned once a model comes down the path, because I think payers too, are primarily focused on cost when you're talking about a purely commercial book of business," Brewer explained. "I think they do focus a little more on quality when you get into the managed Medicare population, reason being because those populations are a little stickier; the payers tend to retain those patients year over year."

Regarding the role of third-party value-based care enablers, the potential value these entities can provide in bridging the gap between payers and practices was acknowledged, particularly in helping to manage risk and develop appropriate tools and programs. The discussion also touched on the importance of real-world data and its impact on clinical practice and NCCN guidelines. The panelists offered their perspectives on the need for more nimble and patient-centered approaches to clinical decision-making, as the rigidity of guidelines can sometimes limit clinicians' ability to provide personalized care.

"Advancements in Precision Medicine in Lung Cancer"

The event's final discussion observed the impact of precision medicine on the treatment of non-small cell lung cancer (NSCLC). Moderated by Lori Brisbin, MS, vice president of precision medicine for Texas Oncology, the conversation highlighted the significant advancements in NSCLC treatment, particularly the role of immunotherapy and targeted therapies.

Jonathan Dowell, MD, professor of internal medicine, The University of Texas Southwestern Medical Center, and Sucharu Prakash, MD, a board member for Texas Oncology based in Paris, Texas, explored how immunotherapy has dramatically changed the landscape for patients with late-stage disease, as well as in earlier-stage settings, including neoadjuvant and adjuvant therapy.

Jonathan Dowell, MD | Image credit: UT Southwestern

"[Immunotherapy has] really dramatically changed the landscape for not only non-small cell lung cancer patients with late-stage disease, but now earlier stage including neoadjuvant therapy, as well as in the small cell space that we're seeing patients, not as many as we'd like, but who have durable responses and long term remissions that we never saw prior to the advent of prior to the advent of immunotherapy," Dowell said.

Next-generation sequencing (NGS) in identifying targetable mutations in NSCLC, such as EGFR, ALK, and KRAS was another topic. Prakash explained why comprehensive NGS testing should be performed at diagnosis, as these molecular profiles can guide treatment decisions and help avoid the use of ineffective or potentially harmful therapies, such as immunotherapy in EGFR-mutant patients.

"Every advanced lung cancer or any solid tumor in my book should get a full panel, broad panel, NGS test," he said. "Why is that important? Because you don't want to miss any targetable mutation now that could have a therapy or, a clinical trial that a patient might be able to go on, right? And it costs the same."

When addressing the challenges of obtaining sufficient tissue for NGS testing and the growing role of liquid biopsies, the panelists noted that liquid biopsies can provide a broader view of tumor heterogeneity and help expedite treatment decisions, particularly in cases where tissue is limited or difficult to obtain.

Regarding the timing of molecular testing, the panelists unanimously recommended testing as soon as possible upon diagnosis, before the initiation of any therapy, to ensure the most informed treatment decisions.

Patient education and perceptions can influence treatment decisions, particularly the tendency for patients to request immunotherapy based on media exposure, even when their molecular profile may indicate a more appropriate targeted therapy. During this discussion, the importance of thorough patient education was emphasized to ensure alignment between the recommended treatment and the patient's understanding of the disease and available options.

Overall, the panel offered perspectives on the rapidly evolving field of precision medicine in lung cancer, highlighting the critical role of comprehensive molecular testing, the growing use of liquid biopsies, and the need for patient-centered, data-driven treatment decisions.

Driving Progress Through Collaboration in Oncology

Beyond the significant advancements in oncology, including precision medicine for lung cancer and innovative therapies for breast cancer and hematology, the event’s discussions delved into the need to integrate cutting-edge treatments like CDK 4/6 inhibitors and next-generation sequencing while addressing challenges such as toxicity and equitable access to care. The perspectives shared reflected a commitment to balancing clinical innovation with patient-centered solutions, paving the way for more personalized and effective cancer care.