Delivering Value-Based Oncology Care in the Age of Biomarker Testing, Targeted Therapies, and Immunotherapies

Cancer treatment has evolved significantly since the days of one-size-fits-all therapy, with current standards of care across disease states ranging from chemotherapy to immunotherapies and targeted therapies. But as newer treatments such as bispecific antibodies and chimeric antigen receptor (CAR) T-cell therapy join the roster, questions arise surrounding sequencing, accessibility, and value.

Panelists discussed these questions during a recent Institute for Value-Based Medicine® event held in Nashville, Tennessee, which brought stakeholders in cancer care delivery together to share strategies to optimize care for patients while considering factors such as cost and accessibility.

Emerging Therapies and Biomarker Testing in Breast Cancer

Various tests for breast cancer help oncologists make decisions for patients, Laura Kennedy, MD, PhD, explained during the first panel. These include things as simple as genomic risk scores, but testing also has evolved with the availability of sequencing assays analyzing circulating tumor DNA (ctDNA), for example, to identify actionable genetic mutations, Kennedy said.

“And I think that we continue to evolve, and in research, there [are] certainly a lot of imaging biomarkers [and] more ctDNA assays being explored,” said Kennedy, an assistant professor of hematology/oncology at Vanderbilt-Ingram Cancer Center in Tennessee. “I think it’s a really exciting time in breast cancer, and we are only getting better at focusing our care for an individual patient on things that hopefully will be worthwhile and helpful for them.”

This panel’s moderator, Sonya Reid, MD, MPH, a associate professor of hematology/oncology at Vanderbilt University Medical Center, raised the question of when biomarker testing should be done in patients with advanced breast cancer to drive value-based care. Kennedy replied that her typical practice is to do biomarker testing at the time of metastatic diagnosis and repeat testing at points of disease progression via liquid biopsy.

Kate Baker, MD, MMHC, medical oncologist and medical director of value-based care at Tennessee Oncology, added, “I think early utilization of biomarker testing is really key for selecting the appropriate therapy for patients with both early-stage and metastatic breast cancer. But primarily in metastatic breast cancer, usually using biomarker testing and liquid biopsy is what I do as well.”

Although molecular testing can help hone treatment strategies for patients with targetable features, several persistent access barriers exist to receiving these tests. Baker noted that insurance denials are one issue, along with access challenges for patients living in rural areas or falling into certain socioeconomic groups. And although some progress has been made on the policy end, with more than 20 states enacting legislation to encourage insurance companies to approve biomarker testing,¹ more work is needed to get buy-in from legislators who must understand that, despite the upfront costs, biomarker testing is a valuable and necessary tool, she said.

“We all know that if patients get early biomarker testing and more personalized, molecular-driven therapy, their outcomes are likely to be better, and their health care utilization may be lower,” Baker said. “Ultimately, it’s going to save money, and it’s about helping the legislators to see that.”

Justin M. Balko, PharmD, PhD, an associate professor of medicine and a translational scientist at Vanderbilt University Medical Center, agreed that when utilized properly, biomarker testing can impact outcomes and make financial sense for payers.

“Is there a way that you can do this and actually affect the patient’s outcome and the care? Is it going to be a meaningful result, and can you do that in a financially responsible way? If you’re doing it the right way, it should work out very clearly from those perspectives,” Balko said.

Collaboration With Pharmacy Is Key to Optimizing Value
Pharmacists are crucial in the process of delivering timely, value-based oncology care. Moderator Jerrick White, PharmD, director of pharmacy services at Tennessee Oncology, began the second discussion of the night by asking which innovative models have been successful for the panelists.

Angie Maynard, PharmD, MS, CPGx, assistant professor of pharmacy practice at Lipscomb University and clinical pharmacist at Nashville General Hospital’s Dr. Robert E. Hardy Cancer Center, highlighted multidisciplinary collaboration that includes pharmacists—something she noted may not be “innovative” anymore, but has meaningfully impacted practice.

“I believe some of my other colleagues, as well as myself, do telehealth so that we can kind of catch adverse events on the forefront before patients come in,” Maynard said. “We can address that and then help with some drug-drug interactions that we’re able to catch, too.”

Medically integrated dispensing pharmacies within oncology practices, which give the pharmacists direct access to the patient’s medical record and providers, are another innovation with potential to increase safety and decrease waste, said Joey Hollenbeck, PharmD, director of pharmacy business management at Tennessee Oncology.

“We also have patient management programs where we monitor adherence,” Hollenbeck said, ”so we not only are kind of the forefront of increasing adherence rates, but we also allow providers to have visibility into their patients at home, their daily practices or daily dosing, so they can say, ‘When this patient comes to see me, I know that they’ve been taking their medication because the pharmacist checked in,’ vs ‘I’m assuming you’ve been taking it for 3 months,’ and they show up and they say, ‘I haven’t had my medicine for 3 months.’ So that’s really where I think we can add some value as pharmacists.”

Colleen McCabe, PharmD, BCOP, a clinical oncology pharmacy specialist at Vanderbilt University Medical Center, agreed that an integrated specialty pharmacy helps provide optimal care. McCabe also noted that although innovation may improve care, it also brings barriers to implementation.

In Tennessee, state law recognizes pharmacists as providers, but under federal law, they cannot bill directly through Medicare. “Pharmacists still are not able to bill on our own as providers,” McCabe said. “That is definitely an obstacle to proving what we can do for patients, especially when we’re seeing them in visits. That’s an obstacle that we have. We’ve been trying to work on overcoming that obstacle, potentially partnering with our [advanced practice providers], as well, to be able to bill for some of our services.”

Hollenbeck agreed, also noting that the infrastructure needed to support integrated pharmacy services is significant. But it is difficult to build that infrastructure when you cannot bill for those services. Limitations in the realm of staffing also challenge innovative models, added Maynard, who is the only oncology pharmacist at Nashville General Hospital.

The panel also emphasized the importance of keeping up-to-date with new studies and considering real-world evidence in formulary decisions, with McCabe using subcutaneous injections for immunotherapy as an example of an innovation that can change practice. With changes like these, the impact across all aspects of workflow must be considered.

Hollenbeck explained impacts of the Inflation Reduction Act of 2022 (IRA), which he said has made certain aspects easier when dealing with Medicare. Assistance from foundations is now more accessible, due to the out-of-pocket maximum dropping to $2000 under the IRA. However, patient assistance programs sometimes carry a higher administrative burden with more steps required, he said.

Regarding patients covered by commercial insurance, however, things have become more difficult, he said. Alternative funding programs (AFPs), which are an entity between the pharmacy and the pharmacy benefit manager, are meant to save money but can impact patient access to specialty drugs. They keep a cut of the savings they deliver and therefore may be incentivized to hold out on therapies until every other potential avenue—including patient assistance programs, which are ideal because they maximize the amount the AFP receives—is exhausted, Hollenbeck explained.

Immunotherapy and Targeted Therapies in Lung Cancer and Melanoma
The panel’s moderator, Melissa Johnson, MD, director of lung cancer research at Sarah Cannon Research Institute in Nashville, opened the next discussion by emphasizing the dynamic nature of the lung cancer treatment paradigm, which includes chemotherapy, immune therapies, targeted therapies, and, sometimes, all of the above.

“Immune therapy has continued to revolutionize the care of our patients with lung cancer, many of whom are living beyond 5 years, which, when I started this deal, wasn’t possible for my patients,” Johnson noted.

A key question surrounding immunotherapy use is the optimal duration of treatment. Robert Ramirez, DO, FACP, a medical oncologist at Vanderbilt-Ingram Cancer Center, explained that the optimal timeline for immunotherapy is not yet clear, and that is something he explains when counseling patients. Typically, he keeps patients on immune therapies for 2 years, regardless of the drug, he said.

McCabe added, “[Compared with] some of our large cytotoxic chemotherapies, [immunotherapies are] generally better tolerated. However, a lot of these [adverse] effects that we have with immunotherapy are long-term—they can be life-lasting. As well as we consider immunotherapies to be generally well tolerated, they have real [adverse] effects. Being able to manage those really helps our patients.”

A major obstacle, however, is being able to triage patients quickly so they can be kept on immunotherapy, McCabe said.

In lung cancer, immunotherapy is now a consideration across treatment line and disease stages, including as a neoadjuvant addition to chemotherapy, Johnson noted. It can be used in the neoadjuvant setting with chemotherapy and in the adjuvant setting, or in the adjuvant setting alone. Working with a multidisciplinary team can help ensure a patient receives the most appropriate treatment, Ramirez said.

“It’s a challenging field because it is changing so quickly,” Ramirez said. “And I think that’s where being at a center that has a multidisciplinary team really is helpful, because we meet every week in our tumor board meetings, and we talk about this, and we talk about the latest data.” Without this step, for example, patients may see their primary care physician with a cough, a pulmonary specialist who may diagnose lung cancer, and then be referred directly to a surgeon, and a medical oncologist may not be involved.

“I think that paradigm needs to shift, because we’re seeing that neoadjuvant or perioperative immunotherapy is certainly beneficial and has a survival impact,” Ramirez said. Johnson agreed, adding that the same is true in the realm of targeted therapies, which can be game-changing when patients have targetable driver oncogenes.

To determine whether a patient will do well on targeted therapy, testing for targetable mutations is necessary, which can be a barrier to treatment initiation, Ramirez said. It can take weeks, and one way to ensure quick treatment is to educate pulmonary specialists and surgeons, who can send the testing out before a patient gets to a medical oncologist.

Balancing Innovation and Affordability in Myeloma
In multiple myeloma, a major change in recent years has been blurring a previous harsh divide between frontline treatment options for transplant-eligible and transplant-ineligible patients, said moderator Jonathan Abbas, MD, a hematologist-oncologist at Tennessee Oncology, as he kicked off the final session of the evening.

These days, in most cases, the standard of care includes a CD38 antibody—daratumumab (Darzalex; Johnson & Johnson) or isatuximab (Sarclisa; Sanofi)—combined with lenalidomide (Revlimid; Bristol Myers Squibb), bortezomib (Velcade; Takeda), and a steroid, Abbas explained.

“We used to save that CD30 monoclonal antibody for the high-risk patients or younger patients,” Eden Biltibo, MD, MSCI, a clinical fellow in hematology and oncology at the Department of Internal Medicine, Division of Hematology and Oncology, at Vanderbilt University Medical Center, said. “But right now, it’s a standard of care. We use it for [older patients who are] transplant ineligible or transplant eligible. Isatuximab has an approval in the transplant-ineligible setting to be used as a quadruplet therapy. Daratumumab had approval in that setting for a while and is really improving the progression-free survival of patients. We use it in every patient, and it should be used in that setting.”

Bradley Yelvington, PharmD, BCOP, a clinical pharmacy specialist in malignant hematology at Vanderbilt University Medical Center, agreed, adding that there is a substantial increase in resource requirements for the patient and infusion center when these latest standards of care are implemented.

Biltibo also discussed the availability of isatuximab administered subcutaneously, which she noted has made a significant impact and can make treatment easier on the patient. The convenience and the possibility that a patient may even be able to receive subcutaneous treatment at home carry weight against the potential efficacy of more frequent intravenous dosing.

The panel agreed that quadruplet therapy that starts with an anti-CD38 therapy—either isatuximab or daratumumab—is poised to stay as the frontline standard for multiple myeloma, as long as the patient is fit enough to receive it.

“The nice part now is that we have lots of additional therapies that have been approved, so we have lots of things for patients beyond what we traditionally used to use—daratumumab—in the third-line setting and beyond,” Yelvington said. Abbas added that in multiple myeloma, a significant portion of patients are lost with each additional line of therapy, so using the best possible option up front is crucial.

Novel therapies such as chimeric antigen receptor (CAR) T-cell therapy and bispecific antibodies are also changing the course of multiple myeloma treatment in the second line and later, but accessibility to patients remains an issue, Biltibo noted.

“I think, ultimately, that’s what it’s going to come down to, bispecifics,” Abbas said. “We are going to find ways, hopefully, to get them into community hospitals, get them into the community, and not necessarily need every patient to come to Nashville, certainly not for 3 to 4 weeks.” Using CAR T-cell therapy is hindered by limitations that have not yet been resolved, although progress has been made with manufacturing times, which are a notorious barrier to CAR T initiation. Bispecifics offer better accessibility, Abbas explained, and Biltibo and Yelvington agreed.

However, Biltibo noted that this brings up sequencing questions when patients receive bispecifics in the frontline setting.

“I see that as a challenge that we need to think about, because CAR Ts are very effective when used before the bispecifics,” Biltibo explained. “But with the kind of drug resistance mechanism that bispecifics cause, the patient might even lose the target after a bispecific, so you cannot really use a BCMA [B-cell maturation antigen] CAR effectively after a BCMA BiTE [bispecific T-cell engager] therapy or even with GPRC5D, so that will be challenging; but bispecifics are more accessible, I would say.”

Moving these therapies to the outpatient setting can help with accessibility, and such programs require emphasis on patient and caregiver education, Biltibo explained. But questions about the optimal use of prophylactic treatments to avoid adverse events for these patients—such as tocilizumab to mitigate the risk of cytokine release syndrome—remain, the panelists agreed. These include issues with insurance coverage and accessibility in the community setting.

Reference
Access to biomarker testing. American Cancer Society Cancer Action Network. Accessed September 23, 2025. https://www.fightcancer.org/what-we-do/access-biomarker-testing