Making Novel Cancer Therapies Available Requires Choices Because Resources Are Limited

Moving forward in clinical research involves answering simple questions: Can you explain why it matters? Can you get someone to pay for it?
These are questions of health policy, said Theresa W. Gillespie, PhD, MA, FAAN, associate director for cancer health equity and community engagement at Winship Cancer Institute of Emory University. “If you can’t get it to a policy level where it’s going to be approved, where it’s going to be paid for, where it’s going to be accessible, then we’re not going to make the progress that we want to make.”

Gillespie is not alone in this view, as other experts have drawn attention to the influence of the Inflation Reduction Act (IRA) and CMS on patient care and access to novel medications. These topics, as well as crucial advancements in the treatment of non–small cell lung cancer (NSCLC), chronic lymphocytic leukemia (CLL), and other hematologic malignancies, were highlights of the Institute for Value-Based Medicine event held February 13, 2025, in Atlanta, Georgia.

Theresa W. Gillespie, PhD, MA, FAAN | Image: Winship Cancer Institute

These sentiments resonated throughout the discussion of various immunotherapies, and the panels highlighted the central role of health care policy in elevating value in cancer care.

Ruth Sacks, MD | Image: Emory University School of Medicine

Addressing social determinants of health (SDOH), or the “hidden factors,” as Ruth Sacks, MD, assistant professor, Department of Hematology and Medical Oncology at Emory University School of Medicine, put it, requires an ongoing commitment from institutions, sponsors, and health systems to fill in gaps that policy alone cannot remedy. “You can be an advocate, but the institution has to care to put those resources in place,” and “it has to come from top to bottom,” said Jade E. Jones, MD, medical oncologist at Emory Winship Cancer Institute. Social workers, patient navigators, and community partnerships are vital in these initiatives.

Jade E. Jones, MD | Image: Winship Cancer Institute

In the realm of chimeric antigen receptor (CAR) T-cell and bispecific therapies, community partnerships can help facilitate Risk Evaluation and Mitigation Strategy (REMS) and educational initiatives. “One piece of it is early referral to a center who [has such therapies] to establish that relationship early [on] before these therapies are needed in an emergency,” argued Sara Scott, PharmD, BCOP, clinical pharmacy specialist at Emory Healthcare, as she highlighted the value of collaborating at the community level to operationalize CAR T-cell and bispecific interventions.

Sabarish Ayyappan, MD | Image: City of Hope Cancer Center, Atlanta

Making bispecific and CAR T-cell therapies accessible in community settings also requires partnering with larger academic institutions, noted Sabarish Ayyappan, MD, medical director for hematologic malignancies at City of Hope Cancer Center, Atlanta. These relationships can better equip physicians to manage step-up dosing and risks for cytokine release syndrome in patients with multiple myeloma or lymphoma, he added.

Nisha Joseph, MD | Image: Emory School of Medicine

“No patient with myeloma should die without seeing a bispecific,” declared Nisha Joseph, MD, associate professor, Department of Hematology and Medical Oncology, Emory School of Medicine. “So, it’s…important that we’re having these kinds of conversations and talk[ing] about how to pragmatically get into the community more.”

“There really needs to be more accountability in terms of helping these patients navigate the system,” Sacks continued. “On a policy level, we need to move forward with advocating for patients across the board, especially patients [with cancer who] are in a very vulnerable position.” The panel emphasized the need to help connect patients with transportation while assisting them in addressing challenges related to insurance coverage, clinical trial access, financial toxicities, and preventive services in oncology care.

Gillespie criticized the use of household income as a benchmark for assessing patients’ financial status when deciding if they qualify for specific assistance. She referenced the hidden factors Sacks alluded to, citing how some treatments can cause income loss when patients must take time off work. Additionally, many travel and lodging expenses are not factored into these financial assessments.

The experts also discussed the need for Medicaid expansion, as Gillespie and Jones mentioned how many patients—who fear financial toxicity or have travel or insurance barriers—delay care and, as a result, show up later in the course of their disease. Given that care delays can critically affect patient outcomes, it is critical to do more to offer accessible screening and prevention services to catch cancer early on. “An ounce of prevention is worth a pound of cure, but we need to be thinking about access for all kinds [of individuals] and value in cancer care across all levels,” Gillespie said.

The IRA and CMS price negotiations, in particular, could significantly improve access to newer, more effective Bruton tyrosine kinase (BTK) inhibitors in CLL, such as zanubrutinib (Brukinsa; BeiGene USA, Inc) and acalabrutinib (Calquence; AstraZeneca Pharmaceuticals LP).

“We just don’t have unlimited resources anymore, and a huge proportion of health care costs comes from cancer therapy,” said Eiran A. Warner, MD, oncologist/hematologist at Piedmont Cancer Institute. “Choices are going to have to be made, and one way of trying to help the health system is to lower cost through [the IRA]. That’s probably where the future is,” he continued, expressing optimism for legislation to dictate more cost-conscious care.

Andres Chang, MD, PhD | Image: Emory University School of Medicine

However, a provider’s autonomy needs to remain a priority because “the ultimate decision, which is the best agent, rests in the expertise of the treating physician,” said Andres Chang, MD, PhD, instructor, Department of Hematology and Medical Oncology at Emory University School of Medicine.
Evaluating outcomes and gathering data associated with minimal residual disease (MRD) or fixed-duration interventions are essential for cost-benefit analyses because “these drugs are not cheap by any means, and if you’ve got to take [them] lifelong, [they] can make anybody bankrupt,” Vipin R. Lohiya, MD, oncologist/hematologist at Piedmont Cancer Institute, added.

Jean Koff, MD, MS, a hematologist at Emory Winship Cancer Institute, echoed this sentiment and alluded to the variety of patient characteristics that influence clinical decisions for BTK inhibitors. She stated, “It’s not going to be one size fits all” when it comes to a patient’s intervention, the influence of doublet or triplet therapy, or the role of MRD. Furthermore, with compelling data to guide treatment decisions, providers may be able to “reach back into [their] pocket and not even have to use a new therapy.”

Role of Specialty Pharmacy in NSCLC
Building on these topics, a panel of NSCLC experts discussed the importance of strong specialty pharmacy programs to aid with high-cost therapies. “There needs to be a team of people that can really coordinate the care and communicate so that we can get these treatments approved in time,” Pauline Kim, PharmD, BCOP, who at the time was a clinical pharmacy specialist with Emory Healthcare, explained. “It needs different coordination from the insurance company, from the clinic, right from the specialty pharmacy,” she added.

Ioana Bonta, MD | Image: Georgia Cancer Specialists

NSCLC panelists also emphasized the need for policy-level changes to improve access to molecular testing and quicken turnaround times. “I would argue that an NGS [next-generation sequencing] panel for lung cancer is just as important as ER [estrogen receptor], PR [progesterone receptor], [and] HER2 [are] for breast cancer, and we need to push [so] that this is done reflexively on a national level and not piecemeal,” stated Jennifer Carlisle, MD assistant professor, Department of Hematology and Medical Oncology, Emory School of Medicine. Additionally, Ioana Bonta, MD, medical oncologist at Georgia Cancer Specialists, mentioned how including genomic testing as part of a cancer institute’s quality measures can be a valuable strategy.

Ultimately, the panelists in the evening discussions expressed an urgent need for action. Looking ahead, deep institutional commitments, strategic partnerships, policy reform, and continued advocacy will be essential to elevate value in cancer care.