Innovation vs Affordability: Cancer Care’s Cost Crisis and Access Gap

Soaring costs for novel cancer therapies have created substantial financial barriers for patients, from crippling out-of-pocket expenses for advanced drugs to inequities in reimbursement for genomic testing.1 Experts convened at the Institute of Value-Based Medicine® (IVBM) event, hosted by The American Journal of Managed Care®, in Detroit, Michigan, on July 10, 2025, with the theme “Driving the Future of Cancer Care.” The event showcased new developments in cancer treatment, but participants noted that gaps persist as they called for continued innovation and improved access to ensure equitable and effective cancer care.

Financial Barriers and Health Care Affordability
“Many of our patients, after we were sending in the drug to get insurance authorization, were coming back with these exceedingly high copays. In some cases, they were unaffordable for the patient,” said Erin Cobain, MD, codirector of the breast cancer clinical research team at the University of Michigan.

Ibrahim Azar, MD | Image: LinkedIn

Although a tenet of the Inflation Reduction Act limits annual out-of-pocket costs for Medicare Part D drugs to a $2000 out-of-pocket cap, burdens on patients remain significant.2 For instance, the approval of CDK4/6 inhibitors such as ribociclib (Kisqali; Novartis) and abemaciclib (Verzenio; Eli Lilly) for breast cancer offers great potential. However, high copays frequently obstruct access.3 A retrospective analysis revealed the mean all-cause health care costs for ribociclib were $20,951 per patient per month (PPPM), and for abemaciclib, they were $23,639 PPPM. The mean total medical costs PPPM were also high, with abemaciclib at $13,425 and ribociclib at $9638.3

Challenges extend to lung cancer, particularly concerning reimbursement and policy for comprehensive genomic testing at early stages, panelists said, repeating a frequent complaint about their ability to deliver precision medicine.4 The Medicare 14-Day Rule, a CMS regulation, further complicates billing for laboratory services, requiring labs to bill hospitals for certain services provided within 14 days of a patient’s discharge.5 However, hospitals sometimes cover the cost of molecular testing, as it can prevent readmissions, which Ibrahim Azar, MD, medical oncologist/hematologist at IHA Trinity Health, noted are “10 times more expensive than, say, next-generation sequencing.”

The integration of artificial intelligence (AI) algorithms also holds promise for making care more equitable, they said, as AI can suggest clinical trials for patients. This could make a difference in underserved communities where patients often lack access to trials. “I think that’s something that’s going to deliver more equitable care because, for example, someone coming from a rural area may not have to go to [the city of] Ann Arbor [,Michigan,] to have access to a promising clinical trial,” said Azar.

Similarly, therapies for gastrointestinal (GI) cancers are sometimes deemed “not medically necessary,” or “investigational” if an oncologist seeks to use a newer therapy that has been approved in some but not all GI cancers.6 Experts suggest that without proper coverage for testing, issues such as dose escalation for specific treatments could lead to significant variations in outcomes, especially given the importance of dihydropyridine dehydrogenase testing to identify patients at higher risk of adverse effects from chemotherapy.

Gazala Khan, MD | Image: Henry Ford Health

“With oncology, we always deal with cost implications, but in this case, especially given that the consequences of not testing for a small minority [of patients] can potentially be devastating, I feel it’s warranted for routine reflex testing, like we do at our institution,” Gazala Khan, MD, medical oncologist specializing in GI cancers at Henry Ford Health. With reflex testing, a pathologist automatically performs a follow-up test if initial results show a need for more detailed analysis.

Ultimately, social determinants of health, such as insurance type, transportation, and health literacy, can profoundly affect patient access to cancer therapies. Roughly 26 million (7.2%) people in the US are uninsured, a number projected to increase to 8.9% over the next decade.7 This rise is primarily attributed to the end of Medicaid’s continuous eligibility provisions and the anticipated expiration of enhanced Marketplace subsidies after 2025, according to the Congressional Budget Office.8

“Lack of insurance, is, in my opinion, a disease and a spectacle because it affects what the patient could be offered. This is more highlighted in the field of hematology, because for 10 years, a lack of insurance can limit a lot of what you could offer patients that could be saving their lives,” said Ahmad Mattour, MD, hematologist at Henry Ford.

Advances in Personalized and Tech-Driven Oncology
Experts at the IVBM event underscored the growing importance of genomic testing, not just in adjuvant therapies, but increasingly in neoadjuvant settings.

“Genomic testing has been something that we’ve been very familiar with, with our adjuvant therapies for patients, and now with options for things such as Oncotype DX and mammograms. Moving it toward how we can make these decisions in the neoadjuvant setting, too, is becoming more important,” said Rebecca Chacko, MD, breast medical oncologist at Henry Ford.

This era of personalization is further enhanced by new therapeutic approvals, such as oral selective estrogen receptor degraders for patients with breast cancer who develop ESR1 mutations. These novel medications amplify the role of genomic testing and continuous monitoring, particularly through circulating tumor DNA (ctDNA) testing, to tailor treatments.9

“The opportunity to have a liquid biopsy approach is very helpful, and I use it routinely, just to see if our patients are candidates for clinical trials of novel targeted therapeutics. We often have clinical trials available to us that are novel targeted therapies, but only a certain biomarker-selected population is able to enroll in that trial. I would say we use it routinely and often at multiple times throughout the patient’s course of metastatic disease,” Cobain stated.

Beyond diagnostics and therapeutics, technology is transforming care delivery itself. Discussions at the event explored the potential of wearable devices in malignant hematology, prompting questions about their broader adoption as patients transition from inpatient to outpatient settings.

“Switching from an inpatient setting to an outpatient setting is not a luxury; it’s a necessity. I say that because the patient population is living longer. Therefore, the potential [number] of conditions being diagnosed is higher. Also, health care is not getting any cheaper, so the contrast between the cost of care inpatient vs outpatient is very staggering,” Mattour said.

The integration of AI and machine learning models is predicted to play an increasingly significant role in automating and optimizing patient care, further streamlining treatment pathways and enhancing efficiency.

Navigating Nuances and Future Directions in Cancer Diagnostics
While experts acknowledged the significant value of ctDNA in advanced and early-stage lung cancer, they also highlighted critical limitations that prevent relying solely on ctDNA or even traditional tissue testing for comprehensive care.

“There’s a lot that we could potentially miss with ctDNA. I also worry about relying on ctDNA in the early stage. If this patient doesn’t have metastatic disease, how much ctDNA do they have, and is technology able to detect it?” asked Angel Qin, MD, associate professor and thoracic medical oncologist at the University of Michigan.

Specifically, some alterations, such as copy number variations, are undetectable with ctDNA, and current assays may lack the sensitivity to identify fusions. Despite these drawbacks, ctDNA offers benefits such as overcoming tumor heterogeneity and enabling serial monitoring for patients on molecular-based therapies, ultimately improving care and survival.10

“A similar study from Dr [Charu] Aggarwal from the University of Pennsylvania11 showed that if you order both [ctDNA and molecular testing] at the same time, you’re able to find more genomic alterations and you’re able to treat more patients who have a high response rate,” Azar stated.

Beyond ctDNA, significant shortfalls persist in other diagnostic areas, notably in gastrointestinal oncology. Current liver ultrasound screening methods for hepatocellular carcinoma (HCC) are a prime example. Screening is not recommended for the general population, and guidelines only endorse it for individuals with a more than 1% annual risk of developing HCC.

“When one looks at how many patients get screened, the numbers are dismally low. They flirt with 30% at best. We’re failing our patients collectively in identifying them as candidates for screening and circumstance,” Pierre Gholam, MD, FAASLD, AGAF, professor of medicine, medical director of Liver Center of Excellence, and distinguished attending physician at Case Western Reserve University School of Medicine, stated.

Furthermore, while ctDNA holds promise in GI oncology, its application is currently limited by a paucity of ongoing trials. For instance, the NRG oncology COBRA trial (NRG-GI005; NCT04068103) is exploring ctDNA’s role in detecting persistent disease after colon cancer resection.12

“When we started piloting ctDNA testing within our institution, we had a prospective study looking at it, but very quickly, I realized that it does generate a lot of patient anxiety in some cases where it’s positive and they’ve completed the adjuvant treatment. In terms of my standard practice, I do that in stage II, term 3, and zero colon cancer to inform patients of recurrence, and then have a conversation about adjuvant treatment or neoadjuvant treatment,” Khan concluded.

While personalized medicine and advanced technologies such as genomic testing and AI promise revolutionary treatments, their impact is blunted if financial barriers and systemic inequities prevent patients from accessing them. Ensuring that innovation translates into equitable, effective care for all, regardless of their economic situation or background, will require sustained, collaborative efforts from policymakers, payers, clinicians, and industry stakeholders.

References
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