The hurdles of treating cancer beyond science and innovation

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Written by SNAP members Erin Cullinane, Andrew Ramirez, and Sari Terrazas (all three authors contributed equally)

Thoughts and views written in this blog post reflect those of the authors only, and not necessarily those of every SNAP member or the SNAP coalition as a whole.

Footnotes are denoted with superscript numbers. References are denoted with brackets.

On a Personal Note

Erin Cullinane: This topic is personal to me. When I was in high school, my aunt was diagnosed with chronic myeloid leukemia (CML). CML is a type of bone marrow and blood cancer that causes the body to produce too many white blood cells. I remember getting the news that she was in the hospital and later learning that the results of the blood tests revealed an extraordinarily high white blood cell count. Further testing led to her diagnosis, and she began treatment soon afterward.

Since then, I have watched her navigate both the disease and the toll of treatment. She has experienced severe inflammation, prompting her care team to pause treatment to see whether her symptoms would improve. During this pause, her white blood cell count rose again. This was a painful reminder of how difficult it can be to balance controlling cancer with managing the side effects of the medications used to treat it.

Alongside these challenges, she is also a mother. She has had to navigate cancer treatment, manage side effects, and continue working to help afford her care, all while raising her child. Treatment costs and copayments add financial pressure to an already demanding life. Her experience is what drives my interest in cancer research. It also reminds me that developing a treatment is only the first step of the work. We also need to consider what it means to live with that treatment and its side effects, along with the costs and the demands it places on a person’s everyday life.

Innovative cancer treatments are not enough to help those who need them

We’ve made immense strides in treating cancer over the last decade. This progress comes from advances in traditional treatments like chemo and radiation, as well as new treatments like CAR T-cell and other immune therapies. Innovative solutions are continuously being discovered and implemented to save human lives. New cancer treatments represent hope. They can offer a chance to slow a tumor’s growth, overcome treatment resistance, or give loved ones more time with their families and friends. However, the prevalence of promising new therapies raises an important question: will patients who need them the most be able to access them?

A discovery in the laboratory is only the beginning. The journey from laboratory discovery to patient care is an extremely arduous process and requires numerous tests, experiments, and safety studies. Even after a new therapy is approved by the Food and Drug Administration (FDA), patients face many more obstacles, such as insurance restrictions, out-of-pocket costs, drug accessibility, and access to specialized care that can put treatment out of reach. Understanding this gap requires critically analyzing the policies that shape who can receive care. In this piece, we will explore the journey of how federal healthcare policies affect patients’ access to current and developing cancer therapies, and what needs to change so that groundbreaking advances can be accessed by everyone regardless of an individual’s income or insurance status.

Cancer treatments start with research at the bench

Cancer drug development often begins with a biological question. Researchers might identify a protein or cellular pathway that is overexpressed or suppressed that allows cancer cells to survive. One way of further investigating this question is to remove the protein or prevent the pathway from occurring to see if it could slow and/or stop tumor growth. Before this potential treatment can move forward in humans, it has to undergo preclinical testing. In the preclinical stage, laboratory-based experiments and tests are conducted through the use of non-animal and animal models. These tests must be done in compliance with Good Laboratory Practice to ensure reliable results. Preclinical studies are designed to reflect the anticipated conditions and variables in human clinical trials. Animal studies are a way to see the full interaction between multiple different cell types and the immune network interactions that happen with these therapies. In addition to assessing the benefit-risk profile, researchers select models that closely resemble the target patient population and use many statistical methods and measures to support their findings. The study design entails determining the appropriate sample size, study duration, and endpoints used to evaluate a drug’s efficacy and safety.

Clinical trials allow for experimental drugs to be used for patients

Once the potential therapeutic passes through these studies, it moves to Good Manufacturing Practice (GMP). Here, developers must prove that they can consistently manufacture a stable, pure, and high-quality version of the drug that will remain stable over time and be safe for human delivery. During the drug’s final stage, developers then have to design a well-detailed pre-investigational new drug application (IND) that has to be approved by the FDA in order to start clinical trials.

A clinical trial has four phases. Broadly, Phase I focuses on safety and dosage for the new drug candidate. This phase is small in scale; the researchers use this phase to observe how the drug treatment interacts with the human body [1]. Phase II investigates effectiveness for the target disease or condition of the new drug to test if it’s efficacious [1]. Only about 33% of all new drugs will move on to Phase III, also known as the pivotal study [1]. This phase involves several hundred to thousands of participants and takes years to complete. The goal of Phase III is to determine whether or not the drug will provide improved treatment when compared to the already available options [1]. Finally, Phase IV is known as post-market safety monitoring. Once the drug is in the market, Phase IV is designed to monitor the thousands of patients who are actively taking this new drug candidate [1]. This step can take years to complete as new side effects arise, aiding in the long-term safety and efficacy of the drug [1]. This entire process can take years, and there is no single timeline that applies to every therapy. A treatment that looks promising in the laboratory may not provide meaningful benefits in people, so careful testing is essential to understanding whether its benefits justify its risks.

Even throughout the clinical trial process, there are barriers that cause gaps in accessibility and equity. Participating in a clinical trial might be the only opportunity for treating their disease and to survive. Clinical trial involvement may require travel and time away from work, which are expenses that are not typically covered [2]. Unfortunately, these hurdles prevent individuals from becoming involved to treat their condition. In spite of this issue, sponsors (i.e., academic institutions, pharmaceutical companies, hospitals) will often pay the research-related costs. The opportunity to participate in research should not depend on whether someone can afford repeated trips to a treatment center. For those in rural areas, the financial burden is exacerbated due to longer travel.

FDA approval does not guarantee treatment access and coverage of costs

When a drug is submitted for approval, the FDA reviews the evidence about its safety and effectiveness, and allows the drug to be marketed for a specific use. Yet, the insurance coverage of a newly approved drug does not coincide with the FDA approval process. Insurers determine coverage under their plans, including any requirements that apply to the proposed treatment [3]. There is no nationwide step where insurance companies approve a drug after the FDA does. For a patient, this distinction matters. A therapy may be available, and an oncologist may even recommend it, but obtaining coverage for this new treatment can still require additional review and hoops to jump through. Even when insurance does pay for the treatment, the deductibles, copayments, and coinsurance can leave patients with substantial expenses.

Treatment costs and lost income can create hardship that affects patients’ well-being and their ability to follow treatment plans. Consider a patient whose oncologist recommends a newly approved therapy. Alongside questions about effectiveness and side effects, this patient must ask: will insurance cover it? What will the out-of-pocket cost be? Can appointments fit around work and caregiving responsibilities, since this patient has 2 young children and is a single mom? These questions will ultimately determine whether a scientific advancement can become a realistic, financially sustainable treatment option. Patients should not have to decide to live based on insurance policies and financial decisions.

Over the past few decades, two major law reforms have affected healthcare policies surrounding clinical trials and cancer treatment plans. These are the Affordable Care Act and the One Big Beautiful Bill Act, which have both had significant impacts on who has to worry about having their care covered. The dichotomy of making cancer-related healthcare policies affordable, accessible, and inclusive is stark when taking a deeper look.

How the Affordable Care Act impacted clinical trial participation for cancer patients

The Patient Protection and Affordable Care Act (ACA) was signed into law by President Barack Obama on March 23rd, 2010. The ACA aimed to reform healthcare and improve the overall healthcare delivery system by expanding coverage and controlling healthcare costs [4]. These alterations fundamentally changed how cancer patients were able to access care. Some of the key changes include:

• Banning insurance companies from denying coverage due to pre-existing conditions, which is critical for cancer patients [5]
• Allowing adult children to stay on their parents’ insurance until age 26
• Creation of state-based marketplaces or exchanges where individuals can compare and buy insurance plans
• Medicaid expansion to adult individuals whose income does not exceed 138% of the poverty line [5]
• Protections for clinical trial participants under Section 2709 [5]

Before these reforms, cancer patients frequently struggled to secure or maintain affordable coverage due to steep medical costs and pre-existing condition exclusions. The ACA directly mitigated many of these barriers. The law intended for Medicaid expansion to be nationwide; however, a 2012 Supreme Court ruling made expansion optional for states. Despite this, 29 states and Washington, D.C. expanded Medicaid coverage within 2 years [6]. A study comparing health and access to care between expansion and non-expansion states found that by the second year of the ACA, states that expanded Medicaid had increased access and decreased financial strain of healthcare costs compared to non-expansion states [6]. Additionally, expanded Medicaid coupled with clinical trial protections created a new path to cutting-edge treatments in clinical trials. A cohort study of 51,751 patients identified an overall 19% increase in Medicaid insurance use in cancer clinical trial participation [7].

In addition to these alterations in America’s healthcare system, the ACA also included a provision, Section 2709, which added protections to clinical trial participants. This section expands clinical trial coverage by implementing the following policies:

• Bars insurance companies from denying an individual participation in a clinical trial
• Insurance companies cannot deny coverage of routine patient costs (e.g., bloodwork, doctor visits, imaging) associated with the trial
• Forbids insurance companies from discriminating against an individual based on trial participation

This afforded access to clinical trial protections to a broader population than had been historically represented in research studies [7]. A study out of California examined cancer clinical trial enrollment pre- and post-ACA and found that fewer cancer patients declined clinical trial enrollment over insurance concerns [8].

Although the ACA was successful in expanding coverage to Americans, the aspect of affordability remains an issue. Insurance premiums continue to rise, which can be attributed to inflation and the expiration of the ACA premium tax cuts at the end of 2025 [9]. The insurance marketplace was supposed to allow Americans to compare plans and find one that fit their needs at a price point they could afford. However, in more rural areas, the plans are limited, with often only one insurer. This can make it very difficult for patients to receive the care they need when they are priced out of even the most affordable option. In 2026, there were 165 counties across the United States that only had 1 insurer offering plans. This is up from 93 counties in 2025 [10]. This poses a hidden barrier to cancer patients seeking clinical trials. In more rural areas that have limited insurer options, clinical trials may not be within the network, and since the ACA does not mandate that insurance companies cover out-of-network providers for clinical trial participants, patients in rural areas may choose to forgo innovative treatment over shouldering the cost. Additionally, the ACA does not address non-medical costs such as travel, lost wages from missing work, and childcare. For low-income or rural cancer patients, these non-medical expenses are too burdensome to risk.

Overall, the ACA fundamentally reshaped cancer research participation by expanding coverage and implementing safeguards to clinical trial participation under Section 2709. However, these protections on paper do not automatically guarantee equal access to clinical trials in practice. As premiums continue to rise, options for rural communities narrow, and the burden of non-medical costs persists, systemic inequalities will continue to dictate who can participate in life-saving clinical trials.

The One Big Beautiful Bill Act exacerbates the difficulties of affording and obtaining life-saving cancer treatments

The One Big Beautiful Bill Act (OBBBA) was signed into law by President Donald Trump on July 4, 2025, altering legislation on human health; the impact on health insurance is one that cannot be overstated. The OBBBA made alterations to Medicaid eligibility, aiming to keep Medicaid only for those who have no other option, as it is a federal and state program for low-income individuals and families. Under the OBBBA, in order to be eligible for Medicaid, recipients must work a minimum of 80 hours per month (whereas previously there was no work requirement), eligibility redetermination cycles shortened from once a year to every 6 months, and reduced coverage for non-citizens (including refugees, asylum seekers, Deferred Action for Childhood Arrivals (DACA) recipients, and Temporary Protected Status holders). Additionally, the bill will require states to increase their funding for Medicaid because of the decrease in federal funding. These alterations will affect how the Marketplace will also be affected by these work requirements, stop automatic enrollment, and end protection against paying excessive tax credits.

Cancer treatment and coverage would not be possible without Medicaid. In 2023, 10% of adults with cancer used Medicaid for their cancer treatment coverage and over one-third of children newly diagnosed with cancer used Medicaid or the Children’s Health Insurance Program. Center on Budget and Policies Priorities estimated that 10.6 million could lose access to Medicaid in about a decade if individual states are unable to cover the remainder of the costs.

What does this mean for those receiving cancer treatments? Due to the policy changes in enrollment and coverage, certain treatments that require prolonged and multi-cycle therapies may be halted or delayed; this will lead to delayed appointments, abandonment of prior treatment strategy, and reduced survival rates. Additionally, maintaining the 80-hour monthly work requirement is especially difficult for cancer patients experiencing debilitating chemotherapy side effects, surgical recovery, or severe fatigue. For those patients receiving higher out-of-pocket expenses, the financial burden will also increase, possibly forcing those with planned treatment to postpone or even halt their treatment plan. Health insurance is a major factor in the survival rate of cancer patients; costs can be in the thousands of dollars for just one type of treatment, an absurd amount of money for most Americans. Those with health insurance can attend screenings and acquire preventive care, improving the possibility of diagnosing and treating cancer. However, this is not possible if coverage is not straightforward.

Patients planning to enroll in Medicaid are able to obtain medical services even if they are not fully enrolled. This retroactive eligibility period will be reduced from 90 days to 30 days with OBBBA, removing another safety net for patients who need immediate treatment. This would reduce the number of people who can be covered via Medicare. The additional emotional and financial burden on the patients and their families will not only create immediate financial instability, but future ones as well from decreased credit scores and increased debt.

Gwen Nichols, M.D., a chief medical officer at Blood Cancer United, really sums up the overall consensus of the OBBBA and the horrific impact it will have on patients: “Cancer is unpredictable — it doesn’t follow a work schedule… Requiring anyone with cancer to work or jump through bureaucratic hoops to keep their health coverage puts lives at risk…”.

How do we put patients first before insurance claims and qualifications?

Improving access requires action at several points along the path from bench discovery to clinical trial to care.

1. Affordable insurance coverage should be protected legislatively. Enrollment and renewal processes should be easy, infrequent, and understandable; patients should have access to help before an administrative problem interrupts care. Exemptions for serious illness need to be straightforward to establish.
2. Coverage decisions need to be easier to navigate. Clear criteria, timely reviews, and accessible appeals would help patients and clinicians understand what is covered and resolve disagreements well before a patient is left with no option.
3. Support needs to extend way beyond medical bills. Transportation, lodging, childcare, and lost wages can determine whether someone attends treatment or participates in a clinical trial. This isn’t the case for all trials. There are some clinical trials that will reimburse patients for these items, but not all. Patient navigation and practical financial assistance should be part of efforts to improve access.
4. All researchers and sponsors should consider these barriers when designing studies. They should examine whether visit schedules are manageable, whether appropriate parts of care happen closer to home, and whether participation requires resources many patients lack.
5. Healthcare policies should be evaluated through their effects on people who need care. Budgetary outcomes matter, but so do coverage stability, treatment affordability, and the availability of local services.

Cancer research creates new possibilities. Turning those possibilities into better outcomes requires a healthcare system that enables patients to benefit from them. A breakthrough only reaches its purpose when it reaches a patient. Researchers, insurers, pharmaceutical companies, and policymakers share a responsibility to make scientific advances accessible. For researchers, that responsibility means looking beyond discovery and engaging with the coverage decisions, pricing practices, and policies that determine whether a treatment reaches a patient. The question cannot end with whether we can develop a better treatment. We must also ask whether the people who need it the most can receive it.

Patients do not choose cancer, and they should not have to fight for access to treatment while fighting for their lives.

Recognition:

Erin Cullinane is a PhD candidate studying bronchial premalignant lesions to better understand the early stages of lung squamous cell carcinoma development.

Andrew Ramirez is an adjunct professor at The College of New Jersey and Middlesex College. He received his PhD from UCLA developing machine learning models to analyze single-cell gene expression data.

Sari Terrazas is molecular biology PhD candidate studying double-stranded (dsRNA) localization and dynamics in paraspeckles at UCLA.

Special thanks to the following SNAP members who provided feedback on this article: Drew Toomer is a fifth-year PhD candidate in the Department of Pharmacology at UNC Chapel Hill; Andrew Mattson is a physics PhD student developing quantum technologies for dark matter detection, gravitational wave observation, and life science/medical applications. He also serves as President of the Science Policy and Diplomacy Group at Johns Hopkins; Breelyn Karno is a PhD candidate at Vanderbilt University studying the metabolic determinants of breast cancer bone metastasis.

Footnotes:

1. As of 2026, 40 states and Washington, D.C. have expanded Medicaid coverage [10].

References:

1. Greenwood, F. (2019, October 24). The clinical trial process | the four phases explained. ALS Therapy Development Institute. https://www.als.net/news/the-clinical-trial-process-the-four-phases-explained/
2. Disparities in Clinical Research and Cancer Treatment | AACR. (2026, July 1). Cancer Progress Report. https://cancerprogressreport.aacr.org/disparities/cdpr24-contents/cdpr24-disparities-in-clinical-research-and-cancer-treatment/
3. Shaw, D. L., Dhruva, S. S., & Ross, J. S. (2018). Coverage of novel therapeutic agents by Medicare Prescription drug Plans following FDA approval. Journal of Managed Care & Specialty Pharmacy, 24(12), 1230–1238. https://doi.org/10.18553/jmcp.2018.24.12.1230
4. United States Congress. (2010). Patient Protection and Affordable Care Act [Legislation]. In Public Law (Vol. 111). https://www.govinfo.gov/content/pkg/PLAW-111publ148/pdf/PLAW-111publ148.pdf
5. Covered California. (2026). Program eligibility by federal poverty level for 2027 [PDF]. http://coveredca.com/pdfs/FPL-chart.pdf
6. Miller, S., & Wherry, L. R. (2017a). Health and Access to Care during the First 2 Years of the ACA Medicaid Expansions. New England Journal of Medicine, 376(10), 947–956. https://doi.org/10.1056/nejmsa1612890
7. Unger JM, Xiao H, Vaidya R, LeBlanc M, Hershman DL. Medicaid Expansion of the Patient Protection and Affordable Care Act and Participation of Patients With Medicaid in Cancer Clinical Trials. JAMA Oncol. 2023;9(10):1371–1379. doi:10.1001/jamaoncol.2023.2800
8. McBride, G. (2003). More states mandate coverage of clinical trial costs, but does it make a difference? JNCI Journal of the National Cancer Institute, 95(17), 1268–1269. https://doi.org/10.1093/jnci/95.17.1268
9. Roeder, A. (2026, February 4). Health insurance premiums are rising — here’s why | Harvard T.H. Chan School of Public Health. Harvard T.H. Chan School of Public Health. https://hsph.harvard.edu/health-policy-management/news/health-insurance-premiums-are-rising-heres-why/
10. Ortaliza, J., Lo, J., & McGough, M. (2026, June 11). How has insurer participation in the ACA marketplaces changed in 2026? KFF. https://www.kff.org/affordable-care-act/how-has-insurer-participation-in-the-aca-marketplaces-changed-in-2026/