The Cost of Groundbreaking Cancer Treatment

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Colette Bilynsky

New treatment strategies are almost constantly being tested in pre-clinical research and clinical trials, with many of them outlined in various OncoBites articles. This is incredibly important work as groundbreaking treatment strategies like CAR-T therapy have the capacity to radically improve patient outcomes. CAR-T therapy takes the patient’s own T-cells and genetically edits them to be able to specifically target cancer cells.  However, this type of cellular therapy is hugely expensive. A single infusion of CAR-T cells costs between $373,000 to $475,000 [1]. This doesn’t even include the cost of the hospital stay, as the infusion is usually done as an inpatient procedure because the patient will need to be monitored post-treatment. This can add another $80,000 [1].

A cost this large is obviously prohibitive for patients to pay out of pocket. Socioeconomic status is a huge social determinant of health, with poverty associated with a lower chance of survival in cancer patients [2]. So, the very patients who are likely to need a highly effective treatment will often be unable to pay for it. For this reason, it is vitally important that insurance companies cover these treatments. Currently, not all insurance companies cover CAR-T cell therapy, and even ones that do will require a prior authorization for CAR-T cell therapy, which can cause a delay in treatment [3].  A huge breakthrough occurred in 2019, when CMS (Centers for Medicare & Medicaid Services) approved a broad coverage policy for FDA-approved CAR-T cell therapies, as well as coverage for routine costs in clinical trials of CAR T-cell therapy [4].

Even with insurance coverage, CAR-T cell therapy is anticipated to have high out-of-pocket medical expenses. This includes not only high insurance deductibles and co-pays for the infusion and any treatment for side effects, but also travel and lodging to one of the 154 centers that provides CAR-T therapy. 12 states do not have any hospitals approved to administer CAR-T cell therapy [5]. This does not include the potential cost of a caretaker, as side effects from these treatments, as well as the accompanying chemotherapy, can make it challenging for patients to independently travel, clean, or feed themselves. The Mayo Clinic requires that patients bring a caregiver with them if traveling to receive CAR-T cell therapy from them [3]. Even if the patient has a partner or friend who is willing to act as advocate and caregiver, the lost wages required from taking the time off can make it prohibitive.

However, even if insurance covers CAR-T therapy for patients, the amount that is reimbursed to medical centers remains low. The American Society of Hematology, a professional society of clinicians and researchers focused on blood diseases (which includes the types of cancer that CAR-T treats), reported that the low reimbursement percentage for CAR-T therapy has made medical centers reluctant to even run a program to administer the cellular therapy. While the 2019 CMS decision increased the amount of coverage and reimbursement for CAR-T cell therapy, the reimbursement that hospitals received for the treatment only went from 50% to 65% [6]. This combination of broad coverage with poor reimbursement for hospitals means that institutions are required to cover the therapy while not receiving enough to cover the costs associated with CAR-T cell therapy. This is partially because of the huge base cost of CAR-T therapy.

The United States pays more than any other country for prescription drugs, for a variety of reasons: bringing a drug to market in the US is increasingly expensive, the supply chains for pharmaceutics is inefficient and purposefully lacks transparency, buyers cannot negotiate prices (unlike in some other countries), and the US has  prolonged  protection of their patents [5]. There are a few ways that the cost of CAR-T cell therapy could be reduced. Firstly, the Medicare billing codes for biologics (a therapeutic classification which cellular therapies are a part of) are unique for each biologic drug. The American Society of Hematology, as well as some independent physicians, have proposed that all CAR-T cell therapies have the same billing code, which could help promote competitive pricing [5]–[7]. Reducing the manufacturing cost of cellular therapies is hypothetically possible, however given the huge difference between the cost to make the therapies and the amount that the pharmaceutical company charges for it, it is unlikely that this would result in a price decrease for hospitals or patients [5]. One way of circumventing the pharmaceutical companies would be to make the therapies “in-house.” Academic or research centers could manufacture the CAR-T cells under good manufacturing compliant platforms. This has already been attempted in Australia, where a study showed that manufacturing CAR-T cell therapy “in-house” decreased manufacturing time and cost of a single infusion to $6,000 (not including the hospital stay)  with the same patient outcomes [5] [8]. While this is obviously still expensive, each CAR-T treatment has to be made per patient, using Good Manufacturing Process reagents and protocols, and testing that the cells were made correctly requires the use of expensive equipment, like flow cytometers, which can range from $100,000 to $500,000. 

The potential of cellular therapies is huge, with new approaches being developed all the time. As a researcher focused on tumor-associated macrophages, I have been watching the trials for CAR-Macrophages, but other biologic cancer treatments like STING-activated natural killer cells and immune agonist antibodies have potential to improve patient outcomes. However, it is vital that we determine how these therapies will be paid for before they can be generally implemented. Regulations on pharmaceutical companies to limit the cost of prescription medications, a less protective patent process, and changes to the CMS coverage policy have the potential to increase access to these types of treatments, and, in my opinion, should be pursued by legislators.

Edited by Emily Chan

Works Cited:

[1]       G. Choi, G. Shin, and S. Bae, “Price and Prejudice? The Value of Chimeric Antigen Receptor (CAR) T-Cell Therapy,” Int. J. Environ. Res. Public. Health, vol. 19, no. 19, p. 12366, Sep. 2022, doi: 10.3390/ijerph191912366.

[2]       S. S. Coughlin, “Social Determinants of Health and Cancer Survivorship,” J. Environ. Health Sci., vol. 7, no. 1, pp. 11–15, 2021.

[3]       Mayo Foundation for Medical Education and Research, “CAR-T Cell Therapy Program – Frequently asked questions,” Mayo Clinic, Feb. 19, 2022. https://www.mayoclinic.org/departments-centers/car-t-cell-therapy-program/sections/gnc-20405547 (accessed Jun. 01, 2023).

[4]       T. Jensen, J. Chin, L. Ashby, R. Hakim, L. Paserchia, and S. Katherine, “Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers,” National Coverage Anaysis, Decision Memo CAG-00451N, Aug. 2019. Accessed: Jun. 01, 2023. [Online]. Available: https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=291

[5]       S. Fiorenza, D. S. Ritchie, S. D. Ramsey, C. J. Turtle, and J. A. Roth, “Value and affordability of CAR T-cell therapy in the United States,” Bone Marrow Transplant., vol. 55, no. 9, Art. no. 9, Sep. 2020, doi: 10.1038/s41409-020-0956-8.

[6]       American Society of Hematology, “CAR T-cell Therapy: An Update on Coverage and Reimbursement,” 2019. https://www.hematology.org:443/advocacy/policy-news-statements-testimony-and-correspondence/policy-news/2019/car-t-cell-therapy-an-update-on-coverage-and-reimbursement (accessed Jun. 01, 2023).

[7]       P. B. Bach, “National Coverage Analysis of CAR-T Therapies — Policy, Evidence, and Payment,” N. Engl. J. Med., vol. 379, no. 15, pp. 1396–1398, Oct. 2018, doi: 10.1056/NEJMp1807382.

[8]       S. Ramanayake et al., “Low-cost generation of Good Manufacturing Practice-grade CD19-specific chimeric antigen receptor-expressing T cells using piggyBac gene transfer and patient-derived materials,” Cytotherapy, vol. 17, no. 9, pp. 1251–1267, Sep. 2015, doi: 10.1016/j.jcyt.2015.05.013.